Poster Abstracts - Clinical Sciences // Présentation d’affiche - Sciences cliniques
Tracks
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Tuesday, April 29, 2025 |
8:30 - 15:30 |
Exhibit and Poster Hall (Ballroom B1) |
Overview
Friday & Saturday // Vendredi et Samedi
Speaker
Zainab Ahmed
University of Montreal
Exploring Canadian Youth Perceptions of HIV Cure and the Use Injectable Therapies
Abstract
Background: For youth living with HIV (YHIV), the need for life-long daily antiretroviral therapy (ART) can be a significant psychological burden. The objective of this study was to understand the perspectives of Canadian YHIV on the prospects of cure, and the role of injectable therapies as means to cure.
Methods: Mixed methods sub-study of the national “Early Pediatric Initiation of Combination Antiretroviral Therapy Canada Child Cure Cohort (EPIC4) (2014-2019).” At the two largest recruitment sites, participants were asked at last visit to complete a semi-structured questionnaire about their study experience and understanding of HIV cure; for children below age 14, this was done by a guardian. Responses pertaining to the theme of cure are presented here.
Results: 42 participants completed the questionnaire (27 youth/15 guardians.) Ages of youth ranged 6-22 years, and median age at ART inhiation was 2.7 years (IQR 0.21-5 years). While 91% were virally suppressed at entry into cohort, 12% interrupted ART during the study. Overall, 61% of participants believed a cure would be found in their lifetime. Among those who believed in the possibility, common themes included “only for some because of cost”, “only if I take my medications well” and “if God wills it”. When asked to define HIV cure, the majority of (71%) of participants responded having a negative HIV test and undetectable VL, while never again needing medication for HIV. When asked if they would consider an injectable treatment given every 3 months a “cure” for HIV, 13% responded yes, 63% no, and 24% replied no but with great enthusiasm for taking such a treatment.
Conclusions: The definition of HIV cure and its applicability for YHIV should be considered in the cure research agenda. Regular injectable treatments, while not considered cure, were considered favorably in over a third of participants.
Methods: Mixed methods sub-study of the national “Early Pediatric Initiation of Combination Antiretroviral Therapy Canada Child Cure Cohort (EPIC4) (2014-2019).” At the two largest recruitment sites, participants were asked at last visit to complete a semi-structured questionnaire about their study experience and understanding of HIV cure; for children below age 14, this was done by a guardian. Responses pertaining to the theme of cure are presented here.
Results: 42 participants completed the questionnaire (27 youth/15 guardians.) Ages of youth ranged 6-22 years, and median age at ART inhiation was 2.7 years (IQR 0.21-5 years). While 91% were virally suppressed at entry into cohort, 12% interrupted ART during the study. Overall, 61% of participants believed a cure would be found in their lifetime. Among those who believed in the possibility, common themes included “only for some because of cost”, “only if I take my medications well” and “if God wills it”. When asked to define HIV cure, the majority of (71%) of participants responded having a negative HIV test and undetectable VL, while never again needing medication for HIV. When asked if they would consider an injectable treatment given every 3 months a “cure” for HIV, 13% responded yes, 63% no, and 24% replied no but with great enthusiasm for taking such a treatment.
Conclusions: The definition of HIV cure and its applicability for YHIV should be considered in the cure research agenda. Regular injectable treatments, while not considered cure, were considered favorably in over a third of participants.
Anwar Alabdulraheem
McGill
Changes in Drug Use Behaviors Before and During Imprisonment in Quebec provincial prisons
Abstract
Introduction:
People in prison are a key population for hepatitis C virus (HCV) and HIV elimination efforts. While injection drug use (IDU) is the primary risk factor for HIV/HCV acquisition in prisons, non-injection drug use (nIDU), through sniffing/snorting, also poses a risk due to limited access to prison-based harm reduction services. We aimed to assess changes in drug use behaviors and associated risk factors before and during imprisonment among adult men incarcerated at l’Établissement de Détention de Montréal, Quebec’s largest provincial prison.
Method:
Participants serving sentences of 2-12 weeks were recruited using convenience sampling. Participants underwent point-of-care HCV-antibody testing and completed a baseline questionnaire assessing drug use patterns both pre-incarceration and in-prison, including IDU and nIDU practices. The McNemar test was used to compare pre-prison and in-prison risk behaviors. Logistic regression analysis examined associations between age, race/ethnicity, prior drug use, mental health diagnosis, or participation in opioid substitution program and the likelihood of continued drug use during imprisonment
Results:
Between March 1, 2022, and February 16, 2024, 538 participants were recruited, 427 (79%) of whom reported a history of drug use. Pre-incarceration IDU or sniffing/snorting was reported by 350(65%) participants. A total of 117 individuals (22%) reported IDU or sniffing/snorting both before and during incarceration, among whom 33 (6%) ceased drug use after incarceration, and 77(14%) continued. One participant initiated drug use during incarceration. The McNemar test showed a significant decline in drug use post-incarceration (67%) compared to pre-incarceration(94%).The logistic regression analysis showed no significant association between continued drug use in prison and its covariates (p>0.05)
Conclusion:
While IDU and nIDU decreased following incarceration, a significant proportion of people in prison continue to engage in high-risk behaviours, underscoring the importance of scaling up harm reduction services, including opioid agonist therapies and prison-based needle and syringe programs, in Canadian provincial prisons.
People in prison are a key population for hepatitis C virus (HCV) and HIV elimination efforts. While injection drug use (IDU) is the primary risk factor for HIV/HCV acquisition in prisons, non-injection drug use (nIDU), through sniffing/snorting, also poses a risk due to limited access to prison-based harm reduction services. We aimed to assess changes in drug use behaviors and associated risk factors before and during imprisonment among adult men incarcerated at l’Établissement de Détention de Montréal, Quebec’s largest provincial prison.
Method:
Participants serving sentences of 2-12 weeks were recruited using convenience sampling. Participants underwent point-of-care HCV-antibody testing and completed a baseline questionnaire assessing drug use patterns both pre-incarceration and in-prison, including IDU and nIDU practices. The McNemar test was used to compare pre-prison and in-prison risk behaviors. Logistic regression analysis examined associations between age, race/ethnicity, prior drug use, mental health diagnosis, or participation in opioid substitution program and the likelihood of continued drug use during imprisonment
Results:
Between March 1, 2022, and February 16, 2024, 538 participants were recruited, 427 (79%) of whom reported a history of drug use. Pre-incarceration IDU or sniffing/snorting was reported by 350(65%) participants. A total of 117 individuals (22%) reported IDU or sniffing/snorting both before and during incarceration, among whom 33 (6%) ceased drug use after incarceration, and 77(14%) continued. One participant initiated drug use during incarceration. The McNemar test showed a significant decline in drug use post-incarceration (67%) compared to pre-incarceration(94%).The logistic regression analysis showed no significant association between continued drug use in prison and its covariates (p>0.05)
Conclusion:
While IDU and nIDU decreased following incarceration, a significant proportion of people in prison continue to engage in high-risk behaviours, underscoring the importance of scaling up harm reduction services, including opioid agonist therapies and prison-based needle and syringe programs, in Canadian provincial prisons.
Aurora Almonte
Clinical Research Project Assistant
The Hospital For Sick Children
Uninfected but still at risk – Working Memory and Academic Achievement in Children who are HIV-Exposed Uninfected
Abstract
Objective:
To evaluate associations between working memory, academic performance and household income in school-aged children HIV and antiretroviral-exposed, uninfected (CHEU) compared to children HIV-unexposed uninfected (CHUU).
Methods:
Children were assessed through the Kids Imaging and Neurocognitive Development study at the Hospital for Sick Children and Children’s Hospital of Eastern Ontario. Working memory and Full Scale IQ (FSIQ) were measured using the Wechsler Intelligence Scale for Children. Academic performance, measured by math, spelling, and word reading, were assessed with the Wechsler Individual Achievement Test. Socioeconomic status, measured by household income, was considered. Linear regression models were used to assess group differences and associations between sex, age, cognitive measures, and income.
Results:
Sixty-three CHEU (mean age 8.79 years) and 42 CHUU (mean age 8.88 years) were included. 17.5% of CHEU and 4.7% of CHUU were provided diagnoses of neurodevelopmental disorders, primarily learning disabilities. CHEU had significantly lower working memory scores than CHUU (p = 0.043) yet academic scores did not differ. Older CHEU had poorer math scores than younger CHEU (p<0.01). Male CHEU performed worse in word reading and spelling than male CHUU (p=0.038 and p=0.015, respectively). In both groups, working memory and FSIQ were strongly correlated to academic performance (p<0.01). Higher income was associated with higher math scores in both groups (p=0.025), while income was associated with literacy skills only in CHUU (p<0.01).
Conclusion:
CHEU demonstrated lower working memory scores, suggestive of neurodevelopmental differences associated with HIV and/or antiretroviral therapy exposure. Though academic performance was similar between groups, CHEU were more likely to perform more poorly in math at older ages and meet criteria for learning disabilities. Male CHEU also performed more poorly in literacy skills, demonstrating a sex-related vulnerability. In CHEU and those with lower incomes, academic development may benefit from working memory interventions and academic enrichment in early childhood.
To evaluate associations between working memory, academic performance and household income in school-aged children HIV and antiretroviral-exposed, uninfected (CHEU) compared to children HIV-unexposed uninfected (CHUU).
Methods:
Children were assessed through the Kids Imaging and Neurocognitive Development study at the Hospital for Sick Children and Children’s Hospital of Eastern Ontario. Working memory and Full Scale IQ (FSIQ) were measured using the Wechsler Intelligence Scale for Children. Academic performance, measured by math, spelling, and word reading, were assessed with the Wechsler Individual Achievement Test. Socioeconomic status, measured by household income, was considered. Linear regression models were used to assess group differences and associations between sex, age, cognitive measures, and income.
Results:
Sixty-three CHEU (mean age 8.79 years) and 42 CHUU (mean age 8.88 years) were included. 17.5% of CHEU and 4.7% of CHUU were provided diagnoses of neurodevelopmental disorders, primarily learning disabilities. CHEU had significantly lower working memory scores than CHUU (p = 0.043) yet academic scores did not differ. Older CHEU had poorer math scores than younger CHEU (p<0.01). Male CHEU performed worse in word reading and spelling than male CHUU (p=0.038 and p=0.015, respectively). In both groups, working memory and FSIQ were strongly correlated to academic performance (p<0.01). Higher income was associated with higher math scores in both groups (p=0.025), while income was associated with literacy skills only in CHUU (p<0.01).
Conclusion:
CHEU demonstrated lower working memory scores, suggestive of neurodevelopmental differences associated with HIV and/or antiretroviral therapy exposure. Though academic performance was similar between groups, CHEU were more likely to perform more poorly in math at older ages and meet criteria for learning disabilities. Male CHEU also performed more poorly in literacy skills, demonstrating a sex-related vulnerability. In CHEU and those with lower incomes, academic development may benefit from working memory interventions and academic enrichment in early childhood.
Tsegaye Bekele
Senior Lead, Research And Analytics
The Ontario HIV Treatment Network
Uptake of Three COVID-19 Vaccine Doses among people living with HIV who completed a 2-dose primary series: Findings from the Ontario HIV Treatment Network (OHTN) Cohort Study
Abstract
Background: Since September 2021, people living with HIV who are moderately to severely immunocompromised have been recommended to receive a third dose of COVID-19 vaccine, with biannual booster doses recommended since fall 2022. We examined the uptake of ≥3 doses of COVID-19 vaccine among people living with HIV who completed a 2-dose primary series in Ontario.
Methods: We analyzed data from the OHTN Cohort Study, a longitudinal cohort of people receiving HIV care in Ontario. Self-reported COVID-19 vaccination was assessed through annual questionnaires (2021-2023). Clinical data were obtained from medical charts and linkage with Public Health Ontario Laboratories database. We used a modified Poisson regression to calculate prevalence ratios and 95% confidence intervals for receipt of ≥3 doses compared with 2 doses.
Results: A total of 2,443 out of 2,746 (89.0%) participants had received a 2-dose primary series (median age: 55 years; 80% men; 61% White; 62% born in Canada). Of the 2,443 2-dose recipients, 1,904 (77.9%) had received ≥3 doses. In unadjusted analysis, uptake of ≥3 doses increased linearly with age from 46.6% among participants aged <30 years to >85% among participants aged ≥60 years. In multivariable analyses, older age, higher education, diabetes, and being a former smoker were associated with higher uptake; whereas uptake was lower among women, heterosexual men and participants who identified as Black, received care in Eastern or Southwestern Ontario, or used recreational drugs, excluding cannabis and alcohol. Clinical HIV covariates were not significantly associated with uptake.
Discussion: Certain HIV priority populations, such as women and people who identify as Black or use recreational drugs, may experience greater barriers to receiving additional doses of COVID-19 vaccines. Given the ongoing burden of COVID-19 in Ontario and circulation of new variants, a targeted approach may help to improve uptake of updated COVID-19 vaccines in these groups.
Methods: We analyzed data from the OHTN Cohort Study, a longitudinal cohort of people receiving HIV care in Ontario. Self-reported COVID-19 vaccination was assessed through annual questionnaires (2021-2023). Clinical data were obtained from medical charts and linkage with Public Health Ontario Laboratories database. We used a modified Poisson regression to calculate prevalence ratios and 95% confidence intervals for receipt of ≥3 doses compared with 2 doses.
Results: A total of 2,443 out of 2,746 (89.0%) participants had received a 2-dose primary series (median age: 55 years; 80% men; 61% White; 62% born in Canada). Of the 2,443 2-dose recipients, 1,904 (77.9%) had received ≥3 doses. In unadjusted analysis, uptake of ≥3 doses increased linearly with age from 46.6% among participants aged <30 years to >85% among participants aged ≥60 years. In multivariable analyses, older age, higher education, diabetes, and being a former smoker were associated with higher uptake; whereas uptake was lower among women, heterosexual men and participants who identified as Black, received care in Eastern or Southwestern Ontario, or used recreational drugs, excluding cannabis and alcohol. Clinical HIV covariates were not significantly associated with uptake.
Discussion: Certain HIV priority populations, such as women and people who identify as Black or use recreational drugs, may experience greater barriers to receiving additional doses of COVID-19 vaccines. Given the ongoing burden of COVID-19 in Ontario and circulation of new variants, a targeted approach may help to improve uptake of updated COVID-19 vaccines in these groups.
Cecilia Costiniuk
Associate Professor
Research Institute Of The McGill University Health Centre
Durability of COVID-19 vaccine immunogenicity in people living with HIV (CIHR Canadian HIV Trials Network 328)
Abstract
Background: In a Canadian multi-centre prospective, observational cohort of PWH receiving ≥2 COVID-19 vaccinations, we examined longitudinal kinetics of COVID-19 vaccine-induced antibodies to assess durability of immunogenicity.
Methods: Data for the current analysis were collected between August 2021-April 2022. Levels of IgG targeting SARS-CoV-2 Spike (S), receptor-binding domain (RBD) and nucleocapsid (N) proteins were measured using an automated high-throughput chemiluminescent ELISA. Vaccine-induced immunity was distinguished by co-positivity with S and RBD proteins, and infection-induced immunity by co-positivity with the S and N protein (signal-to-cutoff ratio ≥ 1.0). For longitudinal evaluation, IgG S and RBD levels were examined 1 month post 1st dose, 3 months post 2nd dose, 1 and 6 months post 3rd dose, and 1 month post 4th dose. The analysis included participants who remained naïve to natural COVID-19 infection and had data available at all 5 sampling time points.
Results: Eighteen participants (all male) were included in the analysis. At study enrolment median (IQR) age was 65 (45, 69) years, CD4 count was 690 (510, 905) cells/mm3, and 16 (89%) had suppressed viral loads on antiretroviral therapy. Median levels of both IgG S and RBD remained detectable at all time points, peaking 1 month post 3rd dose (median (IQR): 3.90 (3.63, 4.45) log10BAU/mL and 4.03 (3.77, 4.33) log10BAU/mL, respectively), declining by 6 months post 3rd dose (to 3.36 (3.04, 3.50) log10BAU/mL and 3.42 (3.05, 3.52), respectively), and then rising again 1 month post 4th dose (to 4.03 (3.76, 4.45) log10BAU/mL and 4.00 (3.76, 4.28) log10BAU/mL respectively).
Conclusion: Following COVID-19 vaccination, PWH displayed peak IgG S and RBD antibodies 1 month after their 3rd vaccine dose. Levels declined 6 months after the 3rd dose but then rose again 1 month after the 4th dose. Findings confirm the importance of timely COVID-19 vaccine booster dosing for PWH.
Methods: Data for the current analysis were collected between August 2021-April 2022. Levels of IgG targeting SARS-CoV-2 Spike (S), receptor-binding domain (RBD) and nucleocapsid (N) proteins were measured using an automated high-throughput chemiluminescent ELISA. Vaccine-induced immunity was distinguished by co-positivity with S and RBD proteins, and infection-induced immunity by co-positivity with the S and N protein (signal-to-cutoff ratio ≥ 1.0). For longitudinal evaluation, IgG S and RBD levels were examined 1 month post 1st dose, 3 months post 2nd dose, 1 and 6 months post 3rd dose, and 1 month post 4th dose. The analysis included participants who remained naïve to natural COVID-19 infection and had data available at all 5 sampling time points.
Results: Eighteen participants (all male) were included in the analysis. At study enrolment median (IQR) age was 65 (45, 69) years, CD4 count was 690 (510, 905) cells/mm3, and 16 (89%) had suppressed viral loads on antiretroviral therapy. Median levels of both IgG S and RBD remained detectable at all time points, peaking 1 month post 3rd dose (median (IQR): 3.90 (3.63, 4.45) log10BAU/mL and 4.03 (3.77, 4.33) log10BAU/mL, respectively), declining by 6 months post 3rd dose (to 3.36 (3.04, 3.50) log10BAU/mL and 3.42 (3.05, 3.52), respectively), and then rising again 1 month post 4th dose (to 4.03 (3.76, 4.45) log10BAU/mL and 4.00 (3.76, 4.28) log10BAU/mL respectively).
Conclusion: Following COVID-19 vaccination, PWH displayed peak IgG S and RBD antibodies 1 month after their 3rd vaccine dose. Levels declined 6 months after the 3rd dose but then rose again 1 month after the 4th dose. Findings confirm the importance of timely COVID-19 vaccine booster dosing for PWH.
Tyrone J Curtis
Postdoctoral Fellow
University Of Victoria
“We have the tools”: Health System Stakeholders’ Perspectives on Implementation of Injectable Cabotegravir as HIV-PrEP among Two-Spirit, Gay, Bisexual, Queer, and other Men who have Sex with Men in Canada
Abstract
Background: Long-acting injectable cabotegravir (CAB-LA) was recently approved as HIV pre-exposure prophylaxis (PrEP) in Canada. To maximize the benefit of CAB-LA PrEP within key populations, including Two-Spirit, gay, bisexual, queer, and other men who have sex with men (2SGBQM), we must understand existing challenges with oral PrEP, adapt PrEP delivery to reduce structural inequities, and proactively address anticipated challenges of CAB-LA PrEP implementation.
Methods: Nine focus groups and ten semi-structured interviews with health system stakeholders (N=37) involved in PrEP provision across Canada were conducted to explore readiness to implement CAB-LA PrEP, resources required for delivery, and potential approaches to maximize access for 2SGBQM. Data were analyzed using reflexive thematic analysis.
Results: Participants emphasized that CAB-LA PrEP could address PrEP inequities for some 2SGBQM who face challenges with oral PrEP access and adherence, including people who travel frequently, experience homelessness, or have limited privacy. Implementation of CAB-LA PrEP in rural communities via pharmacies and among people experiencing homelessness via mobile delivery were highlighted as novel approaches to challenge inequities. Some participants had experience administering long-acting HIV treatment and reported readiness to implement CAB-LA PrEP, while others raised logistical barriers to implementation, including staffing and space requirements for administration and follow-up, discrepancies between STBBI testing and CAB-LA PrEP dosing frequencies, and providers’ inexperience administering gluteal injections. Participants highlighted structural barriers to implementation, including drug cost and provider reimbursement challenges, scope of practice limitations which restrict who can administer injections, and resistance from government stakeholders to adapt and expand PrEP delivery.
Conclusion: CAB-LA PrEP implementation requires learning from existing oral PrEP inequities while adapting PrEP delivery models to meet community needs and address feasibility constraints. Clear guidelines and decision-making tools, innovative approaches to delivery, and additional space and staffing resources are essential for ensuring CAB-LA PrEP works for providers and patients.
Methods: Nine focus groups and ten semi-structured interviews with health system stakeholders (N=37) involved in PrEP provision across Canada were conducted to explore readiness to implement CAB-LA PrEP, resources required for delivery, and potential approaches to maximize access for 2SGBQM. Data were analyzed using reflexive thematic analysis.
Results: Participants emphasized that CAB-LA PrEP could address PrEP inequities for some 2SGBQM who face challenges with oral PrEP access and adherence, including people who travel frequently, experience homelessness, or have limited privacy. Implementation of CAB-LA PrEP in rural communities via pharmacies and among people experiencing homelessness via mobile delivery were highlighted as novel approaches to challenge inequities. Some participants had experience administering long-acting HIV treatment and reported readiness to implement CAB-LA PrEP, while others raised logistical barriers to implementation, including staffing and space requirements for administration and follow-up, discrepancies between STBBI testing and CAB-LA PrEP dosing frequencies, and providers’ inexperience administering gluteal injections. Participants highlighted structural barriers to implementation, including drug cost and provider reimbursement challenges, scope of practice limitations which restrict who can administer injections, and resistance from government stakeholders to adapt and expand PrEP delivery.
Conclusion: CAB-LA PrEP implementation requires learning from existing oral PrEP inequities while adapting PrEP delivery models to meet community needs and address feasibility constraints. Clear guidelines and decision-making tools, innovative approaches to delivery, and additional space and staffing resources are essential for ensuring CAB-LA PrEP works for providers and patients.
Joss de Wet
Md
Spectrum Health
Real-world effectiveness in treatment-experienced (TE) people with HIV (PWH) switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) with distinct patterns of self-reported adherence
Abstract
Introduction: Adherence to antiretroviral therapy (ART) is important for maintaining virologic suppression in PWH. BICSTaR, a multi-country, observational study, evaluated the effectiveness, safety, and patient-reported outcomes of B/F/TAF in treatment-naïve and TE PWH. This analysis examines self-reported adherence through 24 months (24M) in TE participants switching to B/F/TAF.
Methods: Self-reported adherence at baseline, 6M, 12M, and 24M was measured using visual analogue scale (VAS) questionnaires (% ART doses taken in last 30 days) and number of missed doses in the last 4 and 30 days. Group-based trajectory modelling identified adherence patterns, and logistic regression assessed associations between baseline characteristics and adherence trajectories. Effectiveness (HIV-1 RNA <50 copies/mL) at 24M was analyzed by adherence trajectory.
Results: The analysis included 1496 TE participants. At baseline and 24M, median (IQR) VAS adherence scores were 100% (97-100%) and median (IQR) doses missed over the last 4 and 30 days were 0 (0-0) and 0 (0-1), respectively. The model identified five adherence groups (Figure). Most participants had stable ‘near-perfect’ to moderately high adherence (Groups 1-3). In two smaller groups, adherence was initially high but then declined (Group 4) or was initially low but increased over time (Group 5). All groups showed high effectiveness with B/F/TAF at 24M (96% overall [missing=excluded]. Specific baseline characteristics (i.e., age, race, CD4 count, virologic suppression at baseline) were found to be associated with particular adherence groups (Table).
Conclusions: High effectiveness (>90%) and no treatment-emergent resistance were observed following switch to B/F/TAF, regardless of adherence trajectory at 24M.
Methods: Self-reported adherence at baseline, 6M, 12M, and 24M was measured using visual analogue scale (VAS) questionnaires (% ART doses taken in last 30 days) and number of missed doses in the last 4 and 30 days. Group-based trajectory modelling identified adherence patterns, and logistic regression assessed associations between baseline characteristics and adherence trajectories. Effectiveness (HIV-1 RNA <50 copies/mL) at 24M was analyzed by adherence trajectory.
Results: The analysis included 1496 TE participants. At baseline and 24M, median (IQR) VAS adherence scores were 100% (97-100%) and median (IQR) doses missed over the last 4 and 30 days were 0 (0-0) and 0 (0-1), respectively. The model identified five adherence groups (Figure). Most participants had stable ‘near-perfect’ to moderately high adherence (Groups 1-3). In two smaller groups, adherence was initially high but then declined (Group 4) or was initially low but increased over time (Group 5). All groups showed high effectiveness with B/F/TAF at 24M (96% overall [missing=excluded]. Specific baseline characteristics (i.e., age, race, CD4 count, virologic suppression at baseline) were found to be associated with particular adherence groups (Table).
Conclusions: High effectiveness (>90%) and no treatment-emergent resistance were observed following switch to B/F/TAF, regardless of adherence trajectory at 24M.
Ravnit Dhinsa
Research Assistant
BC Centre for Excellence in HIV/AIDS
Acute complications during hospitalized nonfatal overdose are more likely among people with HIV than those without HIV, in British Columbia
Abstract
Background:
People with HIV (PWH) have high rates of nonfatal overdoses (NFODs). NFODs are associated with severe acute complications, which can have long-term health consequences. We compared occurrence of acute complications and hospital length of stay (LOS) during hospitalized NFOD among PWH and people without HIV (PWoH) in British Columbia (BC), examining differences by HIV-status and sex.
Methods:
Using linked administrative data of all known PWH and a 10% random sample of PWoH in BC between 2012 and 2020, we identified first (index) hospitalized NFODs in the Discharge Abstract Database (DAD). Respiratory, brain injury, cardiovascular, renal, and neurological acute complications were identified using diagnostic codes, and intensive care unit (ICU) admission and hospital LOS using flags in the DAD. Proportions of acute complications were compared using Chi-squared tests and LOS (in days) using Kruskal-Wallis tests.
Results:
We identified 206 index hospitalized NFODs (85 females) among 11,274 PWH and 1,190 (620 females) among 473,958 PWoH. Overall, 65.5% of PWH and 58.0% of PWoH experienced acute complications (p=0.0418). ICU admission was the most common complication (54.4% of PWH, 50.3% of PWoH), followed by intubation (17.0% of PWH, 13.4% of PWoH). Males without HIV were more likely to experience acute complications (63.2%) than females (53.2%) (p=0.0005), whereas this did not differ significantly between males and females with HIV. Median hospital LOS did not differ significantly by HIV status (4 days for both PWH [Q1,Q3: 2,11] and PWoH [Q1,Q3: 2,9]).
Conclusions:
In this population-based cohort study, PWH were more likely to experience acute complications during their index hospitalized NFOD than PWoH. While complications were more common among males than females without HIV, no sex differences were observed in PWH. Planned multivariable analyses will adjust for potential confounders in the association between HIV-status and occurrence of acute complications and hospital LOS during a hospitalized NFOD.
People with HIV (PWH) have high rates of nonfatal overdoses (NFODs). NFODs are associated with severe acute complications, which can have long-term health consequences. We compared occurrence of acute complications and hospital length of stay (LOS) during hospitalized NFOD among PWH and people without HIV (PWoH) in British Columbia (BC), examining differences by HIV-status and sex.
Methods:
Using linked administrative data of all known PWH and a 10% random sample of PWoH in BC between 2012 and 2020, we identified first (index) hospitalized NFODs in the Discharge Abstract Database (DAD). Respiratory, brain injury, cardiovascular, renal, and neurological acute complications were identified using diagnostic codes, and intensive care unit (ICU) admission and hospital LOS using flags in the DAD. Proportions of acute complications were compared using Chi-squared tests and LOS (in days) using Kruskal-Wallis tests.
Results:
We identified 206 index hospitalized NFODs (85 females) among 11,274 PWH and 1,190 (620 females) among 473,958 PWoH. Overall, 65.5% of PWH and 58.0% of PWoH experienced acute complications (p=0.0418). ICU admission was the most common complication (54.4% of PWH, 50.3% of PWoH), followed by intubation (17.0% of PWH, 13.4% of PWoH). Males without HIV were more likely to experience acute complications (63.2%) than females (53.2%) (p=0.0005), whereas this did not differ significantly between males and females with HIV. Median hospital LOS did not differ significantly by HIV status (4 days for both PWH [Q1,Q3: 2,11] and PWoH [Q1,Q3: 2,9]).
Conclusions:
In this population-based cohort study, PWH were more likely to experience acute complications during their index hospitalized NFOD than PWoH. While complications were more common among males than females without HIV, no sex differences were observed in PWH. Planned multivariable analyses will adjust for potential confounders in the association between HIV-status and occurrence of acute complications and hospital LOS during a hospitalized NFOD.
Miriam Dushoff
University Of Toronto
GDF-15 as a Biomarker for Unhealthy Aging and Cognitive Decline in Older Adults Living with HIV
Abstract
Background: GDF-15 is one of the most upregulated proteins during aging. In the general population, elevated GDF-15 levels have been associated with many cognitive and neurodegenerative disorders. GDF-15 levels are shown to be elevated in people living with HIV, however the relationship between GDF-15 and cognitive function in people living with HIV, especially older adults, is very poorly studied.
Methods: Data from 64 participants in the Correlates of Healthy Aging in Geriatric HIV (CHANGE HIV) study were analyzed to examine associations between GDF-15, cognitive function—assessed by the Mini-Mental State Examination (MMSE)—and the Rotterdam Healthy Aging Score (HAS). Serum GDF-15 levels were measured by ELISA provided by participants at their baseline visit. The HAS and MMSE scores were obtained using standardized questionnaires completed at the same visit. Relationships between GDF-15 and healthy aging metrics were analyzed using linear regression and Spearman tests.
Results: Participants included 63 males and 1 female, with a mean age of 74 (IQR 71-76). At entry into the cohort, the participants had been living with HIV for an average of 31 years, with a mean CD4 count of 497 cells/mm3, and a mean GDF-15 level of 2470 pg/ml (range:991-7135). Median HAS was 12 (range:3-14) and median MMSE was 29 (range:17-30), where low scores indicate less healthy aging and poor cognitive function, respectively. Elevated GDF-15 levels were correlated with lower HAS (p<0.001) and MMSE scores (p=0.011), indicating poorer aging and cognitive function.
Discussion: These results suggest GDF-15 as a potential biomarker for unhealthy aging in older adults living with HIV. While the correlation between GDF-15 and MMSE was statistically significant, its clinical relevance is unclear due to generally high MMSE scores in this cohort. Further investigation is needed to elucidate the relationship between GDF-15 and cognitive function in this population.
Methods: Data from 64 participants in the Correlates of Healthy Aging in Geriatric HIV (CHANGE HIV) study were analyzed to examine associations between GDF-15, cognitive function—assessed by the Mini-Mental State Examination (MMSE)—and the Rotterdam Healthy Aging Score (HAS). Serum GDF-15 levels were measured by ELISA provided by participants at their baseline visit. The HAS and MMSE scores were obtained using standardized questionnaires completed at the same visit. Relationships between GDF-15 and healthy aging metrics were analyzed using linear regression and Spearman tests.
Results: Participants included 63 males and 1 female, with a mean age of 74 (IQR 71-76). At entry into the cohort, the participants had been living with HIV for an average of 31 years, with a mean CD4 count of 497 cells/mm3, and a mean GDF-15 level of 2470 pg/ml (range:991-7135). Median HAS was 12 (range:3-14) and median MMSE was 29 (range:17-30), where low scores indicate less healthy aging and poor cognitive function, respectively. Elevated GDF-15 levels were correlated with lower HAS (p<0.001) and MMSE scores (p=0.011), indicating poorer aging and cognitive function.
Discussion: These results suggest GDF-15 as a potential biomarker for unhealthy aging in older adults living with HIV. While the correlation between GDF-15 and MMSE was statistically significant, its clinical relevance is unclear due to generally high MMSE scores in this cohort. Further investigation is needed to elucidate the relationship between GDF-15 and cognitive function in this population.
Miriam Dushoff
University Of Toronto
Exploring the Correlation of Pro-inflammatory Markers with Healthy Aging in Older Adults with HIV
Abstract
Background: The median age of Canadians living with HIV is expected to exceed 65 years within the next decade. Elevated inflammatory cytokine levels observed in people living with HIV have been linked to comorbidities, frailty, cognitive decline, and mortality, yet their relationship with healthy aging in older adults living with HIV remains understudied. Identification of inflammatory markers of poor health could provide outcomes for interventional studies to improve healthy aging in older adults living with HIV.
Methods: We analyzed data from 91 participants in the Correlates of Healthy Aging in Geriatric HIV (CHANGE HIV) study to examine relationships between the Rotterdam Healthy Aging Score (HAS) and inflammatory markers C-reactive protein (CRP), interleukin-6 (IL-6), and D-dimer. HAS and serum levels of the inflammatory markers (pg/ml, using ELISA) were measured at cohort entry. Associations were assessed using linear regression, Spearman’s correlation, and Wilcoxon tests.
Results: The participants included 83 males and 8 females, with a mean age of 75 (IQR 72-77). At entry into the cohort, the participants had a mean CD4 count of 567 cells/mm³ and a median HAS of 12 (range 3-14), where low scores indicate unhealthy aging. Median inflammatory marker levels were CRP: 2342009.0, IL-6: 54524.8, and D-dimer: 335763. No clear correlations between HAS and CRP, IL-6, or D-dimer were observed (p>0.05). Additionally, no clear correlations were observed between HAS subcategories (mental health, quality of life, social support, cognitive function, physical function, pain, and chronic disease) and these markers (p>0.05).
Discussion: These findings suggest that immune activation, as indicated by CRP, IL-6, and D-dimer, may not play a central role in unhealthy aging among older adults with HIV, and at this point cannot serve as markers for intervention. Other factors, including social determinants, may be more significant contributors to unhealthy aging and will be explored in this cohort.
Methods: We analyzed data from 91 participants in the Correlates of Healthy Aging in Geriatric HIV (CHANGE HIV) study to examine relationships between the Rotterdam Healthy Aging Score (HAS) and inflammatory markers C-reactive protein (CRP), interleukin-6 (IL-6), and D-dimer. HAS and serum levels of the inflammatory markers (pg/ml, using ELISA) were measured at cohort entry. Associations were assessed using linear regression, Spearman’s correlation, and Wilcoxon tests.
Results: The participants included 83 males and 8 females, with a mean age of 75 (IQR 72-77). At entry into the cohort, the participants had a mean CD4 count of 567 cells/mm³ and a median HAS of 12 (range 3-14), where low scores indicate unhealthy aging. Median inflammatory marker levels were CRP: 2342009.0, IL-6: 54524.8, and D-dimer: 335763. No clear correlations between HAS and CRP, IL-6, or D-dimer were observed (p>0.05). Additionally, no clear correlations were observed between HAS subcategories (mental health, quality of life, social support, cognitive function, physical function, pain, and chronic disease) and these markers (p>0.05).
Discussion: These findings suggest that immune activation, as indicated by CRP, IL-6, and D-dimer, may not play a central role in unhealthy aging among older adults with HIV, and at this point cannot serve as markers for intervention. Other factors, including social determinants, may be more significant contributors to unhealthy aging and will be explored in this cohort.
Kayla U. Fong
Undergraduate Student Researcher
Simon Fraser University
Delivery of the Women-Centred HIV Care Model in Canadian HIV clinics: An environmental scan
Abstract
Background: Women represent approximately 25% of Canadians living with HIV, with unique social and biological factors influencing health. The Women-Centred HIV Care (WCHC) Model was designed to address these care needs, but its provision remains unclear. This environmental scan assesses the delivery of the WCHC Model in Canadian HIV clinics.
Methods: HIV clinics identified from online HIV resources and word-of-mouth were invited to complete a survey about clinic services. Clinics received scores out of 10 in the six domains and five sub-domains of WCHC, using a predetermined scoring system based on their delivery of relevant services. On-site services typically scored higher than off-site referrals. Providing at least 50% of domain services indicated satisfactory domain delivery. Descriptive statistics summarized the results.
Results: Of 59 eligible clinics, 35 participated, representing all regions except Alberta, Northwest Territories, and Nunavut. Clinics across Canada scored high in HIV care and sexual health care, but low in the peer support/leadership/capacity-building domain. In remaining domains, scores varied between provinces, indicating different provincial strengths (Table 1). Mental health and addiction services were infrequently offered on-site. Most clinics (74%; 26/35) provided at least 50% of services in 4-6 domains, and 20% (7/35) achieved this in all 6 domains.
Conclusion: WCHC Model delivery varies between regions and domains. Canada-wide strengths include HIV and sexual health care, while gaps persist in peer support/leadership/capacity-building opportunities, and on-site mental health and addiction care. Our findings inform future service and training priorities enhancing care for women living with HIV.
Methods: HIV clinics identified from online HIV resources and word-of-mouth were invited to complete a survey about clinic services. Clinics received scores out of 10 in the six domains and five sub-domains of WCHC, using a predetermined scoring system based on their delivery of relevant services. On-site services typically scored higher than off-site referrals. Providing at least 50% of domain services indicated satisfactory domain delivery. Descriptive statistics summarized the results.
Results: Of 59 eligible clinics, 35 participated, representing all regions except Alberta, Northwest Territories, and Nunavut. Clinics across Canada scored high in HIV care and sexual health care, but low in the peer support/leadership/capacity-building domain. In remaining domains, scores varied between provinces, indicating different provincial strengths (Table 1). Mental health and addiction services were infrequently offered on-site. Most clinics (74%; 26/35) provided at least 50% of services in 4-6 domains, and 20% (7/35) achieved this in all 6 domains.
Conclusion: WCHC Model delivery varies between regions and domains. Canada-wide strengths include HIV and sexual health care, while gaps persist in peer support/leadership/capacity-building opportunities, and on-site mental health and addiction care. Our findings inform future service and training priorities enhancing care for women living with HIV.
Benedikt Funke
Regional Director Medical Affairs Europe & Canada
Merck & Co.
Switch to DOR/ISL (100/0.25 mg) QD from BIC/FTC/TAF: a Blinded Phase 3 Study in Adults with HIV-1
Abstract
Switch to DOR/ISL (100/0.25 mg) QD from BIC/FTC/TAF: a Blinded Phase 3 Study in Adults with HIV-1
Amy E. Colson, MD, MPH1; Anthony M. Mills, MD2; Moti Ramgopal, MD3; Christopher Bettacchi, MD4; Olayemi Osiyemi, MD5; Federico Hinestrosa, MD6; Gordon Crofoot, MD7; Harold P. Katner, MD8; Hiroyuki Gatanaga, MD9; Margaret Johnson, MD10; Feng-Hsiu Su, MPH, MBA11; Alice Xu, PhD11; Luisa M. Stamm, MD, PhD11; Michelle C. Fox, MD11; Rima Lahoulou, MD12
Background: Doravirine (DOR), an NNRTI, and islatravir (ISL), an investigational nucleoside reverse transcriptase translocation inhibitor, have complementary mechanisms of action and resistance profiles. MK-8591A-052 is an ongoing phase 3 study evaluating the efficacy and safety of switching from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) to DOR/ISL (100/0.25 mg), a once-daily single-tablet regimen. Declines in CD4 T-cell and lymphocyte counts were seen with higher ISL doses.
Methods: In this double-blind, non-inferiority study (NCT05630755), adults with HIV-1, virologic suppression for ≥3 months on BIC/FTC/TAF, and no history of treatment failure or known resistance to DOR were randomized (2:1) to switch to DOR/ISL (100/0.25 mg) or continue BIC/FTC/TAF. Primary efficacy endpoint was % of participants with HIV-1 RNA ≥50 c/mL at week 48 (FDA snapshot; non-inferiority margin 4%). Discontinuation was required for confirmed decline in total lymphocytes (≥30% and to <1.0 x109/L) or in CD4 T-cell count (≥30% and to <350 cells/mm3 from baseline ≥350 or to <200 from baseline ≤349).
Results: Week 48 efficacy and safety results will be presented.
Conclusions: DOR/ISL was demonstrated to be non-inferior to BIC/FTC/TAF, and the safety profiles were generally comparable between DOR/ISL and BIC/FTC/TAF.
Amy E. Colson, MD, MPH1; Anthony M. Mills, MD2; Moti Ramgopal, MD3; Christopher Bettacchi, MD4; Olayemi Osiyemi, MD5; Federico Hinestrosa, MD6; Gordon Crofoot, MD7; Harold P. Katner, MD8; Hiroyuki Gatanaga, MD9; Margaret Johnson, MD10; Feng-Hsiu Su, MPH, MBA11; Alice Xu, PhD11; Luisa M. Stamm, MD, PhD11; Michelle C. Fox, MD11; Rima Lahoulou, MD12
Background: Doravirine (DOR), an NNRTI, and islatravir (ISL), an investigational nucleoside reverse transcriptase translocation inhibitor, have complementary mechanisms of action and resistance profiles. MK-8591A-052 is an ongoing phase 3 study evaluating the efficacy and safety of switching from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) to DOR/ISL (100/0.25 mg), a once-daily single-tablet regimen. Declines in CD4 T-cell and lymphocyte counts were seen with higher ISL doses.
Methods: In this double-blind, non-inferiority study (NCT05630755), adults with HIV-1, virologic suppression for ≥3 months on BIC/FTC/TAF, and no history of treatment failure or known resistance to DOR were randomized (2:1) to switch to DOR/ISL (100/0.25 mg) or continue BIC/FTC/TAF. Primary efficacy endpoint was % of participants with HIV-1 RNA ≥50 c/mL at week 48 (FDA snapshot; non-inferiority margin 4%). Discontinuation was required for confirmed decline in total lymphocytes (≥30% and to <1.0 x109/L) or in CD4 T-cell count (≥30% and to <350 cells/mm3 from baseline ≥350 or to <200 from baseline ≤349).
Results: Week 48 efficacy and safety results will be presented.
Conclusions: DOR/ISL was demonstrated to be non-inferior to BIC/FTC/TAF, and the safety profiles were generally comparable between DOR/ISL and BIC/FTC/TAF.
Benedikt Funke
Regional Director Medical Affairs Europe & Canada
Merck & Co.
Switch to DOR/ISL (100/0.25 mg) QD from Oral ART: an Open-Label Phase 3 Study in Adults with HIV-1
Abstract
Switch to DOR/ISL (100/0.25 mg) QD from Oral ART: an Open-Label Phase 3 Study in Adults with HIV-1
Chloe Orkin, MD1, Rosie Mngqibisa, MD2, Juan Diego Velez, MD3, Princy Kumar, MD4, Dominique Braun, MD5, Andrew Carr, DSc6, Mark Bloch, MD7, Sharon Walmsley, MD8, Pablo Tebas, MD9, Anjana Grandhi, PhD10, Stephanie O. Klopfer, PhD10, Luisa M. Stamm, MD, PhD10, Michelle C. Fox, MD10, Jason Kim, MD, MSCE10
Background: Doravirine (DOR), a NNRTI, and islatravir (ISL), an investigational nucleoside reverse transcriptase translocation inhibitor, have complementary mechanisms of action and resistance profiles. MK-8591A-051 is a phase 3 study evaluating the efficacy and safety of switching from oral ART to DOR/ISL (100/0.25 mg), a once-daily single-tablet regimen. Declines in CD4 and total lymphocyte counts were seen with higher ISL doses.
Methods: In this open-label, non-inferiority study (NCT05631093), adults with HIV-1 RNA <50 c/mL for ≥3 months on oral 2- or 3-drug ART, with no history of treatment failure or known virologic resistance to DOR, were randomized 2:1 to switch to DOR/ISL (100/0.25 mg) or continue baseline ART (bART), stratified by bART regimen. The primary efficacy endpoint was % of participants with HIV-1 RNA ≥50 c/mL at week 48 (FDA Snapshot; non-inferiority margin 4%). Discontinuation was required for confirmed decline in total lymphocytes (≥30% and to <1.0x109/L) or CD4 count (≥30% and to <350 cells/mm3 from baseline ≥350 or to <200 from baseline ≤349).
Results: Week 48 efficacy and safety results will be presented.
Conclusions: DOR/ISL was demonstrated to be non-inferior to bART at Week 48, and the safety profiles were generally comparable between DOR/ISL and bART.
Chloe Orkin, MD1, Rosie Mngqibisa, MD2, Juan Diego Velez, MD3, Princy Kumar, MD4, Dominique Braun, MD5, Andrew Carr, DSc6, Mark Bloch, MD7, Sharon Walmsley, MD8, Pablo Tebas, MD9, Anjana Grandhi, PhD10, Stephanie O. Klopfer, PhD10, Luisa M. Stamm, MD, PhD10, Michelle C. Fox, MD10, Jason Kim, MD, MSCE10
Background: Doravirine (DOR), a NNRTI, and islatravir (ISL), an investigational nucleoside reverse transcriptase translocation inhibitor, have complementary mechanisms of action and resistance profiles. MK-8591A-051 is a phase 3 study evaluating the efficacy and safety of switching from oral ART to DOR/ISL (100/0.25 mg), a once-daily single-tablet regimen. Declines in CD4 and total lymphocyte counts were seen with higher ISL doses.
Methods: In this open-label, non-inferiority study (NCT05631093), adults with HIV-1 RNA <50 c/mL for ≥3 months on oral 2- or 3-drug ART, with no history of treatment failure or known virologic resistance to DOR, were randomized 2:1 to switch to DOR/ISL (100/0.25 mg) or continue baseline ART (bART), stratified by bART regimen. The primary efficacy endpoint was % of participants with HIV-1 RNA ≥50 c/mL at week 48 (FDA Snapshot; non-inferiority margin 4%). Discontinuation was required for confirmed decline in total lymphocytes (≥30% and to <1.0x109/L) or CD4 count (≥30% and to <350 cells/mm3 from baseline ≥350 or to <200 from baseline ≤349).
Results: Week 48 efficacy and safety results will be presented.
Conclusions: DOR/ISL was demonstrated to be non-inferior to bART at Week 48, and the safety profiles were generally comparable between DOR/ISL and bART.
Amanda Galambos
Program Coordinator
University of Saskatchewan
Improving HIV PEP Access in Emergency Medicine Departments in Saskatoon, Saskatchewan: A Continuing Medical Education (CME) Pilot Project
Abstract
Background: Missed opportunities to prescribe HIV post-exposure prophylaxis (PEP) within the required 72 hours by physicians in emergency departments (ED) can occur due to restricted access to antiretroviral medications and lack of knowledge on the use of PEP for HIV prevention.
Description: In April 2023, 1-year CME pilot project was launched in partnership with the Saskatoon ER Sexual Assault Response Team (SART), Saskatoon Infectious Disease Division, and University of Saskatchewan Division of CME. Project goals were to: 1) increase patient access to HIV PEP, 2) reduce ID Specialist consultations for HIV PEP, 3) increase capacity of ED physicians to independently prescribe HIV PEP, and 4) enroll ED physicians as Designated ARV Prescribers to ensure patient HIV PEP cost coverage under Saskatchewan Drug Plan (required until April 2024).
Methods: A live presentation on HIV PEP was delivered by an ID Specialist. The education highlighted when HIV PEP should be prescribed and encouraged consultations with ID as needed. The slide deck was distributed for additional self-review, and instructions on how to become a Designated ARV Prescriber were provided to Saskatoon ED and SART physicians. Enrolment as a Designated ARV Prescriber and learner satisfaction with the pilot project were tracked.
Results: Between April 1, 2023, and April 1, 2024, 32 ED physicians in Saskatoon were enrolled as Designated ARV Prescribers. Additional EDs in Saskatchewan expressed interest in receiving the education.
Conclusion: Strong interest in HIV PEP education led to expanding the pilot project beyond Saskatoon. A provincial HIV PEP education group was created and an online HIV PEP CME course for Saskatchewan ED healthcare providers is being developed, complementing new changes to HIV PEP kits and provincial guidelines. A retrospective chart review of HIV PEP prescribing practices within Saskatoon EDs will be pursued to assess the impact of the HIV PEP pilot project.
Description: In April 2023, 1-year CME pilot project was launched in partnership with the Saskatoon ER Sexual Assault Response Team (SART), Saskatoon Infectious Disease Division, and University of Saskatchewan Division of CME. Project goals were to: 1) increase patient access to HIV PEP, 2) reduce ID Specialist consultations for HIV PEP, 3) increase capacity of ED physicians to independently prescribe HIV PEP, and 4) enroll ED physicians as Designated ARV Prescribers to ensure patient HIV PEP cost coverage under Saskatchewan Drug Plan (required until April 2024).
Methods: A live presentation on HIV PEP was delivered by an ID Specialist. The education highlighted when HIV PEP should be prescribed and encouraged consultations with ID as needed. The slide deck was distributed for additional self-review, and instructions on how to become a Designated ARV Prescriber were provided to Saskatoon ED and SART physicians. Enrolment as a Designated ARV Prescriber and learner satisfaction with the pilot project were tracked.
Results: Between April 1, 2023, and April 1, 2024, 32 ED physicians in Saskatoon were enrolled as Designated ARV Prescribers. Additional EDs in Saskatchewan expressed interest in receiving the education.
Conclusion: Strong interest in HIV PEP education led to expanding the pilot project beyond Saskatoon. A provincial HIV PEP education group was created and an online HIV PEP CME course for Saskatchewan ED healthcare providers is being developed, complementing new changes to HIV PEP kits and provincial guidelines. A retrospective chart review of HIV PEP prescribing practices within Saskatoon EDs will be pursued to assess the impact of the HIV PEP pilot project.
Ryan Goguen
Medical Science Liaison
Viiv Healthcare
Real-world Experience of DTG+3TC Regimen: Results From the French Dat'AIDS Cohort (2015-2022)
Abstract
Background: Phase 3 clinical studies have shown high efficacy and tolerability of DTG+3TC in both naive and maintenance strategies. Few real-world data for DTG+3TC efficacy and tolerance are available.
Methods: The Dat'AIDS cohort includes 33 French HIV centers. Adults with HIV starting DTG+3TC (separate or fixed combination from 01/03/2020) as either first-line in ART-naive people (naive group) or maintenance therapy in ART-experienced suppressed people (MT group) were retrospectively included in the study between 01/01/2015 and 31/12/2022. Main objectives were to evaluate virological failure (VF; 2 consecutive viral loads [VLs] >50 c/mL or 1 VL >200 c/mL) and reasons for treatment interruptions.
Results: Among 88,619 people followed, 252 (3.5%) naive people initiated and 6770 (96.5%) people in MT switched to DTG+3TC. On treatment, 96.1% and 98.6% of the naive and MT groups, respectively, were virologically suppressed at data cutoff. Ninety-eight (1.4%) people stopped DTG+3TC with VL >50 c/mL but only 23 (0.3%) with confirmed VF. After a median follow-up of 1.4 years (IQR: 0.8-2.1), 964 (13.7%) people discontinued DTG+3TC, mostly for adverse events (naive, 7.9%; MT, 5.2%), with neuropsychological disorders in 4.4% and 2% of the naive and MT groups, respectively. Median weight gain was +3.0 kg (IQR: 0.0-5.2) in the naive group and +1.0 kg (IQR: −1.0 to 3.0) in MT. At VF, 26 genotypes were available, and among these, 4 harbored resistance-associated mutations (naive, n=1; MT, n=3); M184V on reverse transcriptase was observed in all cases, associated with N155H on integrase (n=1 in the naive group; VL 5162 c/mL, 11.2 months after DTG+3TC initiation).
Conclusions: Real-world DTG+3TC use in France confirms results of clinical studies in naive and virologically controlled populations. The combination was mainly prescribed in ART-experienced people. Virological failures were infrequent with rare emerging resistance mutations, confirming the robustness of DTG+3TC.
Methods: The Dat'AIDS cohort includes 33 French HIV centers. Adults with HIV starting DTG+3TC (separate or fixed combination from 01/03/2020) as either first-line in ART-naive people (naive group) or maintenance therapy in ART-experienced suppressed people (MT group) were retrospectively included in the study between 01/01/2015 and 31/12/2022. Main objectives were to evaluate virological failure (VF; 2 consecutive viral loads [VLs] >50 c/mL or 1 VL >200 c/mL) and reasons for treatment interruptions.
Results: Among 88,619 people followed, 252 (3.5%) naive people initiated and 6770 (96.5%) people in MT switched to DTG+3TC. On treatment, 96.1% and 98.6% of the naive and MT groups, respectively, were virologically suppressed at data cutoff. Ninety-eight (1.4%) people stopped DTG+3TC with VL >50 c/mL but only 23 (0.3%) with confirmed VF. After a median follow-up of 1.4 years (IQR: 0.8-2.1), 964 (13.7%) people discontinued DTG+3TC, mostly for adverse events (naive, 7.9%; MT, 5.2%), with neuropsychological disorders in 4.4% and 2% of the naive and MT groups, respectively. Median weight gain was +3.0 kg (IQR: 0.0-5.2) in the naive group and +1.0 kg (IQR: −1.0 to 3.0) in MT. At VF, 26 genotypes were available, and among these, 4 harbored resistance-associated mutations (naive, n=1; MT, n=3); M184V on reverse transcriptase was observed in all cases, associated with N155H on integrase (n=1 in the naive group; VL 5162 c/mL, 11.2 months after DTG+3TC initiation).
Conclusions: Real-world DTG+3TC use in France confirms results of clinical studies in naive and virologically controlled populations. The combination was mainly prescribed in ART-experienced people. Virological failures were infrequent with rare emerging resistance mutations, confirming the robustness of DTG+3TC.
Sheliza Halani
Physician
University of Toronto
Gaps and Solutions for Educating and Engaging Providers in Delivering HIV PrEP to Cisgender Women: A Scoping Review
Abstract
Background: There is an underutilization of HIV pre-exposure prophylaxis (PrEP) among Canadian women. We conducted a scoping review to identify provider-level educational needs, curricula, or interventions for prescribing PrEP to women.
Methods: We searched 4 databases (PubMed, CINAHL Plus, SCOPUS, Web of Science) (2012 – 03SEPT2024), using MEsH terms related to HIV PrEP, women, education, teaching, and curricula. We excluded: grey literature, dissertations, non-English articles, clinical-only studies, or articles on training only Infectious Diseases providers. We performed data extraction guided by the Arksey & O’Malley scoping review framework.
Results: We included 32 articles (identified 2888 articles, removed 1296 duplicates, excluded 1473 via title and abstract screening, excluded 88 via full-text screening, and added one companion article). Eight studies were from Africa, 23 from the USA, and 1 from Australia. Twenty of 32 articles were interventional (3 protocols), and 12 were non-interventional. Seven articles focused on PrEP for adolescent girls and young women. Twelve studies discussed unique educational interventions (audio/video recordings, lectures, expert training, case-based scenarios, role-playing, standardized patients, problem-solving workshops, education on counseling/motivational interviewing, animation storyboards, shadowing). Eight studies highlighted decision-support tools (contacting PrEP experts, Extension for Community Healthcare Outcomes, on-site/technical support, templates, electronic prompts, “smart-phrases,” coaching, and provider feedback). Nine studies identified provider challenges (misconceptions, knowledge gaps, discussing topics such as sex work and intimate partner violence) and training needs (cultural competency, flow diagrams for prescribing/monitoring, and ongoing training). Sixteen studies emphasized the integration of PrEP with other services (family planning, contraception, perinatal care, harm reduction, and sexual health care).
Discussion: There is a rich diversity of provider-level educational interventions for PrEP delivery to women, often harmonized with existing services but in limited geographic locations. Provider support should include algorithms and could form the basis of a Canadian implementation trial for HIV PrEP for women.
Methods: We searched 4 databases (PubMed, CINAHL Plus, SCOPUS, Web of Science) (2012 – 03SEPT2024), using MEsH terms related to HIV PrEP, women, education, teaching, and curricula. We excluded: grey literature, dissertations, non-English articles, clinical-only studies, or articles on training only Infectious Diseases providers. We performed data extraction guided by the Arksey & O’Malley scoping review framework.
Results: We included 32 articles (identified 2888 articles, removed 1296 duplicates, excluded 1473 via title and abstract screening, excluded 88 via full-text screening, and added one companion article). Eight studies were from Africa, 23 from the USA, and 1 from Australia. Twenty of 32 articles were interventional (3 protocols), and 12 were non-interventional. Seven articles focused on PrEP for adolescent girls and young women. Twelve studies discussed unique educational interventions (audio/video recordings, lectures, expert training, case-based scenarios, role-playing, standardized patients, problem-solving workshops, education on counseling/motivational interviewing, animation storyboards, shadowing). Eight studies highlighted decision-support tools (contacting PrEP experts, Extension for Community Healthcare Outcomes, on-site/technical support, templates, electronic prompts, “smart-phrases,” coaching, and provider feedback). Nine studies identified provider challenges (misconceptions, knowledge gaps, discussing topics such as sex work and intimate partner violence) and training needs (cultural competency, flow diagrams for prescribing/monitoring, and ongoing training). Sixteen studies emphasized the integration of PrEP with other services (family planning, contraception, perinatal care, harm reduction, and sexual health care).
Discussion: There is a rich diversity of provider-level educational interventions for PrEP delivery to women, often harmonized with existing services but in limited geographic locations. Provider support should include algorithms and could form the basis of a Canadian implementation trial for HIV PrEP for women.
Alshaima Talal J Hashim
Hiv Clinical Fellow
Mcmaster University
The Longest Described Case of Asymptomatic Relapse of Mycobacterium Avium Complex Infection After Seven Years of Latency in a Virologically Suppressed Patient With HIV-1 Infection.
Abstract
Mycobacterium avium complex (MAC) is a serious opportunistic infection in HIV patients and is an AIDS defining illness. The incidence of MAC infection in HIV patients depends on CD4 cell counts, with incidence being highest with CD4 T lymphocyte (CD4) cell counts <50 cells/mm3. The reported incidence of relapsing MAC disease in HIV-infected patients receiving HAART after successful treatment of MAC infection and discontinuation of secondary prophylaxis is uncommon. Relapses are observed in patients with immunological discordance/ reduced T cell repertoire post HAART, and rarely as post MAC IRIS related relapse. Prior Gastrointestinal (GI) MAC infection is identified as a risk factor for non-responders in context of MAC IRIS infections.
We report the longest relapse case of biopsy proven MAC infection presenting with asymptomatic progressive retroperitoneal adenopathy and conglomerate necrotic mass involving the left psoas muscle in a 51-yr old PLWHIV who was virologically suppressed with a CD4 cell count of 460 cells/mm3. She presented eight years after successful treatment of MAC IRIS infection with esophageal ulceration. The current clinical presentation was less compatible with a late MAC IRIS relapsing infection given the absence of fevers and stable CD4 counts. We recommend the consideration of relapsing MAC infection in patients with a suppressed HIV viral load and appropriate CD4 T cell recovery presenting with progressive adenopathy and notably in patients with prior GI associated MAC disease.
We report the longest relapse case of biopsy proven MAC infection presenting with asymptomatic progressive retroperitoneal adenopathy and conglomerate necrotic mass involving the left psoas muscle in a 51-yr old PLWHIV who was virologically suppressed with a CD4 cell count of 460 cells/mm3. She presented eight years after successful treatment of MAC IRIS infection with esophageal ulceration. The current clinical presentation was less compatible with a late MAC IRIS relapsing infection given the absence of fevers and stable CD4 counts. We recommend the consideration of relapsing MAC infection in patients with a suppressed HIV viral load and appropriate CD4 T cell recovery presenting with progressive adenopathy and notably in patients with prior GI associated MAC disease.
Nicholas Iannantuono
Medical Science Liaison
Merck Canada Inc.
Reduction in estimated glomerular filtration rate (eGFR) observed with doravirine (DOR) is caused by inhibition of organic cation transporter 2 (OCT2)
Abstract
Background: In three Phase 3 studies of DOR involving treatment-naïve adults with HIV-1, declines in creatinine-based eGFR of ~10mL/min/1.73 m2 were observed shortly after DOR initiation. This occurred regardless of concomitant tenofovir use and remained stable for up to 3.5 years [1,2]. We investigated in vitro if DOR interferes with renal transporters, OCT2 and multidrug and toxin extrusion protein (MATE1), which are responsible for creatinine transport.
Materials and Methods: In vitro assays were conducted using OCT2- and MATE1-transfected cells with [14C]-creatinine and metformin to assess DOR’s inhibitory effects. The FDA drug interaction risk assessment criteria were applied.
Results: Creatinine uptake ratios in OCT2- and MATE1-transfected cells were elevated (8- fold and 5-fold respectively). DOR inhibited OCT2-mediated creatinine uptake (Figure 1A) with an IC50 of 6.9 μM, suggesting a mechanism for the observed eGFR decline. The IC50 for metformin increased to 67 μM, indicating substrate-dependent inhibition, as DOR does not affect metformin pharmacokinetics [3]. The effect of DOR on MATE1 (Figure 1B) was less pronounced, resulting in ~48% inhibition at 100 μM.
Conclusions: DOR selectively inhibits OCT2-mediated creatinine transport at clinically relevant concentrations, leading to reduced creatine-based eGFR. Importantly, this does not indicate impaired renal function, consistent with clinical data showing improved cystatin-C eGFR in treatment-naïve patients receiving DOR/islatravir [2]. These renal transporter interactions may be reversible with drug cessation, similar to effects seen with other medications, including antiretrovirals [4].
Materials and Methods: In vitro assays were conducted using OCT2- and MATE1-transfected cells with [14C]-creatinine and metformin to assess DOR’s inhibitory effects. The FDA drug interaction risk assessment criteria were applied.
Results: Creatinine uptake ratios in OCT2- and MATE1-transfected cells were elevated (8- fold and 5-fold respectively). DOR inhibited OCT2-mediated creatinine uptake (Figure 1A) with an IC50 of 6.9 μM, suggesting a mechanism for the observed eGFR decline. The IC50 for metformin increased to 67 μM, indicating substrate-dependent inhibition, as DOR does not affect metformin pharmacokinetics [3]. The effect of DOR on MATE1 (Figure 1B) was less pronounced, resulting in ~48% inhibition at 100 μM.
Conclusions: DOR selectively inhibits OCT2-mediated creatinine transport at clinically relevant concentrations, leading to reduced creatine-based eGFR. Importantly, this does not indicate impaired renal function, consistent with clinical data showing improved cystatin-C eGFR in treatment-naïve patients receiving DOR/islatravir [2]. These renal transporter interactions may be reversible with drug cessation, similar to effects seen with other medications, including antiretrovirals [4].
Fatima Kakkar
Associate Professor
University of Montreal
Association Between Reservoir Size and Markers of Cardiovascular Inflammation in Perinatally Infected Children Living with HIV
Abstract
Background: There are limited data on long-term cardiovascular disease risk among perinatally infected children living with HIV (CHIV). Our objective was to assess the association between HIV reservoir size and biomarkers of cardiovascular inflammation among Canadian CHIV.
Methods: Sub-study of the « Early Pediatric Initiation, Canada Child Cure Cohort Study » (EPIC4, 2014-2019). In CHIV with sustained viral suppression (SVS) in whom the inducible HIV-1 reservoir in CD4+ T cells was previously measured (prostratin stimulation assay), serum levels of CRP, IL-1β, IL-6, IL-18, VEGF-1, TNF-α and IFN-γ were measured using the Luminex 200TM XMAP multiplex assay. Multiple linear regression was used to assess potential associations. To avoid overadjustment, factors predictive of reservoir size (age at treatment initiation, duration of SVS) were not included in the models.
Results: Out of 225 EPIC4 participants, 121 had measures of inducible HIV-1 RNA (iRNA) at baseline. Median age was 13 years (range=6 months-23 years), age at CART initiation was 1.6 years (IQR=4 months – 4.7 years), and duration of SVS was 5.6 years (IQR=2.1–8.3). Median number of copies of iRNA produced by 106 CD4+ T cells was 5.8 (IQR=1.1-57.5). Age at cART initiation, duration of cART and proportion of life with SVS were all predictors of iRNA levels (p=0.004, p=0.02, and p=0.01, respectively). There was a significant association between levels of iRNA and serum levels of CRP (p=0.009), IL-6 (p=0.04), IL-1β (p=0.002), and IL-18 (p=0.014), though no association with IFN-γ, VEGF-1 or TNF-α were observed. These association all remained significant after adjusting for age and CMV serostatus.
Conclusions: Reservoir size as measured by iRNA was strongly associated with markers of cardiovascular inflammation in CHIV. These data reinforce the need for early SVS in children to mitigate long-term comorbidities, and the potential use of these biomarkers as proxy measures of long-term disease risk.
Methods: Sub-study of the « Early Pediatric Initiation, Canada Child Cure Cohort Study » (EPIC4, 2014-2019). In CHIV with sustained viral suppression (SVS) in whom the inducible HIV-1 reservoir in CD4+ T cells was previously measured (prostratin stimulation assay), serum levels of CRP, IL-1β, IL-6, IL-18, VEGF-1, TNF-α and IFN-γ were measured using the Luminex 200TM XMAP multiplex assay. Multiple linear regression was used to assess potential associations. To avoid overadjustment, factors predictive of reservoir size (age at treatment initiation, duration of SVS) were not included in the models.
Results: Out of 225 EPIC4 participants, 121 had measures of inducible HIV-1 RNA (iRNA) at baseline. Median age was 13 years (range=6 months-23 years), age at CART initiation was 1.6 years (IQR=4 months – 4.7 years), and duration of SVS was 5.6 years (IQR=2.1–8.3). Median number of copies of iRNA produced by 106 CD4+ T cells was 5.8 (IQR=1.1-57.5). Age at cART initiation, duration of cART and proportion of life with SVS were all predictors of iRNA levels (p=0.004, p=0.02, and p=0.01, respectively). There was a significant association between levels of iRNA and serum levels of CRP (p=0.009), IL-6 (p=0.04), IL-1β (p=0.002), and IL-18 (p=0.014), though no association with IFN-γ, VEGF-1 or TNF-α were observed. These association all remained significant after adjusting for age and CMV serostatus.
Conclusions: Reservoir size as measured by iRNA was strongly associated with markers of cardiovascular inflammation in CHIV. These data reinforce the need for early SVS in children to mitigate long-term comorbidities, and the potential use of these biomarkers as proxy measures of long-term disease risk.
Logan Kennedy
Research Lead
Women's College Hospital
W-PREV: Adapting the Women-Centred HIV Care Model for Women’s HIV/STBBI Prevention
Abstract
Background: Women face significant sexual and reproductive health (SRH)-related challenges, which are often overlooked, hindering their access to care. We aim to reorient and improve SRH care for women by prioritizing their lived/living experiences and collaborate with stakeholders to develop a women-centred, holistic HIV/STBBI prevention program.
Methods: To adapt the Women-Centred HIV Care (WCHC) Model to W-PREV, a model for women’s HIV/STBBI prevention, we conducted a rapid scoping review to identify successful SRH programs for women and held stakeholder consultations to assess prevention needs. We used Arksey and O’Malley’s method for the scoping review, with three team members screening articles. Consultations, both in-person and virtual, involved diverse participants and were recorded with consent, followed by rapid analysis.
Results: Rapid Scoping Review - We identified 107 relevant articles from the past 15 years, reviewing 25. Three themes emerged: (1) normalizing non-judgmental sexual health care reduces women's fear of discussing sexual health with providers; (2) providing SRH information and personal care items in non-clinical settings can connect key populations to resources; (3) engaging key influencers in SRH discussions can reduce community stigma. Stakeholder Consultations - We held 42 consultations with diverse individuals (women, clinicians, service providers, public health officials, community leaders) in Ontario and Saskatchewan between August and October 2024. Key findings included: (1) structural challenges like housing insecurity and lack of mental health care significantly impact SRH; (2) community connection is vital for women and healing; (3) education in community-spaces can facilitate SRH discussions; (4) SRH concerns are interconnected with HIV/STBBI risk; (5) sustainability is crucial.
Conclusions: These insights emphasize the need for a multi-level approach in developing W-PREV. The formative activities for W-PREV highlighted the importance of integrated HIV/STBBI prevention care that addresses women's structural, social, and clinical needs, recognizing competing priorities and promoting holistic prevention strategies.
Methods: To adapt the Women-Centred HIV Care (WCHC) Model to W-PREV, a model for women’s HIV/STBBI prevention, we conducted a rapid scoping review to identify successful SRH programs for women and held stakeholder consultations to assess prevention needs. We used Arksey and O’Malley’s method for the scoping review, with three team members screening articles. Consultations, both in-person and virtual, involved diverse participants and were recorded with consent, followed by rapid analysis.
Results: Rapid Scoping Review - We identified 107 relevant articles from the past 15 years, reviewing 25. Three themes emerged: (1) normalizing non-judgmental sexual health care reduces women's fear of discussing sexual health with providers; (2) providing SRH information and personal care items in non-clinical settings can connect key populations to resources; (3) engaging key influencers in SRH discussions can reduce community stigma. Stakeholder Consultations - We held 42 consultations with diverse individuals (women, clinicians, service providers, public health officials, community leaders) in Ontario and Saskatchewan between August and October 2024. Key findings included: (1) structural challenges like housing insecurity and lack of mental health care significantly impact SRH; (2) community connection is vital for women and healing; (3) education in community-spaces can facilitate SRH discussions; (4) SRH concerns are interconnected with HIV/STBBI risk; (5) sustainability is crucial.
Conclusions: These insights emphasize the need for a multi-level approach in developing W-PREV. The formative activities for W-PREV highlighted the importance of integrated HIV/STBBI prevention care that addresses women's structural, social, and clinical needs, recognizing competing priorities and promoting holistic prevention strategies.
Logan Kennedy
Research Lead
Women's College Hospital
The FIND+ Study (CTN 046): Preliminary Results on the Fertility Desires and Intentions of Youth living with HIV Since Childhood
Abstract
Background: Supporting youth with HIV since childhood has shifted to wellness, highlighting fertility as a relevant issue. Research shows HIV may modify, but not eliminate, the desire for children. Understanding these desires among youth remains limited, and at least one relevant study has indicated reduced fertility potential in male and female participants. The first objective of this study aims to explore their fertility desires and intentions.
Methods: We are conducting a cross-sectional study with a target enrollment of 100 participants, recruiting from two clinics (BC and ON) and nationally through word-of-mouth; participants will complete a 162-item self-administered survey on REDcap. We also aims to validate the modified version of “The HIV Pregnancy Planning Questionnaire” (Loutfy et al.) being used. We present descriptive results from participants to date.
Results: Twenty-six (18 cis-women/8 cis-men) participants have completed the survey. Twenty-one indicated they acquired HIV perinatally, three were unsure, and two did not respond. Participants aged 16 to 40 (mean = 28.1) were born in Canada (46%), as well as sub-Saharan Africa, the Caribbean, and Europe. 92% (24) thought about becoming a parent; 88% (23) desired parenting in the future. 15/26 (58%) agreed that treatment improvements impacted their fertility desires, while 9/26 (39%) disagreed or were neutral respectively. Most participants (22/26; 85%) intended to parent in the future; with plans to have between one and three children. 12/26 (46%) worried their child would be born with HIV.
Conclusion: Fertility desires and parenting intentions among youth living with HIV since childhood are higher than those reported in studies of women and men with HIV. The second objective of the FIND+ study will assess biological fertility potential to explore what reproductive health supports may be needed in the future. This work has implications for care and policy, enhancing reproductive health outcomes and informing family planning.
Methods: We are conducting a cross-sectional study with a target enrollment of 100 participants, recruiting from two clinics (BC and ON) and nationally through word-of-mouth; participants will complete a 162-item self-administered survey on REDcap. We also aims to validate the modified version of “The HIV Pregnancy Planning Questionnaire” (Loutfy et al.) being used. We present descriptive results from participants to date.
Results: Twenty-six (18 cis-women/8 cis-men) participants have completed the survey. Twenty-one indicated they acquired HIV perinatally, three were unsure, and two did not respond. Participants aged 16 to 40 (mean = 28.1) were born in Canada (46%), as well as sub-Saharan Africa, the Caribbean, and Europe. 92% (24) thought about becoming a parent; 88% (23) desired parenting in the future. 15/26 (58%) agreed that treatment improvements impacted their fertility desires, while 9/26 (39%) disagreed or were neutral respectively. Most participants (22/26; 85%) intended to parent in the future; with plans to have between one and three children. 12/26 (46%) worried their child would be born with HIV.
Conclusion: Fertility desires and parenting intentions among youth living with HIV since childhood are higher than those reported in studies of women and men with HIV. The second objective of the FIND+ study will assess biological fertility potential to explore what reproductive health supports may be needed in the future. This work has implications for care and policy, enhancing reproductive health outcomes and informing family planning.
Christina Khoury
Medical Advisor
Merck
Once-Weekly Islatravir Plus Lenacapavir in Virologically Suppressed PWH: Week 48 Safety, Efficacy, and Metabolic Changes
Abstract
Background: Islatravir (ISL), an NRTTI and lenacapavir (LEN), a capsid inhibitor, have potent anti-HIV-1 activity with pharmacokinetic profiles supporting once-weekly oral dosing. In the current trial (NCT05052996), weekly oral ISL+LEN maintained a high rate of virologic suppression at Week24. Here, we report W48 results.
Materials and Methods: In this Phase 2, randomised, open-label, active-controlled study, virologically suppressed adults on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) were randomised 1:1 to receive weekly oral ISL 2 mg + LEN 300 mg or to continue daily B/F/TAF. Virologic outcomes, safety, lymphocyte counts, weight, body mass index (BMI), and adherence (by pill count) were assessed.
Results: Overall, 104 participants (52/group) were randomised and dosed. Median age was 40 years (range 26–76) and 19 (18.3%) were assigned female at birth. At W48, 49 (94.2%) participants assigned to ISL+LEN and 48 (92.3%) assigned to B/F/TAF had HIV-1 RNA <50 copies/mL;. AEs occurring in ≥10% of the ISL+LEN group were upper respiratory tract infection (13.5%), COVID-19 (11.5%), and diarrhoea (11.5%). There were no significant differences between ISL+LEN and B/F/TAF groups in mean change from baseline in CD4+ T-cells (–12 vs –29/µL; P=0.88) or lymphocytes (–0.07 vs –0.03x103/µL; P=0.23). Mean adherence through W48 was 99.2% for ISL+LEN and 98.1% for B/F/TAF.
Conclusions: Weekly oral ISL+LEN maintained a high rate of virologic suppression at W48. ISL+LEN was well tolerated without significant changes in CD4+ T cell count, lymphocyte count, or weight. ISL+LEN has the potential to become the first weekly oral complete regimen for the treatment of HIV-1 infection.
Materials and Methods: In this Phase 2, randomised, open-label, active-controlled study, virologically suppressed adults on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) were randomised 1:1 to receive weekly oral ISL 2 mg + LEN 300 mg or to continue daily B/F/TAF. Virologic outcomes, safety, lymphocyte counts, weight, body mass index (BMI), and adherence (by pill count) were assessed.
Results: Overall, 104 participants (52/group) were randomised and dosed. Median age was 40 years (range 26–76) and 19 (18.3%) were assigned female at birth. At W48, 49 (94.2%) participants assigned to ISL+LEN and 48 (92.3%) assigned to B/F/TAF had HIV-1 RNA <50 copies/mL;. AEs occurring in ≥10% of the ISL+LEN group were upper respiratory tract infection (13.5%), COVID-19 (11.5%), and diarrhoea (11.5%). There were no significant differences between ISL+LEN and B/F/TAF groups in mean change from baseline in CD4+ T-cells (–12 vs –29/µL; P=0.88) or lymphocytes (–0.07 vs –0.03x103/µL; P=0.23). Mean adherence through W48 was 99.2% for ISL+LEN and 98.1% for B/F/TAF.
Conclusions: Weekly oral ISL+LEN maintained a high rate of virologic suppression at W48. ISL+LEN was well tolerated without significant changes in CD4+ T cell count, lymphocyte count, or weight. ISL+LEN has the potential to become the first weekly oral complete regimen for the treatment of HIV-1 infection.
David Kietrys
Associate Professor
Rutgers University
Physical Performance is Impaired in Persons Living with HIV and Negatively Impacted by Concurrent Peripheral Neuropathy
Abstract
Purpose: Compare physical performance of persons living with HIV (PLHIV) to normative values and explore the impact of peripheral neuropathy (PN) on physical performance.
Materials and Methods: PLHIV on antiretroviral therapy were enrolled. The 4-Meter Walk Test (4mWT), 5 Times Sit-to-Stand Test (5XSTS), 6-minute Walk Test (6MWT), and Isometric Mid-thigh Pull Test (IMTP) measured gait speed, walking endurance, lower limb strength, and whole-body strength. Z-scores were used to compare the performance of PLHIV to age and sex-matched normative data. Average z-scores were compared to the expected score of 0 using a one-sample t-test. We compared performance between participants with and without PN using independent t-tests and Cohen’s d effect sizes.
Results: 70 PLHIV participated (age 56.2 ± 12.1 years; 35 with PN; 25 women). On average, PLH walked 1.00 m/s (95% CI: 0.94, 1.06 m/s), which was 0.63 z-score below normative data (p<0.0005). PLH walked 352 meters (95% CI: 331, 372 meters) on average, which was 3.17 z-scores less than expected (p<0.0005). PLH performed the 5XSTS in 12.1 seconds (95% CI: 10.5, 13.7 seconds; 1.04 z-scores worse than expected, p<0.0005). PLHIV produced an average of 10.5 N/kg of bodyweight with IMTP, which was 4.1 N/kg less than expected (mean z-score = -1.02; p<0.0005). Comparing those with and without PN, there was a significant difference in gait speed (0.14 m/sec faster in those without PN; p=0.015, d=0.60), walking endurance (60 meters further in those without PN; p=0.003, d=0.75), and 5XSTS (4.2 seconds faster in those without PN; p=0.007, d=0.67). There was a moderate effect size for IMTP (0.86 z-score lower in those with PN, p=0.001; d=0.8) suggesting that whole-body strength in PLHIV with PN may impaired compared to those without PN.
Conclusions: PLHIV have impairments in physical performance compared to normative data. PN has a compounding negative impact on physical performance.
Materials and Methods: PLHIV on antiretroviral therapy were enrolled. The 4-Meter Walk Test (4mWT), 5 Times Sit-to-Stand Test (5XSTS), 6-minute Walk Test (6MWT), and Isometric Mid-thigh Pull Test (IMTP) measured gait speed, walking endurance, lower limb strength, and whole-body strength. Z-scores were used to compare the performance of PLHIV to age and sex-matched normative data. Average z-scores were compared to the expected score of 0 using a one-sample t-test. We compared performance between participants with and without PN using independent t-tests and Cohen’s d effect sizes.
Results: 70 PLHIV participated (age 56.2 ± 12.1 years; 35 with PN; 25 women). On average, PLH walked 1.00 m/s (95% CI: 0.94, 1.06 m/s), which was 0.63 z-score below normative data (p<0.0005). PLH walked 352 meters (95% CI: 331, 372 meters) on average, which was 3.17 z-scores less than expected (p<0.0005). PLH performed the 5XSTS in 12.1 seconds (95% CI: 10.5, 13.7 seconds; 1.04 z-scores worse than expected, p<0.0005). PLHIV produced an average of 10.5 N/kg of bodyweight with IMTP, which was 4.1 N/kg less than expected (mean z-score = -1.02; p<0.0005). Comparing those with and without PN, there was a significant difference in gait speed (0.14 m/sec faster in those without PN; p=0.015, d=0.60), walking endurance (60 meters further in those without PN; p=0.003, d=0.75), and 5XSTS (4.2 seconds faster in those without PN; p=0.007, d=0.67). There was a moderate effect size for IMTP (0.86 z-score lower in those with PN, p=0.001; d=0.8) suggesting that whole-body strength in PLHIV with PN may impaired compared to those without PN.
Conclusions: PLHIV have impairments in physical performance compared to normative data. PN has a compounding negative impact on physical performance.
David Kietrys
Associate Professor
Rutgers University
Non-pharmaceutical Interventions for Management of Chronic Pain in Persons Living with HIV: A Scoping Review
Abstract
Background: Chronic pain is common in persons living with HIV (PLHIV). While pharmaceuticals are often used in pain management, their efficacy in this population is uncertain, highlighting the need for alternatives. Our aim was to map existing literature on non-pharmaceutical interventions for managing chronic pain in PLHIV to inform clinical practice, identify gaps in knowledge, and prioritize research questions.
Methods: We conducted a scoping review using the JBI framework. We conducted searches for articles published in English from 1984 to June 2024 from six databases, grey literature, and a hand search of citations by expert authors and in key journals. Articles were included if they described or investigated non-pharmaceutical intervention(s) for management of chronic pain in PLHIV. Citations were screened and data extraction was performed by two blinded reviewers, with discrepancies resolved by a third reviewer. Data on interventions, outcomes, and study design characteristics were extracted. Results are presented using descriptive statistics and figures.
Results: Of the 156 articles included, 53 were clinical trials exploring mind-body therapies (n=17), behavioral approaches (n=17), patient education (n=9), exercise (n=6), and other interventions (n=21). Of the clinical trials that were randomized controlled trials (RCTs), favorable results for reduction in pain were reported with exercise (n=4), patient education (n=4), and cannabis (n=2). RCTs using behavioral approaches (n=4) reported mixed results. Other interventions investigated in single or pilot RCTs included massage, ice massage, yoga, vibration, art therapy, palliative care, capsaicin, lower extremity night splints, acupuncture, acupuncture with moxibustion, and Reiki with music. Other outcomes in clinical trials included quality of life, mental health, and physical function.
Conclusions: A range of non-pharmaceutical interventions for chronic pain in PLHIV has been described, and results of clinical trials continue to emerge. Systematic reviews of RCTs should be conducted on the effectiveness of exercise, patient education, cannabis, and behavioral approaches.
Methods: We conducted a scoping review using the JBI framework. We conducted searches for articles published in English from 1984 to June 2024 from six databases, grey literature, and a hand search of citations by expert authors and in key journals. Articles were included if they described or investigated non-pharmaceutical intervention(s) for management of chronic pain in PLHIV. Citations were screened and data extraction was performed by two blinded reviewers, with discrepancies resolved by a third reviewer. Data on interventions, outcomes, and study design characteristics were extracted. Results are presented using descriptive statistics and figures.
Results: Of the 156 articles included, 53 were clinical trials exploring mind-body therapies (n=17), behavioral approaches (n=17), patient education (n=9), exercise (n=6), and other interventions (n=21). Of the clinical trials that were randomized controlled trials (RCTs), favorable results for reduction in pain were reported with exercise (n=4), patient education (n=4), and cannabis (n=2). RCTs using behavioral approaches (n=4) reported mixed results. Other interventions investigated in single or pilot RCTs included massage, ice massage, yoga, vibration, art therapy, palliative care, capsaicin, lower extremity night splints, acupuncture, acupuncture with moxibustion, and Reiki with music. Other outcomes in clinical trials included quality of life, mental health, and physical function.
Conclusions: A range of non-pharmaceutical interventions for chronic pain in PLHIV has been described, and results of clinical trials continue to emerge. Systematic reviews of RCTs should be conducted on the effectiveness of exercise, patient education, cannabis, and behavioral approaches.
Katherine Kooij
Postdoctoral Fellow
Bc Centre For Excellence In Hiv/aids
Initiation of Opioid Agonist Therapy Within Seven Days Following a Nonfatal Opioid Poisoning Among People Living with HIV in British Columbia
Abstract
Background
There’s a high rate of opioid poisonings among people living with HIV (PLWH) in British Columbia (BC). We assessed whether, among PLWH, sex was associated with opioid agonist therapy (OAT) dispensation within seven days of discharge following an opioid poisoning-related healthcare encounter.
Methods
Among PLWH aged ≥19 years in BC, we identified first (index) nonfatal opioid poisoning events that resulted in an emergency department visit, hospitalization, or a healthcare practitioner encounter between 2012-2020 using diagnostic codes. We ascertained OAT from prescription dispensations. We used Kaplan-Meier and log-rank test to compare time to first OAT dispensation by sex, Chi-squared test to assess the association between sex and OAT dispensation within seven days post-event, and logistic regression to adjust for potential confounders.
Results
Among 11,040 PLWH, we identified 602 index opioid poisonings (204 females). Eighty-two percent of females and 71% of males received OAT at least once post-event; median time to first OAT dispensation was one day (Q1-Q3, 0-73) among 167 females and four days (0-130) among 282 males (Figure 1). Forty-eight percent of females and 35% of males received a first post-event OAT dispensation within seven days, p=0.003. Adjusting for age, socio-structural, and health-related factors, females had higher odds of OAT initiation within seven days (aOR 2.06, 95% CI 1.37-3.10) compared to males.
Conclusion
Females with HIV were more likely to have an OAT dispensation within seven days following index opioid poisoning. Future analyses will assess whether OAT initiation within seven days is associated with risk for repeat drug poisoning.
There’s a high rate of opioid poisonings among people living with HIV (PLWH) in British Columbia (BC). We assessed whether, among PLWH, sex was associated with opioid agonist therapy (OAT) dispensation within seven days of discharge following an opioid poisoning-related healthcare encounter.
Methods
Among PLWH aged ≥19 years in BC, we identified first (index) nonfatal opioid poisoning events that resulted in an emergency department visit, hospitalization, or a healthcare practitioner encounter between 2012-2020 using diagnostic codes. We ascertained OAT from prescription dispensations. We used Kaplan-Meier and log-rank test to compare time to first OAT dispensation by sex, Chi-squared test to assess the association between sex and OAT dispensation within seven days post-event, and logistic regression to adjust for potential confounders.
Results
Among 11,040 PLWH, we identified 602 index opioid poisonings (204 females). Eighty-two percent of females and 71% of males received OAT at least once post-event; median time to first OAT dispensation was one day (Q1-Q3, 0-73) among 167 females and four days (0-130) among 282 males (Figure 1). Forty-eight percent of females and 35% of males received a first post-event OAT dispensation within seven days, p=0.003. Adjusting for age, socio-structural, and health-related factors, females had higher odds of OAT initiation within seven days (aOR 2.06, 95% CI 1.37-3.10) compared to males.
Conclusion
Females with HIV were more likely to have an OAT dispensation within seven days following index opioid poisoning. Future analyses will assess whether OAT initiation within seven days is associated with risk for repeat drug poisoning.
Ashley Lacombe-Duncan
Associate Professor
University of Michigan
Anal Cytology Among Trans Women: Implications for Cancer Screening From The Montreal-Toronto Trans Study
Abstract
Background: HPV-related anal cancer disproportionately affects people living with HIV and trans women/transfeminine persons. Consequently, the 2023 International Anal Neoplasia Society (IANS)’s consensus guidelines for anal cancer screening recommend screening initiation at age 35 years for trans women with HIV and 45 for trans women without HIV, though trans-specific Canadian guidelines are absent. We examined the prevalence of and factors associated with anal cytology uptake among trans women in Montreal and Toronto, Canada.
Methods: This study utilized retrospective chart review data collected from the charts of 1035 trans women/transfeminine persons accessing care at six HIV/primary care clinics in Toronto and Montreal, Canada, 2018-2019. The outcome measure included history of anal cytology (yes/no), and hypothesized associated sociodemographic (e.g., age), clinical (e.g., HIV status), and social/structural factors (e.g., income source). Data were analyzed utilizing bivariable and multivariable logistic regression analyses.
Results: Few patients (n=16/1035, 1.5%) had ever received anal cytology (n=6/71, 8.4% of trans women with HIV). In multivariable analyses adjusting for age, those with HIV, those having ever had an STI diagnosis, and those not taking feminizing hormone therapy all had higher odds of anal cytology (adjusted Odds Ratio (aOR): 9.70, 95% confidence interval (CI): 2.85, 33.01, p<0.001; aOR: 4.95, 95% CI: 1.29, 17.62, p=0.014; and, aOR: 5.20, 1.89, 14.32, p=0.001, respectively).
Conclusions/Implications: The associations between HIV status and prior STI diagnosis and anal cytology suggest trans women/transfeminine persons are being screened at higher rates aligned with existing international guidelines. However, we found a low prevalence of ever having received anal cytology among trans women overall, including trans women with HIV. More research is needed to determine if this has changed since publishing of the IANS guidelines and/or to explore barriers to anal cytology provision among trans women (e.g., resource limitations).
Methods: This study utilized retrospective chart review data collected from the charts of 1035 trans women/transfeminine persons accessing care at six HIV/primary care clinics in Toronto and Montreal, Canada, 2018-2019. The outcome measure included history of anal cytology (yes/no), and hypothesized associated sociodemographic (e.g., age), clinical (e.g., HIV status), and social/structural factors (e.g., income source). Data were analyzed utilizing bivariable and multivariable logistic regression analyses.
Results: Few patients (n=16/1035, 1.5%) had ever received anal cytology (n=6/71, 8.4% of trans women with HIV). In multivariable analyses adjusting for age, those with HIV, those having ever had an STI diagnosis, and those not taking feminizing hormone therapy all had higher odds of anal cytology (adjusted Odds Ratio (aOR): 9.70, 95% confidence interval (CI): 2.85, 33.01, p<0.001; aOR: 4.95, 95% CI: 1.29, 17.62, p=0.014; and, aOR: 5.20, 1.89, 14.32, p=0.001, respectively).
Conclusions/Implications: The associations between HIV status and prior STI diagnosis and anal cytology suggest trans women/transfeminine persons are being screened at higher rates aligned with existing international guidelines. However, we found a low prevalence of ever having received anal cytology among trans women overall, including trans women with HIV. More research is needed to determine if this has changed since publishing of the IANS guidelines and/or to explore barriers to anal cytology provision among trans women (e.g., resource limitations).
Tanya Lazor
Postdoctoral Fellow
Centre For Addiction And Mental Health / CTN
Feasibility of Evaluating Standard THC Units (STU) Across Product Types Among People Living with HIV in Ontario, Canada
Abstract
Aims: Canada’s legalization of recreational cannabis has resulted in greater product diversification. We need accurate measures of quantity to evaluate risks and benefits, and to provide public health guidance on safer levels of use. We investigated the use of survey data to determine STU across product types.
Methods: We recruited 292 participants of a multi-site clinical HIV cohort, the Ontario HIV Treatment Network Cohort Study, who reported cannabis use in the past year to complete an extensive cannabis questionnaire (August 2022-December 2023). We inquired about use of smoked flower, vaped flower, edibles, beverages, capsules, topicals, vape cartridges, concentrates/extracts, hashish, oil drops, and tinctures. Stratified by product type, we calculated STU for each participant’s self-reported use by multiplying amount used by THC content and dividing by 5 mg. We removed outliers using pre-specified cutoff values.
Results: With a mean age of 50 years, most participants were men (84%), White (72%), and used cannabis in the past month (89%). The most consumed products in the past year were smoked flower (68%), edibles (55%), vaped flower (25%), beverages (19%), vaped cartridges (18%), and hashish (17%). Only a portion of participants who indicated use provided information on amount used and THC content to calculate STU, going from 35% for concentrates/extracts to 73% for edibles. STUs were highest for vaped flower (M=276, SD=98), followed by smoked flower reported in grams (M=124, SD=146), hashish (M=86, SD 282), and smoked flower reported in joints (M=60, SD=86). Mean STU ranged broadly across product types and SDs for some products were high.
Conclusions: People with HIV reported a broad range of use across product types. Calculation of STU per product type was feasible using THC content ranges and amounts used in a jurisdiction under federal legalization. Future research should further refine the questionnaire and algorithm to best determine STU.
Methods: We recruited 292 participants of a multi-site clinical HIV cohort, the Ontario HIV Treatment Network Cohort Study, who reported cannabis use in the past year to complete an extensive cannabis questionnaire (August 2022-December 2023). We inquired about use of smoked flower, vaped flower, edibles, beverages, capsules, topicals, vape cartridges, concentrates/extracts, hashish, oil drops, and tinctures. Stratified by product type, we calculated STU for each participant’s self-reported use by multiplying amount used by THC content and dividing by 5 mg. We removed outliers using pre-specified cutoff values.
Results: With a mean age of 50 years, most participants were men (84%), White (72%), and used cannabis in the past month (89%). The most consumed products in the past year were smoked flower (68%), edibles (55%), vaped flower (25%), beverages (19%), vaped cartridges (18%), and hashish (17%). Only a portion of participants who indicated use provided information on amount used and THC content to calculate STU, going from 35% for concentrates/extracts to 73% for edibles. STUs were highest for vaped flower (M=276, SD=98), followed by smoked flower reported in grams (M=124, SD=146), hashish (M=86, SD 282), and smoked flower reported in joints (M=60, SD=86). Mean STU ranged broadly across product types and SDs for some products were high.
Conclusions: People with HIV reported a broad range of use across product types. Calculation of STU per product type was feasible using THC content ranges and amounts used in a jurisdiction under federal legalization. Future research should further refine the questionnaire and algorithm to best determine STU.
Benoît Lemire
Pharmacien
Cusm
Assessment of Pharmacist Staffing in HIV and Viral Hepatitis Clinics Across Canada
Abstract
Background: Pharmacists play a vital role in the care of people living with HIV and viral hepatitis. However, pharmacist staffing across Canada remains poorly characterized. This project assessed Canadian pharmacist staffing in HIV and viral hepatitis care.
Methods: A survey was distributed to members of the Canadian HIV and Viral Hepatitis Pharmacists Network to collect data on pharmacist full-time equivalents (FTEs) and activities. An active outpatient was defined as a person with at ≥1 clinic visit in the last two years. A pharmacist with expertise was defined as someone with significant experience or advanced training. Participation was voluntary, and respondents consented to data presentation. Descriptive statistics are presented.
Results: A total of 19 responses were received from 7 provinces. All centres treated adults, 9 cared for neonates receiving vertical transmission prophylaxis, and 6 provided care to pediatric patients. The median number of FTEs per site was 1.0 (IQR 1-1.8). Clinics reported a median of 3,048 clinic visits annually (IQR 1,878 – 4,950) and a median of 1,280 active patients (IQR 542 – 1,763). The median number of active patients per FTE was 939 (IQR 460 – 1,477; range 230-2288), and the median number of annual clinic visits per FTE was 2,267 (IQR 1,878 – 3,173). Pharmacists dedicated 69% of their time to pharmaceutical care, followed by drug distribution (15%), teaching (7%), management (5%), and research (4%). Expert pharmacists provided direct care to all or most people living with HIV and viral hepatitis in 79% (15/19) and 17% (3/18) of the centres, respectively. Pharmacists’ engagement in HIV prevention care was minimal, with only 1 centre providing care to a significant proportion of patients on PrEP.
Conclusions: Pharmacist staffing and involvement with various patient populations varied significantly across Canada. These findings may support clinics to advocate for increased pharmacist resources.
Methods: A survey was distributed to members of the Canadian HIV and Viral Hepatitis Pharmacists Network to collect data on pharmacist full-time equivalents (FTEs) and activities. An active outpatient was defined as a person with at ≥1 clinic visit in the last two years. A pharmacist with expertise was defined as someone with significant experience or advanced training. Participation was voluntary, and respondents consented to data presentation. Descriptive statistics are presented.
Results: A total of 19 responses were received from 7 provinces. All centres treated adults, 9 cared for neonates receiving vertical transmission prophylaxis, and 6 provided care to pediatric patients. The median number of FTEs per site was 1.0 (IQR 1-1.8). Clinics reported a median of 3,048 clinic visits annually (IQR 1,878 – 4,950) and a median of 1,280 active patients (IQR 542 – 1,763). The median number of active patients per FTE was 939 (IQR 460 – 1,477; range 230-2288), and the median number of annual clinic visits per FTE was 2,267 (IQR 1,878 – 3,173). Pharmacists dedicated 69% of their time to pharmaceutical care, followed by drug distribution (15%), teaching (7%), management (5%), and research (4%). Expert pharmacists provided direct care to all or most people living with HIV and viral hepatitis in 79% (15/19) and 17% (3/18) of the centres, respectively. Pharmacists’ engagement in HIV prevention care was minimal, with only 1 centre providing care to a significant proportion of patients on PrEP.
Conclusions: Pharmacist staffing and involvement with various patient populations varied significantly across Canada. These findings may support clinics to advocate for increased pharmacist resources.
David Lessard
Research Institute Of The Mcgill University Health Centre
Baseline Social Support, Psychological Distress, and HIV-Related Stigma Among ART-Experienced Migrant Adults Living with HIV Switched to B/F/TAF in Montreal, Canada – the ASAP-Switch Study
Abstract
Background: In Canada, many migrant people with HIV (MWH) are referred for HIV care with limited known clinical history and antiretroviral treatments (ART) that can be renewed locally, while facing important psychosocial challenges. We evaluated the degree of social support, psychosocial distress, and HIV-related stigma among MWH enrolled in a cohort testing the feasibility of free-of-charge ART switch.
Methods: In May 2024, we initiated a 52-week prospective cohort at a hospital-based clinic in Montreal (Canada) – Antiretroviral Speed Access Program Switch Study (ASAP-Switch). ART-experienced MWH recently arrived in Quebec (<2 years) were switched to Bictegravir/Emtricitabine/Tenofovir-Alafenamide (B/F/TAF) free-of-charge. We measured social support with the 8-item Medical Outcomes Study Social Support Survey (MOS-SSS), with higher scores on an averaged 0–100 scale indicating better support. The 6-item Kessler Psychosocial Distress Scale (K6) was used to assess absence (0-18) or presence (9-30) of serious mental illness. HIV-related stigma was measured using the 6-point AIDS-Related Stigma Scale, with higher scores indicating greater internalized stigma. We computed descriptive statistics of socio-demographic and psycho-social variables collected at baseline.
Results: As of December 2024, 20/50(40%) participants have been recruited, prescribed B/F/TAF in a median (m) of 6 days from first clinic visit (Interquartile range [IQR]=0-19), and completed at least 4/72 weeks of follow-up. Among these, 17/20(85%) are active participants (3 withdrawals); 9/17(53%) are female; 13/17(76%) are aged <50 years; and 10/17(59%) are heterosexual. At baseline, concerning social support, mean score on the MOS-SSS was 31 (Standard Deviation=14.2). Most participants did not meet criteria for serious mental illness on the K6 scale (m=10; IQR=6-14) and the HIV-related stigma mean score was 2/6 (IQR=1-3).
Conclusion: Psychological distress and stigma were low in 17 MWH rapidly switched to B/F/TAF, despite limited social support. Monitoring these indicators along the HIV care cascade and offering mental health interventions could improve their care.
Methods: In May 2024, we initiated a 52-week prospective cohort at a hospital-based clinic in Montreal (Canada) – Antiretroviral Speed Access Program Switch Study (ASAP-Switch). ART-experienced MWH recently arrived in Quebec (<2 years) were switched to Bictegravir/Emtricitabine/Tenofovir-Alafenamide (B/F/TAF) free-of-charge. We measured social support with the 8-item Medical Outcomes Study Social Support Survey (MOS-SSS), with higher scores on an averaged 0–100 scale indicating better support. The 6-item Kessler Psychosocial Distress Scale (K6) was used to assess absence (0-18) or presence (9-30) of serious mental illness. HIV-related stigma was measured using the 6-point AIDS-Related Stigma Scale, with higher scores indicating greater internalized stigma. We computed descriptive statistics of socio-demographic and psycho-social variables collected at baseline.
Results: As of December 2024, 20/50(40%) participants have been recruited, prescribed B/F/TAF in a median (m) of 6 days from first clinic visit (Interquartile range [IQR]=0-19), and completed at least 4/72 weeks of follow-up. Among these, 17/20(85%) are active participants (3 withdrawals); 9/17(53%) are female; 13/17(76%) are aged <50 years; and 10/17(59%) are heterosexual. At baseline, concerning social support, mean score on the MOS-SSS was 31 (Standard Deviation=14.2). Most participants did not meet criteria for serious mental illness on the K6 scale (m=10; IQR=6-14) and the HIV-related stigma mean score was 2/6 (IQR=1-3).
Conclusion: Psychological distress and stigma were low in 17 MWH rapidly switched to B/F/TAF, despite limited social support. Monitoring these indicators along the HIV care cascade and offering mental health interventions could improve their care.
Mona Loutfy
Women's College Hospital
Canadian Physicians’ Perceptions and Experiences with Cabotegravir and Rilpivirine Long-Acting Antiretroviral Therapy: Full Analysis Results from a Cross-Sectional Survey
Abstract
Background: Cabotegravir and rilpivirine long-acting (CAB+RPV LA) is the only long-acting regimen for virologically suppressed people with HIV, offering a reduced dosing schedule (monthly or every 2 months) that may improve adherence and ease HIV status disclosure concerns. This study describes the real-world experience of Canadian physicians prescribing CAB+RPV LA, focusing on its acceptability, convenience, and perceived barriers.
Methods: Physicians treating ≥50 people with HIV and routinely prescribing CAB+RPV LA completed an online survey between September 2023 and February 2024. The study assessed physician and practice characteristics, perceptions and experiences with CAB+RPV LA, and barriers to its implementation.
Results: Thirty-four physicians (76.5% cisgender men, 50% primary care practitioners, 88.2% trained in infectious disease and/or HIV medicine, 82.3% with >10 years of HIV treatment experience, and 94.1% with 1-4 years of CAB+RPV LA prescribing experience) were surveyed. More than three quarters (82.4%) had very positive views on implementing CAB+RPV LA. Sixty-eight percent found it somewhat to extremely easy to integrate CAB+RPV LA administration into their workflow, and 82.4% reported optimal implementation within 6 months or less. Ninety-one percent considered CAB+RPV LA support programs suitable as alternate administration sites, and 85.3% found primary care practices to be suitable alternate administration sites. Twenty-nine percent had moderate concerns about injection site reactions, while none were extremely concerned, and 8.8% were extremely concerned about oral bridging. Reduced pill burden (88.2%), patient convenience (94.1%), demonstrated efficacy in clinical trials (88.2%), and patient preference (97.1%) were valued as important factors in prescribing decisions for CAB+RPV LA.
Conclusion: Understanding physician experiences with CAB+RPV LA is crucial for optimizing long-acting HIV treatments and enhancing patient care. This real-world data from a small sample of Canadian physicians indicates a positive overall opinion, successful integration within 6 months or less, and the benefits of CAB+RPV LA.
Methods: Physicians treating ≥50 people with HIV and routinely prescribing CAB+RPV LA completed an online survey between September 2023 and February 2024. The study assessed physician and practice characteristics, perceptions and experiences with CAB+RPV LA, and barriers to its implementation.
Results: Thirty-four physicians (76.5% cisgender men, 50% primary care practitioners, 88.2% trained in infectious disease and/or HIV medicine, 82.3% with >10 years of HIV treatment experience, and 94.1% with 1-4 years of CAB+RPV LA prescribing experience) were surveyed. More than three quarters (82.4%) had very positive views on implementing CAB+RPV LA. Sixty-eight percent found it somewhat to extremely easy to integrate CAB+RPV LA administration into their workflow, and 82.4% reported optimal implementation within 6 months or less. Ninety-one percent considered CAB+RPV LA support programs suitable as alternate administration sites, and 85.3% found primary care practices to be suitable alternate administration sites. Twenty-nine percent had moderate concerns about injection site reactions, while none were extremely concerned, and 8.8% were extremely concerned about oral bridging. Reduced pill burden (88.2%), patient convenience (94.1%), demonstrated efficacy in clinical trials (88.2%), and patient preference (97.1%) were valued as important factors in prescribing decisions for CAB+RPV LA.
Conclusion: Understanding physician experiences with CAB+RPV LA is crucial for optimizing long-acting HIV treatments and enhancing patient care. This real-world data from a small sample of Canadian physicians indicates a positive overall opinion, successful integration within 6 months or less, and the benefits of CAB+RPV LA.
Amy Ly
Research Coordinator
Women's College Hospital
A Qualitative study on implementation preparation for the Women-Centred HIV Care Pocketbook using a community-based version of the Consolidated Framework for Implementation Research
Abstract
Systemic inequities create barriers to person-centred healthcare for cis/trans women, Two-Spirit, and gender-diverse individuals. Building on the evidence-based, community-informed Women-Centred HIV Care (WCHC) Model, the WCHC-Pocketbook was developed as a communication tool to address these disparities by empowering women with HIV to self-advocate and improve patient-provider communication. This study aimed to obtain feedback on a WCHC-Pocketbook prototype.
A community-based, descriptive qualitative study was conducted to explore factors relevant to the implementation of the WCHC-Pocketbook. Semi-structured interviews were conducted (January to July 2024) with 38 participants (18 women with HIV, 10 clinicians, and 10 community-based providers) purposefully sampled for diversity through CBOs, clinics, and social media. Interviews were audio-recorded and supplemented by a demographic survey. Rapid qualitative analysis – organized by the Consolidated Framework for Implementation Research (CFIR) – was conducted.
Priorities emerged across all CFIR domains (inner setting, outer setting, individual characteristics, intervention, implementation process). Findings for the Implementation Domain were: (a) the WCHC-Pocketbook is relevant and acceptable but requires revisions (e.g. incorporating information on aging, infant feeding, and newcomer priorities); (b) women emphasized collaborative use, rather than placing the responsibility on women. For the Outer Setting, participants believed the WCHC-Pocketbook could enhance connections across agencies. Providers and women expressed a willingness to integrate the WCHC-Pocketbook into practices/care (Inner Setting Domain). However, findings across Inner Setting, Individual Characteristics, and Implementation Process Domains raised considerations for implementation: (a) limited time for use during clinical appointments; (b) individual focus precludes fostering community connections; and (c) potential organizational buy-in barriers.
The WCHC-Pocketbook is supported by women with HIV, healthcare, and CBO-service providers. This study demonstrated interest in the WCHC-Pocketbook as a communication tool with potential to improve health self-advocacy, engagement, and care for women with HIV in Canada. This pre-implementation study identified considerations that will inform next steps for the WCHC-Pocketbook.
A community-based, descriptive qualitative study was conducted to explore factors relevant to the implementation of the WCHC-Pocketbook. Semi-structured interviews were conducted (January to July 2024) with 38 participants (18 women with HIV, 10 clinicians, and 10 community-based providers) purposefully sampled for diversity through CBOs, clinics, and social media. Interviews were audio-recorded and supplemented by a demographic survey. Rapid qualitative analysis – organized by the Consolidated Framework for Implementation Research (CFIR) – was conducted.
Priorities emerged across all CFIR domains (inner setting, outer setting, individual characteristics, intervention, implementation process). Findings for the Implementation Domain were: (a) the WCHC-Pocketbook is relevant and acceptable but requires revisions (e.g. incorporating information on aging, infant feeding, and newcomer priorities); (b) women emphasized collaborative use, rather than placing the responsibility on women. For the Outer Setting, participants believed the WCHC-Pocketbook could enhance connections across agencies. Providers and women expressed a willingness to integrate the WCHC-Pocketbook into practices/care (Inner Setting Domain). However, findings across Inner Setting, Individual Characteristics, and Implementation Process Domains raised considerations for implementation: (a) limited time for use during clinical appointments; (b) individual focus precludes fostering community connections; and (c) potential organizational buy-in barriers.
The WCHC-Pocketbook is supported by women with HIV, healthcare, and CBO-service providers. This study demonstrated interest in the WCHC-Pocketbook as a communication tool with potential to improve health self-advocacy, engagement, and care for women with HIV in Canada. This pre-implementation study identified considerations that will inform next steps for the WCHC-Pocketbook.
Lawrence Mbuagbaw
Associate Professor
McMaster University
Socio-economical determinants of virtual care use among people with HIV Ontario: A cross-sectional study
Abstract
Background: People living with HIV face several socio-economic factors that impact their HIV-related health outcomes. While virtual care may help reduce barriers to timely HIV care, the socio-demographic factors influencing virtual visit uptake among this group remain unexplored.
Objectives: We assessed the association between the social-economical factors and virtual care use among people living with HIV in a clinical cohort in Ontario, Canada.
Methods: We used 2022 data from the Ontario HIV Treatment Network Cohort Study (OCS) when virtual care was first introduced. OCS is a multi-site cohort including patients from 10 HIV clinics, with data collected from medical charts, interviews, and record linkage with the provincial public health lab for viral load tests. The three care modes—virtual, in-person, and a combination of both—were analyzed using three-category multinomial logistic regression to identify predictors of the patient's use of virtual care mode.
Results: A total of 1,930 participants were included, out of which 19% received virtual care, 45.6% received in-person care, and 34.3% received care through both virtual and in-person modalities. The median age of the participants was 55 years (IQR: 45-62], and 78% of the sample were men who have sex with men (MSM). Residence in the Southwestern and Eastern region of Ontario, as compared to the Toronto region, was associated with virtual care use. Females and men who do not have sex with men (non-MSM) compared to MSM, people with a high school degree as compared to university degree, and HIV diagnosis within the last 10 years as compared to > 10 years of diagnosis used in-person care as compared to virtual care.
Conclusion: During the pandemic, virtual care was introduced to enhance healthcare access. Its uptake is linked to various socio-economic factors and health-related factors. However, further research is needed outside of the COVID-19 context.
Objectives: We assessed the association between the social-economical factors and virtual care use among people living with HIV in a clinical cohort in Ontario, Canada.
Methods: We used 2022 data from the Ontario HIV Treatment Network Cohort Study (OCS) when virtual care was first introduced. OCS is a multi-site cohort including patients from 10 HIV clinics, with data collected from medical charts, interviews, and record linkage with the provincial public health lab for viral load tests. The three care modes—virtual, in-person, and a combination of both—were analyzed using three-category multinomial logistic regression to identify predictors of the patient's use of virtual care mode.
Results: A total of 1,930 participants were included, out of which 19% received virtual care, 45.6% received in-person care, and 34.3% received care through both virtual and in-person modalities. The median age of the participants was 55 years (IQR: 45-62], and 78% of the sample were men who have sex with men (MSM). Residence in the Southwestern and Eastern region of Ontario, as compared to the Toronto region, was associated with virtual care use. Females and men who do not have sex with men (non-MSM) compared to MSM, people with a high school degree as compared to university degree, and HIV diagnosis within the last 10 years as compared to > 10 years of diagnosis used in-person care as compared to virtual care.
Conclusion: During the pandemic, virtual care was introduced to enhance healthcare access. Its uptake is linked to various socio-economic factors and health-related factors. However, further research is needed outside of the COVID-19 context.
Lawrence Mbuagbaw
Associate Professor
McMaster University
Association between virtual visits and health outcomes in people living with HIV: A cross-sectional study
Abstract
Background: Virtual care has been integrated as a modality of care in Ontario, yet its effectiveness for people living with HIV remains largely unexplored.
Objectives: We aimed to determine the association of visit modality (virtual, in-person, or both) on adherence to antiretroviral therapy (ART), viral load, and quality of life (QOL) in people living with HIV in Ontario, Canada.
Methods: We conducted a cross-sectional study using data from the 2022 Ontario HIV Treatment Network Cohort Study (OCS), collected during the COVID-19 pandemic when virtual visits were first introduced. Participants were grouped into three categories based on the mode of care: virtual, in-person, or a combination of both. Data were collected through self-reported questionnaires and medical records, with viral load data linked to Public Health Ontario Laboratories (PHOL). Regression was used to examine the factors associated with optimal ART adherence, viral load suppression, and quality of life (mental and physical).
Results: In 2022, 1930 participants accessed HIV care in the OCS. Among them, 19.0% received virtual care, 45.6% received in-person care, and 34.3% received care through virtual and in-person modalities. The median age of the participants was 55 years (IQR: 45-62). In the multivariable logistic regression model, virtual care was associated with an increased likelihood of optimal adherence to antiretroviral therapy (Adjusted Odds Ratio (AOR) 1.30, 95% confidence interval (CI): 1.00-1.70) and an increased likelihood of achieving viral load suppression (AOR 1.67, 95% CI:1.03-2.63). Moreover, combined virtual and in-person care is associated with an improved mental quality of life compared to in-person care (Adjusted Mean difference (MD) - 0.96, 95% CI 0.05,1.87).
Conclusion: Virtual care is positively associated with adherence to antiretroviral therapy (ART) and viral suppression within this context. However, future research is necessary to establish causality and to assess the long-term effects of virtual care.
Objectives: We aimed to determine the association of visit modality (virtual, in-person, or both) on adherence to antiretroviral therapy (ART), viral load, and quality of life (QOL) in people living with HIV in Ontario, Canada.
Methods: We conducted a cross-sectional study using data from the 2022 Ontario HIV Treatment Network Cohort Study (OCS), collected during the COVID-19 pandemic when virtual visits were first introduced. Participants were grouped into three categories based on the mode of care: virtual, in-person, or a combination of both. Data were collected through self-reported questionnaires and medical records, with viral load data linked to Public Health Ontario Laboratories (PHOL). Regression was used to examine the factors associated with optimal ART adherence, viral load suppression, and quality of life (mental and physical).
Results: In 2022, 1930 participants accessed HIV care in the OCS. Among them, 19.0% received virtual care, 45.6% received in-person care, and 34.3% received care through virtual and in-person modalities. The median age of the participants was 55 years (IQR: 45-62). In the multivariable logistic regression model, virtual care was associated with an increased likelihood of optimal adherence to antiretroviral therapy (Adjusted Odds Ratio (AOR) 1.30, 95% confidence interval (CI): 1.00-1.70) and an increased likelihood of achieving viral load suppression (AOR 1.67, 95% CI:1.03-2.63). Moreover, combined virtual and in-person care is associated with an improved mental quality of life compared to in-person care (Adjusted Mean difference (MD) - 0.96, 95% CI 0.05,1.87).
Conclusion: Virtual care is positively associated with adherence to antiretroviral therapy (ART) and viral suppression within this context. However, future research is necessary to establish causality and to assess the long-term effects of virtual care.
Mark McGovern
Merck Canada
Viral Blips in the Doravirine Phase 3 Clinical Trials DRIVE-FORWARD and DRIVE-AHEAD
Abstract
Background:
We examined associations between transient viremia (‘blips’), baseline characteristics, and virologic failure (VF) in two phase 3 studies of doravirine (DOR), a non-nucleoside reverse transcriptase inhibitor for HIV-1 treatment.
Materials and Methods:
Post-hoc analysis of blips (HIV-1 RNA ≥50 copies/mL immediately preceded and followed by<50copies/mL) in DRIVE-FORWARD (MK-1439-018) and DRIVE-AHEAD (MK-1439A-021). Cox proportional hazard models were used to analyze relationships between baseline characteristics (age, history of AIDS, HIV-1 RNA, CD4 count, race, sex, and study), blips, and VF.
Results:
In the double-blind phase, blips occurred in 11.1-11.9% of the DOR groups and 12.1-15.4% of the Comparator groups, and most participants with blips had only one episode (table). Baseline HIV-1 RNA ≤100,000 copies/mL was associated with a lower hazard ratio (HR) for blips, 0.41 (95% CI: 0.29, 0.58). VF was more common in participants with blips (13.6%, 23/169) vs those without blips (6.1%, 71/1169), and blips were associated with an increased HR for VF, 3.79 (2.32, 6.18). Treatment regimen did not appear to impact risk for blips or VF after blip. Only 6 participants had VF after blip in the extension phase.
Conclusions:
In DRIVE-FORWARD and DRIVE-AHEAD, the DOR and Comparator groups had similar rates of viral blips; in both groups, blips were more common in participants with baseline HIV-1 RNA >100,000 copies/mL and were associated with increased risk for subsequent VF. Blips were less common after ≥2 years on DOR or switching to DOR.
We examined associations between transient viremia (‘blips’), baseline characteristics, and virologic failure (VF) in two phase 3 studies of doravirine (DOR), a non-nucleoside reverse transcriptase inhibitor for HIV-1 treatment.
Materials and Methods:
Post-hoc analysis of blips (HIV-1 RNA ≥50 copies/mL immediately preceded and followed by<50copies/mL) in DRIVE-FORWARD (MK-1439-018) and DRIVE-AHEAD (MK-1439A-021). Cox proportional hazard models were used to analyze relationships between baseline characteristics (age, history of AIDS, HIV-1 RNA, CD4 count, race, sex, and study), blips, and VF.
Results:
In the double-blind phase, blips occurred in 11.1-11.9% of the DOR groups and 12.1-15.4% of the Comparator groups, and most participants with blips had only one episode (table). Baseline HIV-1 RNA ≤100,000 copies/mL was associated with a lower hazard ratio (HR) for blips, 0.41 (95% CI: 0.29, 0.58). VF was more common in participants with blips (13.6%, 23/169) vs those without blips (6.1%, 71/1169), and blips were associated with an increased HR for VF, 3.79 (2.32, 6.18). Treatment regimen did not appear to impact risk for blips or VF after blip. Only 6 participants had VF after blip in the extension phase.
Conclusions:
In DRIVE-FORWARD and DRIVE-AHEAD, the DOR and Comparator groups had similar rates of viral blips; in both groups, blips were more common in participants with baseline HIV-1 RNA >100,000 copies/mL and were associated with increased risk for subsequent VF. Blips were less common after ≥2 years on DOR or switching to DOR.
Michael McKimm
MSL
ViiV Healthcare
Real-World Experience of Two-Drug Regimen Dolutegravir /Lamivudine for the Treatment of HIV-1 among Vulnerable Patients Living with HIV in Canada: A Chart Review Study
Abstract
Background: Vulnerable persons living with HIV (PWH), including those who use drugs, are on social assistance, and seniors (≥65 years) with diminished autonomy, face unique adherence challenges to antiretroviral therapies (ARTs), potentially leading to incomplete virologic suppression, poorer health outcomes and higher HIV transmission rates. Simpler, safe and effective single-tablet regimens may be particularly beneficial for these individuals. We evaluated clinical outcomes among vulnerable PWH who switched to single-tablet, 2-drug dolutegravir/lamivudine (DTG/3TC).
Methods: A chart review study was conducted among PWH (aged ≥18 years) from 10 clinics in Canada who switched to DTG/3TC between 09/09/2019 and 31/05/2023, with ≥1 pre-defined vulnerability criteria: recent drug use, opioid agonist therapy use, history of homelessness, receiving social assistance, Indigenous identity, or aged ≥65 years with diminished autonomy (‘vulnerable senior’). Data were collected for demographic and clinical characteristics at baseline (≤12-months pre-switch), and for viral load, CD4+ cell counts, and treatment discontinuation at 12 (±2) months following DTG/3TC initiation.
Results: We identified 108 PWH (mean [SD] age: 52.0±11.5 years; male: 78.7%; drug use: 49.1%; vulnerable senior: 9.3%; social assistance: 63.9%; homelessness: 17.6%; Indigenous: 4.6%). At baseline, 93.5% (n=101/108) were virally-suppressed <50 cps/mL (96.3% <200 cps/mL, n=104/108) with median (IQR) CD4+ cell count of 660 (487-840) cells/mm³ (n=108). Primary reasons for switching to DTG/3TC were ART simplification (57.4%) and side effects from previous regimen (19.4%). Viral load and CD4+ cell counts were available at 12-months for 55 (50.9%) and 37 (34.3%) PWH, respectively. Among those with viral load tests, 94.5% (n=52/55) were virally-suppressed <50 cps/mL (98.2% <200 cps/mL, n=54/55), with median (IQR) CD4+ cell count of 540 (436-804) cells/mm³ (n=37). Six of the 9 (9/108; 8.3%) discontinuations reported were due to lifestyle/convenience factors.
Conclusions: Study results demonstrate the real-world effectiveness of DTG/3TC among vulnerable treatment-experienced PWH, with sustained viral suppression observed at 12 months.
Methods: A chart review study was conducted among PWH (aged ≥18 years) from 10 clinics in Canada who switched to DTG/3TC between 09/09/2019 and 31/05/2023, with ≥1 pre-defined vulnerability criteria: recent drug use, opioid agonist therapy use, history of homelessness, receiving social assistance, Indigenous identity, or aged ≥65 years with diminished autonomy (‘vulnerable senior’). Data were collected for demographic and clinical characteristics at baseline (≤12-months pre-switch), and for viral load, CD4+ cell counts, and treatment discontinuation at 12 (±2) months following DTG/3TC initiation.
Results: We identified 108 PWH (mean [SD] age: 52.0±11.5 years; male: 78.7%; drug use: 49.1%; vulnerable senior: 9.3%; social assistance: 63.9%; homelessness: 17.6%; Indigenous: 4.6%). At baseline, 93.5% (n=101/108) were virally-suppressed <50 cps/mL (96.3% <200 cps/mL, n=104/108) with median (IQR) CD4+ cell count of 660 (487-840) cells/mm³ (n=108). Primary reasons for switching to DTG/3TC were ART simplification (57.4%) and side effects from previous regimen (19.4%). Viral load and CD4+ cell counts were available at 12-months for 55 (50.9%) and 37 (34.3%) PWH, respectively. Among those with viral load tests, 94.5% (n=52/55) were virally-suppressed <50 cps/mL (98.2% <200 cps/mL, n=54/55), with median (IQR) CD4+ cell count of 540 (436-804) cells/mm³ (n=37). Six of the 9 (9/108; 8.3%) discontinuations reported were due to lifestyle/convenience factors.
Conclusions: Study results demonstrate the real-world effectiveness of DTG/3TC among vulnerable treatment-experienced PWH, with sustained viral suppression observed at 12 months.
Michael McKimm
MSL
ViiV Healthcare
Treatment-Emergent Integrase Strand Transfer Inhibitor (INSTI) Resistance-Associated Mutations Among People With HIV-1 Treated With Dolutegravir (DTG) + Lamivudine (3TC) With Pre-existing M184V/I From Real-world and Interventional Studies
Abstract
Background: DTG + 3TC has a high barrier to resistance and is recommended as first-line and maintenance therapy for HIV-1. We report INSTI mutation incidence in populations using DTG + 3TC, including those with pre-existing M184V/I, from real-world evidence (RWE) and interventional studies.
Methods: We conducted a systematic literature review, searching Ovid MEDLINE®, Embase®, PubMed, Cochrane databases, and congresses for RWE and interventional studies reporting DTG + 3TC use (January 2013-March 2024). All publications with ≥10 people using DTG + 3TC (all studies) and all publications with ≥10 people using DTG + 3TC that evaluated baseline M184V/I, even if 0 people with baseline M184V/I were reported (studies evaluating baseline M184V/I), were included. To avoid double-counting from studies with multiple publications or study population overlap, unique populations were collectively represented by a “lead” publication with most recent data and/or highest N.
Results: We identified 300 publications (n=249 RWE, n=51 interventional) reporting DTG + 3TC use (108 discrete cohorts and trials, 47,350 unique people after accounting for population overlap). Of those, 30 lead studies (N=10,383) reported ≥10 people and evaluated baseline M184V/I. Overall prevalence of baseline M184V/I was 5% (512/10,383) among studies evaluating baseline M184V/I and 0.9% (406/47,350) among all studies. Prevalence of M184V/I in interventional studies was 20% (219/1096) and 8% (221/2914) among studies evaluating baseline M184V/I and among all studies, respectively (several interventional studies focused on M184V/I, overestimating prevalence). Treatment-emergent INSTI resistance was reported in 6/47,350 (0.01%) people across all studies and 2/10,383 (0.02%) among studies evaluating baseline M184V/I. No treatment-emergent INSTI resistance cases had known baseline M184V/I.
Conclusions: No cases of treatment-emergent INSTI resistance development were identified among people with HIV-1 who had M184V/I before DTG + 3TC therapy (0/512). Results indicate that using DTG + 3TC when M184V/I is present may not increase risk of INSTI mutation development.
Methods: We conducted a systematic literature review, searching Ovid MEDLINE®, Embase®, PubMed, Cochrane databases, and congresses for RWE and interventional studies reporting DTG + 3TC use (January 2013-March 2024). All publications with ≥10 people using DTG + 3TC (all studies) and all publications with ≥10 people using DTG + 3TC that evaluated baseline M184V/I, even if 0 people with baseline M184V/I were reported (studies evaluating baseline M184V/I), were included. To avoid double-counting from studies with multiple publications or study population overlap, unique populations were collectively represented by a “lead” publication with most recent data and/or highest N.
Results: We identified 300 publications (n=249 RWE, n=51 interventional) reporting DTG + 3TC use (108 discrete cohorts and trials, 47,350 unique people after accounting for population overlap). Of those, 30 lead studies (N=10,383) reported ≥10 people and evaluated baseline M184V/I. Overall prevalence of baseline M184V/I was 5% (512/10,383) among studies evaluating baseline M184V/I and 0.9% (406/47,350) among all studies. Prevalence of M184V/I in interventional studies was 20% (219/1096) and 8% (221/2914) among studies evaluating baseline M184V/I and among all studies, respectively (several interventional studies focused on M184V/I, overestimating prevalence). Treatment-emergent INSTI resistance was reported in 6/47,350 (0.01%) people across all studies and 2/10,383 (0.02%) among studies evaluating baseline M184V/I. No treatment-emergent INSTI resistance cases had known baseline M184V/I.
Conclusions: No cases of treatment-emergent INSTI resistance development were identified among people with HIV-1 who had M184V/I before DTG + 3TC therapy (0/512). Results indicate that using DTG + 3TC when M184V/I is present may not increase risk of INSTI mutation development.
Rosie Murphy
Research Coordinator
British Columbia Centre For Excellence In HIV/AIDS
Incidence of Reduced Renal Function and Associated Characteristics Amongst British Columbia's HIV Pre-Exposure Prophylaxis (PrEP) Program Participants on Emtricitabine-Tenofovir DF (FTC-TDF)
Abstract
Background:
HIV PrEP with FTC-TDF has been publicly funded in British Columbia since 2018. We quantified the extent of reduced renal function and determined associated characteristics in PrEP program participants.
Methods:
Participants with ≥1 FTC-TDF prescription(s) dispensed between 1-Jan-2018 and 31-Dec-2023, with ≥1 follow up eGFR ≥7 days after first dispense were included (study follow-up to 30-Jun-2024). Baseline participant and clinical characteristics are described and stratified by those with and without decreased renal function (≥2 consecutive follow-up eGFR <60mL/min, ≥30-days apart). Between group comparisons were made using Fisher’s exact and Wilcoxon’s rank sum tests. Multivariate analysis was performed to determine adjusted hazard ratios (aHR), identifying key characteristics associated with time to reduced renal function.
Results:
Overall, 10,078 participants were included, with median (Q1-Q3) follow-up of 1.9 (0.7-3.9) years. Median eGFR testing rate was 3.4 (2.1-4.5) per person year (PY). 146 (1.4%) had reduced renal function (rate: 6.2 per 1000 PY). Baseline characteristics varied between groups (Table). Several variables were associated with time to reduced renal function: age at enrolment ≥50 years (aHR 5.34[95% CI, 3.65, 7.82] p=0.001)(Reference: <50), baseline eGFR <60mL/min, (aHR 190[95% CI, 73, 490]p<0.001), baseline eGFR 60-89mL/min (aHR 27[95% CI, 12, 58] p<0.001)(Reference: ≥90), and higher proportion of days covered by PrEP medication (PDC)(aHR 1.01[95% CI, 1, 1.01] p=0.014).
Conclusions:
Reduced renal function was infrequent with FTC-TDF PrEP. Participants aged ≥50, those with lower baseline eGFR, and those with higher PDC were disproportionately affected. Quarterly renal testing may be reconsidered for those at low risk of renal impairment.
HIV PrEP with FTC-TDF has been publicly funded in British Columbia since 2018. We quantified the extent of reduced renal function and determined associated characteristics in PrEP program participants.
Methods:
Participants with ≥1 FTC-TDF prescription(s) dispensed between 1-Jan-2018 and 31-Dec-2023, with ≥1 follow up eGFR ≥7 days after first dispense were included (study follow-up to 30-Jun-2024). Baseline participant and clinical characteristics are described and stratified by those with and without decreased renal function (≥2 consecutive follow-up eGFR <60mL/min, ≥30-days apart). Between group comparisons were made using Fisher’s exact and Wilcoxon’s rank sum tests. Multivariate analysis was performed to determine adjusted hazard ratios (aHR), identifying key characteristics associated with time to reduced renal function.
Results:
Overall, 10,078 participants were included, with median (Q1-Q3) follow-up of 1.9 (0.7-3.9) years. Median eGFR testing rate was 3.4 (2.1-4.5) per person year (PY). 146 (1.4%) had reduced renal function (rate: 6.2 per 1000 PY). Baseline characteristics varied between groups (Table). Several variables were associated with time to reduced renal function: age at enrolment ≥50 years (aHR 5.34[95% CI, 3.65, 7.82] p=0.001)(Reference: <50), baseline eGFR <60mL/min, (aHR 190[95% CI, 73, 490]p<0.001), baseline eGFR 60-89mL/min (aHR 27[95% CI, 12, 58] p<0.001)(Reference: ≥90), and higher proportion of days covered by PrEP medication (PDC)(aHR 1.01[95% CI, 1, 1.01] p=0.014).
Conclusions:
Reduced renal function was infrequent with FTC-TDF PrEP. Participants aged ≥50, those with lower baseline eGFR, and those with higher PDC were disproportionately affected. Quarterly renal testing may be reconsidered for those at low risk of renal impairment.
Hugh Ngo
Sr. Medical Manager
Gilead Sciences
Global survey to evaluate engagement in care and treatment experiences of people with HIV (PWH)
Abstract
Introduction: Understanding experiences of people with HIV (PWH) is vital to enhance engagement in care to achieve long-term treatment success. A 45-minute, cross-sectional, online survey was co-developed by investigators and community advocates from 11 countries and translated into local languages. Survey questions assessed the experiences of PWH across the care cascade.
Methods: Participants (≥18 years old with a self-reported HIV diagnosis) were recruited through patient databases, consumer panels, advocacy groups, and physician referrals. Preliminary analyses (n=347) reported here includes participants who completed the survey in English across Canada, the U.S., South Africa, and the U.K.
Results: Of 338 participants who initiated antiretroviral therapy (ART), similar proportions began treatment within 7 days (n=102/338, 30%), 8-30 days (n=105/338, 31%), and >30 days from diagnosis (n=131/338, 39%) (Table). Reasons for starting treatment >30 days included: physician recommendation based on CD4 count (n=45/131, 34%), fear of potential side effects (n=42/131, 32%), and time needed to accept diagnosis (n=37/131, 28%). Most participants did not report adherence challenges with oral (n=265/315, 84%) or injectable (n=11/13, 85%) ART. The same top 3 reasons were identified as most important factors for remaining on and switching treatment: achieving/maintaining undetectable viral load, reducing side effects, and long-term safety/effectiveness; however, these reasons differed in order of importance (Figure). The overall median 10-item HIV Treatment Satisfaction Questionnaire score was 54/60 (n=328), and highest for bictegravir/emtricitabine/tenofovir alafenamide (57/60, n=51) amongst those on daily oral ART.
Conclusions: Results showed 39% of participants delayed starting HIV treatment, highlighting opportunities to improve rapid initiation.
Methods: Participants (≥18 years old with a self-reported HIV diagnosis) were recruited through patient databases, consumer panels, advocacy groups, and physician referrals. Preliminary analyses (n=347) reported here includes participants who completed the survey in English across Canada, the U.S., South Africa, and the U.K.
Results: Of 338 participants who initiated antiretroviral therapy (ART), similar proportions began treatment within 7 days (n=102/338, 30%), 8-30 days (n=105/338, 31%), and >30 days from diagnosis (n=131/338, 39%) (Table). Reasons for starting treatment >30 days included: physician recommendation based on CD4 count (n=45/131, 34%), fear of potential side effects (n=42/131, 32%), and time needed to accept diagnosis (n=37/131, 28%). Most participants did not report adherence challenges with oral (n=265/315, 84%) or injectable (n=11/13, 85%) ART. The same top 3 reasons were identified as most important factors for remaining on and switching treatment: achieving/maintaining undetectable viral load, reducing side effects, and long-term safety/effectiveness; however, these reasons differed in order of importance (Figure). The overall median 10-item HIV Treatment Satisfaction Questionnaire score was 54/60 (n=328), and highest for bictegravir/emtricitabine/tenofovir alafenamide (57/60, n=51) amongst those on daily oral ART.
Conclusions: Results showed 39% of participants delayed starting HIV treatment, highlighting opportunities to improve rapid initiation.
Sofia Nicolls
Masters Student
University of British Columbia
Assessing Human Papillomavirus Self-Sampling Attitudes in Women and Persons with a Cervix Living with HIV in Canada
Abstract
Objectives: To determine the thoughts, attitudes, and perceptions of HPV self-sampling as a method of screening for cervical cancer for women and people with a cervix living with HIV (WLWH) and to investigate associations between self-sampling attitudes and demographic/clinical characteristics.
Methods: A randomized trial assessing HPV vaccine dosing has a planned enrollment of 450 WLWH aged 18-45 recruited from 11 Canadian sites. Participants were given a brief description of HPV self-sampling and instructions on how to perform the test. Participants completed a questionnaire assessing their perceptions of the acceptability and comfort of HPV self-sampling before using the self-sampling methodology. Participant clinical and demographic characteristics (e.g., age, ethnicity, HIV viral load, and CD4+ T-cell count) were collected. Questionnaire responses were based on a 5-point Likert scale (strongly agree to strongly disagree) and dichotomized to "agree" and "disagree" for each statement. Participants’ clinical and demographic characteristics were included in bivariate analysis. Chi-square and Fisher's exact tests assessed relationships between questionnaire results and clinical characteristics.
Results: Of the 77 completed survey responses, the median CD4+ T cell count was 769 cells/mm³ (IQR 522-908). Participants' median age was 40 (IQR 36-43). 80.5% of participants felt confident that they would be able to collect their samples correctly, and 81.8% did not think they would experience any difficulties with self-collection. Most participants (73.7%) preferred to self-collect their sample instead of provider-collected sampling. Given the opportunity, 88% of participants agreed they would likely use self-collection methods for future cervical cancer screening. Many participants were concerned about receiving a positive HPV result (64.9%), passing HPV on to their partner(s) (71.4%), and disclosing their HPV status to friends or family (53.2%).
Conclusions: HPV self-sampling appears to be a favoured screening method for this population; however, many participants expressed concern about the implications of receiving a positive HPV test result.
Methods: A randomized trial assessing HPV vaccine dosing has a planned enrollment of 450 WLWH aged 18-45 recruited from 11 Canadian sites. Participants were given a brief description of HPV self-sampling and instructions on how to perform the test. Participants completed a questionnaire assessing their perceptions of the acceptability and comfort of HPV self-sampling before using the self-sampling methodology. Participant clinical and demographic characteristics (e.g., age, ethnicity, HIV viral load, and CD4+ T-cell count) were collected. Questionnaire responses were based on a 5-point Likert scale (strongly agree to strongly disagree) and dichotomized to "agree" and "disagree" for each statement. Participants’ clinical and demographic characteristics were included in bivariate analysis. Chi-square and Fisher's exact tests assessed relationships between questionnaire results and clinical characteristics.
Results: Of the 77 completed survey responses, the median CD4+ T cell count was 769 cells/mm³ (IQR 522-908). Participants' median age was 40 (IQR 36-43). 80.5% of participants felt confident that they would be able to collect their samples correctly, and 81.8% did not think they would experience any difficulties with self-collection. Most participants (73.7%) preferred to self-collect their sample instead of provider-collected sampling. Given the opportunity, 88% of participants agreed they would likely use self-collection methods for future cervical cancer screening. Many participants were concerned about receiving a positive HPV result (64.9%), passing HPV on to their partner(s) (71.4%), and disclosing their HPV status to friends or family (53.2%).
Conclusions: HPV self-sampling appears to be a favoured screening method for this population; however, many participants expressed concern about the implications of receiving a positive HPV test result.
Kelly O'Brien
Professor
University of Toronto
Disability and Engagement in Physical Activity among Adults Living with HIV: A Structural Equation Model Using the Episodic Disability Questionnaire
Abstract
PURPOSE:To describe relationships between dimensions of disability among adults living with HIV and the influence of engagement in physical activity.
METHODS:We used structural equation modeling to determine relationships between dimensions of disability as measured in the Episodic Disability Questionnaire(EDQ): i) physical, ii) cognitive, iii) mental-emotional health challenges, iv) difficulties with day-to-day activities, v) uncertainty, and vi) challenges to social inclusion. We used data from the HIV in Motion and EDQ studies, involving adults in Canada, Ireland, United States and United Kingdom who completed the EDQ and reported whether they met the Canadian Physical Activity (PA) Guidelines (≥150 minutes of moderate to vigorous aerobic physical activity in the past week). We conducted a confirmatory factor analysis with EDQ domain scores representing disability dimensions, and established a structural model to assess relationships between disability dimensions for exercisers (met PA guidelines) versus non-exercisers. Model fit was evaluated using Root Mean Square Error of Approximation (RMSEA<0.05). We classified standardized path coefficients >0.2-0.5 as moderate and >0.5 a strong effect.
RESULTS:Of the 590 participants, most were from Canada (53%), men (78%), and had not met PA guidelines (59%). The measurement model had good overall fit (RMSEA=0.046). Physical health challenges strongly predicted difficulties with day-to-day activities (path coefficient:0.54) and moderately predicted uncertainty(0.36). Uncertainty moderately predicted mental-emotional health challenges (0.49) and social inclusion challenges(0.21). Uncertainty had the largest indirect influence on social inclusion through mental-emotional health challenges(0.49*0.45:0.22). Exercisers had lower disability scores for all domains. Compared with non-exercisers, exercisers demonstrated a stronger relationship between cognitive challenges and day-to-day activities (0.31 versus 0.11) and weaker relationship between physical challenges and uncertainty (0.22 versus 0.44).
CONCLUSIONS:Uncertainty is a key dimension of disability experienced by adults living with HIV, predicting mental-emotional health and social inclusion. Exercise moderated disability experiences, highlighting areas for rehabilitation to mitigate disability and enhance health outcomes.
METHODS:We used structural equation modeling to determine relationships between dimensions of disability as measured in the Episodic Disability Questionnaire(EDQ): i) physical, ii) cognitive, iii) mental-emotional health challenges, iv) difficulties with day-to-day activities, v) uncertainty, and vi) challenges to social inclusion. We used data from the HIV in Motion and EDQ studies, involving adults in Canada, Ireland, United States and United Kingdom who completed the EDQ and reported whether they met the Canadian Physical Activity (PA) Guidelines (≥150 minutes of moderate to vigorous aerobic physical activity in the past week). We conducted a confirmatory factor analysis with EDQ domain scores representing disability dimensions, and established a structural model to assess relationships between disability dimensions for exercisers (met PA guidelines) versus non-exercisers. Model fit was evaluated using Root Mean Square Error of Approximation (RMSEA<0.05). We classified standardized path coefficients >0.2-0.5 as moderate and >0.5 a strong effect.
RESULTS:Of the 590 participants, most were from Canada (53%), men (78%), and had not met PA guidelines (59%). The measurement model had good overall fit (RMSEA=0.046). Physical health challenges strongly predicted difficulties with day-to-day activities (path coefficient:0.54) and moderately predicted uncertainty(0.36). Uncertainty moderately predicted mental-emotional health challenges (0.49) and social inclusion challenges(0.21). Uncertainty had the largest indirect influence on social inclusion through mental-emotional health challenges(0.49*0.45:0.22). Exercisers had lower disability scores for all domains. Compared with non-exercisers, exercisers demonstrated a stronger relationship between cognitive challenges and day-to-day activities (0.31 versus 0.11) and weaker relationship between physical challenges and uncertainty (0.22 versus 0.44).
CONCLUSIONS:Uncertainty is a key dimension of disability experienced by adults living with HIV, predicting mental-emotional health and social inclusion. Exercise moderated disability experiences, highlighting areas for rehabilitation to mitigate disability and enhance health outcomes.
Kelly O'Brien
Professor
University of Toronto
Disability and Associations with Intrinsic and Extrinsic Contextual Factors among Adults Living with HIV: Findings from the HIV in Motion and Episodic Disability Questionnaire Studies
Abstract
PURPOSE: To assess associations between dimensions of disability and contextual factors (intrinsic and extrinsic) among adults living with HIV.
METHODS: We conducted a cross-sectional study using data from the HIV in Motion (n=231) and Episodic Disability Questionnaire (n=359) studies with adults in Canada, Ireland, United States and United Kingdom. Participants completed the Episodic Disability Questionnaire (EDQ)(6 domains: physical, cognitive, mental-emotional health challenges, difficulties with day-to-day activities, uncertainty, and challenges to social inclusion) and questionnaires assessing intrinsic contextual factors (concurrent health conditions (pain, mental health), engagement in exercise, and 51 living strategies), and extrinsic contextual factors (Social Support Scale, HIV Stigma Scale). We conducted regression analyses using EDQ domain scores and contextual factors (predictor variables) to examine associations between disability and contextual factors. Standardized regression coefficients of >0.2-0.49 were classified as moderate and ≥0.5 as strong.
RESULTS: Of the 590 participants, the majority were from Canada(53%), men(78%), and taking antiretroviral therapy(98%). Living with pain (standardized coefficient range:0.24-0.51) or a mental health condition (0.29-0.47) was associated with greater disability scores, whereas social support (coefficient range:-0.24 to -0.42), and engagement in aerobic (-0.16 to -0.28) or strength (-0.14 to -0.19) exercise was associated with lower disability scores. Stigma was associated with higher disability scores. Living strategies associated with lower disability scores included: maintaining control over life(11 strategies), positive attitudes and beliefs(5 strategies) and engaging in social interaction(1 strategy). Living strategies associated with higher disability scores included: smoking cigarettes, feelings of hopelessness, blocking HIV from the mind, and isolating self from others(8 strategies). Age and gender were not associated with disability scores.
CONCLUSIONS: Modifiable contextual factors including social support, stigma, engagement in exercise, living strategies, and living with pain or mental health condition demonstrated associations with disability. Findings suggest areas to target rehabilitation interventions to mitigate disability and enhance health outcomes for adults with HIV.
METHODS: We conducted a cross-sectional study using data from the HIV in Motion (n=231) and Episodic Disability Questionnaire (n=359) studies with adults in Canada, Ireland, United States and United Kingdom. Participants completed the Episodic Disability Questionnaire (EDQ)(6 domains: physical, cognitive, mental-emotional health challenges, difficulties with day-to-day activities, uncertainty, and challenges to social inclusion) and questionnaires assessing intrinsic contextual factors (concurrent health conditions (pain, mental health), engagement in exercise, and 51 living strategies), and extrinsic contextual factors (Social Support Scale, HIV Stigma Scale). We conducted regression analyses using EDQ domain scores and contextual factors (predictor variables) to examine associations between disability and contextual factors. Standardized regression coefficients of >0.2-0.49 were classified as moderate and ≥0.5 as strong.
RESULTS: Of the 590 participants, the majority were from Canada(53%), men(78%), and taking antiretroviral therapy(98%). Living with pain (standardized coefficient range:0.24-0.51) or a mental health condition (0.29-0.47) was associated with greater disability scores, whereas social support (coefficient range:-0.24 to -0.42), and engagement in aerobic (-0.16 to -0.28) or strength (-0.14 to -0.19) exercise was associated with lower disability scores. Stigma was associated with higher disability scores. Living strategies associated with lower disability scores included: maintaining control over life(11 strategies), positive attitudes and beliefs(5 strategies) and engaging in social interaction(1 strategy). Living strategies associated with higher disability scores included: smoking cigarettes, feelings of hopelessness, blocking HIV from the mind, and isolating self from others(8 strategies). Age and gender were not associated with disability scores.
CONCLUSIONS: Modifiable contextual factors including social support, stigma, engagement in exercise, living strategies, and living with pain or mental health condition demonstrated associations with disability. Findings suggest areas to target rehabilitation interventions to mitigate disability and enhance health outcomes for adults with HIV.
Marie-Audrey Peel
Resident And Masters Student
Université De Montréal
Correlates of PrEP Willingness to inform PrEP Candidacy among People Who Inject Drugs: Results from a Canadian Urban Cohort
Abstract
Despite high HIV incidence estimates relative to other key populations in Canada, research on HIV preexposure prophylaxis (PrEP) has consistently overlooked people who inject drugs (PWID). As a result, PrEP is underused in this population and PWID rarely claim candidacy to this prevention method. While studies show willingness to use PrEP among PWID, what drives this interest is unclear.
Secondary analyses of data collected between 2016 and 2022 in HEPCO, a community-based open cohort of PWID. Bivariate analyses were conducted to examine associations between willingness to use PrEP and variables selected from a candidacy conceptual model: health services use, competing health needs, substance and sexual risk behaviors, and calculated ARCH-IDU (HIV risk validated score). Multivariate logistic regression models were elaborated to examine the association between PrEP willingness and high ARCH-IDU (>45), adjusting for (i) sex and (ii) contextual factors (e.g. housing status).
Of 466 individuals (82.4% males, Med = 42 years), 47.8% (221) were willing to use PrEP. Most had competing health needs, including psychological distress in 53.4% (249). Willingness to use PrEP was not associated with healthcare utilization, measured by medical and ER visits. Among HIV risk factors, cocaine injection was associated with willingness to use PrEP (X2=4.596, p-value=0.032). A high ARCH-IDU score was also associated with this outcome (X2 =4.678, p-value=0.031). In the multivariate model, high ARCH-IDU predicted increased likelihood of PrEP willingness, but fell short of statistical significance (1.42, CI 95%=0.97;2.07).
Almost half of PWID were willing to use PrEP. Absence of association between healthcare utilization and PrEP willingness could reflect missed opportunities for PrEP counselling. Of all individual HIV risk factors examined, only cocaine injection was correlated with willingness. A validated tool like ARCH-IDU, could be useful in clinical settings to initiate PrEP discussion, as it might capture unmeasured factors associated with willingness to use PrEP.
Secondary analyses of data collected between 2016 and 2022 in HEPCO, a community-based open cohort of PWID. Bivariate analyses were conducted to examine associations between willingness to use PrEP and variables selected from a candidacy conceptual model: health services use, competing health needs, substance and sexual risk behaviors, and calculated ARCH-IDU (HIV risk validated score). Multivariate logistic regression models were elaborated to examine the association between PrEP willingness and high ARCH-IDU (>45), adjusting for (i) sex and (ii) contextual factors (e.g. housing status).
Of 466 individuals (82.4% males, Med = 42 years), 47.8% (221) were willing to use PrEP. Most had competing health needs, including psychological distress in 53.4% (249). Willingness to use PrEP was not associated with healthcare utilization, measured by medical and ER visits. Among HIV risk factors, cocaine injection was associated with willingness to use PrEP (X2=4.596, p-value=0.032). A high ARCH-IDU score was also associated with this outcome (X2 =4.678, p-value=0.031). In the multivariate model, high ARCH-IDU predicted increased likelihood of PrEP willingness, but fell short of statistical significance (1.42, CI 95%=0.97;2.07).
Almost half of PWID were willing to use PrEP. Absence of association between healthcare utilization and PrEP willingness could reflect missed opportunities for PrEP counselling. Of all individual HIV risk factors examined, only cocaine injection was correlated with willingness. A validated tool like ARCH-IDU, could be useful in clinical settings to initiate PrEP discussion, as it might capture unmeasured factors associated with willingness to use PrEP.
Madhavi Prasad
Resident Physician
CHEO
Transition of adolescents living with HIV from pediatric to adult care: A survey of current practices and perceptions among HIV care providers in Canada
Abstract
Background
Growing numbers of adolescents with perinatal HIV are surviving childhood and transitioning to adult care. Differences between pediatric and adult care and psychosocial concerns can lead to decreased retention in care and loss to follow up. This study assessed current practices and barriers to provision of optimal transitional care for providers caring for adolescents with HIV.
Methods
A survey targeting Canadian pediatric and adult HIV healthcare providers was developed and distributed via regional and national HIV care organizations; responses were collected October to December 2024.
Results
Forty survey responses, including 24 from adult HIV healthcare providers, were analyzed. Most providers practiced in Ontario (42%), worked in tertiary care centres (68%) and provided HIV care for >10 years (53%). Only 35% reported satisfaction with how patients were transitioned. One participant reported formal training in transition care. Lack of time, low health literacy of patients, and systemic differences between pediatric and adult care were reported as the top 3 barriers to providing optimal transitional care. Only 28% thought 17-18y was the right age for transition; most (67%) thought an age range up to 25y was best. Half (50%) felt they had sufficient resources and skill to adequately address transition needs.
Conclusions
Challenges persist in ensuring a seamless transition from pediatric to adult care. Systemic barriers such as lack of time and resources can hinder access to quality care. By implementing evidence-based strategies and addressing these challenges, healthcare providers can aid adolescents with HIV in achieving optimal health outcomes throughout their lifespan.
Growing numbers of adolescents with perinatal HIV are surviving childhood and transitioning to adult care. Differences between pediatric and adult care and psychosocial concerns can lead to decreased retention in care and loss to follow up. This study assessed current practices and barriers to provision of optimal transitional care for providers caring for adolescents with HIV.
Methods
A survey targeting Canadian pediatric and adult HIV healthcare providers was developed and distributed via regional and national HIV care organizations; responses were collected October to December 2024.
Results
Forty survey responses, including 24 from adult HIV healthcare providers, were analyzed. Most providers practiced in Ontario (42%), worked in tertiary care centres (68%) and provided HIV care for >10 years (53%). Only 35% reported satisfaction with how patients were transitioned. One participant reported formal training in transition care. Lack of time, low health literacy of patients, and systemic differences between pediatric and adult care were reported as the top 3 barriers to providing optimal transitional care. Only 28% thought 17-18y was the right age for transition; most (67%) thought an age range up to 25y was best. Half (50%) felt they had sufficient resources and skill to adequately address transition needs.
Conclusions
Challenges persist in ensuring a seamless transition from pediatric to adult care. Systemic barriers such as lack of time and resources can hinder access to quality care. By implementing evidence-based strategies and addressing these challenges, healthcare providers can aid adolescents with HIV in achieving optimal health outcomes throughout their lifespan.
Erin Ready
Clinical Pharmacy Specialist
St. Paul's Hospital Ambulatory Pharmacy
Assessing ChatGPT’s Capability in Understanding and Reporting Antiretroviral Therapy Drug Interaction Effects: the ACCURATE-DDI Study
Abstract
Background:
Artificial intelligence platforms, such as ChatGPT, are transforming access to medication information. However, their ability to accurately identify antiretroviral (ARV) drug-drug interactions (DDIs) remains unclear. This study evaluates ChatGPT’s analysis of ARV-related DDIs compared to established HIV-specific DDI tools.
Methods:
Using ChatGPT4o-mini in November 2024, we tested 94 ARV DDI pairs. We asked ChatGPT to classify each interaction as “no interaction,” “potential interaction,” or “serious interaction.” We calculated accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), using the HIV/HCV Drug Therapy Guide and the University of Liverpool HIV Drug Interactions Checker as the correct classification. A subset of 25 pairs was qualitatively analyzed for responses to the query, “Can I take Drug A with Drug B?” Severity, mechanism, clinical effects, and management were scored (0 = incorrect, 1 = mixed, 2 = correct), yielding a composite score (maximum = 8). Responses were independently assessed by HIV-specialized pharmacist/pharmacologist reviewers; score discrepancies of 2+ between two reviewers were resolved by consensus involving a third reviewer.
Results:
ChatGPT correctly classified 40.4% (38/94) of DDI pairs, with errors primarily due to false negatives (34/56 errors; 60.7%). Sensitivity was 46.0%, specificity 29.0%, PPV 56.9%, and NPV 20.9%. The mean composite score was 3.9/8. ChatGPT was better able to categorize the severity of potential DDIs (1.6/2), compared to mechanism (0.7/2), clinical effects (0.9/2), and management (1/2). ChatGPT showed limited accuracy in identifying severity of serious DDIs (0.4/2), despite often correctly identifying mechanism (1.4/2) and clinical effects (1.6/2). Serious DDI management was often incorrect (0.9/2). ChatGPT performed poorly when assessing ritonavir DDIs involving mechanism other than CYP3A4 inhibition.
Conclusion:
ChatGPT demonstrated limited accuracy and specificity, often generating responses that combined correct and incorrect information. Notably, ChatGPT demonstrated a high rate of false negative classifications, frequently underreporting the severity of serious DDIs.
Artificial intelligence platforms, such as ChatGPT, are transforming access to medication information. However, their ability to accurately identify antiretroviral (ARV) drug-drug interactions (DDIs) remains unclear. This study evaluates ChatGPT’s analysis of ARV-related DDIs compared to established HIV-specific DDI tools.
Methods:
Using ChatGPT4o-mini in November 2024, we tested 94 ARV DDI pairs. We asked ChatGPT to classify each interaction as “no interaction,” “potential interaction,” or “serious interaction.” We calculated accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), using the HIV/HCV Drug Therapy Guide and the University of Liverpool HIV Drug Interactions Checker as the correct classification. A subset of 25 pairs was qualitatively analyzed for responses to the query, “Can I take Drug A with Drug B?” Severity, mechanism, clinical effects, and management were scored (0 = incorrect, 1 = mixed, 2 = correct), yielding a composite score (maximum = 8). Responses were independently assessed by HIV-specialized pharmacist/pharmacologist reviewers; score discrepancies of 2+ between two reviewers were resolved by consensus involving a third reviewer.
Results:
ChatGPT correctly classified 40.4% (38/94) of DDI pairs, with errors primarily due to false negatives (34/56 errors; 60.7%). Sensitivity was 46.0%, specificity 29.0%, PPV 56.9%, and NPV 20.9%. The mean composite score was 3.9/8. ChatGPT was better able to categorize the severity of potential DDIs (1.6/2), compared to mechanism (0.7/2), clinical effects (0.9/2), and management (1/2). ChatGPT showed limited accuracy in identifying severity of serious DDIs (0.4/2), despite often correctly identifying mechanism (1.4/2) and clinical effects (1.6/2). Serious DDI management was often incorrect (0.9/2). ChatGPT performed poorly when assessing ritonavir DDIs involving mechanism other than CYP3A4 inhibition.
Conclusion:
ChatGPT demonstrated limited accuracy and specificity, often generating responses that combined correct and incorrect information. Notably, ChatGPT demonstrated a high rate of false negative classifications, frequently underreporting the severity of serious DDIs.
Parisa Safavi
Pharmacist
Vch
A Cross-sectional Analysis of Antiretroviral Dosing in Chronic Kidney Disease Among People Living with HIV in British Columbia
Abstract
Background:
As people living with HIV (PLWH) age, the prevalence of age-related comorbidities such as chronic kidney disease (CKD) is expected to increase. We sought to estimate the prevalence of CKD in PLWH enrolled in the British Columbia Centre for Excellence in HIV/AIDS Drug Treatment Program (DTP) and characterize antiretroviral (ARV) dosing in this context.
Methods:
We conducted a cross-sectional analysis of PLWH in the DTP, using the Seek and Treat for Optimal Prevention of HIV/AIDS database. PLWH ≥19 years with an active ARV prescription as of index date 01-Mar-2020 were included. CKD cases were identified by lab linkage (≥2 eGFR values <60mL/min ≥90 days apart) or CKD case-finding algorithm applied to healthcare records within 1 year prior to index date; dialysis status was identified by case-finding algorithm. Renal ARV dosing was evaluated using Canadian monograph recommendations. Data were summarized descriptively.
Results:
Of 7,436 clients, 352 (4.7%) had CKD. Of the 222 with lab linkage, 139 (62.6%) had eGFR 50-60mL/min, 72 (32.4%) eGFR 30-49mL/min, 11 (5.0%) eGFR <30mL/min; 5 (2.3%) were on dialysis. Compared to PLWH on ARVs overall, characteristics of PLWH with CKD differed (see Table). Most (n=208, 94.0%) were prescribed ≥1 ARV with renal dosing implications (lamivudine, emtricitabine, tenofovir); none received higher-than-monograph-recommended-renal-doses of tenofovir-DF. Higher-than-monograph-recommended-renal-doses of ARVs were prescribed in 63/222 (28.4%); lamivudine was the ARV most commonly prescribed at higher-than-monograph-recommended-renal-doses.
Conclusion:
The estimated CKD prevalence in PLWH on ARVs in BC appears to be low, and the majority are receiving ARV regimens appropriate for their renal function.
As people living with HIV (PLWH) age, the prevalence of age-related comorbidities such as chronic kidney disease (CKD) is expected to increase. We sought to estimate the prevalence of CKD in PLWH enrolled in the British Columbia Centre for Excellence in HIV/AIDS Drug Treatment Program (DTP) and characterize antiretroviral (ARV) dosing in this context.
Methods:
We conducted a cross-sectional analysis of PLWH in the DTP, using the Seek and Treat for Optimal Prevention of HIV/AIDS database. PLWH ≥19 years with an active ARV prescription as of index date 01-Mar-2020 were included. CKD cases were identified by lab linkage (≥2 eGFR values <60mL/min ≥90 days apart) or CKD case-finding algorithm applied to healthcare records within 1 year prior to index date; dialysis status was identified by case-finding algorithm. Renal ARV dosing was evaluated using Canadian monograph recommendations. Data were summarized descriptively.
Results:
Of 7,436 clients, 352 (4.7%) had CKD. Of the 222 with lab linkage, 139 (62.6%) had eGFR 50-60mL/min, 72 (32.4%) eGFR 30-49mL/min, 11 (5.0%) eGFR <30mL/min; 5 (2.3%) were on dialysis. Compared to PLWH on ARVs overall, characteristics of PLWH with CKD differed (see Table). Most (n=208, 94.0%) were prescribed ≥1 ARV with renal dosing implications (lamivudine, emtricitabine, tenofovir); none received higher-than-monograph-recommended-renal-doses of tenofovir-DF. Higher-than-monograph-recommended-renal-doses of ARVs were prescribed in 63/222 (28.4%); lamivudine was the ARV most commonly prescribed at higher-than-monograph-recommended-renal-doses.
Conclusion:
The estimated CKD prevalence in PLWH on ARVs in BC appears to be low, and the majority are receiving ARV regimens appropriate for their renal function.
Mary Lou Smith
University Of Toronto & Hospital for Sick Children
Intelligence and Language Outcomes in School-Aged Children who are HIV-Exposed, Uninfected: The Role of Sex, Perinatal Risk Factors, and Socioeconomic Status
Abstract
Background: Children who are HIV-exposed uninfected (CHEU) are at increased risk for neurodevelopmental impairments. Most studies report on neurodevelopmental outcomes in the first two years of life, with limited data available for school-aged CHEU. We examined the intellectual and language outcomes in school-aged CHEU compared to children who are HIV-unexposed uninfected (CHUU).
Methods: CHEU and CHUU aged 6–10 years were recruited at The Hospital for Sick Children and Children’s Hospital of Eastern Ontario in Ontario, Canada. Intellectual and language abilities were measured using the WISC-V and CELF-5. Generalized linear models investigated associations of HEU-status with each neurodevelopmental outcome. An interaction term with sex was included to assess sex-specific effects. Gestational age, being small for gestational age (SGA), and household income were investigated as covariates.
Results: 65 CHEU (35 female, median age 9.00 years) and 42 CHUU (18 female, 8.96 years) were included. HEU-status was associated with significantly lower working memory and expressive language scores. In males, HEU-status was associated with lower scores on working memory, processing speed, overall intelligence, core, and expressive language abilities. No significant differences were observed in females by HEU-status. Household income was associated with all measures of intelligence and language. Lower working memory scores persisted in male CHEU after adjusting for covariates.
Conclusion: Male CHEU and those with lower household income were the most vulnerable to cognitive and language deficits. Working memory deficits in CHEU indicate a specific cognitive vulnerability due to HEU exposure status. Our findings highlight the need for early interventions, including ensuring financial security and close neuropsychological follow-up.
Methods: CHEU and CHUU aged 6–10 years were recruited at The Hospital for Sick Children and Children’s Hospital of Eastern Ontario in Ontario, Canada. Intellectual and language abilities were measured using the WISC-V and CELF-5. Generalized linear models investigated associations of HEU-status with each neurodevelopmental outcome. An interaction term with sex was included to assess sex-specific effects. Gestational age, being small for gestational age (SGA), and household income were investigated as covariates.
Results: 65 CHEU (35 female, median age 9.00 years) and 42 CHUU (18 female, 8.96 years) were included. HEU-status was associated with significantly lower working memory and expressive language scores. In males, HEU-status was associated with lower scores on working memory, processing speed, overall intelligence, core, and expressive language abilities. No significant differences were observed in females by HEU-status. Household income was associated with all measures of intelligence and language. Lower working memory scores persisted in male CHEU after adjusting for covariates.
Conclusion: Male CHEU and those with lower household income were the most vulnerable to cognitive and language deficits. Working memory deficits in CHEU indicate a specific cognitive vulnerability due to HEU exposure status. Our findings highlight the need for early interventions, including ensuring financial security and close neuropsychological follow-up.
Jonathan Smith
Medical Science Liaison
Viiv Healthcare
Interim Results From the REGAL Cohort: A REtrospective Real-world Study of the Effectiveness and Tolerability of the Antiretroviral Treatment ReGimens DTG/3TC CompAred to BIC/FTC/TAF in Older Persons Living With HIV
Abstract
Background: As the population with HIV aged ≥50 years increases, age-related comorbidities and polypharmacy must be considered. Traditionally, antiretroviral therapy (ART) included three drugs. Two-drug regimens decrease polypharmacy and may reduce drug-drug interactions with non-ART medications. Real-world data comparing the two drug regimen dolutegravir/lamivudine (DTG/3TC) and three-drug regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) are limited in people aged ≥50 years.
Methods: To compare real-world outcomes after switching to DTG/3TC versus BIC/FTC/TAF, we are conducting a retrospective chart review (n=7 countries) of ART-experienced, virologically suppressed people aged ≥50 years at DTG/3TC or BIC/FTC/TAF initiation with ≥24 weeks of follow-up. Demographics, clinical characteristics, and effectiveness were abstracted for up to 48 weeks after DTG/3TC or BIC/FTC/TAF initiation and summarized descriptively. Index was defined as DTG/3TC or BIC/FTC/TAF initiation date.
Results: At interim analysis (N=152), 88 people were on DTG/3TC and 64 were on BIC/FTC/TAF. Mean (SD) age was 59.4 (6.83) years for DTG/3TC and 60.0 (5.07) years for BIC/FTC/TAF; 92.0% on DTG/3TC were assigned male at birth and 78.1% on BIC/FTC/TAF. Mean (SD) time from HIV diagnosis to index was 18.0 (8.60) and 18.9 (9.29) years for DTG/3TC and BIC/FTC/TAF, respectively. At index, ~85% of people per treatment group had >1 comorbidity (≥3 comorbidities: DTG/3TC, 39.1%; BIC/FTC/TAF, 57.8%). Non-ART comedications were reported in >85% of people per group; 33.3% on DTG/3TC and 40.6% on BIC/FTC/TAF had ≥3 comedications. At index date, mean CD4+ cell count was 722.3 and 697.4 cells/mm³ among people on DTG/3TC and BIC/FTC/TAF, respectively. Before index, 3 (6%) people on DTG/3TC and 8 (20%) on BIC/FTC/TAF had prior virologic failure. No virologic failure occurred at 24 or 48 weeks. By 48 weeks, 1 person per group switched treatment.
Conclusions: In a population of virologically suppressed people aged ≥50 years with age-related comorbidities and comedications, both DTG/3TC and BIC/FTC/TAF were effective.
Methods: To compare real-world outcomes after switching to DTG/3TC versus BIC/FTC/TAF, we are conducting a retrospective chart review (n=7 countries) of ART-experienced, virologically suppressed people aged ≥50 years at DTG/3TC or BIC/FTC/TAF initiation with ≥24 weeks of follow-up. Demographics, clinical characteristics, and effectiveness were abstracted for up to 48 weeks after DTG/3TC or BIC/FTC/TAF initiation and summarized descriptively. Index was defined as DTG/3TC or BIC/FTC/TAF initiation date.
Results: At interim analysis (N=152), 88 people were on DTG/3TC and 64 were on BIC/FTC/TAF. Mean (SD) age was 59.4 (6.83) years for DTG/3TC and 60.0 (5.07) years for BIC/FTC/TAF; 92.0% on DTG/3TC were assigned male at birth and 78.1% on BIC/FTC/TAF. Mean (SD) time from HIV diagnosis to index was 18.0 (8.60) and 18.9 (9.29) years for DTG/3TC and BIC/FTC/TAF, respectively. At index, ~85% of people per treatment group had >1 comorbidity (≥3 comorbidities: DTG/3TC, 39.1%; BIC/FTC/TAF, 57.8%). Non-ART comedications were reported in >85% of people per group; 33.3% on DTG/3TC and 40.6% on BIC/FTC/TAF had ≥3 comedications. At index date, mean CD4+ cell count was 722.3 and 697.4 cells/mm³ among people on DTG/3TC and BIC/FTC/TAF, respectively. Before index, 3 (6%) people on DTG/3TC and 8 (20%) on BIC/FTC/TAF had prior virologic failure. No virologic failure occurred at 24 or 48 weeks. By 48 weeks, 1 person per group switched treatment.
Conclusions: In a population of virologically suppressed people aged ≥50 years with age-related comorbidities and comedications, both DTG/3TC and BIC/FTC/TAF were effective.
Cara Spence
Assistant Professor
University Of Saskatchewan
Clinical Outcomes of Infants Born to Women Living with HIV in Saskatchewan – A Retrospective Study
Abstract
Background
Saskatchewan (SK) continues to record the highest HIV incidence rates in Canada. Epidemiological shifts have seen a significant increase in HIV among women of childbearing years, representing 62% of new diagnoses in SK. A corresponding surge in syphilis co-infections among this patient population has placed increased risks and rates of congenital syphilis and vertical transmission among infants born to women living with HIV (WLWH). This study reports demographic and clinical outcomes for infants born to WLHW in central and northern SK.
Methods
Data was retrieved from the CPARG database and clinical electronic medical records from January 1, 2018, to December 31, 2023. 180 live infants born to 184 WLWH receiving care at the Jim Pattison Children’s Hospital (JPCH) in Saskatoon, SK. JPCH provides care to all infants born to WLWH in Saskatoon, central, and northern regions, representing 68% of all cases in SK. Three time periods were analyzed and compared: T1=Jan.1, 2018–Dec. 31, 2019; T2=Jan.1, 2020–Dec. 31, 2021; T3=Jan.1, 2022–Dec. 31, 2023.
Findings
Table 1: Infants Outcomes Born to WLWH January 1, 2018 – December 31, 2023 (attached)
Conclusions
As WLWH continue to have children, some having two or more pregnancies during the time period, they also continue to face factors which limit their engagement in clinical care for themselves and their infants, as well as risks of co-infections and vertical transmission. Despite high rates of reported ARV adherence at the time of delivery, seven infants were born HIV+ in SK between 2020-2023. Maternal engagement in care is correlated with low infant birth weights and vertical transmission, suggesting the importance of establishing best practices for engagement, specifically practices and approaches that are responsive and respectful to Indigenous populations and ways of being.
Saskatchewan (SK) continues to record the highest HIV incidence rates in Canada. Epidemiological shifts have seen a significant increase in HIV among women of childbearing years, representing 62% of new diagnoses in SK. A corresponding surge in syphilis co-infections among this patient population has placed increased risks and rates of congenital syphilis and vertical transmission among infants born to women living with HIV (WLWH). This study reports demographic and clinical outcomes for infants born to WLHW in central and northern SK.
Methods
Data was retrieved from the CPARG database and clinical electronic medical records from January 1, 2018, to December 31, 2023. 180 live infants born to 184 WLWH receiving care at the Jim Pattison Children’s Hospital (JPCH) in Saskatoon, SK. JPCH provides care to all infants born to WLWH in Saskatoon, central, and northern regions, representing 68% of all cases in SK. Three time periods were analyzed and compared: T1=Jan.1, 2018–Dec. 31, 2019; T2=Jan.1, 2020–Dec. 31, 2021; T3=Jan.1, 2022–Dec. 31, 2023.
Findings
Table 1: Infants Outcomes Born to WLWH January 1, 2018 – December 31, 2023 (attached)
Conclusions
As WLWH continue to have children, some having two or more pregnancies during the time period, they also continue to face factors which limit their engagement in clinical care for themselves and their infants, as well as risks of co-infections and vertical transmission. Despite high rates of reported ARV adherence at the time of delivery, seven infants were born HIV+ in SK between 2020-2023. Maternal engagement in care is correlated with low infant birth weights and vertical transmission, suggesting the importance of establishing best practices for engagement, specifically practices and approaches that are responsive and respectful to Indigenous populations and ways of being.
Tai-Te Su
Postdoctoral Fellow
University of Toronto
Five-Year Trajectories of Disability and the Associated Factors Among Adults Aging with HIV in the Ontario HIV Treatment Network Cohort Study
Abstract
Objectives: To investigate trajectories of disability and associated contextual factors among adults aging with HIV.
Methods: We analyzed longitudinal data from adults living with HIV enrolled in the Ontario HIV Treatment Network Cohort Study (OCS) who had between one to five annual self-reported disability assessments form 2019–2023. Disability was measured using summary scores from the short-form World Health Organization Disability Assessment Schedule (WHODAS 2.0; range 0 to 48, with higher scores indicating greater disability). We assessed intrinsic (age, gender, race, education, household income, number of comorbidities, smoking, alcohol consumption) and extrinsic (stigma, social support) contextual factors at baseline. We used growth mixture modeling to identify subgroups with similar patterns of disability over time, while accounting for individual variations in these trajectories. Multinomial logistic regression was applied to examine associations between contextual factors and disability trajectories.
Results: In 2019, the mean age of 1,896 OCS participants was 51.8 (standard deviation±12.1) and 77% were men. Three disability trajectories were identified: low (n=1,112; 58.7%), moderate (n=442; 23.3%), and high-increasing disability (n=342; 18.0%). Variability in disability within and between participants was observed in the moderate and high-increasing trajectory groups. Factors associated with the high-increasing disability trajectory were: identifying as women (b=0.10, 95% CI:0.04, 0.14), lower household income (b=0.08, 95% CI:0.03, 0.13), comorbidities (b=0.05, 95% CI:0.04, 0.06), and HIV stigma (b=0.05, 95% CI:0.03, 0.07). Conversely, older participants (b=0.04, 95% CI:0.01, 0.06), identifying as Black or African (b=0.09, 95% CI:0.03, 0.15), and reporting greater social support (b=0.08, 95% CI:0.05, 0.10) were more likely to follow the low disability trajectory.
Conclusion: Disability experiences among OCS participants followed three distinct trajectories over a 5-year period. Results highlight the heterogeneous nature of disability over time, and underscore the potential role of modifiable factors, such as HIV stigma and social support, to reduce disability among adults aging with HIV.
Methods: We analyzed longitudinal data from adults living with HIV enrolled in the Ontario HIV Treatment Network Cohort Study (OCS) who had between one to five annual self-reported disability assessments form 2019–2023. Disability was measured using summary scores from the short-form World Health Organization Disability Assessment Schedule (WHODAS 2.0; range 0 to 48, with higher scores indicating greater disability). We assessed intrinsic (age, gender, race, education, household income, number of comorbidities, smoking, alcohol consumption) and extrinsic (stigma, social support) contextual factors at baseline. We used growth mixture modeling to identify subgroups with similar patterns of disability over time, while accounting for individual variations in these trajectories. Multinomial logistic regression was applied to examine associations between contextual factors and disability trajectories.
Results: In 2019, the mean age of 1,896 OCS participants was 51.8 (standard deviation±12.1) and 77% were men. Three disability trajectories were identified: low (n=1,112; 58.7%), moderate (n=442; 23.3%), and high-increasing disability (n=342; 18.0%). Variability in disability within and between participants was observed in the moderate and high-increasing trajectory groups. Factors associated with the high-increasing disability trajectory were: identifying as women (b=0.10, 95% CI:0.04, 0.14), lower household income (b=0.08, 95% CI:0.03, 0.13), comorbidities (b=0.05, 95% CI:0.04, 0.06), and HIV stigma (b=0.05, 95% CI:0.03, 0.07). Conversely, older participants (b=0.04, 95% CI:0.01, 0.06), identifying as Black or African (b=0.09, 95% CI:0.03, 0.15), and reporting greater social support (b=0.08, 95% CI:0.05, 0.10) were more likely to follow the low disability trajectory.
Conclusion: Disability experiences among OCS participants followed three distinct trajectories over a 5-year period. Results highlight the heterogeneous nature of disability over time, and underscore the potential role of modifiable factors, such as HIV stigma and social support, to reduce disability among adults aging with HIV.
Alice Tseng
Toronto General Hospital
Identifying factors associated with significant weight gain in treatment-experienced people switching to a second generation INSTI (WEIGH-IN EXPERIENCED)
Abstract
Background: Risk factors for significant weight gain attributable to antiretroviral therapy (ART) are inconsistently reported. We assessed factors for significant weight increases in treatment-experienced people switching to a second-generation integrase inhibitor (2G-INSTI).
Methods: Single-centre, retrospective database analysis of adults switching to a dolutegravir or bictegravir-based regimen between 1-Jul-2008 and 30-Sep-2022. The primary outcome measure was weight change one year post-switch. Participant-level weight change overtime (or slope) was calculated using linear regression. Logistic regression was used to estimate the association between regimen and significant (≥10%) weight gain.
Results: 314 patients (76% male, 55% white, median age 53 years, weight 77.3 kg, body mass index 25.5 kg/m2, 14 years HIV, mean ART duration 8.1 years, 2.8 prior ARV regimens) were on 1st generation INSTI (22%)/NNRTI (35%)/PI (32%)/multi-class (11%) with 57% TDF/10% TAF for mean 6.2 years (CD4 561, 91% with HIV RNA < 50 copies/ml) before switching to a 2G-INSTI (81%) or 2G-INSTI+ PI/NNRTI/other (19%); 24% were switched to 2G INSTI plus TAF. Mean weight increase on pre-switch ART was 0.8 kg/1.2%/year (standard deviation, SD 3.0 kg/4.5%), with 37%/12%/51% experiencing increasing/decreasing/stable weight respectively. At one year post-switch, the mean weight increase was 1.9 kg/2.8% (SD 5.8 kg/7.8%, respectively), with 54%/27/19% experiencing increasing/decreasing/stable weight respectively; 12% had significant (≥10%) weight gain (mean 12.7 kg). In unadjusted models, age, CD4, BMI, viral load were associated with significant weight gain, while pre-switch ART was not. In adjusted models, age and CD4 remained associated with ≥10% weight gain at 1 year (odds ratio 0.95 per year of age [95% CI 0.92-0.99, p = 0.008] and 0.998 per unit of CD4 [95% CI 0.996-0.999, p=0.03]).
Conclusions: In our experienced cohort, greater weight gain occurred in the first year on 2G-INSTI compared to pre-switch ART. Demographic factors but not pre-switch ART regimen were associated with weight gain.
Methods: Single-centre, retrospective database analysis of adults switching to a dolutegravir or bictegravir-based regimen between 1-Jul-2008 and 30-Sep-2022. The primary outcome measure was weight change one year post-switch. Participant-level weight change overtime (or slope) was calculated using linear regression. Logistic regression was used to estimate the association between regimen and significant (≥10%) weight gain.
Results: 314 patients (76% male, 55% white, median age 53 years, weight 77.3 kg, body mass index 25.5 kg/m2, 14 years HIV, mean ART duration 8.1 years, 2.8 prior ARV regimens) were on 1st generation INSTI (22%)/NNRTI (35%)/PI (32%)/multi-class (11%) with 57% TDF/10% TAF for mean 6.2 years (CD4 561, 91% with HIV RNA < 50 copies/ml) before switching to a 2G-INSTI (81%) or 2G-INSTI+ PI/NNRTI/other (19%); 24% were switched to 2G INSTI plus TAF. Mean weight increase on pre-switch ART was 0.8 kg/1.2%/year (standard deviation, SD 3.0 kg/4.5%), with 37%/12%/51% experiencing increasing/decreasing/stable weight respectively. At one year post-switch, the mean weight increase was 1.9 kg/2.8% (SD 5.8 kg/7.8%, respectively), with 54%/27/19% experiencing increasing/decreasing/stable weight respectively; 12% had significant (≥10%) weight gain (mean 12.7 kg). In unadjusted models, age, CD4, BMI, viral load were associated with significant weight gain, while pre-switch ART was not. In adjusted models, age and CD4 remained associated with ≥10% weight gain at 1 year (odds ratio 0.95 per year of age [95% CI 0.92-0.99, p = 0.008] and 0.998 per unit of CD4 [95% CI 0.996-0.999, p=0.03]).
Conclusions: In our experienced cohort, greater weight gain occurred in the first year on 2G-INSTI compared to pre-switch ART. Demographic factors but not pre-switch ART regimen were associated with weight gain.
Anne-Marie Tynan
Map Centre For Urban Health Solutions, St. Michael's Hospital
Effectiveness of Aerobic Exercise among Adults Living with HIV: An Updated Systematic Review and Meta-Analysis using the Cochrane Collaboration Protocol
Abstract
OBJECTIVES: To examine the effectiveness of aerobic exercise on immunological, virological, cardiorespiratory, strength, weight, body composition, flexibility, and quality of life outcomes in adults living with HIV.
METHODS: We conducted an update of a systematic review using the Cochrane Collaboration protocol. We searched databases up to January 2021. We included randomized controlled trials comparing aerobic exercise with no exercise or another intervention performed at least 3 times per week for at least 4 weeks among adults living with HIV. Two reviewers independently determined study eligibility. Data were extracted from studies that met inclusion criteria using standardized forms. We assessed risk of bias using Cochrane risk of bias assessment. Meta-analyses were conducted using random-effects models with Review Manger (RevMan) computer software.
RESULTS: Forty-four studies met inclusion criteria (24 from previous review; 20 from this update). There were 1,799 participants at study completion; the majority were women (55%), and taking antiretroviral therapy (39/44 studies). Exercise interventions included aerobic exercise alone (19 studies) or a combination of aerobic and resistive exercise (25 studies), ranging from 5 to 52 weeks. One-hundred fourteen (114) meta-analyses were performed (90 of which were new or updated for this review). Main results indicated statistically significant improvements in selected outcomes of cardiorespiratory (maximum oxygen consumption, exercise time), strength (chest press, leg press, knee flexion), body composition (lean body mass, percent body fat), flexibility (sit and reach test), and quality of life (SF-36 questionnaire, Beck Depression Inventory) among exercisers compared with non-exercisers. No significant differences in change in CD4 count and viral load were found.
CONCLUSIONS:Performing aerobic exercise or a combination of aerobic and resistive exercise at least three times per week for at least 5 weeks is safe and can lead to improvements in cardiorespiratory fitness, strength, body composition, flexibility, and quality of life for adults living with HIV.
METHODS: We conducted an update of a systematic review using the Cochrane Collaboration protocol. We searched databases up to January 2021. We included randomized controlled trials comparing aerobic exercise with no exercise or another intervention performed at least 3 times per week for at least 4 weeks among adults living with HIV. Two reviewers independently determined study eligibility. Data were extracted from studies that met inclusion criteria using standardized forms. We assessed risk of bias using Cochrane risk of bias assessment. Meta-analyses were conducted using random-effects models with Review Manger (RevMan) computer software.
RESULTS: Forty-four studies met inclusion criteria (24 from previous review; 20 from this update). There were 1,799 participants at study completion; the majority were women (55%), and taking antiretroviral therapy (39/44 studies). Exercise interventions included aerobic exercise alone (19 studies) or a combination of aerobic and resistive exercise (25 studies), ranging from 5 to 52 weeks. One-hundred fourteen (114) meta-analyses were performed (90 of which were new or updated for this review). Main results indicated statistically significant improvements in selected outcomes of cardiorespiratory (maximum oxygen consumption, exercise time), strength (chest press, leg press, knee flexion), body composition (lean body mass, percent body fat), flexibility (sit and reach test), and quality of life (SF-36 questionnaire, Beck Depression Inventory) among exercisers compared with non-exercisers. No significant differences in change in CD4 count and viral load were found.
CONCLUSIONS:Performing aerobic exercise or a combination of aerobic and resistive exercise at least three times per week for at least 5 weeks is safe and can lead to improvements in cardiorespiratory fitness, strength, body composition, flexibility, and quality of life for adults living with HIV.
Sharon Walmsley
University Health Network
Sexually transmitted infections in a cohort of cis and transgender female sex workers in Argentina.
Abstract
Introduction
Female sex workers (FSW) are at high risk of acquiring sexually transmitted infections (STIs). Gender-specific vulnerability, discrimination and marginalization often limit access to health services. We aimed to compare the baseline prevalence of STIs in a cohort of cisgender (CGW) and transgender (TGW) FSW.
Materials and Methods
“MAS por Nosotras” is an ongoing prospective cohort aimed to evaluate the sexual and reproductive health of FSW, in Buenos Aires, Argentina. Each visit includes collection of medical and psychosocial information, including STI testing [HIV, HBV, HCV, syphilis serologies and HPV, Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) PCR]. Data from the baseline visit is presented.
Results
Between June 2023-March 2024, 200 FSW (99 TGW and 101 CGW) were enrolled, Median age was: TGW 29 [IQR 24-39], CGW 36 [IQR 30-47], (p<0.001). In the month prior to enrollment, 44.8% of TGW and 22.8% of CGW had >20 sexual partners (p=0.001), and 57.6% of TGW and 52.5% of CGW reported having at least one condomless anal and/or vaginal intercourse (p=.05). 16.2% of TGW and 3.1% of CGW were on HIV-PrEP, (p=.0001). Baseline STI´s prevalence is displayed in Table 1.
Five new HIV diagnoses (4 TGW, 1 CGW) were detected at baseline. NG sites were: anal (4.8%), cervical (2.1%), urethral (1.1%), and oropharyngeal (0.5%); and CT sites were: anal (3%), and cervical (1%).
Conclusions
TGW had a higher overall STI prevalence. Use of Prep was limited and condomless sex frequent. Our results reinforce the need of expanding and tailoring prevention strategies with a gender-focused perspective.
Female sex workers (FSW) are at high risk of acquiring sexually transmitted infections (STIs). Gender-specific vulnerability, discrimination and marginalization often limit access to health services. We aimed to compare the baseline prevalence of STIs in a cohort of cisgender (CGW) and transgender (TGW) FSW.
Materials and Methods
“MAS por Nosotras” is an ongoing prospective cohort aimed to evaluate the sexual and reproductive health of FSW, in Buenos Aires, Argentina. Each visit includes collection of medical and psychosocial information, including STI testing [HIV, HBV, HCV, syphilis serologies and HPV, Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) PCR]. Data from the baseline visit is presented.
Results
Between June 2023-March 2024, 200 FSW (99 TGW and 101 CGW) were enrolled, Median age was: TGW 29 [IQR 24-39], CGW 36 [IQR 30-47], (p<0.001). In the month prior to enrollment, 44.8% of TGW and 22.8% of CGW had >20 sexual partners (p=0.001), and 57.6% of TGW and 52.5% of CGW reported having at least one condomless anal and/or vaginal intercourse (p=.05). 16.2% of TGW and 3.1% of CGW were on HIV-PrEP, (p=.0001). Baseline STI´s prevalence is displayed in Table 1.
Five new HIV diagnoses (4 TGW, 1 CGW) were detected at baseline. NG sites were: anal (4.8%), cervical (2.1%), urethral (1.1%), and oropharyngeal (0.5%); and CT sites were: anal (3%), and cervical (1%).
Conclusions
TGW had a higher overall STI prevalence. Use of Prep was limited and condomless sex frequent. Our results reinforce the need of expanding and tailoring prevention strategies with a gender-focused perspective.
Christina Wiesmann
Postdoctoral Research Fellow
Simon Fraser University
Investigation of the effectiveness of a once-a-day B/F/TAF treatment regimen in combination with a multidisciplinary model of care at improving HIV viral suppression.
Abstract
Providing healthcare to vulnerable inner-city populations, characterized by unstable housing and high rates of infections, requires innovative care models to address their complex medical and social needs. Traditional healthcare systems have proven inadequate for this population, particularly when it comes to ensuring consistent antiretroviral therapy (ART) adherence, as well as ensuring that individuals are prescribed an HIV medication which effectively suppresses their infection. The Vancouver Infectious Diseases Centre (VIDC) has developed a multidisciplinary care model centered on addressing social, psychological, and addiction-related needs in addition to medical care.
This study aims to evaluate the effectiveness of this multidisciplinary care model in achieving virologic suppression in HIV-infected individuals using B/F/TAF, a once-daily ART regimen with a high barrier to resistance. This is a single-arm, prospective, observational study. All participants enrolled in the study have previous indication of non-adherence to their HIV medication, and/or a detectable viral load in the past year. The primary endpoint is virologic suppression (HIV plasma viral load < 200 copies/mL) at 24 weeks.
To date, a total of 50 individuals meeting the preliminary study criteria have been identified (either non-adherent to their medication or have had a detectable viral load in the past year). 35 of these individuals have been screened and meet all inclusion criteria, and 29 have had their baseline visit completed. At baseline, 4/29 individuals (14%) were viremic. To date, 12 individuals have completed their week 12 visit and 2/12 (17%) are viremic and 11 individuals have completed their week 24 visit and 3/11 (27%) are viremic.
Many individuals living in Vancouver’s inner-city have an unsuppressed HIV viral load, and/or are nonadherent to their medication. Prescribing B/F/TAF in combination with a multidisciplinary care model may help to achieve increased rates of HIV suppression among this vulnerable population.
This study aims to evaluate the effectiveness of this multidisciplinary care model in achieving virologic suppression in HIV-infected individuals using B/F/TAF, a once-daily ART regimen with a high barrier to resistance. This is a single-arm, prospective, observational study. All participants enrolled in the study have previous indication of non-adherence to their HIV medication, and/or a detectable viral load in the past year. The primary endpoint is virologic suppression (HIV plasma viral load < 200 copies/mL) at 24 weeks.
To date, a total of 50 individuals meeting the preliminary study criteria have been identified (either non-adherent to their medication or have had a detectable viral load in the past year). 35 of these individuals have been screened and meet all inclusion criteria, and 29 have had their baseline visit completed. At baseline, 4/29 individuals (14%) were viremic. To date, 12 individuals have completed their week 12 visit and 2/12 (17%) are viremic and 11 individuals have completed their week 24 visit and 3/11 (27%) are viremic.
Many individuals living in Vancouver’s inner-city have an unsuppressed HIV viral load, and/or are nonadherent to their medication. Prescribing B/F/TAF in combination with a multidisciplinary care model may help to achieve increased rates of HIV suppression among this vulnerable population.
Alexander Wong
University Of Saskatchewan
Four-year outcomes from the BICSTaR study: Observational analysis of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV in Canada, France and Germany
Abstract
Background: BICSTaR, a multi-country, prospective, observational study, evaluated the effectiveness and safety of B/F/TAF. After 2 years in the main study, eligible participants from Canada, France and Germany could enter a 3-year extension phase.
Methods: Data from June-2018 to Sept-2023 were analyzed, including HIV-1 RNA <50 copies/mL (missing=excluded [M=E]/discontinuation=failure [D=F]), safety, and patient-reported outcomes (PROs; SF-36 and HIV-SI).
Results: Of 800 participants (178 from Canada), 465 (58%) reconsented for the extension phase (TN 70 [15%], TE 395 [85%]) (Table). At 4 years, viral load remained undetectable (HIV-1 RNA <50 copies/mL) in 98% and 97% (M=E) of TN and TE participants, respectively (Figure). Significant increases in CD4 cell count and CD4/CD8 ratio from baseline were observed in both groups. No treatment-emergent resistance to B/F/TAF was reported. Discontinuation of B/F/TAF due to drug-related adverse events occurred in 7% overall, with weight gain as the most commonly reported reason (3%). Median change in body weight at 4 years was +4.4 kg (P=0.019) and +1.6 kg (P<0.001) for TN and TE participants, respectively. At 4 years, HIV-SI scores improved in TN participants (median change [Q1, Q3]: -3 [-6, 1]; P=0.053) and remained stable in TE participants (0 [-2, 2]; P=0.798). SF-36 mental component summary scores showed improvement in TN but no change in TE participants (median change: +3.3, P=0.030, and +0.7, P=0.225, respectively). SF-36 physical component summary scores remained stable in both groups.
Conclusions: After 4 years, B/F/TAF demonstrated high effectiveness and tolerability with some improvements in PROs in TN participants.
Methods: Data from June-2018 to Sept-2023 were analyzed, including HIV-1 RNA <50 copies/mL (missing=excluded [M=E]/discontinuation=failure [D=F]), safety, and patient-reported outcomes (PROs; SF-36 and HIV-SI).
Results: Of 800 participants (178 from Canada), 465 (58%) reconsented for the extension phase (TN 70 [15%], TE 395 [85%]) (Table). At 4 years, viral load remained undetectable (HIV-1 RNA <50 copies/mL) in 98% and 97% (M=E) of TN and TE participants, respectively (Figure). Significant increases in CD4 cell count and CD4/CD8 ratio from baseline were observed in both groups. No treatment-emergent resistance to B/F/TAF was reported. Discontinuation of B/F/TAF due to drug-related adverse events occurred in 7% overall, with weight gain as the most commonly reported reason (3%). Median change in body weight at 4 years was +4.4 kg (P=0.019) and +1.6 kg (P<0.001) for TN and TE participants, respectively. At 4 years, HIV-SI scores improved in TN participants (median change [Q1, Q3]: -3 [-6, 1]; P=0.053) and remained stable in TE participants (0 [-2, 2]; P=0.798). SF-36 mental component summary scores showed improvement in TN but no change in TE participants (median change: +3.3, P=0.030, and +0.7, P=0.225, respectively). SF-36 physical component summary scores remained stable in both groups.
Conclusions: After 4 years, B/F/TAF demonstrated high effectiveness and tolerability with some improvements in PROs in TN participants.
Kevin Woodward
Executive And Medical Director
Hq Toronto
nPEP to PrEP Cascade Improvement
Abstract
Background:
Individuals accessing non-occupational PEP (nPEP) for sexual exposure often have clear indications for ongoing HIV prevention with PrEP. Previous research has examined uptake of PrEP in the period after a course of nPEP(1). We reviewed three years of data to measure the impact of same-day nPEP with same-site PrEP initiation among gay, bisexual, and other men who have sex with men (gbMSM) in Ontario utilizing a nurse-led model of care, and characterize the steps of the nPEP to PrEP cascade.
Materials and Methods:
Individuals at HQ clinic not on PrEP were included. nPEP eligibility and identification were determined using a risk assessment tool. Participants underwent HIV testing at baseline and were scheduled a one-month appointment. Primary endpoint was the proportion of eligible nPEP users who began PrEP after completing treatment. To assess differences in our PrEP conversion rate, we established a performance threshold for the current study. We defined our performance criterion using the 99th percentile CI based on the PrEP conversion rate from L’Actuel clinic in Montreal (1).
Results:
Since July 2022, 1090 individuals requested nPEP. 49 more individuals were assessed for nPEP during the visit. Of those assessed (1139), 205 were found ineligible for nPEP and 7 were positive for HIV at initial screening. 850 individuals were started on nPEP (n=850) and 545 (64%) returned for a one-month follow-up. Of those, 366 individuals converted from nPEP to PrEP. Overall, 459 started within 24 months of initiation. Based on data from L’Actuel, a conversion rate of 33.5% (31%,36%) was achieved. Our point estimate is 54% (49.5%,58.4%) conversion rate, which is statistically significantly higher.
Conclusions:
The model of care of same-site nPEP and PrEP initiation in our nurse-led clinic significantly streamlines the nPEP to PrEP cascade.
References:
Zahedi N, et al. J Acquir Immune Defic Syndr. 2020 Dec 1;85(4):408-415.
Individuals accessing non-occupational PEP (nPEP) for sexual exposure often have clear indications for ongoing HIV prevention with PrEP. Previous research has examined uptake of PrEP in the period after a course of nPEP(1). We reviewed three years of data to measure the impact of same-day nPEP with same-site PrEP initiation among gay, bisexual, and other men who have sex with men (gbMSM) in Ontario utilizing a nurse-led model of care, and characterize the steps of the nPEP to PrEP cascade.
Materials and Methods:
Individuals at HQ clinic not on PrEP were included. nPEP eligibility and identification were determined using a risk assessment tool. Participants underwent HIV testing at baseline and were scheduled a one-month appointment. Primary endpoint was the proportion of eligible nPEP users who began PrEP after completing treatment. To assess differences in our PrEP conversion rate, we established a performance threshold for the current study. We defined our performance criterion using the 99th percentile CI based on the PrEP conversion rate from L’Actuel clinic in Montreal (1).
Results:
Since July 2022, 1090 individuals requested nPEP. 49 more individuals were assessed for nPEP during the visit. Of those assessed (1139), 205 were found ineligible for nPEP and 7 were positive for HIV at initial screening. 850 individuals were started on nPEP (n=850) and 545 (64%) returned for a one-month follow-up. Of those, 366 individuals converted from nPEP to PrEP. Overall, 459 started within 24 months of initiation. Based on data from L’Actuel, a conversion rate of 33.5% (31%,36%) was achieved. Our point estimate is 54% (49.5%,58.4%) conversion rate, which is statistically significantly higher.
Conclusions:
The model of care of same-site nPEP and PrEP initiation in our nurse-led clinic significantly streamlines the nPEP to PrEP cascade.
References:
Zahedi N, et al. J Acquir Immune Defic Syndr. 2020 Dec 1;85(4):408-415.
Jim Young
McGill University
Detectable HIV viral load in the Canadian Coinfection Cohort (CCC) before, during and after the COVID-19 pandemic
Abstract
Background
The COVID-19 pandemic disrupted healthcare and may have disproportionately affected vulnerable people, such as those living with HIV and hepatitis C. We investigate whether detectable HIV RNA became more common over this period in CCC participants.
Methods
We selected all participants enrolled before March 2018 with at least one follow up visit after March 2018 and six months or more after starting antiretroviral therapy. Participants were classified as: men reporting sex with men (gbMSM); Indigenous; injecting drugs at their last visit prior to March 2018 (active PWID); or in none of these groups (‘Other’). We modelled the probability of a detectable viral load from March 2018 to March 2024 using a generalised additive model, with covariate adjustment for age. The model included a random intercept allowing for repeated observations from the same individuals.
Results
Among 928 selected participants, the median duration of HIV infection was 18 years, the median age was 52; 31% were female. The probability of detectable HIV RNA (>50 copies/mL) declined among most participants, particularly among Indigenous peoples and active PWID, but increased slightly among those at low risk (Figure). Both the probability of transmissible HIV RNA (>1000 copies/mL) and the probability of reported poor adherence to antiretrovirals also declined over the same period.
Conclusion
Despite the pandemic, the probability of a detectable HIV viral load steadily decreased over time for most in the CCC, particularly those at greatest risk of poor adherence. This suggests engagement in care has been maintained even in vulnerable populations.
The COVID-19 pandemic disrupted healthcare and may have disproportionately affected vulnerable people, such as those living with HIV and hepatitis C. We investigate whether detectable HIV RNA became more common over this period in CCC participants.
Methods
We selected all participants enrolled before March 2018 with at least one follow up visit after March 2018 and six months or more after starting antiretroviral therapy. Participants were classified as: men reporting sex with men (gbMSM); Indigenous; injecting drugs at their last visit prior to March 2018 (active PWID); or in none of these groups (‘Other’). We modelled the probability of a detectable viral load from March 2018 to March 2024 using a generalised additive model, with covariate adjustment for age. The model included a random intercept allowing for repeated observations from the same individuals.
Results
Among 928 selected participants, the median duration of HIV infection was 18 years, the median age was 52; 31% were female. The probability of detectable HIV RNA (>50 copies/mL) declined among most participants, particularly among Indigenous peoples and active PWID, but increased slightly among those at low risk (Figure). Both the probability of transmissible HIV RNA (>1000 copies/mL) and the probability of reported poor adherence to antiretrovirals also declined over the same period.
Conclusion
Despite the pandemic, the probability of a detectable HIV viral load steadily decreased over time for most in the CCC, particularly those at greatest risk of poor adherence. This suggests engagement in care has been maintained even in vulnerable populations.
