CROI 2024 Abstract eBook

Abstract eBook

Poster Abstracts

1136 CAPRISA 018 Trial: Acceptability of Tenofovir Alafenamide Implants for HIV PrEP in African Women Tanuja N. Gengiah 1 , Craig J Heck 2 , Lara Lewis 1 , Leila E. Mansoor 1 , Ishana Harkoo 1 , Diana Chetty 1 , Nqobile Myeni 1 , Marc M. Baum 3 , John A. Moss 3 , James F. Rooney 4 , Catherine Hankins 5 , Bruno Pozzetto 6 , Quarraisha Abdool Karim 1 , Salim S. Abdool Karim 1 1 Centre for the AIDS Programme of Research in South Africa, Durban, South Africa, 2 Columbia University Medical Center, New York, NY, USA, 3 Oak Crest Institute of Science, Monrovia, CA, USA, 4 Gilead Sciences, Inc, Foster City, CA, USA, 5 Amsterdam Institute for Global Health and Development, Amsterdam, Netherlands, 6 Centre International de Recherche en Infectiologie, Lyon, France Background: In South Africa, young women carry a disproportionately higher HIV risk. Long-acting HIV pre-exposure prophylaxis (PrEP) methods may better align with women's preferences, behaviors, and lifestyles-potentially improving PrEP uptake, adherence, and persistence. We studied the acceptance of implants for PrEP in women participating in a tenofovir alafenamide (TAF) implant trial. Methods: CAPRISA 018, a Phase I trial, assessed the safety and efficacy of sub-dermal TAF implants for PrEP. After receiving 1 or 2 TAF (110 mg) or placebo implants (4:1 randomization), participants (N=30) completed longitudinal (0-52 weeks) acceptability assessments on product attributes (implant size, quantity, insertion site, palpability, visibility), physical experiences (insertion procedures, pain, reactions/side effects, scarring), removal procedures, and method likes and dislikes. We averaged scores (range: 1-6, increasing with acceptability), reported minimum temporal means [min-max values] to assess acceptability (scores >4), and performed sub-group analyses by removal timing (scheduled [Week 48] vs. early). For early removals, acceptability was assessed 4 weeks post removal. Results: Participants were young (median age: 26 years) Black African women. Overall pre-removal product attributes (5.4 [3.6-6.0]) and physical experiences (4.9 [1.7-6.0]) remained acceptable over time (Figure 1). On average, women with scheduled removals had high levels of acceptability for product attributes and physical experiences during the study and 4 weeks after implant removal. Early removals occurred on average 4 months (0-8 months) after implant insertion among 11 (37%) of women. Women with early removals, on average, reported acceptable pre-removal and post-removal product attributes and physical experiences; however, all reported unacceptable levels of side effects at least once during the study (100% in early removals versus 47% in scheduled removals, p=0.004). Both groups reported that implants were acceptable as a potential long-term PrEP method (5.3 [3.0-6.0]), and the most-cited reason for liking the implants was possibility of long-term HIV protection. Conclusion: Although women in the trial reported high levels of acceptability for implant attributes, physical experiences, and insertion and removal procedures overall, higher than expected early discontinuation rates due to side effects were observed. The implants potential for long-term HIV protection was its most favored attribute for acceptability.

or standard care. All participants underwent baseline HIV testing and were switched from their original PEP regimen (if applicable) to B/F/TAF to complete 28 days. CBC, ALT and creatinine were assessed at week 2; medication adherence at week 4; HIV serology at weeks 6 and 12; and adverse events at all visits. Results: Of 120 individuals screened for participation in the trial, 119 participants were enrolled and are included in this analysis; all were HIV negative at baseline. Median (interquartile range) age was 29 (25, 34) years and 22% had previously used PEP. Most (86%) were men who have sex with men. Medication adherence was high; among 101 participants with available data, all took all 28 days of PEP except for two who stopped prematurely after 7 and 8 days respectively. B/F/TAF was well-tolerated, with only 11% experiencing adverse events of grade ≥2 severity; 38% experiencing AEs at least possibly related to study drug (Table), most often gastrointestinal. No HIV seroconversions were observed. Conclusion: B/F/TAF PEP was associated with high tolerability, high adherence and no HIV seroconversion in this cohort. These data support the use of this single tablet regimen as HIV PEP after sexual exposures. 1135 Uptake and Predictors of PEP Uptake in the SEARCH Dynamic Choice HIV Prevention Trials James Ayieko 1 , Laura B. Balzer 2 , Elijah Kakande 3 , Jane Kabami 3 , Collette Aoko 4 , Gabriel Chamie 5 , Catherine A. Koss 5 , Elizabeth Bukusi 1 , Moses R. Kamya 6 , Maya L. Petersen 2 , Diane Havlir 5 1 Kenya Medical Research Institute, Nairobi, Kenya, 2 University of California Berkeley, Berkeley, CA, USA, 3 Infectious Diseases Research Collaboration, Kampala, Uganda, 4 Kenya Medical Research Institute, Kilifi, Kenya, 5 University of California San Francisco, San Francisco, CA, USA, 6 Makerere University College of Health Sciences, Kampala, Uganda Background: Post-exposure prophylaxis (PEP) remains underutilized in sub-Saharan Africa. PEP could respond to user preferences for on-demand biomedical prevention, including for vaginal exposures, and could serve as a gateway to PrEP; data are limited on this strategy. Methods: We assessed PEP uptake in 3 randomized trials of Dynamic Choice HIV Prevention (DCP) among persons >15 years with current or anticipated HIV risk recruited from Outpatient Departments (OPD), Antenatal Clinics (ANC), and community settings in rural western Kenya and Uganda (SEARCH; NCT04810650). The DCP intervention included structured participant choice of: 1) PrEP or PEP, with option to change over time; 2) service location; 3) HIV self testing (HIVST) option, together with 24/7 phone access to clinician. Providers were trained on client-centered care, emphasizing support for flexible product choice (PrEP or PEP). In the DCP arm, PEP pill-in-pocket was offered (5 pills with HIVST) for rapid PEP start; participants notified the provider for HIV testing and refill of the remaining PEP supply. In this pre-specified secondary analysis, we conducted a by-arm comparison of self-reported PEP use and describe use patterns across these settings. Results: From April-July 2021, 1,233 participants (612 DCP; 621 standard of care [SoC]) enrolled (ANC 400, OPD 403, Community 430): 72% were women, 41% aged 15-24 years. Over 18 months of follow-up, 129 courses of PEP were dispensed. In DCP arm: 101 PEP courses among 50 participants; 28 participants used multiple PEP courses; 10 transitioned to PrEP the month after PEP start. In SoC: 28 PEP courses among 20 participants; 8 participants used multiple PEP courses; 2 participants transitioned to PrEP the month after PEP start. Biomedical covered time (% of follow-up using PrEP or PEP) was 51% (4422/8712) in DCP vs. 16% (1424/8994) in SoC; PEP accounted for ~2% of covered time in both arms (101/4422 vs. 28/1424). Overall, DCP significantly increased PEP covered time (% of follow-up time when using PEP): 1.1%(DCP) vs. 0.3%(SoC); difference of 0.8% (95%CI: 0.1-1.15%) p=0.03. Among DCP participants, PEP covered time was highest in the community (2.2%), men (1.8%) and youth (1.1%). There were no discontinuations for drug toxicity or seroconversions among those who used PEP. Conclusion: Across 3 settings in rural Africa, PEP was feasible to deliver, a desired choice for some individuals, and a gateway to PrEP. Event-driven interventions such as PEP should be included in prevention choice approaches.

Poster Abstracts

1137 Safety and Pharmacokinetics of Ultra-Long-Acting Dolutegravir In-Situ Forming Implant Thy Le, Isabella C. Young, Craig Sykes, Amanda P. Schauer, Mackenzie Cottrell,

Angela D. Kashuba, S Rahima Benhabbour University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

Background: Long-acting injectables (LAIs) for HIV PrEP can increase user acceptability, adherence, and reduce stigma. Current LAIs are not removable

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