CROI 2024 Abstract eBook

Abstract eBook

Poster Abstracts

1144 No Significant Interactions From Hormone Therapy on F/TAF-Based PrEP in Trans Women: iFACT3 Study Akarin Hiransuthikul 1 , Narukjaporn Thammajaruk 2 , Stephen Kerr 1 , Rena Janamnuaysook 2 , Siriporn Nonenoy 2 , Piranun Hongchookiat 2 , Rapee Trichavaroj 2 , Yardpiroon Tawon 3 , Jakkrapatara Boonruang 2 , Nipat Teeratakulpisarn 2 , Tim R. Cressey 3 , Peter L. Anderson 4 , Nittaya Phanuphak 2 , for the iFACT 3 Study Team 1 Chulalongkorn University, Bangkok, Thailand, 2 Institute of HIV Research and Innovation (IHRI), Bangkok, Thailand, 3 Chiang Mai University, Chiang Mai, Thailand, 4 University of Colorado Anschutz Medical Campus, Aurora, CO, USA Background: We previously observed comparable plasma and urine levels of tenofovir (TFV) and emtricitabine (FTC), as well as intracellular tenofovir diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) concentrations in peripheral blood mononuclear cells (PBMCs), when F/TAF-based oral daily PrEP was administered with and without feminizing hormone therapy (FHT) in trans women in Thailand. We assessed the potential impact of FHT on antiretroviral drug concentrations in the rectal compartment of trans women receiving oral daily F/TAF-based PrEP. Methods: iFACT3 was a pharmacokinetic and safety study assessing the potential drug-drug interactions between FHT and oral daily F/TAF-based PrEP among trans women Thailand. Between January and February 2022, 20 trans women who had not undergone orchiectomy and had not received injectable FHT within the last 3 months were enrolled. Oral FHT (estradiol valerate 2 mg and cyproterone acetate 25 mg) was prescribed to participants at baseline until week 9, while oral daily PrEP (FTC 200 mg/TAF 25 mg) was initiated at week 3 until week 12. PK sampling was performed at week 3 (FHT without PrEP) and 9 (FHT with PrEP) for estradiol; and weeks 9 (PrEP with FHT) and 12 (PrEP without FHT) for PrEP drug parameters. Plasma, urine, and PBMCs samples were collected from all participants; and rectal tissue samples in subset. Results: Ten participants who underwent rectal tissue sampling were included in this analysis. Median age and body mass index were 28.5 (IQR: 24-32) years and 21.2 (IQR: 19.9-21.9) kg/m 2 , respectively. Median TFV-DP and FTC-TP concentrations in rectal tissue between weeks 9 and 12 were not statistically significant (TFV-DP, 37.6 [IQR: 21.4-45.8] vs 27.4 [IQR: 21.4-56.3] fmol/mg, p=0.72; and FTC-TP, 14.5 [12.4-17.0] vs 11.6 [8.0-14.5] fmol/mg, p=0.20). All participants had quantifiable TFV-DP and FTC-TP concentrations at both visits. Conclusion: Intracellular TFV-DP and FTC-TP concentrations in rectal tissue were comparable when F/TAF-based PrEP was administered with and without FHT. These findings align with our previously data in the plasma, urine, and PBMCs compartments, indicating no clinically significant drug-drug interactions from FHT towards F/TAF-based oral daily PrEP are anticipated.

12% (334) were in care, and 2.5% (69) declined testing. Of those testing negative, 93% (1,547) were reached for follow-up after 3-6 months; mean age was 32.1 years; 60% (929/1,547) were male. Only 44% (675) had retested. HIV status disclosure to seropositive partner was 24% (376); 86% (1,330) reported at least one prevention measure [SMC (35%), PrEP (5.8%), abstinence (17%), being faithful (33%), condoms (49%)]. Retesting was associated with age <20 (AOR=3.46; 95%CI 1.56-4.52), disclosure (AOR=8.83; 95%CI 6.54-11.9), and use of a prevention method (AOR=3.31; 95%CI 2.22-4.93). Partners reporting being faithful were 46% less likely to retest (AOR=0.54; 95%CI 0.41-0.70). Those using PrEP were three times more likely to disclose (AOR= 3.31; 95%CI 1.93-5.08). Ten (1.5%) partners seroconverted. Conclusion: Low uptake of HIV prevention suggests ongoing HIV risk. Low retesting rates, such as among those who reported being faithful as a prevention method, suggest seronegative partners would not receive timely treatment. It is critical for HIV-seronegative partners to be actively followed up for disclosure, behavior change, and HIV prevention methods. 1143 NLPrEP Trial 24-Week Data: Nurse-Led PrEP Superior to Physician-Led PrEP Among Cis Women in Zambia Lloyd B. Mulenga 1 , Sombo Fwoloshi 1 , Suilanji Sivile 1 , Linah Mwango 2 , Evelyn Mwamba 1 , Chofwe Chola 1 , Davies Kampamba 1 , Lottie Hachaambwa 2 , Aggrey Mweemba 1 , C. William Wester 3 , Mpanji Siwingwa 1 , Pawel Olowski 4 , Lameck Chirwa 1 , Cassidy W Claassen 5 1 University Teaching Hospital, Lusaka, Zambia, 2 Ciheb Zambia, Lusaka, Zambia, 3 Vanderbilt University, Nashville, TN, USA, 4 Maryland Global Initiatives Corporation, Lusaka, Zambia, 5 University of Maryland, Baltimore, MD, USA Background: There is significant interest in HIV pre-exposure prophylaxis (PrEP) among women in sub-Saharan African countries like Zambia. Oral PrEP uptake with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) may be limited by access to physicians to prescribe PrEP, and concern for kidney and bone mineral density abnormalities. PrEP with tenofovir alafenamide (TAF) and FTC has fewer bone and kidney side effects and thus may require less physician oversight and laboratory monitoring. We designed a 48-week trial to assess outcomes of a nurse-led PrEP service delivery model using TAF/FTC compared to standard-of-care (SOC) physician-led PrEP using TDF/FTC. Methods: Quasi-experimental (pre-post) design study comparing TDF/FTC to TAF/FTC for oral PrEP among cis-gender women in six Ministry of Health facilities in Lusaka, Zambia. Inclusion criteria included HIV-negative, assigned female at birth, ≥18 years of age, and eligible for PrEP per national guidelines. The control group was enrolled first and received SOC with physician-led oral TDF/FTC. The intervention group was enrolled thereafter and received nurse-led oral TAF/ FTC. Study outcomes included uptake of PrEP, PrEP refill rates at 4 weeks, TFV metabolite concentrations at 24 and 48 weeks, PrEP persistence at 48 weeks, and HIV seroconversion. Results: We screened 1,005 cis-gender women, of whom 900 (89.6%) were eligible for PrEP. 432 were enrolled in the SOC TDF/FTC group, and 450 were enrolled in the interventional TAF/FTC arm. PrEP refill rates at 1 month were 80% (347/432) in the TDF arm vs. 91.6% (412/450) in the TAF arm (p<0.001). Retention in PrEP services at 24 weeks were 35% (150/432) for the TDF arm vs. 77% (348/450) for the TAF arm (p<0.001). Participants in the intervention arm were 6 times more likely to continue PrEP at 24 weeks (odds ratio (OR)=6.36, p<0.001). At 24 weeks, TFV metabolite concentrations were ascertained in 106 (71%) of 150 individuals in the TDF arm compared to 280 (80.5%) of 348 in the TAF arm. HIV seroconversion rates at 24 weeks were identical in both study arms, with 1 (0.2%) of 432 participants in the SOC arm vs. 1 (0.2%) of 450 in the intervention arm. Conclusion: In this non-randomized pre/post-trial, nurse-led PrEP with TAF/ FTC showed significant advantages, including higher PrEP refill rates and improved PrEP persistence at 24 weeks compared to the physician-led SOC with TDF/FTC. HIV

Poster Abstracts

1145 No Significant Interactions From Hormone Therapy Toward F/TDF-Based PrEP in Trans Men: iMACT Study Akarin Hiransuthikul 1 , Narukjaporn Thammajaruk 2 , Stephen Kerr 1 , Rena Janamnuaysook 2 , Siriporn Nonenoy 2 , Piranun Hongchookiat 2 , Rapee Trichavaroj 2 , Yardpiroon Tawon 3 , Jakkrapatara Boonruang 2 , Nipat Teeratakulpisarn 2 , Tim R. Cressey 3 , Peter L. Anderson 4 , Nittaya Phanuphak 2 , for the iMACT Study Team 1 Chulalongkorn University, Bangkok, Thailand, 2 Institute of HIV Research and Innovation (IHRI), Bangkok, Thailand, 3 Chiang Mai University, Chiang Mai, Thailand, 4 University of Colorado Anschutz Medical Campus, Aurora, CO, USA Background: Potential drug-drug interactions between masculinizing hormone (MHT) and oral PrEP in trans men is not well understood. We previously observed that plasma total testosterone concentrations were comparable when oral daily PrEP was administered with and without MHT.

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