P-305. No Clinically Significant Drug–Drug Interactions with Co-administration of Feminizing or Masculinizing Hormone Therapy and Twice-yearly Lenacapavir PrEP in Gender-Diverse Persons

作者：Jill Blumenthal, Maribel Acevedo-Quiñones, Nittaya Phanuphak, Juan Hinojosa, Javier R Lama, Michelle S Cespedes, Nkosiphile Ndlovu, Carlos Brites, Sarah B. Puryear, Leo Brown, Christoph C Carter, Priyanka Arora, Marjorie Z. Imperial, Kim Etchevers, R. Singh, Pamela Wong, Olivia T. Van Gerwen · 发表于：Open Forum Infectious Diseases · 年份：2026 · DOI：10.1093/ofid/ofaf695.525 · 研究领域：HIV/AIDS drug development and treatment、HIV/AIDS Research and Interventions、HIV Research and Treatment

Abstract Background Transgender and gender-diverse persons are priority groups in HIV prevention; however, concerns over potential drug–drug interactions between gender-affirming hormone therapy (GAHT) and pre-exposure prophylaxis (PrEP) may hinder PrEP uptake. We report the pharmacokinetic (PK) effects of co-administration of masculinizing and feminizing GAHT with twice-yearly subcutaneous lenacapavir (LEN) PrEP. Methods PURPOSE 2 (NCT04925752), a Phase 3, randomized, controlled trial, demonstrated the efficacy of twice-yearly LEN PrEP in cisgender men, transgender women, transgender men, and gender nonbinary individuals. Participant characteristics, including self-reported gender identity, were collected at baseline. GAHT use was queried at each study visit. Plasma/serum concentrations of estradiol, testosterone, and dihydrotestosterone (testosterone active metabolite) were evaluated in a subset of gender-diverse participants receiving LEN and uninterrupted estradiol or testosterone for 26 weeks. Population PK (popPK) analyses assessed the impact of feminizing or masculinizing GAHT on LEN PK compared with LEN PK in participants not taking GAHT. Results Among 2183 participants who received LEN in PURPOSE 2, 486 (22.3%) self-identified as gender diverse: 315 (14.4%) transgender women; 29 (1.3%) transgender men; 136 (6.2%) gender nonbinary; and 6 (0.3%) other gender. Concomitant GAHT use was reported by 253 (11.6%) participants. In a subset of participants assigned male at bir...