Cabotegravir Maintains Protective Efficacy in the Setting of Bacterial Sexually Transmitted Infections: A Secondary Analysis of HPTN 083

作者：Meredith E. Clement, Brett Hanscom, Daniel Haines, José A. Bazan, Nuntisa Chotirosniramit, Ryan Kofron, Sharon Mannheimer, Kenneth H. Mayer, Mayara Secco Torres Silva, Lydia Soto-Torres, Alex R. Rinehart, James F. Rooney, Andrea Jennings, Kailazarid Gomez Feliciano, Marybeth McCauley, Beatriz Grinsztejn, Raphael J. Landovitz, for HPTN 083 Study Team, Sue Ellen Abdalian, Roberto C. Arduino, José A. Bazan, Juan Carlos Hinojosa Boyer, Robinson Cabello, Suwat Chariyalertsak, Jesse L. Clark, Carlos del Rı́o, Eileen F. Dunne, Carl J. Fichtenbaum, Ian Frank, Julie Franks, Jorge A. Gallardo-Cartagena, Aditya H. Gaur, Pedro Gonzáles, Beatriz Grinsztejn, Roy M. Gulick, Trần Việt Hà, Christopher Hall, Javier Antonio Valencia Huamani, Christopher B. Hurt, Jessica Justman, Esper G Kallas, Colleen F. Kelley, Raphael J. Landovitz, Albert Liu, Marcelo Losso, José Valdez Ramalho Madruga, Manya Magnus, Kenneth H. Mayer, Keren Middelkoop, Richard Novák, Edgar T. Overton, Temitope Oyedele, Nittaya Phanuphak, Rachel M. Presti, Daniel Reirden, Anne Rompalo, Breno Santos, Omar Sued, Shobha Swaminathan, Cornelius Van Dam · 发表于：Clinical Infectious Diseases · 年份：2024 · DOI：10.1093/cid/ciae572 · 研究领域：Reproductive tract infections research、HIV/AIDS Research and Interventions、Adolescent Sexual and Reproductive Health

BACKGROUND: Sexually transmitted infections (STIs) have been shown to facilitate human immunodeficiency virus (HIV) transmission and acquisition. HPTN 083, a global clinical trial, demonstrated superiority of long-acting cabotegravir (CAB-LA) versus daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for HIV prevention among transgender women and cisgender men who have sex with men. This analysis assessed whether CAB-LA maintained protective efficacy when bacterial STIs (syphilis, rectal/urethral gonorrhea, and chlamydia) were present. METHODS: STI events per 100 person-years were calculated, including by subgroups (age, race/ethnicity, gender, education, treatment arm, drug use, alcohol use, region/country, condom usage, partner number, marital status, baseline STI). Association between baseline factors and STI incidence was modeled using Poisson regression. Cox proportional hazards modeling with STI status as a time-varying covariate was used to evaluate potential interactions between STI status and the relative efficacy of CAB-LA versus TDF/FTC. FINDINGS: Among 3859 participants, overall STI incidence rate was 50.7 infections/100 person-years. STIs were diagnosed in 1562 (40.5%) participants; 79% of STIs occurred in 25% of the participants. STI incidence was not different by preexposure prophylaxis arm. In the final multivariable model, age, region, race, education level, marital status, and baseline STI were associated with incident STI (P < .05). HIV inciden...