HIV pre-exposure prophylaxis in men who have sex with men and transgender women: a secondary analysis of a phase 3 randomised controlled efficacy trial

摘要: Summary Background For maximum effect pre-exposure prophylaxis should be targeted to the subpopulations that account for largest proportion of infections (population-attributable fraction [PAF]) and whom number needed treat (NNT) prevent infection is lowest. We aimed estimate PAF NNT participants in iPrEx (Pre-Exposure Prophylaxis Initiative) trial. Methods The study was a randomised controlled efficacy trial with coformulated tenofovir disoproxil fumarate emtricitabine 2499 men who have sex (MSM) transgender women. Participants aged 18 years or older were male at birth enrolled from 11 sites Brazil, Ecuador, Peru, South Africa, Thailand, USA. randomly assigned (1:1) receive either pill active placebo, taken daily. calculated association between demographic risk behaviour during screening subsequent seroconversion among placebo recipients using Poisson model, we subgroups. registered ClinicalTrials.gov, NCT00458393. Findings Patients July 10, 2007, Dec 17, 2009, followed up until Nov 21, 2010. Of MSM women trial, 1251 1248 placebo. 83 patients group became infected HIV follow-up. reporting receptive anal intercourse without condom seroconverted significantly more often than those no (adjusted hazard ratio [AHR] 5·11, 95% CI 1·55–16·79). overall 64% (prevalence 60%). Most this came partners unknown serostatus (PAF 53%, prevalence 54%, AHR 4·76, 1·44–15·71); by contrast, an HIV-positive partner 1% 1%, 7·11, 0·70–72·75). per year cohort 62 (95% 44–147). NNTs lowest self-reporting (NNT 36), cocaine use (12), sexually transmitted (41). Having one insertive had highest (100 77, respectively). Interpretation Pre-exposure may most effective population level if toward report condom, even they perceive their negative. Substance history testing STIs also inform individual decisions start prophylaxis. Consideration can aid discussion benefits risks Funding National Institute Allergy Infectious Diseases Bill & Melinda Gates Foundation.