On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection

摘要: Background Antiretroviral preexposure prophylaxis has been shown to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection in some studies, but conflicting results have reported among probably due challenges adherence a daily regimen. Methods We conducted double-blind, randomized trial antiretroviral therapy for HIV-1 men who unprotected anal sex with men. Participants were randomly assigned take combination tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or placebo before after sexual activity. All participants received risk-reduction counseling condoms regularly tested HIV-2 other sexually transmitted infections. Results Of 414 underwent randomization, 400 did not HIV enrolled (199 TDF-FTC group 201 group). followed median 9.3 months (interquartile range, 4.9 20.6). A total 16 infections occurred during follow-up, 2 (incidence, 0.91 per 100 person-years) 14 6.60 person-years), relative reduction 86% (95% confidence interval, 40 98; P=0.002). took 15 pills month (P=0.57). The rates serious adverse events similar two study groups. In group, as compared there higher gastrointestinal (14% vs. 5%, P=0.002) renal (18% 10%, P=0.03). Conclusions The use activity provided protection against treatment was associated increased events. (Funded by National Agency Research on AIDS Viral Hepatitis [ ANRS] others; ClinicalTrials.gov number, NCT01473472.)