6/28/23, 12:41 AM ANRS IPERGAY Pathway Feedback Search Clinical Topics Home Studies ANRS IPERGAY ANRS IPERGAY Disease Human immunodeficiency virus i Trial question What is the role of antiretroviral therapy for preexposure HIV-1 prophylaxis among men who have unprotected anal sex with men? Study design Multi-center Double blinded RCT Population 400 male patients Inclusion criteria: men who have unprotected anal sex with men and who are at high risk for HIV infection Key exclusion criteria: positive results on testing for HBsAg, chronic infection with HCV, a CrCl < 60 mL/min, an ALT level > 2.5 times the upper limit of the normal range, and glycosuria or proteinuria > 1+ on urine dipstick testing Interventions N=199 truvada (fixed-dose combination of 300 mg of tenofovir disoproxil fumarate and 200 mg of emtricitabine) N=201 placebo (matching placebo pills) Primary outcome Incidence of human immunodeficiency virus 1 infection 6.6/100 py 6.6 4.9/100 py https://web.pathway.md/studies/recjOXLBccB9g5d0g 1/2 6/28/23, 12:41 AM ANRS IPERGAY Pathway 3.3/100 py 1.6/100 py Significant decrease 0.91 0.0/100 py Truvada Placebo Significant decrease in the incidence of human immunodeficiency virus 1 infection (0.91 /100 py vs. 6.6 /100 py; RR 0.14, 95% CI 0.02 to 0.6) Secondary outcomes No significant difference in new STI (41% vs. 33%; RR 1.24, 95% CI -0.24 to 2.72) Significant increase in reduction in sexual partners within the past 2 months (8 vs. 7.5; RR 1.07, 95% CI 0.44 to 1.7) Safety outcomes No significant difference in adverse events and serious adverse events. Significant difference in drug-related gastrointestinal adverse events (14% vs. 5%) and renal adverse events (18% vs. 10%). Conclusion In men who have unprotected anal sex with men and who are at high risk for HIV infection, truvada was superior to placebo with respect to the incidence of human immunodeficiency virus 1 infection. Reference Molina JM, Capitant C, Spire B et al. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. Open reference URL https://web.pathway.md/studies/recjOXLBccB9g5d0g 2/2