ANRS IPERGAY
Trial question
What is the role of ART 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 immunodeficiency virus 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
0.91
6.6
6.6/100 py
4.9/100 py
3.3/100 py
1.6/100 py
0.0/100 py
Truvada
Placebo
Significant decrease ▼
Significant decrease in the incidence of HIV 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)
Borderline significant increase in treatment adherence (15 pills/month vs. 15 pills/month; )
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 immunodeficiency virus infection, truvada was superior to placebo with respect to the incidence of HIV 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.
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