6/28/23, 11:37 PM IPrEx Pathway Feedback Search Clinical Topics Home Studies IPrEx IPrEx Disease Human immunodeficiency virus i Trial question What is the role of preexposure chemoprophylaxis in HIV-seronegative men or transgender woMSM? Study design Multi-center Double blinded RCT Population Characteristics of study participants 1.0% female N = 2499 99.0% male 2499 patients (29 female, 2470 male) Inclusion criteria: HIV-seronegative men or transgender woMSM Key exclusion criteria: elevated hepatic aminotransferase levels, hyperbilirubinemia, and renal insufficiency, previous receipt of antiretroviral therapy, or acute hepatitis B infection, diabetes, tuberculosis, and cancer Interventions N=1251 oral antiretroviral drugs (emtricitabine and tenofovir disoproxil fumarate (FTC-TDF) once daily plus HIV testing, risk-reduction counseling, condoms, and management of STIs) N=1248 placebo (matching placebo plus HIV testing, risk-reduction counseling, condoms, and management of STIs) Primary outcome Emergence of HIV infection in modified intention-to-treat population https://web.pathway.md/studies/recaeREvqkDGreNNX 1/2 6/28/23, 11:37 PM IPrEx Pathway 64.0 64 48.0 36 32.0 16.0 Significant increase 0.0 Oral antiretroviral drugs Placebo Significant increase in emergence of HIV infection in the modified intention-to-treat population (36 vs. 64; RR 44, 95% CI 15 to 63) Secondary outcomes Borderline significant decrease in pill use on 50% days (23 vs. 47; HR 0.5, 95% CI 0.3 to 0.82) Safety outcomes No significant difference in serious adverse events (p=0.57). Significant difference in nausea during the first week more frequently reported in the FTC-TDF group than the placebo (p < 0.001). Conclusion In HIV-seronegative men or transgender woMSM, oral antiretroviral drugs were superior to placebo with respect to emergence of HIV infection in the modified intention-to-treat population. Reference Grant RM, Lama JR, Anderson PL et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. Open reference URL https://web.pathway.md/studies/recaeREvqkDGreNNX 2/2