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- Title
2010 - Daily emtricitabine plus tenofovir disoproxil fumarate reduced risk for HIV infection in men who have sex with men.
- Authors
Kalil, Andre C.; Sandkovsky, Uriel S.
- Abstract
Question Does daily emtricitabine (FTC) plus tenofovir disoproxil fumarate (TDF) prevent HIV infection in men and transgender women who have sex with men? Methods Design Randomized placebo-controlled trial (Preexposure Prophylaxis Initiative [iPrEx] trial). ClinicalTrials.gov NCT00458393. Allocation Unclear allocation concealment.* Blinding Blinded (participants and endpoint monitoring committee).* Follow-up period >2.8 years (median 1.2 y). Setting 11 centers in Brazil, Ecuador, Peru, South Africa, Thailand, and the USA. Participants 2499 persons >18 years of age (mean age 27 y) who were male at birth; having sex with men; HIV-seronegative and at high-risk for HIV infection in the past 6 months (had anal sex with >4 or >6 male partners, depending on study site, or unprotected anal sex with a partner who had HIV or unknown infection status; current sexually transmitted infection; or past transactional sex activity); scored >80 on the Karnofsky scale; and had creatinine clearance >60 mg/dL. Exclusion criteria included serious, active illnesses (e.g., tuberculosis, cancer requiring treatment, and diabetes needing hypoglycemic agents); use of nephrotoxic agents; past nontraumatic pathologic bone fracture; and possible past use of antiretroviral drugs or anti-HIV vaccines in a blinded clinical trial. Intervention Daily oral FTC, {200 mg}†, plus TDF, {300 mg}† (n =>1251), or placebo (n =>1248). Outcomes HIV infection (positive antibody test or detectable HIV-RNA). Other outcomes included adverse events. Patient follow-up 82% (intention-to-treat analysis). Main results Daily FTC-TDF reduced emergent HIV infection more than placebo (Table). More participants receiving FTC-TDF had grade 2 nausea and >5% unintentional weight loss than those receiving placebo (2% vs 1%, P =>0.04 for both events); groups did not differ for other adverse events or serious adverse events (5% in each group, P =>0.57). Conclusion Daily emtricitabine plus tenofovir disoproxil fumarate reduced risk for HIV infection in high-risk men and transgender women who have sex with men.
- Publication
ACP Journal Club, 2011, Vol 154, Issue 4, p1
- ISSN
1056-8751
- Publication type
Article