TITLE

2010 - Daily emtricitabine plus tenofovir disoproxil fumarate reduced risk for HIV infection in men who have sex with men

AUTHOR(S)
Kalil, Andre C.; Sandkovsky, Uriel S.
PUB. DATE
April 2011
SOURCE
ACP Journal Club;4/17/2011, Vol. 154 Issue 4, p1
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
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.
ACCESSION #
64279632

 

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