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Pre-exposure Prophylaxis for HIV Infection Among African Women

August 2012 — The primary results of a trial of once-daily oral Truvada for pre-exposure prophylaxis for HIV infection among women in Africa (FEM-PrEP) are presented in an article published in The New England Journal of Medicine. The FEM-PrEP study was stopped early, on April 18, 2011, because of a lack of efficacy. Despite targeted counseling and support, adherence to the daily drug regimen appeared to be low. FEM-PrEP was a randomized, double-blind, placebo-controlled trial.

Earlier studies had shown that daily, oral pre-exposure prophylaxis with 300 mg of tenofovir disoproxil fumarate (TDF) — an oral prodrug of tenofovir — alone or in combination with 200 mg of emtricitabine (FTC) (TDF-FTC [Truvada] from Gilead Sciences) can reduce the risk of sexually acquired HIV infection in men and women. Consequently, an advisory committee of the U.S. Food and Drug Administration recommended that the label indications for Truvada be changed to include HIV prevention.

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