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Preexposure prophylaxis for HIV infection among African women

Journal Contribution - Journal Article

Background: Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others. Methods: In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women in Kenya, South Africa, and Tanzania to receive either a combination of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) or placebo once daily. The primary objective was to assess the effectiveness of TDF-FTC in preventing HIV acquisition and to evaluate safety. Results: HIV infections occurred in 33 women in the TDF-FTC group (incidence rate, 4.7 per 100 person-years) and in 35 in the placebo group (incidence rate, 5.0 per 100 person-years), for an estimated hazard ratio in the TDF-FTC group of 0.94 (95% confidence interval, 0.59 to 1.52; P=0.81). The proportions of women with nausea, vomiting, or elevated alanine aminotransferase levels were significantly higher in the TDF-FTC group (P=0.04, P
Journal: New England Journal of Medicine
ISSN: 0028-4793
Issue: 5
Volume: 367
Pages: 411-422
Number of pages: 12
Publication year:2012
Keywords:Viral diseases, HIV, AIDS, Pre-exposure, Prophylaxis, Women, Effectiveness, Assessment, Combination therapy, Tenofovir, Disoproxil, Fumarate, Emtricitabine, Transmission prevention, Safety, Evaluation, Adverse effects, Hepatic, Renal function, Randomized controlled trials, Randomized clinical trials, Kenya, Tanzania, Africa-East, South Africa, Africa-Southern