Pre-exposure prophylaxis with antiretroviral drugs has been effective in the prevention of HIV infection in some trials but not in others. This randomized, double-blind, placebo-controlled trial assigned 2,120 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 to assess the effectiveness of TDF-FTC in preventing HIV acquisition and to evaluate safety. The study was stopped early, on April 18, 2011, because of lack of efficacy. Prophylaxis with TDF-FTC did not significantly reduce the rate of HIV infection and was associated with increased rates of side effects, as compared with placebo. Despite substantial counseling efforts, drug adherence appeared to be low.
Pre-exposure prophylaxis for HIV infection among African women
Written By
Van Damme L. Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, Malaheleha M, Owino F, Manongi R, Onyango J, Temu L, Monedi MC, Mak’Oketch P, Makanda M, Reblin I, Makatu SE, Saylor L, Kiernan H, Kirkendale S, Wong C, Grant R, Kashuba A, Nanda K, Mandala J, Fransen K, Deese J, Crucitti T, Mastro TD, Taylor D on behalf of the FEM-PrEP study group