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N Engl J Med. 2012 Aug 2;367(5):411-22. doi: 10.1056/NEJMoa1202614. Epub 2012 Jul 11.

Preexposure prophylaxis for HIV infection among African women.

Collaborators (223)

Abele R, Adagi L, Agingu W, Ambia J, Andreasen A, Asewe J, de Baetselier I, Bonyo T, Cates W, Chiduo S, Chilwane MC, Defechereux P, Dorflinger L, Gaddiel J, Headley J, Kiyanga P, Lalbahadur T, Lanham M, Lemons A, Liegler T, Ma YR, Maboa RM, Malone S, Masaki M, Mawere F, McKenna K, Mlay A, Mohale LB, Mueller M, Mullins S, Naicker S, Ndyetabura T, Ogola D, Ogola RB, Omondi J, Omullo P, Omungo Z, Ogada T, Ollotu I, Otunga S, Onuonga E, Parker C, Perry B, Ratlhagana MJ, Rammutla E, Sam N, Segoe T, Siguntu P, Skhosana JS, Thole TT, Thulare NG, Troxler A, Chetty-Tulsee S, Veena V, Venkatasubramanian L, Wassonga L, White N, Alexander T, Cates W, Chiliade P, Corneli A, Chen M, Deese J, Dorflinger L, Headley J, Kariuki J, Kiernan H, Kirkendale S, Lanham M, Lemons A, Ma S, Mandala J, McKenna K, Mastro TD, Mueller M, Mullins S, Nanda K, Omungo Z, Parker C, Perry B, Rountree W, Saylor L, Taylor D, Troxler A, Van Damme L, Veena V, Wong C, Agot K, Ojwang F, Millah D, Olang'o IL, Liwindi J, Oduor M, Ochieng R, Mbaja L, Kosiyo P, Ogosi J, Akowo D, Lishindu F, Chepkoech L, Mukoshi L, Nyawasa V, David J, Nyadimo M, Aluoch E, Odawa E, Nyangidi E, Auma M, Akumu J, Onundo S, Omondi M, Juma JG, Ochola D, Omullo P, Ouma L, Oluoch L, Otieno C, Hagoi J, Adhiambo MF, Koloo S, Odero R, Odhul T, Owiti E, Yuko M, Asewe J, Onyango J, Ahmed K, Carrim-Ganey N, Malahleha M, Rebone M, Mtimkulu VT, Skhosana JS, Monedi MC, Ratlhagana MJ, Makatu SE, Phohu MK, Thulare NG, Rammutla E, Matsane ED, Mohale LB, Mashego TL, Naicker S, Matlala MF, Thole TT, Madlala MM, Morolo MB, Chilwane MC, Ratlhogo SE, Mamabolo MT, Lubethe MM, Modibane E, Malamatsho RM, Neluheni F, Lombaard J, Foulkes S, Grobler A, Makanda MM, Venter G, Book HH, Siguntu P, Johnson M, Barsch E, Tsikkos D, Segoe T, Manongi RN, Bendera M, Kimango H, Ngowi M, Samba T, Msuya A, Mandao B, Mbuya E, Otaru M, Karabashanga J, Sululu C, Ona R, Chuwa A, Lyamuya J, Lyimo H, Lyaruu M, Laurent G, Mosha D, Swai V, Makia F, Monyo A, Kagaruki G, Noel J, Maliwa E, Aaron S, Mgonja V, Temba F, Crucitti T, Fransen K, De Baetselier I, Vermoesen T, Abdellati S, Cuylaerts V, Beelaert G, Mangelschots M, Garcia SR, De Rooy M, Claus M, Thys W, Nys P, Casier L, Baeten Y, Grant R, Defechereux P, Liegler T, Schmidt T, Javier J, Angeles Z, Kashuba AD, White N, Malone S, Chetty-Tulsee S, Lalbahadur T, Farley T, Hicks C, Sanne I, Dominik R, Adebamowo C, Chatani M.



Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others.


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.


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<0.001, and P=0.03, respectively). Rates of drug discontinuation because of hepatic or renal abnormalities were higher in the TDF-FTC group (4.7%) than in the placebo group (3.0%, P=0.051). Less than 40% of the HIV-uninfected women in the TDF-FTC group had evidence of recent pill use at visits that were matched to the HIV-infection window for women with seroconversion. 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. (Supported by the U.S. Agency for International Development and others; FEM-PrEP number, NCT00625404.).

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