Preexposure prophylaxis for HIV infection among African women
Lut Van Damme, Amy Corneli, Khatija Ahmed, Kawango Agot, Johan Lombaard, Saidi Kapiga, Mookho Malahleha, Fredrick Owino, Rachel Manongi, Jacob Onyango, Lucky Temu, Modie Constance Monedi, Paul Mak'Oketch, Mankalimeng Makanda, Ilse Reblin, Shumani Elsie Makatu, Lisa Saylor, Haddie Kiernan, Stella Kirkendale, Christina Wong, Robert Grant, Angela Kashuba, Kavita Nanda, Justin Mandala, Katrien Fransen, Jennifer Deese, Tania Crucitti, Timothy D Mastro, Douglas Taylor, FEM-PrEP Study Group, Rachel Abele, Lucie Adagi, Walter Agingu, Julie Ambia, Aura Andreasen, Jesse Asewe, Irith de Baetselier, Teresa Bonyo, Ward Cates, Sarah Chiduo, Mmamolefe Ciphrich Chilwane, Patricia Defechereux, Laneta Dorflinger, John Gaddiel, Jennifer Headley, Peter Kiyanga, Tharnija Lalbahadur, Michele Lanham, Ansley Lemons, Terry Liegler, Yun-Rong Ma, Rebone Malobane Maboa, Stephanie Malone, Martha Masaki, Florence Mawere, Kevin McKenna, Amina Mlay, Lerato Buskien Mohale, Monique Mueller, Sarah Mullins, Sarisha Naicker, Theonest Ndyetabura, Dorine Ogola, Rachel Beldina Ogola, Joy Omondi, Paul Omullo, Zablon Omungo, Teresa Ogada, Isaya Ollotu, Sheilla Otunga, Eunice Onuonga, Caleb Parker, Brian Perry, Mary-Jane Malebo Ratlhagana, Elizabeth Rammutla, Noel Sam, Theo Segoe, Phumzile Siguntu, Joseph Short Skhosana, Thamara Thelma Thole, Ntsutsa Getrude Thulare, Amanda Troxler, Savi Chetty-Tulsee, Valentine Veena, Lalitha Venkatasubramanian, Lennah Wassonga, Nicole White, Thomas Alexander, Ward Cates, Philippe Chiliade, Amy Corneli, Mario Chen, Jennifer Deese, Laneta Dorflinger, Jennifer Headley, Janet Kariuki, Haddie Kiernan, Stella Kirkendale, Michele Lanham, Ansley Lemons, Sabrina Ma, Justin Mandala, Kevin McKenna, Timothy D Mastro, Monique Mueller, Sarah Mullins, Kavita Nanda, Zablon Omungo, Caleb Parker, Brian Perry, Wes Rountree, Lisa Saylor, Doug Taylor, Amanda Troxler, Lut Van Damme, Valentine Veena, Christina Wong, Kawango Agot, Frank Ojwang, Damatise Millah, Immaculate Lilian Olang'o, Joshua Liwindi, Moses Oduor, Rachel Ochieng, Leonard Mbaja, Paul Kosiyo, Jackline Ogosi, Dominic Akowo, Florence Lishindu, Lennah Chepkoech, Lillian Mukoshi, Victor Nyawasa, Juma David, Magginerro Nyadimo, Emma Aluoch, Edward Odawa, Eric Nyangidi, Margaret Auma, Josephine Akumu, Syprose Onundo, Maureen Omondi, Juma Geoffrey Juma, David Ochola, Paul Omullo, Lilian Ouma, Lennah Oluoch, Carolyne Otieno, Josephine Hagoi, Mary Florence Adhiambo, Sheilla Koloo, Rose Odero, Thomas Odhul, Elizabeth Owiti, Martin Yuko, Jesse Asewe, Jacob Onyango, Khatija Ahmed, Nazira Carrim-Ganey, Mookho Malahleha, Maboa Rebone, Vuyelwa Thokozile Mtimkulu, Joseph Short Skhosana, Modie Constance Monedi, Mary-Jane Malebo Ratlhagana, Shumani Elsie Makatu, Mary Kgomotso Phohu, Ntsutsa Getrude Thulare, Elizabeth Rammutla, Ellen Ditaba Matsane, Lerato Buskien Mohale, Tumelo Loudwick Mashego, Sarisha Naicker, Mafora Florah Matlala, Thamara Thelma Thole, Mamokoma Martina Madlala, Matshidiso Bedzia Morolo, Mmamolefe Ciphrich Chilwane, Shalate Elizabeth Ratlhogo, Mamogola Thamaris Mamabolo, Muriel Maria Lubethe, Ellen Modibane, Ross Mathame Malamatsho, Fulufhelo Neluheni, Johan Lombaard, Sharne Foulkes, Anli Grobler, Mankalimeng Manka Makanda, Gustav Venter, Heidrun Heidi Book, Phumzile Siguntu, Mandy Johnson, Eva Barsch, Dimi Tsikkos, Theo Segoe, Rachel Nathaniel Manongi, Mary Bendera, Herman Kimango, Midlaster Ngowi, Thasiana Samba, Anna Msuya, Beatrice Mandao, Elizabeth Mbuya, Magdalena Otaru, Josephine Karabashanga, Caroline Sululu, Rebecca Ona, Agatha Chuwa, Jeniffer Lyamuya, Henry Lyimo, Method Lyaruu, Gisela Laurent, Deogratias Mosha, Veneranda Swai, Furaha Makia, Anthony Monyo, Gastom Kagaruki, Jackson Noel, Emilian Maliwa, Sydney Aaron, Violet Mgonja, Frida Temba, Tania Crucitti, Katrien Fransen, Irith De Baetselier, Tine Vermoesen, Said Abdellati, Vicky Cuylaerts, Geert Beelaert, Marianne Mangelschots, Sergio Ribas Garcia, Maria De Rooy, Maarten Claus, Wendy Thys, Patrick Nys, Lieve Casier, Yvette Baeten, Robert Grant, Patricia Defechereux, Teri Liegler, Timothy Schmidt, Jacqueline Javier, Zoila Angeles, Angela D M Kashuba, Nicole White, Stephanie Malone, Savi Chetty-Tulsee, Tharnija Lalbahadur, Tim Farley, Charles Hicks, Ian Sanne, Rosalie Dominik, Clement Adebamowo, Manju Chatani, Lut Van Damme, Amy Corneli, Khatija Ahmed, Kawango Agot, Johan Lombaard, Saidi Kapiga, Mookho Malahleha, Fredrick Owino, Rachel Manongi, Jacob Onyango, Lucky Temu, Modie Constance Monedi, Paul Mak'Oketch, Mankalimeng Makanda, Ilse Reblin, Shumani Elsie Makatu, Lisa Saylor, Haddie Kiernan, Stella Kirkendale, Christina Wong, Robert Grant, Angela Kashuba, Kavita Nanda, Justin Mandala, Katrien Fransen, Jennifer Deese, Tania Crucitti, Timothy D Mastro, Douglas Taylor, FEM-PrEP Study Group, Rachel Abele, Lucie Adagi, Walter Agingu, Julie Ambia, Aura Andreasen, Jesse Asewe, Irith de Baetselier, Teresa Bonyo, Ward Cates, Sarah Chiduo, Mmamolefe Ciphrich Chilwane, Patricia Defechereux, Laneta Dorflinger, John Gaddiel, Jennifer Headley, Peter Kiyanga, Tharnija Lalbahadur, Michele Lanham, Ansley Lemons, Terry Liegler, Yun-Rong Ma, Rebone Malobane Maboa, Stephanie Malone, Martha Masaki, Florence Mawere, Kevin McKenna, Amina Mlay, Lerato Buskien Mohale, Monique Mueller, Sarah Mullins, Sarisha Naicker, Theonest Ndyetabura, Dorine Ogola, Rachel Beldina Ogola, Joy Omondi, Paul Omullo, Zablon Omungo, Teresa Ogada, Isaya Ollotu, Sheilla Otunga, Eunice Onuonga, Caleb Parker, Brian Perry, Mary-Jane Malebo Ratlhagana, Elizabeth Rammutla, Noel Sam, Theo Segoe, Phumzile Siguntu, Joseph Short Skhosana, Thamara Thelma Thole, Ntsutsa Getrude Thulare, Amanda Troxler, Savi Chetty-Tulsee, Valentine Veena, Lalitha Venkatasubramanian, Lennah Wassonga, Nicole White, Thomas Alexander, Ward Cates, Philippe Chiliade, Amy Corneli, Mario Chen, Jennifer Deese, Laneta Dorflinger, Jennifer Headley, Janet Kariuki, Haddie Kiernan, Stella Kirkendale, Michele Lanham, Ansley Lemons, Sabrina Ma, Justin Mandala, Kevin McKenna, Timothy D Mastro, Monique Mueller, Sarah Mullins, Kavita Nanda, Zablon Omungo, Caleb Parker, Brian Perry, Wes Rountree, Lisa Saylor, Doug Taylor, Amanda Troxler, Lut Van Damme, Valentine Veena, Christina Wong, Kawango Agot, Frank Ojwang, Damatise Millah, Immaculate Lilian Olang'o, Joshua Liwindi, Moses Oduor, Rachel Ochieng, Leonard Mbaja, Paul Kosiyo, Jackline Ogosi, Dominic Akowo, Florence Lishindu, Lennah Chepkoech, Lillian Mukoshi, Victor Nyawasa, Juma David, Magginerro Nyadimo, Emma Aluoch, Edward Odawa, Eric Nyangidi, Margaret Auma, Josephine Akumu, Syprose Onundo, Maureen Omondi, Juma Geoffrey Juma, David Ochola, Paul Omullo, Lilian Ouma, Lennah Oluoch, Carolyne Otieno, Josephine Hagoi, Mary Florence Adhiambo, Sheilla Koloo, Rose Odero, Thomas Odhul, Elizabeth Owiti, Martin Yuko, Jesse Asewe, Jacob Onyango, Khatija Ahmed, Nazira Carrim-Ganey, Mookho Malahleha, Maboa Rebone, Vuyelwa Thokozile Mtimkulu, Joseph Short Skhosana, Modie Constance Monedi, Mary-Jane Malebo Ratlhagana, Shumani Elsie Makatu, Mary Kgomotso Phohu, Ntsutsa Getrude Thulare, Elizabeth Rammutla, Ellen Ditaba Matsane, Lerato Buskien Mohale, Tumelo Loudwick Mashego, Sarisha Naicker, Mafora Florah Matlala, Thamara Thelma Thole, Mamokoma Martina Madlala, Matshidiso Bedzia Morolo, Mmamolefe Ciphrich Chilwane, Shalate Elizabeth Ratlhogo, Mamogola Thamaris Mamabolo, Muriel Maria Lubethe, Ellen Modibane, Ross Mathame Malamatsho, Fulufhelo Neluheni, Johan Lombaard, Sharne Foulkes, Anli Grobler, Mankalimeng Manka Makanda, Gustav Venter, Heidrun Heidi Book, Phumzile Siguntu, Mandy Johnson, Eva Barsch, Dimi Tsikkos, Theo Segoe, Rachel Nathaniel Manongi, Mary Bendera, Herman Kimango, Midlaster Ngowi, Thasiana Samba, Anna Msuya, Beatrice Mandao, Elizabeth Mbuya, Magdalena Otaru, Josephine Karabashanga, Caroline Sululu, Rebecca Ona, Agatha Chuwa, Jeniffer Lyamuya, Henry Lyimo, Method Lyaruu, Gisela Laurent, Deogratias Mosha, Veneranda Swai, Furaha Makia, Anthony Monyo, Gastom Kagaruki, Jackson Noel, Emilian Maliwa, Sydney Aaron, Violet Mgonja, Frida Temba, Tania Crucitti, Katrien Fransen, Irith De Baetselier, Tine Vermoesen, Said Abdellati, Vicky Cuylaerts, Geert Beelaert, Marianne Mangelschots, Sergio Ribas Garcia, Maria De Rooy, Maarten Claus, Wendy Thys, Patrick Nys, Lieve Casier, Yvette Baeten, Robert Grant, Patricia Defechereux, Teri Liegler, Timothy Schmidt, Jacqueline Javier, Zoila Angeles, Angela D M Kashuba, Nicole White, Stephanie Malone, Savi Chetty-Tulsee, Tharnija Lalbahadur, Tim Farley, Charles Hicks, Ian Sanne, Rosalie Dominik, Clement Adebamowo, Manju Chatani
Abstract
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<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.
Conclusions: 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 ClinicalTrials.gov number, NCT00625404.).
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Source: PubMed