1. Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial
- Author
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Chinula, Lameck, Chinula, Lameck, Ziemba, Lauren, Brummel, Sean, McCarthy, Katie, Coletti, Anne, Krotje, Chelsea, Johnston, Benjamin, Knowles, Kevin, Moyo, Sikhulile, Stranix-Chibanda, Lynda, Hoffman, Risa, Sax, Paul E, Stringer, Jeffrey, Chakhtoura, Nahida, Jean-Philippe, Patrick, Korutaro, Violet, Cassim, Haseena, Fairlie, Lee, Masheto, Gaerolwe, Boyce, Ceejay, Frenkel, Lisa M, Amico, K Rivet, Purdue, Lynette, Shapiro, Roger, Mmbaga, Blandina Theophil, Patel, Faeezah, van Wyk, Jean, Rooney, James F, Currier, Judith S, Lockman, Shahin, Best, Brookie M, Blanchette, Cheryl D, Browning, Renee, Jaliaah, Nagawa, Mirochnick, Mark, Murtaugh, William A, Patras, Emmanuel, Whalen, Frances, Momper, Jeremiah D, Ponatshego, Ponego L, Tirelo, Lesedi, Seme, Boitshepo J, Modise, Georginah O, Raesi, Mpho S, Budu, Marian E, Ramogodiri, Moakanyi, Oliveira, Ricardo H, Hofe, Cristina B, de Abreu, Thalita Fernandes, Pestanha, Lorena M, João, Esaú, Sidi, Leon C, Fuller, Trevon, Cruz, Maria LS, Pinto, Jorge, Ferreira, Flãvia, Correa, Mãrio, Romeiro, Juliana, Pilotto, Jose H, Fernandes, Luis EBC, Moreira, Luiz F, Gomes, Ivete M, Naik, Shilpa, Nevrekar, Neetal, Mave, Vidya, Kinikar, Aarti, Horne, Elizea, Soma-Kasiram, Hamisha, Violari, Avy, Mathiba, Sisinyana R, Nyati, Mandisa, Theron, Gerhard, de Jager, Jeanne, Rossouw, Magdel, Rossouw, Lindie, Hanley, Sherika, Desmond, Alicia C, Gazu, Rosemary, Govender, Vani, Chalermchockcharoenkit, Amphan, Thamkhantho, Manopchai, Werarak, Peerawong, Rungmaitree, Supattra, Achalapong, Jullapong, Sitiritkawin, Lukkana, Cressey, Tim R, Sukrakanchana, Pra-ornsuda, Aurpibul, Linda, Tongprasert, Fuanglada, Khamrong, Chintana, Kiattivej, Sopida, Wabwire, Deo, Kabugo, Enid, Maena, Joel, Nakayiwa, Frances, Ndyanabangi, Victoria, Nagaddya, Beatrice, Sekabira, Rogers, Ashaba, Justus, Mitchell, Charles D, Chinula, Lameck, Chinula, Lameck, Ziemba, Lauren, Brummel, Sean, McCarthy, Katie, Coletti, Anne, Krotje, Chelsea, Johnston, Benjamin, Knowles, Kevin, Moyo, Sikhulile, Stranix-Chibanda, Lynda, Hoffman, Risa, Sax, Paul E, Stringer, Jeffrey, Chakhtoura, Nahida, Jean-Philippe, Patrick, Korutaro, Violet, Cassim, Haseena, Fairlie, Lee, Masheto, Gaerolwe, Boyce, Ceejay, Frenkel, Lisa M, Amico, K Rivet, Purdue, Lynette, Shapiro, Roger, Mmbaga, Blandina Theophil, Patel, Faeezah, van Wyk, Jean, Rooney, James F, Currier, Judith S, Lockman, Shahin, Best, Brookie M, Blanchette, Cheryl D, Browning, Renee, Jaliaah, Nagawa, Mirochnick, Mark, Murtaugh, William A, Patras, Emmanuel, Whalen, Frances, Momper, Jeremiah D, Ponatshego, Ponego L, Tirelo, Lesedi, Seme, Boitshepo J, Modise, Georginah O, Raesi, Mpho S, Budu, Marian E, Ramogodiri, Moakanyi, Oliveira, Ricardo H, Hofe, Cristina B, de Abreu, Thalita Fernandes, Pestanha, Lorena M, João, Esaú, Sidi, Leon C, Fuller, Trevon, Cruz, Maria LS, Pinto, Jorge, Ferreira, Flãvia, Correa, Mãrio, Romeiro, Juliana, Pilotto, Jose H, Fernandes, Luis EBC, Moreira, Luiz F, Gomes, Ivete M, Naik, Shilpa, Nevrekar, Neetal, Mave, Vidya, Kinikar, Aarti, Horne, Elizea, Soma-Kasiram, Hamisha, Violari, Avy, Mathiba, Sisinyana R, Nyati, Mandisa, Theron, Gerhard, de Jager, Jeanne, Rossouw, Magdel, Rossouw, Lindie, Hanley, Sherika, Desmond, Alicia C, Gazu, Rosemary, Govender, Vani, Chalermchockcharoenkit, Amphan, Thamkhantho, Manopchai, Werarak, Peerawong, Rungmaitree, Supattra, Achalapong, Jullapong, Sitiritkawin, Lukkana, Cressey, Tim R, Sukrakanchana, Pra-ornsuda, Aurpibul, Linda, Tongprasert, Fuanglada, Khamrong, Chintana, Kiattivej, Sopida, Wabwire, Deo, Kabugo, Enid, Maena, Joel, Nakayiwa, Frances, Ndyanabangi, Victoria, Nagaddya, Beatrice, Sekabira, Rogers, Ashaba, Justus, and Mitchell, Charles D
- Abstract
BackgroundDrugs taken during pregnancy can affect maternal and child health outcomes, but few studies have compared the safety and virological efficacy of different antiretroviral therapy (ART) regimens. We report the primary safety outcomes from enrolment up to 50 weeks post partum and a secondary virological efficacy outcome at 50 weeks post partum of three commonly used ART regimens for HIV-1.MethodsIn this multicentre, open-label, randomised, controlled, phase 3 trial, we enrolled pregnant women aged 18 years or older with confirmed HIV-1 infection at 14-28 weeks of gestation. Women were enrolled at 22 clinical research sites in nine countries (Botswana, Brazil, India, South Africa, Tanzania, Thailand, Uganda, the USA, and Zimbabwe). Participants were randomly assigned (1:1:1) to one of three oral regimens: dolutegravir, emtricitabine, and tenofovir alafenamide; dolutegravir, emtricitabine, and tenofovir disoproxil fumarate; or efavirenz, emtricitabine, and tenofovir disoproxil fumarate. Up to 14 days of antepartum ART before enrolment was permitted. Women with known multiple gestation, fetal anomalies, acute significant illness, transaminases more than 2·5 times the upper limit of normal, or estimated creatinine clearance of less than 60 mL/min were excluded. Primary safety analyses were pairwise comparisons between ART regimens of the proportion of maternal and infant adverse events of grade 3 or higher up to 50 weeks post partum. Secondary efficacy analyses at 50 weeks post partum included a comparison of the proportion of women with plasma HIV-1 RNA of less than 200 copies per mL in the combined dolutegravir-containing groups versus the efavirenz-containing group. Analyses were done in the intention-to-treat population, which included all randomly assigned participants with available data. This trial was registered with ClinicalTrials.gov, NCT03048422.FindingsBetween Jan 19, 2018, and Feb 8, 2019, we randomly assigned 643 pregnant women to the dolutegravir
- Published
- 2023