Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010/VESTED): a multicentre, open-label, randomised, controlled, phase 3 trial

• Published in: The Lancet (British edition) Vol. 397; no. 10281; pp. 1276 - 1292
• Main Authors: Lockman, Shahin, Brummel, Sean S, Ziemba, Lauren, Stranix-Chibanda, Lynda, McCarthy, Katie, Coletti, Anne, Jean-Philippe, Patrick, Johnston, Ben, Krotje, Chelsea, Fairlie, Lee, Hoffman, Risa M, Sax, Paul E, Moyo, Sikhulile, Chakhtoura, Nahida, Stringer, Jeffrey SA, Masheto, Gaerolwe, Korutaro, Violet, Cassim, Haseena, Mmbaga, Blandina T, João, Esau, Hanley, Sherika, Purdue, Lynette, Holmes, Lewis B, Momper, Jeremiah D, Shapiro, Roger L, Thoofer, Navdeep K, Rooney, James F, Frenkel, Lisa M, Amico, K Rivet, Chinula, Lameck, Currier, Judith, Best, Brookie M., Blanchette, Cheryl, Browning, Renee, Cheng, Yao, Fox, Andee, Jaliaah, Nagawa, Knowles, Kevin, Mirochnick, Mark, Murtaugh, William A., Patras, Emmanuel, Pinilla, Mauricio, van Wyk, Jean, Whalen, Frances
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 03.04.2021; Elsevier B.V; Elsevier Limited
• Subjects: Adenine - administration & dosage; Adenine - adverse effects; Adenine - analogs & derivatives; Adult; Adverse events; Age; Alanine; Allergies; Analysis; Anti-HIV agents; Anti-HIV Agents - administration & dosage; Anti-HIV Agents - adverse effects; Antiretroviral agents; Antiretroviral drugs; Antiretroviral therapy; Antiviral agents; Biometrics; CD4 antigen; Clinical trials; Creatinine; Disease transmission; Dosage; Drug dosages; Drug resistance; Drug therapy; Drug Therapy, Combination; Efavirenz; Emtricitabine; Emtricitabine - administration & dosage; Emtricitabine - adverse effects; Female; Fetuses; Gestation; Gestational Age; Heterocyclic Compounds, 3-Ring - administration & dosage; Heterocyclic Compounds, 3-Ring - adverse effects; Highly active antiretroviral therapy; HIV; HIV (Viruses); HIV Infections - drug therapy; HIV Infections - prevention & control; Human immunodeficiency virus; Humans; Infant mortality; Infant, Newborn; Infants; Infectious Disease Transmission, Vertical - prevention & control; Infectious diseases; Mental health; Miscarriage; Neonates; Oxazines - administration & dosage; Oxazines - adverse effects; Piperazines - administration & dosage; Piperazines - adverse effects; Pregnancy; Pregnancy Complications, Infectious - drug therapy; Pregnancy Outcome; Pregnant women; Premature birth; Public health; Pyridones - administration & dosage; Pyridones - adverse effects; Randomization; Ribonucleic acid; RNA; Safety; Secondary analysis; Small for gestational age; Stillbirth; Tenofovir; Tenofovir - administration & dosage; Tenofovir - adverse effects; Ultrasonic imaging; Ultrasonography, Prenatal; Womens health; South Africa; Botswana; United States > US

Antiretroviral therapy (ART) during pregnancy is important for both maternal health and prevention of perinatal HIV-1 transmission; however adequate data on the safety and efficacy of different ART regimens that are likely to be used by pregnant women are scarce. In this trial we compared the safety...