Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants

Summary

The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil fumarate, and efavirenz/emtricitabine/tenofovir disoproxil fumarate in pregnant women living with HIV-1 and to compare the safety of these regimens for their infants.

Timeline

Start

2018-01-19

Primary completion

2020-10-03

Completion

2020-10-03

Publications

• Results Lockman S, Brummel SS, Ziemba L, Stranix-Chibanda L, McCarthy K, Coletti A, Jean-Philippe P, Johnston B, Krotje C, Fairlie L, Hoffman RM, Sax PE, Moyo S, Chakhtoura N, Stringer JS, Masheto G, Korutaro V, Cassim H, Mmbaga BT, Joao E, Hanley S, Purdue L, Holmes LB, Momper JD, Shapiro RL, Thoofer NK, Rooney JF, Frenkel LM, Amico KR, Chinula L, Currier J; IMPAACT 2010/VESTED Study Team and Investigators. 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. Lancet. 2021 Apr 3;397(10281):1276-1292. doi: 10.1016/S0140-6736(21)00314-7.
• Masheto G, Brummel SS, Ziemba L, Shepherd J, Mbengeranwa T, Igawa L, Coletti A, Mukura D, Rossouw L, Theron G, Krotje C, Jean-Philippe P, Chakhtoura N, Cassim H, Mathiba SR, Maena J, Murtaugh W, Fairlie L, Currier J, Hoffman R, Chinula L, Sax PE, Stranix-Chibanda L, Lockman S; IMPAACT 2010/VESTED Study Team and Investigators. Markers of Maternal Bone and Renal Toxicity Through 50 Weeks Postpartum: IMPAACT 2010 (VESTED) Trial. J Acquir Immune Defic Syndr. 2024 Oct 1;97(2):172-179. doi: 10.1097/QAI.0000000000003478.
• Eke AC, Brummel SS, Aliyu MH, Stranix-Chibanda L, Eleje GU, Ezebialu IU, Korutaro V, Wabwire D, Matubu A, Mbengeranwa T, Chakhtoura N, Chinula L, McCarthy K, Knowles K, Krotje C, Linton MF, Dooley KE, Sax PE, Brown T, Lockman S; IMPAACT 2010/VESTED Study Team. Lipid and Glucose Profiles in Pregnant Women With HIV on Tenofovir-based Antiretroviral Therapy. Clin Infect Dis. 2025 Mar 17;80(3):594-601. doi: 10.1093/cid/ciae441.
• Jacobson DL, Crider KS, DeMarrais P, Brummel S, Zhang M, Pfeiffer CM, Moore CA, McCarthy K, Johnston B, Mohammed T, Vhembo T, Kabugho E, Muzorah GA, Cassim H, Fairlie L, Machado ES, Ngocho JS, Shapiro RL, Serghides L, Chakhtoura N, Chinula L, Lockman S. Dolutegravir- Versus Efavirenz-Based Treatment in Pregnancy: Impact on Red Blood Cell Folate Concentrations in Pregnant Women and Their Infants. J Infect Dis. 2024 Nov 15;230(5):1224-1234. doi: 10.1093/infdis/jiae308.
• Chinula L, Ziemba L, Brummel S, McCarthy K, Coletti A, Krotje C, Johnston B, Knowles K, Moyo S, Stranix-Chibanda L, Hoffman R, Sax PE, Stringer J, Chakhtoura N, Jean-Philippe P, Korutaro V, Cassim H, Fairlie L, Masheto G, Boyce C, Frenkel LM, Amico KR, Purdue L, Shapiro R, Mmbaga BT, Patel F, van Wyk J, Rooney JF, Currier JS, Lockman S; IMPAACT 2010/VESTED Study Team and Investigators. 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. Lancet HIV. 2023 Jun;10(6):e363-e374. doi: 10.1016/S2352-3018(23)00061-9. Epub 2023 May 8.

Drugs

Indications