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
The Lancet Apr 07, 2021
Lockman S, Brummel SS, Ziemba L, et al. - Via a multicenter, open-label, randomized controlled, phase 3 trial at 22 clinical research sites in nine countries (Botswana, Brazil, India, South Africa, Tanzania, Thailand, Uganda, the US, and Zimbabwe), the safety and efficacy of three antiretroviral regimens initiated in pregnancy were examined: dolutegravir, emtricitabine, and tenofovir alafenamide fumarate; dolutegravir, emtricitabine, and tenofovir disoproxil fumarate; and efavirenz, emtricitabine, and tenofovir disoproxil fumarate. A total of 643 pregnant women were enrolled and randomized. Dolutegravir-containing regimens, when initiated in pregnancy, were identified to exhibit superior virological efficacy at delivery compared with the efavirenz, emtricitabine, and tenofovir disoproxil fumarate regimen. The frequency of composite adverse pregnancy outcomes and of neonatal deaths was noted to be lowest in correlation with the dolutegravir, emtricitabine, and tenofovir alafenamide fumarate regimen.
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