Efficacy and Safety of Three Different ART Regimens during Pregnancy

Viral suppression of HIV during pregnancy is important for both maternal health and prevention of mother-to-child transmission. Antiretroviral therapy (ART) is an effective method to manage HIV, but rigorous studies on the safety and efficacy of different ART regimens in pregnant women have been limited. To address this, a recent phase 3 trial was conducted to compare three ART regimens: dolutegravir, emtricitabine, and tenofovir alafenamide fumarate; dolutegravir, emtricitabine, and tenofovir disoproxil fumarate; and efavirenz, emtricitabine, and tenofovir disoproxil fumarate.

This randomized controlled, phase 3 clinical trial was conducted across 22 clinical research sites in 9 countries across the world. Pregnant women with confirmed HIV-1 infection were randomly assigned to one of the three ART regimens. The study showed that when started during pregnancy, dolutegravir-containing regimens were superior at suppressing viral RNA levels at delivery compared with the efavirenz, emtricitabine, and tenofovir disoproxil fumarate regimen. Additionally, the dolutegravir, emtricitabine, and tenofovir alafenamide fumarate regimen had the lowest frequency of adverse pregnancy outcomes and neonatal deaths.

These results support the WHO recommendation for use of dolutegravir in all populations, including pregnant women, and highlights a preference for the use of tenofovir alafenamide fumarate in combination with dolutegravir and emtricitabine over the other combinations. The findings of this study support efforts to reduce mortality, adverse outcomes, and transmission of HIV to the fetus through optimization of safe and effective ART regimens in pregnant individuals.   

Lockman et al. 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.