There are still limited safety data available for dolutegravir use in pregnancy. The authors therefore compared the birth outcomes among women initiating dolutegravir-based antiretroviral therapy (ART) with those among women initiating efavirenz-based ART in pregnancy in Botswana. They conducted an observational study that included birth outcome data covering 45% of all deliveries in the country from 2014 onwards. In 2016, Botswana changed its first-line ART from efavirenz-tenofovir-emtricitabine to dolutegravir-tenofovir-emtricitabine, including for pregnant women. Therefore women starting either efavirenz-based ART between 2014 and 2016 or dolutegravir-based ART between 2016 and 2017 were included. 1729 pregnant women who initiated dolutegravir-based ART and 4593 who initiated efavirenz-based ART were included. The risk for any adverse birth outcome among women on dolutegravir versus efavirenz was similar (33·2% vs. 35·0%), as was the risk of any severe birth outcome (10·7% vs. 11·3%). There were also no significant differences between the regimens for stillbirth, neonatal death, preterm birth, very preterm birth, small for gestational age (SGA) or very SGA. Therefore adverse birth outcomes were similar among pregnant women who initiated dolutegravir-based and efavirenz-based ART, showing that dolutegravir is safe for pregnancy.
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