Zash R, et al. - Authors compared birth outcomes of women initiating dolutegravir-based antiretroviral therapy (ART) with those of women initiating efavirenz-based ART in pregnancy in Botswana. Similar adverse birth outcomes were seen among pregnant women who initiated dolutegravir-based and efavirenz-based ART. Findings suggested a probability of safe initiation of dolutegravir-based ART in pregnancy.

Methods

• Experts, in this observational study captured birth outcome data at eight government hospitals throughout Botswana (~45% of all deliveries in the country) in an ongoing study that started on August 15, 2014.
• In this trial, they included women starting either efavirenz-based ART or dolutegravir-based ART during singleton pregnancy (regimen started and delivery occurring between August 15, 2014, and August 15, 2016 for efavirenz-based ART and between November 1, 2016, and September 30, 2017 for dolutegravir-based ART).
• Births to mothers who had switched regimen or stopped ART were excluded.
• The combined endpoints of any adverse outcome (stillbirth, preterm birth [< 37 weeks' gestation], small for gestational age [SGA; less than the tenth percentile of birthweight by gestational age], or neonatal death [within 28 days of age]) and severe adverse outcomes (stillbirth, neonatal death, very preterm birth [<32 weeks' gestation], and very SGA [less than the third percentile of birthweight by gestational age]) were the primary outcomes.
• In order to estimate adjusted risk ratios (aRRs), they fitted log-binomial regression models, controlling for maternal age, gravidity, and education.

Results

• As per data, this analysis included 1,729 pregnant women who initiated dolutegravir-based ART and 4,593 who initiated efavirenz-based ART.
• Findings suggested that among women on dolutegravir vs efavirenz, the risk for any adverse birth outcome was similar (33·2% vs 35·0%; aRR 0·95, 95% CI 0·88-1·03), as was the risk of any severe birth outcome (10·7% vs 11·3%; 0·94, 0·81-1·11).
• In the individual outcomes of stillbirth, neonatal death, preterm birth, very preterm birth, SGA, or very SGA, no significant differences by regimen were noted.