Birth and Infant Growth Outcomes Following Prenatal Exposure to Bictegravir

Despite increasing bictegravir (BIC) use during pregnancy, infant health outcomes data remain limited. We evaluated birth and growth outcomes among HIV-exposed infants (HEI) with prenatal maternal BIC exposures.

A retrospective cohort study of HEIs with prenatal BIC exposure at Children's National Hospital during 2019-2022. Infant (birth outcomes, HIV status, growth indicators) and maternal (demographics, viral load, BIC use in pregnancy) data were obtained from medical records. Descriptive statistics were used to summarize infant head circumference (HC) at 0-1 month and weight-for-length (WFL) and length-for-age (LFA) at 2-3 months using mean z-scores overall and by duration of BIC exposure.

Sixty mothers (median age=34 years [IQR:26-37], 50% Black, 70% with latest HIV RNA<50 copies/mL) used BIC in pregnancy and delivered 60 HEIs (88% term, 12% preterm, median birth weight=3.2 kg [IQR 2.8-3.4]). Twenty-eight (46%) mothers initiated BIC pre-conception or in the first trimester. Most (73%) mothers continued BIC through delivery, 10% discontinued in the first trimester, 27% initiated in second and third trimester and 17% had unknown duration. Most infants had normal HC (n=49, 92%), WFL (n=52, 85%), and LFA (n=51, 92%). Abnormal HC (n=4), WFL (n=8), and LFA (n=4) were observed in 8% (95% CI: 2.3%-19.6%), 15% (95% CI: 6.9%-28.1%), and 8% (95% CI: 2.2%-18.9%), respectively, with no relationship to the duration of BIC exposures. Fifty-seven (95%) HEIs were definitively HIV-negative; 3 (5%) HEIs were lost to care.

Most HEIs with prenatal BIC exposure had favorable birth outcomes and exhibited normal early growth.