Pregnancy and Neonatal Outcomes Following Prenatal Exposure to Dolutegravir: Findings From the Antiretroviral Pregnancy Registry.

BACKGROUND

Safe and effective antiretrovirals (ARVs) are essential for managing HIV-1 in pregnant individuals and ensuring positive pregnancy outcomes. International guidelines recommend dolutegravir-based regimens as the preferred option for pregnant individuals or those planning to conceive.

SETTING

The Antiretroviral Pregnancy Registry (APR) is a voluntary, international, prospective, exposure-registration cohort study providing early warning signals of major teratogenicity with ARV use.

METHODS

Pregnancy and neonatal outcomes following prenatal dolutegravir exposure were assessed among prospectively reported pregnancies starting in 2013, after dolutegravir approval for HIV-1 treatment, through January 31, 2025. Birth defect prevalence after first-trimester dolutegravir exposure was compared with prevalence during the second and third trimesters, for other ARVs, and the general US population.

RESULTS

Among 2075 pregnancies exposed to dolutegravir, initial exposure occurred during periconception, later first trimester, second trimester, and third trimester in 53%, 14%, 24%, and 9% of pregnancies, respectively. Overall, 93% (1970/2127) of pregnancy outcomes resulted in live births. Birth defect prevalence after first-trimester dolutegravir exposure was 3.3% (95% CI, 2.4%-4.4%), which was comparable to rates for other ARVs and the general US population. A single neural tube defect (anencephaly) was reported among pregnancies with earliest dolutegravir exposure during periconception, corresponding to a prevalence of 0.1% (1/1120). Among the 1802 singleton live births without defects, 89% (n=1605) were delivered at ≥37 weeks of gestation, and 85% (n=1540) had a birth weight ≥2500 g.

CONCLUSION

Findings confirm the safety of prenatal dolutegravir exposure and reinforce dolutegravir-based regimens as safe options for all people of childbearing potential.