Journal of acquired immune deficiency syndromes (1999) · 2026
Pregnancy and Neonatal Outcomes Following Prenatal Exposure to Dolutegravir: Findings From the Antiretroviral Pregnancy Registry.
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Vannappagari Vani, Albano Jessica D, Mofenson Lynne, Ragone Leigh, Cook Taylor, Scheuerle Angela E, Kisare Michelle, Short William R, Thorne Claire, Beckerman Karen P, Carneal-Frazer Nicole, Tilson Hugh, de Ruiter Annemiek
Аннотация
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.
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.