• Kunjal Patel, Yanling Huo, Jennifer Jao, Kathleen M Powis, Paige L Williams, Deborah Kacanek, Lynn M Yee, Ellen G Chadwick, Stephanie Shiau, Denise L Jacobson, Sean S Brummel, Leila Sultan-Beyer, Christian R Kahlert, Rebecca Zash, George R Seage, Pediatric HIV/AIDS Cohort Study, and Swiss Mother and Child HIV Cohort Study.
• From the Department of Epidemiology (K.P., P.L.W., G.R.S.), the Center for Biostatistics in AIDS Research (K.P., Y.H., P.L.W., D.K., D.L.J., S.S.B., G.R.S.), and the Department of Immunology and Infectious Diseases (K.M.P.), Harvard T.H. Chan School of Public Health, the Departments of Pediatrics and Medicine, Massachusetts General Hospital (K.M.P.), and the Department of Medicine, Beth Israel Deaconess Medical Center (R.Z.) - all in Boston; the Departments of Pediatrics (J.J., E.G.C.) and Obstetrics and Gynecology (L.M.Y.), Northwestern University Feinberg School of Medicine, Chicago; the Department of Biostatistics and Epidemiology, Rutgers School of Public Health, Piscataway, NJ (S.S.); and the Department of Gynecology, University Hospital Zurich, Zurich (L.S.-B.), and Department of Infectious Diseases and Hospital Epidemiology, Children's Hospital of Eastern Switzerland, St. Gallen (C.R.K.) - both in Switzerland.
• N. Engl. J. Med. 2022 Sep 1; 387 (9): 799809799-809.

BackgroundData on the effectiveness and safety of dolutegravir-based antiretroviral therapy (ART) for human immunodeficiency virus type 1 (HIV-1) infection in pregnancy as compared with other ART regimens commonly used in the United States and Europe, particularly when initiated before conception, are limited.MethodsWe conducted a study involving pregnancies in persons with HIV-1 infection in the Pediatric HIV/AIDS Cohort Study whose initial ART in pregnancy included dolutegravir, atazanavir-ritonavir, darunavir-ritonavir, oral rilpivirine, raltegravir, or elvitegravir-cobicistat. Viral suppression at delivery and the risks of infants being born preterm, having low birth weight, and being small for gestational age were compared between each non-dolutegravir-based ART regimen and dolutegravir-based ART. Supplementary analyses that included participants in the Swiss Mother and Child HIV Cohort Study were conducted to improve the precision of our results.ResultsOf the pregnancies in the study, 120 were in participants who received dolutegravir, 464 in those who received atazanavir-ritonavir, 185 in those who received darunavir-ritonavir, 243 in those who received rilpivirine, 86 in those who received raltegravir, and 159 in those who received elvitegravir-cobicistat. The median age at conception was 29 years; 51% of the pregnancies were in participants who started ART before conception. Viral suppression was present at delivery in 96.7% of the pregnancies in participants who received dolutegravir; corresponding percentages were 84.0% for atazanavir-ritonavir, 89.2% for raltegravir, and 89.8% for elvitegravir-cobicistat (adjusted risk differences vs. dolutegravir, -13.0 percentage points [95% confidence interval {CI}, -17.0 to -6.1], -17.0 percentage points [95% CI, -27.0 to -2.4], and -7.0 percentage points [95% CI, -13.3 to -0.0], respectively). The observed risks of preterm birth were 13.6 to 17.6%. Adjusted risks of infants being born preterm, having low birth weight, or being small for gestational age did not differ substantially between non-dolutegravir-based ART and dolutegravir. Results of supplementary analyses were similar.ConclusionsAtazanavir-ritonavir and raltegravir were associated with less frequent viral suppression at delivery than dolutegravir. No clear differences in adverse birth outcomes were observed with dolutegravir-based ART as compared with non-dolutegravir-based ART, although samples were small. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others.).Copyright © 2022 Massachusetts Medical Society.

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