Abstract
Background: Data 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. Methods: We 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 dolutegravirbased ART. Supplementary analyses that included participants in the Swiss Mother and Child HIV Cohort Study were conducted to improve the precision of our results. Results: Of 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. Conclusions: Atazanavir-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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 799-809 |
| Number of pages | 11 |
| Journal | New England Journal of Medicine |
| Volume | 387 |
| Issue number | 9 |
| DOIs | |
| State | Published - Sep 1 2022 |
Funding
The Pediatric HIV/AIDS Cohort Study (PHACS) was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; Office of the Director, National Institutes of Health ; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health (HD052102; principal investigator, George R. Seage III; program director, Liz Salomon) and the Tulane University School of Medicine (HD052104; principal investigator, Russell Van Dyke; co–principal investigator, Ellen Chadwick; project director, Patrick Davis), and through the Harvard T.H. Chan School of Public Health for PHACS 2020 (P01HD103133; multiple principal investigators: Ellen Chadwick, Sonia Hernandez-Diaz, Jennifer Jao, and Paige Williams; program director, Liz Salomon). Data-management services were provided by Frontier Science (data management center director, Suzanne Siminski), and regulatory services and logistic support were provided by Westat (project directors, Julie Davidson and Tracy Wolbach). The Swiss Mother and Child HIV Cohort Study has been financed within the framework of the Swiss HIV Cohort Study, supported by the Swiss National Science Foundation (grant 201369).
ASJC Scopus subject areas
- General Medicine
