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Dolutegravir in Pregnancy as Compared with Current HIV Regimens in the United States

List of authors.
  • Kunjal Patel, D.Sc.,
  • Yanling Huo, M.S.,
  • Jennifer Jao, M.D.,
  • Kathleen M. Powis, M.D.,
  • Paige L. Williams, Ph.D.,
  • Deborah Kacanek, Sc.D.,
  • Lynn M. Yee, M.D.,
  • Ellen G. Chadwick, M.D.,
  • Stephanie Shiau, Ph.D.,
  • Denise L. Jacobson, Ph.D.,
  • Sean S. Brummel, Ph.D.,
  • Leila Sultan-Beyer, M.D.,
  • Christian R. Kahlert, M.D.,
  • Rebecca Zash, M.D.,
  • and George R. Seage, III, D.Sc.
  • for the Pediatric HIV/AIDS Cohort Study and the Swiss Mother and Child HIV Cohort Study



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.


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 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.


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.


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. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others.)

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Funding and Disclosures

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).

Disclosure forms provided by the authors are available with the full text of this article at

The conclusions and opinions expressed in this article are those of the authors and do not necessarily reflect those of the National Institutes of Health or the U.S. Department of Health and Human Services. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.

We thank the participants and their partners and families for their participation in PHACS and the Swiss Mother and Child HIV Cohort Study, as well as the people and institutions involved in the conduct of these studies. The following institutions, clinical site leaders, and staff participated in conducting PHACS SMARTT in 2020 (listed alphabetically by institution): Ann and Robert H. Lurie Children’s Hospital of Chicago: Jessica D’Angelo, Margaret Ann Sanders, and Kathleen Malee; Baylor College of Medicine: Mary Paul, Ruth Eser-Jose, Chivon McMullen-Jackson, and Lynnette Harris; BronxCare Health System: Murli Purswani, Mahoobullah Mirza Baig, Alma Villegas, and Marvin Alvarado; Children’s Diagnostic and Treatment Center: Lisa-Gaye Robinson, Jawara Dia Cooley, James Blood, and Patricia Garvie; Keck Medicine of the University of Southern California: Toni Frederick, Mariam Davtyan, and Guadalupe Morales-Avendano; New York University School of Medicine: William Borkowsky, Nagamah Sandra Deygoo, and Jennifer Lewis; Rutgers–New Jersey Medical School: Arry Dieudonne, Linda Bettica, Juliette Johnson, and Karen Surowiec; St. Jude Children’s Research Hospital: Katherine Knapp, Jamie Russell-Bell, Megan Wilkins, and Stephanie Love; San Juan Hospital Research Unit Department of Pediatrics, San Juan Puerto Rico: Nicolas Rosario, Lourdes Angeli-Nieves, and Vivian Olivera; SUNY Downstate Medical Center: Stephan Kohlhoff, Ava Dennie, Jean Kaye, and Jenny Wallier; Tulane University School of Medicine: Karen Craig, Russell Van Dyke, and Patricia Sirois; University of Alabama, Birmingham: Cecelia Hutto, Paige Hickman, Julie Huldtquist, and Dan Marullo; University of California, San Diego: Stephen A. Spector, Veronica Figueroa, Megan Loughran, and Sharon Nichols; University of Colorado, Denver: Elizabeth McFarland, Christine Kwon, Carrie Glenny, and Jennifer Englund; University of Florida, Center for HIV/AIDS Research, Education, and Service: Mobeen Rathore, Saniyyah Mahmoudi, Sarah El-Hassan, and Jamilah Tejan; University of Illinois, Chicago: Karen Hayani, Lourdes Richardson, Renee Smith, and Alina Miller; University of Miami: Gwendolyn Scott, Gustavo Gil Garcia, Gabriel Fernandez, and Anai Cuadra; and University of Puerto Rico School of Medicine, Medical Science Campus: Zoe M. Rodriguez, Lizmarie Torres, and Nydia Scalley. The following persons are members of the Swiss HIV Cohort Study and the Swiss Mother and Child HIV Cohort Study: Irene Abela, Karoline Aebi-Popp, Alexia Anagnostopoulos, Manuel Battegay, Marc Baumann, Enos Bernasconi, Dominique L. Braun, Heiner C. Bucher, Alexandra Calmy, Matthias Cavassini, Angela Ciuffi, Pierre-Alex Crisinel, Katie Darling, Andrea Duppenthaler, Günter Dollenmaier, Matthias Egger, Luigia Elzi, Jan Fehr, Jacques Fellay, Katyuska Francini, Hansjakob Furrer, Christoph A. Fux, Huldrych F. Günthard (president of the SHCS), Anna Hachfeld, David Haerry (deputy of the “Positive Council”), Barbara Hasse, Hans H. Hirsch, Matthias Hoffmann, Irene Hösli, Michael Huber, Christian R. Kahlert (chairman of the Mother and Child Substudy), Laurent Kaiser, Olivia Keiser, Thomas Klimkait, Lisa Kottanattu, Roger D. Kouyos, Helen Kovari, Katharina Kusejko (head of the data center), Gladys Martinetti, Begoña Martinez de Tejada, Catia Marzolini, Karin J. Metzner, Nicolas Müller, Johannes Nemeth, Dunja Nicca, Paolo Paioni, Giuseppe Pantaleo, Matthieu Perreau, Christian Polli, Andri Rauch (chairman of the scientific board), Nicole Ritz, Patrick Schmid, Roberto Speck, Marcel Stöckle (chairman of the clinical and laboratory committee), Leila Sultan-Beyer, Philip Tarr, Marthe Thanh Lecompte, Alexandra Trkola, Noémie Wagner, Gilles Wandeler, and Sabine Yerly.

We dedicate this work to the memory of our dear colleague and friend, Dr. George R. Seage III.

Author Affiliations

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.

Dr. Patel can be contacted at or at the Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Ave., Boston, MA 02115.

George R. Seage III, D.Sc., is deceased.

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