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Journal of Perinatal Medicine

Official Journal of the World Association of Perinatal Medicine

Editor-in-Chief: Dudenhausen, Joachim W.

Editorial Board Member: / Bancalari, Eduardo / Milner, Anne / Genc, Mehmet R. / Chervenak, Frank A. / Chappelle, Joseph / Bergmann, Renate L. / Bernardes, J.F. / Bevilacqua, G. / Blickstein, Isaac / Cabero Roura, Luis / Carbonell-Estrany, Xavier / Carrera, Jose M. / D`Addario, Vincenzo / D'Alton, MD, Mary E. / Dimitrou, G. / Grunebaum, Amos / Hentschel, Roland / Köpcke, W. / Kawabata, Ichiro / Keirse, Marc J.N.C. / Kurjak M.D., Asim / Lee, Ben H. / Levene, Malcolm / Lockwood, Charles J. / Marsal, Karel / Makatsariya, Alexander / Nishida, Hiroshi / Ogata, Edward / Papp, Zoltán / Pejaver, Ranjan Kumar / Pooh, Ritsuko K. / Romero, Roberto / Saugstad, Ola D. / Schenker, Joseph G. / Sen, Cihat / Seri, Istvan / Vetter, Klaus / Winn, Hung N. / Young, Bruce K. / Zimmermann, Roland

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Birth defects among a cohort of infants born to HIV-infected women on antiretroviral medication

D. Heather Watts
  • Eunice Kennedy Shriver National Institute for Child Health and Human Development, Bethesda, MD, USA
  • :
/ Sharon Huang
  • Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA, USA
/ Mary Culnane
  • National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA
/ Kathleen A. Kaiser
  • Frontier Science and Technology Research Foundation, Inc., Amherst, NY, USA
/ Angela Scheuerle
  • Tesserae Genetics, Dallas, TX, USA
/ Lynne Mofenson
  • Eunice Kennedy Shriver National Institute for Child Health and Human Development, Bethesda, MD, USA
/ Kenneth Stanley
  • Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA, USA
/ Marie-Louise Newell
  • University College London Institute of Child Health, London, UK and Africa Centre, University of KwaZulu-Natal, South Africa
/ Laurent Mandelbrot
  • Université Paris-Diderot, Colombes, France
/ Jean-Francois Delfraissy
  • Agence Nationale de Recherches sur le SIDA, Paris, France
/ Coleen K. Cunningham
  • Department of Pediatrics, Duke University Medical Center, Durham, NC, USA
Published Online: 2010-12-13 | DOI: https://doi.org/10.1515/jpm.2010.139


Objective: To determine rate of and risk factors for birth defects in infants born to HIV-infected women receiving nucleoside and protease inhibitor antiretroviral (ARV) therapy.

Methods: Birth defects were evaluated among infants on the Pediatric AIDS Clinical Trials Group 316 trial that studied addition of peripartum nevirapine to established ARV regimen for prevention of mother-to-child transmission. Maternal therapy was categorized by trimester of earliest exposure. Birth defects were coded using conventions of the Antiretroviral Pregnancy Registry.

Results: Birth defects were detected in 60/1414 (4.2%; 95% CI 3.3–5.4%) infants including 30/636 (4.7%; 95% CI 3.2–6.7%) with first trimester ARV exposure and 30/778 (3.9%; 95% CI 2.6–5.5%) with exposure only after the first trimester (P=0.51). Rates of classes of defects were similar between first trimester compared to later exposure groups except heart defects which occurred in 16 (2.5%; 95% CI 1.4–4.1%) with first trimester ARV exposure and in six (0.8%; 95% CI 0.3–1.7%) infants with later exposure (P=0.02). Exposure to ARV was not associated with specific types of heart defects. Two cases of cardiomyopathy were noted.

Conclusion: ARV use in early pregnancy was not associated with an increased risk of birth defects overall. The possible association of ARV exposure with heart defects requires further surveillance.

Keywords: Antiretrovirals; birth defects; HIV

Corresponding author: D. Heather Watts, MD PAMA/CRMC/NICHD 6100 Executive Blvd, Room 4B11 Bethesda MD 20892-7510 USA Tel.: +1 301-435-6874

Received: 2010-05-21

Revised: 2010-08-26

Accepted: 2010-08-30

Published Online: 2010-12-13

Published Online: 2010-12-13

Published in Print: 2011-03-01

Citation Information: Journal of Perinatal Medicine. Volume 39, Issue 2, Pages 163–170, ISSN (Online) 1619-3997, ISSN (Print) 0300-5577, DOI: https://doi.org/10.1515/jpm.2010.139, December 2010

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