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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 / Greenough, 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, M.J.M.C. / Kurjak M.D., Asim / Lee, Ben H. / Levene, Malcolm / Lockwood, Charles J. / Marsal, Karel / Makatsariya, Alexander / Nishida, Hiroshi / 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

1 / Sharon Huang2 / Mary Culnane3 / Kathleen A. Kaiser4 / Angela Scheuerle5 / Lynne Mofenson1 / Kenneth Stanley2 / Marie-Louise Newell6 / Laurent Mandelbrot7 / Jean-Francois Delfraissy8 / Coleen K. Cunningham9

1Eunice Kennedy Shriver National Institute for Child Health and Human Development, Bethesda, MD, USA

2Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA, USA

3National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA

4Frontier Science and Technology Research Foundation, Inc., Amherst, NY, USA

5Tesserae Genetics, Dallas, TX, USA

6University College London Institute of Child Health, London, UK and Africa Centre, University of KwaZulu-Natal, South Africa

7Université Paris-Diderot, Colombes, France

8Agence Nationale de Recherches sur le SIDA, Paris, France

9Department of Pediatrics, Duke University Medical Center, Durham, NC, USA

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

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

Publication History

Published Online:


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

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