Abstract
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.
Original language | English (US) |
---|---|
Pages (from-to) | 163-170 |
Number of pages | 8 |
Journal | Journal of Perinatal Medicine |
Volume | 39 |
Issue number | 2 |
DOIs | |
State | Published - Mar 1 2011 |
Keywords
- Antiretrovirals
- HIV
- birth defects
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Obstetrics and Gynecology
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In: Journal of Perinatal Medicine, Vol. 39, No. 2, 01.03.2011, p. 163-170.
Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Birth defects among a cohort of infants born to HIV-infected women on antiretroviral medication
AU - Watts, D. Heather
AU - Huang, Sharon
AU - Culnane, Mary
AU - Kaiser, Kathleen A.
AU - Scheuerle, Angela
AU - Mofenson, Lynne
AU - Stanley, Kenneth
AU - Newell, Marie Louise
AU - Mandelbrot, Laurent
AU - Delfraissy, Jean Francois
AU - Cunningham, Coleen K.
N1 - Funding Information: Overall support for the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) was provided by the National Institute of Allergy and Infectious Diseases (NIAID) [U01 AI068632], the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Mental Health (NIMH) [AI068632]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. This work was supported by the Statistical and Data Analysis Center at Harvard School of Public Health, under the National Institute of Allergy and Infectious Diseases cooperative agreement 5 U01 AI41110 with the Pediatric AIDS Clinical Trials Group (PACTG) and 1 U01 AI068616 with the IMPAACT Group. Support of the sites was provided by the National Institute of Allergy and Infectious Diseases (NIAID) the NICHD International and Domestic Pediatric and Maternal HIV Clinical Trials Network funded by NICHD (contract number N01- DK-9-001/HHSN267200800001C). In addition to those listed in the masthead, the International PACTG 316 team includes Brigitte Bazin, MD (ANRS France), Paula Britto, MS (Statistical and Data Analysis Center, Harvard School of Public Health, Boston, MA), Yvonne Bryson, MD (UCLA School of Medicine, Los Angeles, CA), Nina Sublette, ACRN, MSN (Regional Medical Center, Memphis, TN), Bethann Cunningham-Schrader and Kathleen A. Kaiser, AAS, COTA, MS (Frontier Science and Technology Research Foundation, Buffalo, NY), Mobeen Rathore, MD (University of Florida, Jacksonville, FL), Scharla Estep, MS, RPh (NIAID, Bethesda, MD), Maria Gigliotti, MS (Boehringer Ingelheim), Adolfo Gonzalez-Garcia, MD (University of Miami), Mark Mirochnick, MD (Boston University, Boston, MA), Claire Rekacewicz, MD (ARNS, Villejuif, France), Maureen Shannon, MS, FNP (San Francisco General Hospital, San Francisco, CA) and John L. Sullivan, MD (University of Massachusetts, Worcester, MA). The European Collaborative Study (ECS) includes investigators and study sites throughout Europe (listed below). Collaborating investigators include PACTG: Dr. Heather Watts and Dr. Lynne Mofenson (NICHD), Dr. Beverly E. Sha and Ruth M. Davis, RN (Rush-Presbyterian/St. Lukes Chicago), Dr. Arlene D. Bardeguez and Jocelyn Grandchamp, RN (University of Med. and Dentistry of NJ), Lisa Melton and Audra Deveikis (Long Beach Memorial), Dr. William T. Shearer and Dr. Hunter A. Ham-mill (Baylor College of Medicine), Dr. Ram Yogev and Donna Sta-nislawski (Children’s Memorial and Prentice Women’s Hospital), Dr. Charles D. Mitchell and Patricia Bryan, RN (University of Miami), Dr. William Borkowsky and Maryann Minter, RN (Bellevue Hospital), Dr. Diane Wara and Maureen Shannon, RN, MS FNP, CNM (UCSF Moffitt Hospital), Dr. Diane Wara and Dr. Karen Beckerman (San Francisco General), Dr. Ana Puga and Dr. Winston Bliss (Children’s Diagnostic and Treatment Center), Dr. Jane Pitt and Dr. Gina Brown (Columbia University), Dr. Gary Kaufman and Laureen Katz, RN (Boston Medical Center), Andrew D. Hull and Stephen A. Spector (UCSD Medical Center), Dr. Elizabeth Livingston and Lori Ferguson, RN (Duke University), Dr. Mobeen Rathore and Dr. Isaac Delke (University of Florida Health Sciences Center), Dr. Wil-ma Lim and Betsy Pitkin, RN (University of North Carolina at Chapel Hill), Dr. Jorge Gandia and Dr. Eleanor Jimenez (San Juan City Hospital), Dr. Sohail Rana and Marilyn Dennis (Howard University Hospital), Dr. Alice Stek and Dr. Andrea Kovacs (University of Southern California), Dr. Elizabeth J. McFarland and Carol Sal-benblatt, RN (Children’s Hospital), Dr. Myron J. Levin and Dr. Adriana Weinberg (The Denver Medical Center), Susan Laverty, RN and Dr. Geoffrey A. Weinberg (University of Rochester), Dr. Hannah Gay and Netta Boudreaux, RN (University of Mississippi Medical Center), Dr. Susanne R. Lavoie and Tima Y. Smith, RN (Medical College of Virginia), Dr. Edwin Thorpe and Ms. Nina Sublette (The Regional Medical Center), Dr. Dan Lancaster and Dr. Debra Terry (Methodist Hospital Central), Dr. Gregory J. Wilson and Peggy Bender, FNP (Vanderbilt University Medical Center), I. Heyer, RN, BSN and Dr. L. Lugo (University of Puerto Rico), Harold W. Lischner, MSN and Kelly R. Hassey, MSN, CRNP (St. Christopher’s Hospital for Children), Deb Goldman, ARNP and Dr. Jane Hitti (Children’s Hospital and Medical Center), Dr. Robert Maupin and Dr. Thomas Alchediak (Tulane University Hospital), Dr. Katherine Luzuriaga and Sheila Noone, RN, PhD (University of Massachusetts Medical School), Dr. Juan C. Salazar and Dr. Winston Campbell (University of Connecticut), Gail Karas, RN and Dr. Juan C. Salazar (Connecticut Children’s Medical Center), Dr. George Wendel and Dr. Janet Squires (Children’s Medical Center), Dr. Theodore Jones and Dr. Ellen Moore (Children’s Hospital of Michigan), Dr. Mobeen Rathore and Dr. Isaac Delke (University of Florida Health Sciences Center), Dr. Jaime Deville and Maryanne Dillon, BSN (University of California Medical Center), Dr. Ruth Tuomala (Brigham and Women’s Hospital), Dr. Sandra Burchett (Children’s Hospital), Dr. John Farley and Barbara Davis, RN, M Ed. (University of Maryland), Dr. Kenneth Rich and Dr. Mark Vajaranant (University of Illinois), Dr. Indu Pathak and Dr. Hamida Khakoo (Metropolitan Hospital Center), Dr. Nancy Wade and Dr. Renee Samelson (Children’s Hospital at Albany Medical Center), Emily Barr and Dr. John Nosovitch (State University of New York Upstate Medical University), Pam Daniel and Patty Kohler, RN (University of Cincinnati), Dr. Margaret Keller and Marie Beall (Harbor University of California Medical Center), Angela Ranzini and Marian Lake (St. Peter’s Medical Center), Dr. Robert Pass and Dr. Marilyn Crain (University of Alabama), Dr. Valerie Whiteman and Dr. Ellen Tidaldi (Temple University School of Medicine), Car-la Duff, RN and Dr. John Sleaseman (University of Florida, Gainesville), Dr. Hector Cintron and Wanda Figueroa (Ramon Ruiz), Dr. George Johnson and Moya Clarken, RN (Medical University of South Carolina), Dr. Savita Pahwa (North Shore LIJ Research Institute), Dr. Sunanda Gaur and Patricia Whitley Williams (Robert Wood Johnson AIDS Program), Dr. Michael Hughes and Dr. David Shapiro (Statistical and Data Analysis Center, Harvard School of Public Health). European Collaborative Study: Dr. I. Grosch-Wör-ner, Dr. K. Seel (Charite Virchow-Klinikum, Berlin, Germany); Dr. J. Jimenez (Hospital 12 De Octubre, Madrid, Spain); Dr. A.B. Boh-lin, Dr. S. Lindgren (Huddinge and Karolinska Hospitals, Sweden); Dr. A. Mûr, Dr. A. Paya (Hospital del Mar, Barcelona, Spain); Dr. O. Coll, Dr. C. Fortuny (Hospital Clinic, Barcelona, Spain); Dr. M. Casellas Caro (Hospital Vall D’Hebron, Barcelona, Spain); Dr. M. Leyes, Dr. L. Ciria (Hospital Son Dureta, Mallorca); Prof. P. Mar-tinelli, Dr. W. Buffolano, Dr. M. Sansone (II Policlinico, Naples, Italy); Dr. C. Tibaldi, Dr. N. Ziarati (S Anna Hospital, Torino, Italy); Dr. S. Alberico, Dr. C. Salvatore (Burlo Garofolo Hospital, Trieste, Italy); Prof. M. Temmerman (University of Ghent); Dr. I. Hoesli, Dr. C. Rudin (University of Basel); Dr. X. Carnet, Dr. J. Pich (Clinical Pharmacology Unit, University of Barcelona); Dr. M. Ravizza, Prof. G. Pardi, Dr. L. Mangiarotti (San Paolo Hospital, Milan, Italy); Dr. V. Savasi, Dr. A.E. Semprini, Prof. E. Ferrazzi (Sacco Hospital, Milan, Italy); Dr. M. Sharland, Ms. T. Chester (St. George’s Hospital, London UK), Dr. A. Fakoya (Newham General Hospital, London, UK), Dr. G. Scaravelli (PUI, Rome, Italy), Dr. W. Coroleou, Dr. Cavalle Gelabret (H. Germans Trials I pujol, Badalona, Spain) Prof. C. Loveday (University College London, UK); France: Scientific Committee: Annie Metro (ANRS), Marie-Jeanne Mayaux, Stephane Blanche, Christine Rouzioux, Marc Tardieu [Enquete Pediatrique Francaise (EPF)]; Jean-Pierre Aboulker (Service Commun 10, INSERM); Bertrand Baumelou (Boehringer Ingel-heim, France); Clinicians: Veronique Chambrin, Hassina Razafi-mahefa (Hopital Antoine Beclere, Clamart), Laurent Mandelbrot, Guislaine Firtion (Hopital Cochin-Port Royal, Paris), Nicole Ciraru-Vigneron, Claudine Bruner (Hopital Lariboisiere, Paris), Alain Ber-rebi, Joelle Tricoire (Hopital Purpan, Toulouse), Claude Hocke, Daniele Douard (Hopital Pellegrin, Bordeaux), Catherine Crenn-Hebert, Corinne Floch-Tulal (Hopital Louis-Mourier, Colombes), Etienne Wilmer, Annick Ottenvalter (Hopital Robert Debre, Paris), Marie-Aude Khuong, Jean-Marc Retbi (Hopital Delafontaine, Saint-Denis), Vincent Jeantils, Eric Lachassine (Hopital Jean-Verdier, Bondy), Sophie Matheron, Jean-Louis Benifla (Hopital Bichat-Claude-Bernard, Paris), Cristianne Huraux-Rendu, Joelle Teboul (Hopital Henri-Mondor, Creteil), Deborah Fried, Brigitte Heller-Roussin (Hopital Intercommunal Montreuil), Brigitte Clavier, Vero-nique Brossard (Hopital Charles Nicolle, Rouen), Andre Bongain, Fabrice Monpoux (Hopital de l’Archet, Nice), Michel Levardon, Fabienne Mazy (Hopital Beaujon, Clichy), Veronique Cayol, Catherine Dolfus (Hopital Saint-Antoine-Trousseau, Paris), Paul Benos, Joelle Nicolas (Hopital Arnaud De Villeneuve, Montpellier), Daniel Raudrant, Laurent Cotte (Hopital de l’Hotel Dieu, Lyon), Cecile Francois, Francoise Mechinaud (Hopital de l’Hotel-Dieu, Nantes), Rose Nguyen, Adrien May (Hopital Louise Michel, Evry), Bene-dicte Mougeon, Alain Devidas (Hopital Gilles de Corbeil, Corbeil); Brazil: Dr. Susie Andries Nogueira, Dr. Márcia Bondarowisky (Federal University of Rio de Janeiro, Brazil), Esaú Custódio João Filho, MD, Marcos Machado D’Ippolito, MD (Hospital dos Servidores in Rio de Janiero, Brazil); Bahamas: Dr. M. Perry Gomez, Dr. P. McNeil (Princes Margaret Hospital, Bahamas).
PY - 2011/3/1
Y1 - 2011/3/1
N2 - 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.
AB - 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.
KW - Antiretrovirals
KW - HIV
KW - birth defects
UR - http://www.scopus.com/inward/record.url?scp=79952809543&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79952809543&partnerID=8YFLogxK
U2 - 10.1515/JPM.2010.139
DO - 10.1515/JPM.2010.139
M3 - Article
C2 - 21142844
AN - SCOPUS:79952809543
SN - 0300-5577
VL - 39
SP - 163
EP - 170
JO - Journal of Perinatal Medicine
JF - Journal of Perinatal Medicine
IS - 2
ER -