Secondary Logo

Institutional members access full text with Ovid®

Share this article on:

First Trimester Exposure to Antiretroviral Therapy and Risk of Birth Defects

Phiri, Kelesitse MS, ScD*; Hernandez-Diaz, Sonia MD, MPH, DrPH*; Dugan, Kate B. MPH*; Williams, Paige L. BSPH, MS, PhD; Dudley, Judith A. BS; Jules, Astride MD, MPH; Callahan, S. Todd MD, MPH; Seage, George R. III ScD*; Cooper, William O. MD, MPH

The Pediatric Infectious Disease Journal: July 2014 - Volume 33 - Issue 7 - p 741–746
doi: 10.1097/INF.0000000000000251
HIV Reports

Background: Use of antiretroviral (ARV) drugs during pregnancy has been associated with an increased risk of birth defects, but the evidence remains inconclusive.

Methods: We identified infants born to human immunodeficiency virus (HIV)-infected mothers between 1994 and 2009 using Tennessee Medicaid data linked to vital records. Maternal HIV status was based on diagnosis codes, prescriptions for ARVs and HIV-related laboratory testing. ARV exposure was identified from pharmacy claims. Birth defects diagnoses during the first year of life were identified from maternal and infant claims and vital records and were confirmed through medical record review. Multivariate logistic regression models were used to evaluate associations between first trimester ARV dispensing and birth defects.

Results: Of 806 infants included in the study, 32 (4.0%) had at least 1 major birth defect, most (44%) in the cardiac system. There was no increased risk for infants exposed in the first trimester to ARVs compared with unexposed infants (odds ratio = 1.07; 95% confidence interval: 0.50–2.31). Of the 20 infants exposed to efavirenz, none had a birth defect (0%; 95% confidence interval: 0.0–13.2).

Conclusions: There was no significant association between first trimester ARV dispensing and the risk of birth defects in this Medicaid cohort of HIV-positive women.

Supplemental Digital Content is available in the text.

From the *Department of Epidemiology; Department of Biostatistics, Harvard School of Public Health, Boston, MA; and Department of Preventive Medicine, Vanderbilt University School of Medicine, Nashville, TN.

Accepted for publication November 14, 2013.

This work was supported by the Eunice Kennedy Shriver National Institute of Child and Human Development [R01HD056940-01].

S.H.-D. has consulted for Novartis, AstraZeneca and GSK. The authors have no other funding or conflicts of interest to disclose.

Meetings where the information has been presented: first trimester exposure to ARV therapy and risk of birth defects among infants born to HIV-infected women on Tennessee Medicaid Program. Poster presentation: 4 th International Workshop of HIV Pediatrics. July 20–21, 2012; abstract no. P_21. Washington DC.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (

Address for correspondence: Kelesitse Phiri, Department of Epidemiology, 677 Huntington Avenue, Boston, MA 02115. E-mail:

© 2014 by Lippincott Williams & Wilkins, Inc.