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Birth Defects After Exposure to Efavirenz-Based Antiretroviral Therapy at Conception/First Trimester of Pregnancy

A Multicohort Analysis

Martinez de Tejada, Begoña MD, PhD European Pregnancy and Paediatric HIV Cohort Collaboration Study Group

JAIDS Journal of Acquired Immune Deficiency Syndromes: March 1, 2019 - Volume 80 - Issue 3 - p 316–324
doi: 10.1097/QAI.0000000000001922
Clinical Science

Background: To investigate the association between efavirenz (EFV) use during conception or first trimester (T1) of pregnancy and the occurrence of birth defects.

Setting: Seven observational studies of pregnant HIV-positive women across 13 European countries and Thailand.

Methods: Individual-level data were pooled on singleton pregnancies included in participating cohorts in 2002–2015. Birth defects were coded according to ICD-10 and the EUROCAT classification. We performed mixed-effects logistic regression models to assess the association between EFV exposure in utero and likelihood of birth defects.

Results: We included 24,963 live births from 21,093 women. At conception, 30.2% (7537) women were on a non–EFV-based regimen, 4.8% (1200) on EFV, and 65% (16,226) were unexposed to antiretroviral therapy (ART). There were 412 infants with ≥1 birth defect, a prevalence of 1.65% (95% confidence interval: 1.50 to 1.82). Limb/musculoskeletal and congenital heart defects were the most common defects reported. Birth defects were present in 2.4%, 1.6%, and 1.3% of infants exposed to non-EFV, EFV, and unexposed to ART during conception/T1 (P = 0.135), respectively. The association between exposure to ART during conception/T1 and birth defects remained nonsignificant in adjusted analyses, as did exposure to EFV versus non-EFV (adjusted odds ratio 0.61; 95% confidence interval: 0.36 to 1.03, P = 0.067). Among the 21 birth defects in 19 infants on EFV, no neural tube defects were reported.

Conclusions: Prevalence of birth defects after exposure to EFV-based compared with non–EFV-based ART in conception/T1 was not statistically different in this multicohort study, and even lower. EFV is at least as safe as other ART drugs currently recommended for antenatal use.

Service of Obstetrics, Department of Obstetrics and Gynecology, Faculty of Medicine, University Hospitals of Geneva, Geneva, Switzerland.

Correspondence to: Begoña Martinez de Tejada, MD, PhD, Department of Obstetrics and Gynecology, Faculty of Medicine, Geneva University Hospitals, 30 Boulevard de la Cluse, 1211 Geneva 14, Switzerland (e-mail:

Supported in part by the EU Seventh Framework Programme (FP7/2007-2013) under EuroCoord grant agreement no. 260694.

The author has no funding or conflicts of interest to disclose.

Author contributions of the European Pregnancy and Paediatric HIV Cohort Collaboration Study Group are listed in Appendix 1.

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 Web site (

Received October 18, 2018

Accepted November 11, 2018

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.