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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% CI: 1.50-1.82). 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 respectively non-EFV, EFV and unexposed to ART during conception/T1 (p=0.135). The association between exposure to ART during conception/T1 and birth defects remained non-significant in adjusted analyses, as did exposure to EFV vs non-EFV (adjusted odds ratio 0.61; 95% CI: 0.36-1.03, p=0.067). Among the 21 birth defects in 19 infants on EFV, no neural tube defects were reported.

CONCLUSIONS
Prevalence of birth defects following exposure to EFV-based compared to non-EFV-based ART in conception/T1 was not statistically different in this multi-cohort study, and even lower. EFV is at least as safe as other ART drugs currently recommended for antenatal use.