- Efavirenz (EFV) use during conception and first trimester (T1) of pregnancy appears to be safe, conferring no additional clinically relevant birth defects risk vs non-EFV-based regimens.
Why this matters
- 24,963 live births.
- 412 infants with ≥1 birth defect (prevalence, 1.65%; 95% CI, 1.50-1.82).
- Proportion of infants with ≥1 birth defect was not significantly different among non-ART (1.3%; 95% CI, 1.1-1.5), EFV-based (1.6%; 95% CI, 0.96-2.6), and non-EFV-based regimen (2.4%; 95% CI, 2.1-2.8) T1 exposed infants, respectively (P=.135).
- Most common birth defects in EFV-exposed were limb/musculoskeletal (n=9), genetic syndromes/microdeletions (n=4), congenital heart defects (n=2).
- No significant increased birth defects risk with T1 EFV exposure (adjusted OR [aOR], 0.61; 95% CI, 0.36-1.03; P=.067) vs non-EFV (aOR, 0.63; 95% CI, 0.34-1.17; P=.145), no ART (aOR, 0.67; 95% CI, 0.36-1.27; P=.222), respectively, by multivariate analysis.
- Pooled data analysis evaluating association between EFV exposure in utero vs non-EFV-containing regimens by timing of exposure, birth defects occurrence across 7 European countries and Thailand, 2002-2015.
- Funding: EU Seventh Framework Program.
- Birth defect risk underreported.
- Potential heterogeneity.