More evidence for safe use of efavirenz-based antiretroviral HIV regimens during pregnancy

  • Martinez de Tejada B
  • J Acquir Immune Defic Syndr
  • 14 Dec 2018

  • curated by Liz Scherer
  • Clinical Essentials
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Takeaway

  • 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

  • EFV is currently recommended as an alternative for treatment of antiretroviral therapy (ART)-naive patients with HIV.
  • Select appropriate ART regimens based on current guidelines, individual characteristics.

Key results

  • 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.

Study design

  • 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.

Limitations

  • Birth defect risk underreported.
  • Potential heterogeneity.