CROI 2019—Prenatal exposure to InSTI not tied to neural tube defects

  • Jim Kling
  • Conference Reports
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  • Researchers found no association between prenatal exposure to integrase inhibitors (InSTIs) and risk for neural tube defects.

Why this matters

  • A previous study raised concerns that dolutegravir could be associated with neural tube defects.

Study design

  • Retrospective analysis of data from the French Perinatal Cohort (309 infants).
  • 3 groups: G1, ongoing exposure at conception; G2, exposure initiated during pregnancy, first-line therapy; and G3, exposure initiated during pregnancy, second-line therapy.
  • Women who received InSTIs but not a protease inhibitor or non-nucleoside reverse-transcriptase inhibitor were matched with women who received darunavir and the same other drugs.
  • Funding: French National Agency for Research on AIDS.

Key results

  • Exposures: raltegravir, 224; dolutegravir, 41; elvitegravir, 44.
  • No significant difference in birth defects by exposure period: G1, 5.5%; G2, 2.7%; G3, 3.0% (P=.18).
  • No neural tube defects occurred in G1 children. Two birth defects occurred in children exposed to dolutegravir (Down syndrome, persistent ductus arteriosus).
  • No significant differences between exposed infants and matched control patients with respect to frequency (6.3% vs 3.7%; P=.26) or type of birth defects.
  • Stillbirth and preterm birth frequencies were similar between infants exposed at conception and matched control patients.
  • No difference in birth defect rates between G2 or G3 and matched control patients.


  • Raltegravir was the most commonly used InSTI.

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