- 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.
- 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.
- 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.