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NO INCREASE IN BIRTH DEFECTS IN INFANTS EXPOSED TO INTEGRASE INHIBITORS AT CONCEPTION
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Reported by Jules Levin
CROI 2019 March 4-7 Seattle
Jeanne Sibiude1,2,3, Jérôme Le Chenadec4, Laurent Mandelbrot1,2,3, Stéphane Blanche5,6, Catherine Dollfus7,Nathalie Lelong8, Elisa Arezes1, 9, LamyaAit Si Semi1, Sophie Matheron10, Christine Rouzioux5,6, Josiane Warszawski4,9,11, and Roland Tubiana12,13, for the ANRS CO1-French Perinatal Cohort Study
1AP-HP Hôpital L. Mourier, Colombes;2UMR 1137, INSERM, IAME;3Univ Paris-Diderot, Paris;4CESP INSERM U1018, Le Kremlin-Bicêtre;5AP-HP Hôpital Necker-Enfants Malades, Paris; 6Univ Paris-Descartes, Paris; 7AP-HP Hôpital Trousseau, Paris; 8Inserm, UMR S953, Université Paris 6, Paris; 9Univ Paris Sud/Paris Saclay, Le Kremlin-Bicêtre;10AP-HP Hôpital Bichat, Paris; 11AP-HP Hôpital Bicêtre, le Kremlin-Bicêtre;12Univ Paris-Sorbonne, Paris 13AP-HP Hôpital Pitié Salpétrière, Paris, FRANCE
Results: Overall, 301 women were exposed to InSTIat conception (G1): 218 exposed to raltegravir, 41 to dolutegravir and 42 to elvitegravir. Rates of birth defects for InSTI-exposed infants at conception (G1: 5.8% 18/301) did not significantly differ from those of InSTI-exposed infants of the two other groups: 2.7% (5/183) in G2 and 2.7% (9/324) in G3, p=0.09. There was no neural tube defect among infants exposed to InSTIat conception. There were only two birth defects among the 41 infants exposed to dolutegravir (a case of Down syndrome, and a persistantductus arteriosus).When restricting to matched infants, birth defect rates in G1 were not significantly different from the matched InSTI-unexposed group (5,7%, 14/246 vs 2,9%, 7/246, respectively, p=0.13). The EUROCAT types of birth defects were similar for InSTI-exposed at conception and matched infants. There was no difference in stillbirth rates (2,5% vs 2,5%, p=1), nor in preterm birth rates (16,8% vs 16,1%, p=1) between pregnancies exposed at conception and the matched pregnancies. Among women exposed at conception, 65% were still receiving InSTIat delivery. Similarly, there was no difference in birth defect rates between InSTI-exposed infants in G2 and G3 and the matched unexposed infants.
Conclusion: We found no evidence of a higher birth defect rate among 301 women exposed to InSTIat conception, mostly exposed to raltegravir, however in the current context, surveillance must be pursued for this class of ART.
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