Risk of birth defects and perinatal outcomes in HIV-infected women exposed to integrase strand inhibitors during pregnancy

Objectives: Following an alert on neural tube defects and dolutegravir, we sought to evaluate if the exposure integrase strand transfer inhibitors (INSTIs) at conception was associated with birth or other adverse pregnancy outcomes. Methods: In prospective national French Perinatal Cohort (EPF), studied perinatal outcomes by matching each pregnant woman exposed INSTIs a darunavir/ritonavir receiving same backbone of nucleoside reverse transcriptase matched for characteristics such as age, geographic origin, centre year delivery. Results: Among 808 women during (raltegravir = 703, dolutegravir 57 elvitegravir 48), reported slightly higher rate in infants raltegravir (6.7%) vs. later pregnancy: 2.9% initiated first-line, 2.5% second-line treatment, P =0.04. When compared controls, not significantly defects: 6.4 2.3%, 0.08. There no cluster defect type were observed. Other outcomes, preterm stillbirths, did differ between raltegravir-exposed counterparts. No difference any outcome observed elvitegravir/cobicistat dolutegravir. Conclusion: We found nonsignificant trend association defects, which needs be evaluated larger surveillance data, these drugs are increasingly prescribed living HIV.