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Background: Raltegravir is an integrase inhibitor, largely used in the recent years, but tolerance data in pregnancy is scarce. Potential teratogenicity has not yet been evaluated for this molecule in a clinical context. We aimed to describe the rates and types of birth defects among children exposed to raltegravir in utero and to study the association with trimester of exposure.
Methods: EPF is a multicenter national cohort, which prospectively enrolls pregnant HIV-infected women delivering in 90 centers throughout France. Children are followed by pediatricians until two years of age. All births exposed to raltegravir were included. Birth defects were defined using the EUROCAT classification. Rates of birth defects were compared according to timing of exposure to raltegravir (1st trimester vs 2nd and 3rd trimester) using χ2 tests.
Results: We included 479 fetuses born between 2008 and 2015, exposed to raltegravir, among which 6 stillbirths (1.3%) and 2 late miscarriages (0.4%). There were no terminations of pregnancies for birth defects. Rates of birth defects were 4.2% for all births (20/479, [95% CI 2.4%-6.0%]), and 4.2% among live births (20/471 [2.4%-6.1%]). This incidence was similar to that reported in a previous study in EPF for live births exposed to any ARV (4.4% [4.0%-4.7%]). Birth defect rates did not differ significantly between first trimester exposure to raltegravir (5.7%; 8/140) and 2nd or 3rd-trimester exposure (3.5%; 12/339; p=0.32). The anomalies did not follow any pattern and concerned various organs: 7 heart defects, 5 polydactylies, and 8 other defects. Other notable adverse outcomes were preterm births (14.2%), and 2 cases of HIV perinatal infection (0.4%). The follow-up was complete to 24 months for 63% of children. For 15% of children, only the birth questionnaire was available.
Conclusions: This is the largest prospective cohort of children exposed in utero to raltegravir with homogenous evaluation of birth defects. We did not find a significant association between 1st trimester exposure to raltegravir and birth defects. This finding is quite reassuring as this molecule is often prescribed to women of child-bearing age, and thus many children may be exposed in the first trimester of pregnancy.