Introduction: The Antiretroviral Pregnancy Registry (APR) is designed to detect major teratogenic effects of antiretroviral medications; other pregnancy outcomes are also recorded when reported. We compared available pregnancy and birth outcomes of women exposed to oral rilpivirine-containing regimens (oral-RPV cohort) versus non-rilpivirine regimens (non-RPV cohort) over the period 2011 to 2023.
Methods: Maternal age-adjusted prevalence ratio (aPR) of pregnancy and birth outcomes was compared for prospectively reported pregnancies; aPR of birth defects was compared between first-trimester exposures and combined second/third-trimester exposures.
Results: In total, 6937 pregnancies were recorded, including 4617 (oral-RPV cohort, 781 [16.9%]; non-RPV cohort, 3836 [83.1%]) from the United States. Among live births, the prevalence of birth defects was lower in the oral-RPV cohort (1.6% versus 3.8%; aPR: 0.4 [95% confidence interval (CI): 0.2-0.8]). The prevalence of birth defects in the first-trimester oral-RPV exposure versus second/third-trimester exposure did not differ (aPR: 3.4 [95% CI: 0.4-26.3]). The aPR of induced abortions (1.1 [0.6-1.9]), stillbirths (0.6 [0.2-1.6]) and premature birth (0.8 [0.7-1.1]) were similar between cohorts. Prevalences for spontaneous abortion were 5.8% (oral-RPV cohort) versus 3.2% (non-RPV cohort) below the expected background rate (15%-20%). Low birth weights were less reported in oral-RPV, while very low birth weights were similar between cohorts.
Conclusions: Review of available data from the APR does not indicate an association between adverse pregnancy or birth outcomes and oral-RPV exposure, overall or by timing of exposure. Since APR targets primarily teratogenic effects, findings for non-teratogenic effects should be interpreted with caution.
Keywords: antiretroviral therapy; birth defects; human immunodeficiency virus‐1; pregnancy outcomes; rilpivirine.
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