Evaluating the association of prenatal PrEP exposure with perinatal and growth outcomes from infancy through early childhood

As pre-exposure prophlaxis (PrEP) implementation continues to scale-up among pregnant populations, accruing safety data following prenatal PrEP exposure remains important. Methods Data from the PrEP Implementation for Mothers in Antenatal Care study (NCT03070600) was analyzed to evaluate the relationship between prenatal PrEP exposure and birth and infant/child outcomes. Women enrolled during pregnancy at 20 maternal and child health (MCH) clinics in western Kenya and were followed through 9-months postpartum. Those who report swallowing PrEP at any antenatal visits were identified as prenatally PrEP-exposed. In an extension cohort, enrollees and their children were followed through 36 months postpartum. Infant anthropometry was assessed by trained study nurses. Among a subset, we evaluated prenatal PrEP exposure using tenofovir-diphosphate (TFV-DP) concentrations in dried blood spots (DBS). ResultsOverall, 4188 women were included in the analysis, of whom 548 (13.6%) used PrEP during pregnancy, initiating at a median of 26 weeks gestation (IQR 22-30) for a median duration of 11.9 weeks in pregnancy (IQR 7.1-17). Compared to PrEP-unexposed pregnancies, there was no difference in pregnancy loss, stillbirth, preterm birth, or neonatal death among PrEP-exposed pregnancies (all p>0.55). There were no differences in infant length or weight at 6-weeks, 6-months, 9-months (p>0.30) between children with and without prenatal PrEP exposure, including underweight, stunting, and wasting. Results were similar at 24-months, 30-months and 36-months. We found no differences in adverse perinatal and infant outcomes among Kenyan women with quantifiable prenatal TFV-DP exposure. ConclusionsWe found no significant differences in adverse birth or infant-child outcomes by prenatal PrEP exposure status, including among those confirmed with a biologic measure. These data support findings from prior studies that demonstrate the safety of PrEP use during pregnancy.