Background: Thorough drug safety evaluation includes assessing potential impact of use on obstetric (OB) and infant outcomes. The MTN-016 study is the first pregnancy exposure registry for anti-HIV PrEP and microbicide agents. We evaluated OB and infant outcomes for registrants enrolled from third trimester TFV gel exposure studies. Methods: Data were restricted to registrants enrolled from studies with planned TFV vaginal gel exposure: MTN-002 (open label, single dose prior to cesarean) and MTN-008 (2:1 placebocontrolled, 7-day use). Registry study visits occurred before delivery when possible, and at < 1, 1, 6 and 12 months for infants. Infant malformation endpoints were determined by geneticists via independent review of physical exam (PE) and photo data. Results: All 16 MTN-002 and 90% (88/98) of MTN-008 mothers were registered, with 25% (n = 4) of MTN-002 and 97% (n = 86) of MTN-008 participants enrolling prior to known pregnancy outcome. Demographics were similar for MTN-008 enrollees and non-enrollees in the registry. Infant retention at 12 months was 88% (MTN-002) and 80% (MTN-008). One defect (ear canal) was noted in MTN-002, a rate (6%) comparable to the 3% US background rate for malformations (p = 0.51); no defects were noted in infants from MTN-008. Compared to placebo (n = 30), TFV gel (n = 58) was not associated with preterm delivery (1/58 (2%) vs. 2/30 (7%), p = 0.27), postpartum hemorrhage (11/58 (19%) vs. 3/30 (10%), p = 0.36), nonreassuring fetal status (3/58 (5%) vs. 1/30 (3%), p = 1.0), chorioamnionitis (1/58 (2%) vs. 2/30 (7%), p = 0.27), gestational diabetes (0/58 (0%) vs. 1/30 (3%), p = 0.34), or abnormal infant PE findings in the first year of life (14/58 (24%) vs. 8 (27%), p = 1.0).Conclusions: This first report from a novel pregnancy registry suggests third trimester TFV gel exposure is not associated with infant malformation or adverse OB or infant outcomes. Future HIV chemoprevention studies should include safety evaluation, including registry participation, for pregnant mothers and their infants.
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