Maternal and pregnancy outcomes in women offered daily oral preexposure prophylaxis during pregnancy and postpartum

OBJECTIVE: To compare maternal safety and pregnancy outcomes among women who did and did not use daily oral emtricitabine-tenofovir disoproxil fumarate (FTC/TDF) for preexposure prophylaxis (PrEP) during pregnancy and postpartum. DESIGN: Parallel cohort design, with follow-up from pregnancy to 6 months postpartum. SETTING: Seven research clinics in Malawi, South Africa, Uganda, and Zimbabwe. PARTICIPANTS: Three hundred fifty pregnant women aged 16-24 years at 32 weeks or less gestation, meeting local criteria for PrEP. At entry, PrEP initiators and decliners were enrolled 2 : 1. Participants could start or stop PrEP at any time. MAIN OUTCOME MEASURES: Maternal adverse events were defined as grade ≥3 signs, symptoms, and diagnoses, and grade ≥2 chemistry abnormalities according to Division of AIDS toxicity tables. Adverse pregnancy outcomes included fetal loss, preterm birth, and small-for-gestational-age. RESULTS: From March to December 2022, 350 eligible participants enrolled: 229 initiating and 121 declining PrEP at entry. Median duration of PrEP use was 34 weeks (interquartile range [IQR]: 16-40). Sixty maternal adverse events were reported over 230.3 person-years (incidence rate: 25.6, 95% confidence interval [95% CI]: 20.0-32.8). Although those on PrEP had higher rates of adverse events, this was not statistically significant (adjusted incidence rate ratio: 1.84, 95% CI: 0.53-6.30). Most frequent grade ≥3 adverse events were complications of pregnancy or delivery. Five (8%) were considered related to PrEP use. Among those with delivery information, 79 (24%) participants reported adverse pregnancy outcomes, with no differences between PrEP groups. No participants acquired HIV infections during follow-up. CONCLUSION: Daily oral FTC-TDF remains a well tolerated and essential component of HIV prevention in pregnancy.