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.