Pregnancy outcomes and infant growth among babies with in utero exposure to tenofovir-based pre-exposure prophylaxis for HIV prevention.

BACKGROUND: Global guidelines recommend pre-exposure prophylaxis (PrEP) use by women at risk for HIV, including during pregnancy, a period with heightened HIV risk. However, data to support safety of PrEP use during pregnancy are limited, particularly from women using PrEP throughout pregnancy.

METHODS: In an open-label delivery study of PrEP integrated with ART for high risk HIV serodiscordant couples in Kenya and Uganda (the Partners Demonstration Project), women who became pregnant while using PrEP were offered the option to continue PrEP throughout pregnancy. We compared pregnancy outcomes and one-year infant growth from pregnancies with exposure to PrEP throughout pregnancy to those without any exposure, with data from the placebo arm of a prior efficacy trial of PrEP conducted in the same setting.

RESULTS: Outcomes from 30 women who elected to continue PrEP throughout pregnancy were compared to those from 96 pregnancies among PrEP-unexposed women. There were small non-significant decreases in the frequency of pregnancy loss (16.7% PrEP-exposed versus 23.5% PrEP-unexposed, adjusted odds ratio [aOR] = 0.59, p = 0.4) and preterm delivery (0 versus 7.7%, [aOR] = 0.54, exact p = 0.6). No congenital anomalies occurred among PrEP-exposed infants. PrEP-exposed infants had slightly lower adjusted mean z-scores for length (-1.73 versus -0.79, p = 0.05) and head circumference (0.24 versus 1.07, p = 0.04) one month after birth but were comparable to PrEP-unexposed infants in these measurements one year after birth.

CONCLUSIONS: This first evaluation among women using PrEP throughout pregnancy indicates no greater frequency of adverse pregnancy outcomes or restricted infant growth; these findings support recommendations permitting PrEP use during pregnancy.