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

Abstract

Background: Global guidelines recommend preexposure 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 1-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 with those from 96 pregnancies among PrEP-unexposed women. There were small nonsignificant 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) 1 month after birth but were comparable to PrEP-unexposed infants in these measurements 1 year after birth.

Conclusion: 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.

Conflict of interest statement

Conflicts of Interest

The authors declare no conflicts of interest. Gilead Sciences donated the PrEP medication but had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Figures

Figure 1.

Age and gender-adjusted z-scores for infant a) weight, b) length, and c) head circumference. Slopes for z-scores for weight (0.01 for PrEP-exposed and −0.06 for PrEP-unexposed, slope difference=0.07) and length (0.19 for PrEP-exposed and −0.04 for PrEP-unexposed, slope difference=0.23) are greater among PrEP-exposed relative to PrEP-unexposed infants (p

Figure 1.

Age and gender-adjusted z-scores for infant a) weight, b) length, and c) head circumference. Slopes for z-scores for weight (0.01 for PrEP-exposed and −0.06 for PrEP-unexposed, slope difference=0.07) and length (0.19 for PrEP-exposed and −0.04 for PrEP-unexposed, slope difference=0.23) are greater among PrEP-exposed relative to PrEP-unexposed infants (p

Figure 1.

Age and gender-adjusted z-scores for infant a) weight, b) length, and c) head circumference. Slopes for z-scores for weight (0.01 for PrEP-exposed and −0.06 for PrEP-unexposed, slope difference=0.07) and length (0.19 for PrEP-exposed and −0.04 for PrEP-unexposed, slope difference=0.23) are greater among PrEP-exposed relative to PrEP-unexposed infants (p