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AIDS. 2018 May 11. doi: 10.1097/QAD.0000000000001867. [Epub ahead of print]

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

Author information

1
Department of Global Health, University of Washington, Seattle, USA.
2
Department of Epidemiology, University of Washington, Seattle, USA.
3
Centres for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
4
Department of Medicine, University of Washington, Seattle, USA.
5
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, USA.
6
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA.
7
College of Health Sciences, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
8
Kabwohe Clinical Research Center, Kabwohe, Uganda.
9
Infectious Disease Institute, Makerere University, Kampala, Uganda.
10
Department of Obstetrics & Gynecology, University of Washington, Seattle, USA.
11
Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.

Abstract

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.

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