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

Heffron, Reneea,b; Mugo, Nellya,e; Hong, Tinga; Celum, Conniea,b,c; Marzinke, Mark A.g,h; Ngure, Kennetha,i; Asiimwe, Stephenj; Katabira, Ellyk; Bukusi, Elizabeth A.a,d,f; Odoyo, Josephinef; Tindimwebwa, Ednaj; Bulya, Nuluk; Baeten, Jared M.a,b,c for the Partners Demonstration Project and the Partners PrEP Study Teams

doi: 10.1097/QAD.0000000000001867

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.

aDepartment of Global Health

bDepartment of Epidemiology

cDepartment of Medicine

dDepartment of Obstetrics & Gynecology, University of Washington, Seattle, USA

eCentres for Clinical Research

fMicrobiology Research, Kenya Medical Research Institute, Nairobi, Kenya

gDepartment of Pathology

hDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA

iCollege of Health Sciences, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya

jKabwohe Clinical Research Center

kInfectious Disease Institute, Makerere University, Kampala, Uganda.

Correspondence to Renee Heffron, PhD, International Clinical Research Center, University of Washington, 325 Ninth Avenue Box 359927, Seattle, Washington, USA. Tel: +1 2065203800; fax: +1 2065203831; e-mail:

Received 6 December, 2017

Revised 17 March, 2018

Accepted 26 March, 2018

Copyright © 2018 Wolters Kluwer Health, Inc.