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.
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.
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.
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: email@example.com
Received 6 December, 2017
Revised 17 March, 2018
Accepted 26 March, 2018