TY - JOUR
T1 - Pregnancy outcomes and infant growth among babies with in-utero exposure to tenofovir-based preexposure prophylaxis for HIV prevention
AU - Partners Demonstration Project
AU - Partners PrEP Study Teams M
AU - Heffron, Renee
AU - Mugo, Nelly
AU - Hong, Ting
AU - Celum, Connie
AU - Marzinke, Mark A.
AU - Ngure, Kenneth
AU - Asiimwe, Stephen
AU - Katabira, Elly
AU - Bukusi, Elizabeth A.
AU - Odoyo, Josephine
AU - Tindimwebwa, Edna
AU - Bulya, Nulu
AU - Baeten, Jared M.
AU - Donnell, Deborah
AU - Barnabas, Ruanne
AU - Haberer, Jessica
AU - Haugen, Harald
AU - Hendrix, Craig
AU - Kidoguchi, Lara
AU - Morrison, Susan
AU - Morton, Jennifer
AU - Ware, Norma
AU - Wyatt, Monique
AU - Mugo, Nelly Rwamba
AU - Coombs, Robert W.
AU - Frenkel, Lisa
AU - Lingappa, Jairam
AU - McElrath, M. Juliana
AU - Fife, Kenneth
AU - Were, Edwin
AU - Tumwesigye, Elioda
AU - Ndase, Patrick
AU - Ronald, Allan
AU - Cohen, Craig
AU - Wangisi, Jonathan
AU - Campbell, James
AU - Tappero, Jordan
AU - Kiarie, James
AU - Farquhar, Carey
AU - John-Stewart, Grace
N1 - Publisher Copyright:
Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
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U2 - 10.1097/QAD.0000000000001867
DO - 10.1097/QAD.0000000000001867
M3 - Article
C2 - 30001244
AN - SCOPUS:85056560728
SN - 0269-9370
VL - 32
SP - 1707
EP - 1713
JO - AIDS
JF - AIDS
IS - 12
ER -