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

Partners Demonstration Project, Partners PrEP Study Teams M

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1707-1713
Number of pages7
JournalAIDS
Volume32
Issue number12
DOIs
StatePublished - Jan 1 2018

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Tenofovir
Pregnancy Outcome
HIV
Pregnancy
Growth
Odds Ratio
Parturition

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

Cite this

Pregnancy outcomes and infant growth among babies with in-utero exposure to tenofovir-based preexposure prophylaxis for HIV prevention. / Partners Demonstration Project; Partners PrEP Study Teams M.

In: AIDS, Vol. 32, No. 12, 01.01.2018, p. 1707-1713.

Research output: Contribution to journalArticle

Partners Demonstration Project ; Partners PrEP Study Teams M. / Pregnancy outcomes and infant growth among babies with in-utero exposure to tenofovir-based preexposure prophylaxis for HIV prevention. In: AIDS. 2018 ; Vol. 32, No. 12. pp. 1707-1713.
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title = "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.",
author = "{Partners Demonstration Project} and {Partners PrEP Study Teams M} and Renee Heffron and Nelly Mugo and Ting Hong and Connie Celum and Marzinke, {Mark A.} and Kenneth Ngure and Stephen Asiimwe and Elly Katabira and Bukusi, {Elizabeth A.} and Josephine Odoyo and Edna Tindimwebwa and Nulu Bulya and Baeten, {Jared M.} and Jared Baeten and Deborah Donnell and Ruanne Barnabas and Jessica Haberer and Harald Haugen and Craig Hendrix and Lara Kidoguchi and Susan Morrison and Jennifer Morton and Norma Ware and Monique Wyatt and Mugo, {Nelly Rwamba} and Coombs, {Robert W.} and Lisa Frenkel and Hendrix, {Craig W.} and Jairam Lingappa and McElrath, {M. Juliana} and Kenneth Fife and Edwin Were and Elioda Tumwesigye and Patrick Ndase and Allan Ronald and Craig Cohen and Jonathan Wangisi and James Campbell and Jordan Tappero and James Kiarie and Carey Farquhar and Grace John-Stewart",
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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 - Baeten, Jared

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 - Hendrix, Craig W.

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

PY - 2018/1/1

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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

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