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Emerging evidence from a systematic review of safety of pre‐exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading?

Davey, Dvora L Joseph ; Pintye, Jillian ; Baeten, Jared M ; Aldrovandi, Grace ; Baggaley, Rachel ; Bekker, Linda‐Gail ; Celum, Connie ; Chi, Benjamin H ; Coates, Thomas J ; Haberer, Jessica E ; Heffron, Renee ; Kinuthia, John ; Matthews, Lynn T ; McIntyre, James ; Moodley, Dhayendre ; Mofenson, Lynne M ; Mugo, Nelly ; Myer, Landon ; Mujugira, Andrew ; Shoptaw, Steven ; Stranix‐Chibanda, Lynda ; John‐Stewart, Grace ; Group, for the PrEP in Pregnancy Working

Journal of the International AIDS Society, 2020-01, Vol.23 (1)

eScholarship, University of California

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Título:
Emerging evidence from a systematic review of safety of pre‐exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading?
Autor: Davey, Dvora L Joseph ; Pintye, Jillian ; Baeten, Jared M ; Aldrovandi, Grace ; Baggaley, Rachel ; Bekker, Linda‐Gail ; Celum, Connie ; Chi, Benjamin H ; Coates, Thomas J ; Haberer, Jessica E ; Heffron, Renee ; Kinuthia, John ; Matthews, Lynn T ; McIntyre, James ; Moodley, Dhayendre ; Mofenson, Lynne M ; Mugo, Nelly ; Myer, Landon ; Mujugira, Andrew ; Shoptaw, Steven ; Stranix‐Chibanda, Lynda ; John‐Stewart, Grace ; Group, for the PrEP in Pregnancy Working
Assuntos: Adult ; Anti-HIV Agents ; Biomedical and Clinical Sciences ; Breast Feeding ; breastfeeding ; Clinical Sciences ; Epidemiology ; Female ; Good Health and Well Being ; Health Sciences ; HIV ; HIV Infections ; HIV-1 ; HIV/AIDS ; Humans ; Infant Mortality ; Infection ; Infectious ; Infectious Diseases ; Midwifery ; Other Medical and Health Sciences ; Patient Safety ; Pediatric ; Perinatal Period - Conditions Originating in Perinatal Period ; PMTCT ; Postnatal Care ; Pre-Exposure Prophylaxis ; preexposure prophylaxis ; Pregnancy ; Pregnancy Complications ; PrEP ; PrEP in Pregnancy Working Group ; Prevention ; prevention of mother to child transmission ; Public Health ; Public Health and Health Services ; Reproductive health and childbirth ; Reproductive Medicine ; Tenofovir ; Young Adult
É parte de: Journal of the International AIDS Society, 2020-01, Vol.23 (1)
Notas: Journal of the International AIDS Society, vol 23, iss 1
e25426
Descrição: IntroductionHIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout.MethodsWe used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women.Results and discussionWe identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation.ConclusionsExpanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.
Editor: eScholarship, University of California
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Emerging evidence from a systematic review of safety of pre‐exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading?

eScholarship, University of California

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