Questions over PrEP safety during pregnancy should not prevent treatment

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Unanswered questions about the safety of taking PrEP during pregnancy and breastfeeding should not be allowed to stand in the way of access to PrEP for women who need it at these times, Aidsmap reports a systematic review concludes. The review led by Dr Dvora Joseph, at the department of epidemiology, Fielding School of Public Health, University of California-Los Angeles and the division of epidemiology and biostatistics, School of Public Health and Family Medicine, University of Cape Town, found no evidence of harm for women who took PrEP during pregnancy. PrEP use did not lead to higher frequencies of premature birth, stillbirth, low birth weight or poorer infant outcomes, except for one early measurement of infant body size in one small study.

The report says the World Health Organisation recommends that women at high risk of HIV infection during pregnancy or postpartum should be offered tenofovir disoproxil (TDF)-based pre-exposure prophylaxis but PrEP implementation for pregnant and postpartum women has been held back in some countries with high HIV incidence by concerns over a lack of data on the safety of PrEP for pregnant women and their infants.

The PrEP in Pregnancy Working Group carried out a systematic review of published studies and ongoing clinical trials in order to assess the evidence and identify whether ongoing trials are likely to address unanswered questions.

The five completed studies reported on PrEP use in 1042 pregnancies. Four out of five studies found no difference in maternal or infant outcomes in pregnant women exposed to PrEP compared to pregnant women not exposed to PrEP.

The report says nine studies are currently ongoing or planned to investigate the delivery of PrEP during pregnancy or post-partum.

Introduction: HIV 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.
Methods: We 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, 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 discussion: We 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.
Conclusions: Expanding 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.

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

Full Aidsmap report

Journal of the International AIDS Society abstract

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