An international study led by the University of KwaZulu-Natal’s Professor Dhayendre Moodley confirmed the safe use of tenofovir disoproxil fumarate and emtricitabine as pre-exposure prophylaxis (PrEP) in pregnant women not living with HIV.
Until December 2019, pregnant and lactating women were excluded from the PrEP roll-out in South Africa due to the absence of safety data for its use in pregnancy. The novel study, published in The Lancet HIV, is a pioneering approach providing much-needed safety data to allow for a more informed choice during pregnancy to protect mother and baby from the long-term effects of HIV.
Human immunodeficiency virus type 1 (HIV) is the leading cause of death worldwide among women of reproductive age. In countries of sub-Saharan Africa with a high burden of HIV – where women represent 56% of new adult HIV infections – fertility rates are also high, and women spend a significant proportion of their reproductive years pregnant or breastfeeding. A 2018 study found that women in two prevention studies were more likely to contract HIV while pregnant (three times higher), and during the six months after giving birth (four times higher), compared to any other period.
Increased HIV risk may be due to unprotected sex as well as physiological changes that accompany pregnancy, including immune and hormonal alterations and shifts in the vaginal microbiome. According to the World Health Organization, PrEP is a promising intervention to prevent HIV acquisition. Therefore, determining the safety of PrEP during pregnancy is vital. Adverse pregnancy outcomes in low and middle-income countries (LMICs) are frequent and may be due to several factors including poor antenatal care and other infections such as undiagnosed and untreated sexually transmitted infections.
The CAP016 PrEP study was conducted in Durban, South Africa, between 2017 and 2019. Initially, 693 pregnant women were screened and 540 were randomly assigned to immediate PrEP (n=271) or deferred PrEP (n=269). The study aimed to assess pregnancy outcomes and frequency of maternal and neonatal adverse events in pregnant women randomly assigned to initiate PrEP in the second trimester of pregnancy (14-28 weeks) or initiate PrEP after cessation of breastfeeding.
The study assessed if the early start of PrEP was associated with preterm birth, low birth weight, stillbirth or for small gestational age infants. Moodley commented, ‘Our findings suggest that initiation of tenofovir disoproxil fumarate and emtricitabine PrEP in pregnancy does not increase the occurrence of preterm birth, small for gestational age, or any adverse pregnancy outcome (preterm birth, low birthweight, small for gestational age, or stillbirth). Moreover, this study is likely to be the last clinical trial comparing PrEP with no PrEP, and provides a valuable benchmark for adverse pregnancy outcomes for future planned studies of novel PrEP strategies.’
Funded by Gilead Sciences and the South African Medical Research Council (SAMRC), the collaborative team included scientists from UKZN, Stellenbosch University, Wits, the University of Southampton (UK), as well as the South African Medical Research Council, the Centre for the AIDS Programme of Research in South Africa (CAPRISA), KwaZulu-Natal Department of Health, and Gilead Sciences (USA).
Vice-President of Medical Affairs at Gilead Sciences, Dr James Rooney, said, ‘Gilead is proud to be a part of this research as we work collectively to study PrEP options for all those who may benefit.’
SAMRC President and CEO, Professor Glenda Gray, who was part of the study team said, ‘HIV and AIDS remain a significant problem in South Africa, where women continue to bear a disproportionate burden of HIV. We need to double down on interventions that can work. PrEP in pregnancy is the first step in preventing HIV in women and critical in our battle to eradicate HIV in children.’
Go to: https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00369-1/fulltext to read the full study.
Words: MaryAnn Francis
