Durban - A groundbreaking international study, led by the University of KwaZulu-Natal’s Professor Dhayendre Moodley, has confirmed that the HIV prevention drug, PrEP, is safe for pregnant women not living with HIV.
The drug, comprised of tenofovir disoproxil fumarate and emtricitabine, has been used successfully as a pre-exposure prophylaxis (PrEP) in South Africa, but until December 2019, pregnant and lactating women were excluded due to the absence of safety data for its use in pregnancy.
The study, published in The Lancet HIV, provides 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.
HIV is the leading cause of death worldwide among women of reproductive age. In the countries of sub-Saharan Africa with a high HIV burden, 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 nearly three times more likely to become infected with HIV while they were pregnant and four times as likely in the six months after giving birth, compared with the risk of HIV infection at other times.
Increased HIV risk may be due to condomless sex as well as physiological changes that accompany pregnancy, including immune and hormonal alterations and shifts in the vaginal microbiome.
The World Health Organisation (WHO) views PrEP as a promising intervention to prevent HIV acquisition and hence determining the safety of PrEP in pregnant women is vital.
The PrEP study was conducted in Durban between 2017 and 2019. Initially, 693 pregnant women were screened and 540 were randomly assigned to immediate PrEP or deferred PrEP. 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 birthweight, stillbirth or 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 any adverse pregnancy outcomes (preterm birth, low birthweight, small for gestational age babies, 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, the collaborative team included scientists from the Universities of KZN, Stellenbosch, Witwatersrand, and Southampton (UK) as well as the South African Medical Research Council, the Centre for the Programme of Aids Research in South Africa, the 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.”
South African Medical Research Council (SAMRC) President and CEO Professor Glenda Gray, who was part of the study team, said, “HIV and AIDS remains 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.”
For the full study see https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(22)00369-1/fulltext.
The Independent on Saturday