Until December 2019, pregnant and lactating women were excluded from the PrEP (pre-exposure prophylaxis) roll-out in South Africa based on 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.
Adolescents and young adults account for one-third of all new HIV infections worldwide and three-quarters of all new HIV infections in sub-Saharan Africa, which is disproportionately high compared to other age groups.
And it is anticipated that new infections are likely to increase. As part of efforts to mitigate the HIV epidemic, youth prevention programmes must be implemented.
In comparison to the risk of HIV infection at other times, a 2018 study indicated that women in two preventive studies were approximately three times more likely to contract the virus while pregnant and four times more likely to do so in the six months following childbirth.
Sexual relationships between people of reproductive age are more likely to occur concurrently, which is a circumstance that accelerates the spread of HIV, reports the World Health Organization (WHO).
It seems likely that condom-free sex and physiological changes during pregnancy, such as immunological and hormonal changes, can increase HIV risk. Approximately one-fifth of the population in South Africa is HIV positive, making it the country with the highest HIV prevalence worldwide.
The safety of PrEP in pregnant women must be established because, in the opinion of the WHO, it is a promising method to prevent HIV infection. Poor prenatal care and other diseases, such as undetected and untreated STDs, can contribute to adverse pregnancy outcomes, which are common in low- and middle-income countries.
The PrEP study was conducted between 2017 and 2019 in Durban. After screening 693 pregnant women, 540 were randomly assigned to either immediate PrEP (n = 271) or deferred PrEP (n = 269). The study’s objective was to determine if pregnant women randomly allocated to start taking PrEP during their second trimester of pregnancy (14–28 weeks) or after they stopped nursing would experience unfavourable pregnancy outcomes and the frequency of maternal and neonatal adverse events.
The study looked at whether starting PrEP early was linked to preterm birth, low birth weight, stillbirth, or infants with short gestational ages. The results imply that starting tenofovir disoproxil fumarate and emtricitabine PrEP during pregnancy does not raise the risk of preterm delivery, small for gestational age births, or any other undesirable pregnancy outcomes.
Another study on PrEP and its effect on HIV-1 transmission in South Africa, A Cost-Effectiveness Analysis research, revealed that when used on women in the targeted age groups who are most at risk for infection, PrEP can prevent up to 30% of new infections.
Moodley, the research author said an important baseline for negative pregnancy outcomes is provided by this study, which is also probably the final clinical trial comparing PrEP with no PrEP. This study paves the way for the next studies of innovative PrEP techniques.
Professor Glenda Gray, president and CEO of the South African Medical Research Council and a member of the study team, said that HIV and AIDS are still serious issues in South Africa, where women continue to experience disproportionately high rates of infection.
“We need to intensify the interventions that have a chance of success. Prenatal PrEP is essential in the fight to end HIV in children and is the first step in preventing HIV in women.”