Posted on February 10, 2020
"Study Also to Examine Whether Pregnant Women Accept, Use These HIV Prevention Tools"
"The first clinical trial specifically designed to test the safety of the monthly dapivirine vaginal ring in pregnant women has begun in southern and eastern Africa. The National Institutes of Health-funded study also will test the safety of a daily oral antiviral tablet for HIV pre-exposure prophylaxis (PrEP) in pregnant women and will assess how much they accept and use these two HIV prevention tools. The study will complement an ongoing NIH-funded trial of PrEP in adolescents and young women during pregnancy and the first six months after birth. PrEP is available in some countries and is being rolled out in others, while the dapivirine ring is under regulatory review by the European Medicines Agency for potential use in sub-Saharan Africa."
“'Women need reliable HIV prevention methods that they know are safe during pregnancy for themselves and their babies,” said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. “This new clinical trial will provide important data on the safety of PrEP and the dapivirine ring during pregnancy and will help expectant parents make well-informed HIV prevention choices.'”
"Studies have found that for women of reproductive age, the risk of acquiring HIV is two to four times greater during pregnancy and the first six months after childbirth than at other times. In sub-Saharan Africa, women tend to be pregnant for a substantial portion of their reproductive years, with an estimated 5.1 births per woman."
"Limited evidence from earlier clinical trials and reports suggests that PrEP and the dapivirine ring are safe for pregnant women and their fetuses, but the safety of these tools during pregnancy has not yet been proven in a clinical trial designed specifically to address this question."