South Africa: Use of dapivirine vaginal ring in the periconception period for HIV-1 prevention is safe and effective, finds a new study.
The study, published in the Journal of Acquired Immune Deficiency Syndromes, shows that dapivirine use in the periconception period does not seem to be associated with adverse effects on pregnancy or infant outcomes. Findings provide support for additional safety studies of the dapivirine ring throughout pregnancy.
Monthly use of dapivirine vaginal ring has been shown to be safe and effective for the prevention of HIV-1 in non-pregnant women of reproductive age. However, the effect of dapivirine on infant and pregnancy outcomes is still not known.
Bonus Makanani, Johns Hopkins University Research Project, Blantyre, Malawi, and colleagues in this randomized, double-blind, placebo-controlled phase 3 study compared pregnancy incidence and outcomes by study arm among HIV-1–uninfected women who became pregnant while participating in ASPIRE trial.
For the purpose, researchers observed 2629 sexually active women aged 18 to 45 years from Malawi, South Africa, Uganda, and Zimbabwe who were using the dapivirine vaginal ring or placebo for HIV-1 prevention.
Despite contraceptive counselling and provision of highly effective contraceptive methods, 169 of these women became pregnant resulting in 179 incident pregnancies and 181 pregnancy outcomes. Once pregnancy was diagnosed, study product use was stopped; therefore, exposure was limited to early pregnancy.
The researchers found that there were no differences in the incidence of pregnancy between the dapivirine ring and placebo arms, and there were no adverse effects on pregnancy outcomes, infant congenital anomalies, or infant growth through the first year of life.
“Our findings provide important evidence supporting the safety of dapivirine use in early pregnancy and provide support for additional studies of the dapivirine ring at different gestational ages in order to confirm the safety of dapivirine ring use throughout pregnancy.” concluded the authors.
For further reference log on to 10.1097/QAI.0000000000001861