A vaginal ring that researchers are hopeful will be approved as a method for preventing HIV in women was found to be safe and acceptable in teen girls, according to results of a study conducted in the United States and reported at the 9th IAS Conference on HIV Science (IAS 2017) in Paris. The study is the first to evaluate the ring, which contains an antiretroviral (ARV) drug called dapivirine and is used for a month at a time, in girls under age 18.
The dapivirine ring has already been shown to be both safe and to help protect against HIV among women ages 18-45 in two Phase III trials – ASPIRE , which was conducted by the National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN), and The Ring Study, led by the International Partnership for Microbicides (IPM), a non-profit organization that also developed the dapivirine ring. Together, the two trials enrolled more than 4,500 women from four African countries. IPM is seeking regulatory approval of the ring for adult women of the same age.
If approved, the dapivirine ring would be the first biomedical prevention product exclusively for women. The new study, known as MTN-023/IPM 030, was designed to provide the kind of information about safety and tolerability that regulatory authorities would need to expand approval of the ring to also include girls under age 18.
MTN-023/IPM 030 was conducted by the MTN in collaboration with the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN), which is also funded by the NIH. MTN is planning to launch a second trial later this year, called REACH, that will collect safety data among adolescent girls and young women in Africa, who are among the most vulnerable population at risk of acquiring HIV.
“If the ring is approved for women older than age 18, it’s imperative that we have the data in hand to show that the ring is safe to use in younger women as well,” explained Sharon Hillier, Ph.D., principal investigator of the MTN, and professor and vice chair of the department of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine. “HIV doesn’t distinguish between a 16-year-old and an 18-year-old. Access to safe and effective HIV prevention shouldn’t either. Young women of all ages deserve to be protected.”