(CN) — A vaginal ring that protects against HIV infection was found to be safe and acceptable in a study of adolescent girls in the United States, researchers reported Tuesday at an international conference in Paris.
The study is the first to evaluate the ring, which releases the antiretroviral drug dapivirine daily for a month at a time, in girls younger than 18.
Presented at the ninth annual International AIDS Society Conference on HIV Science in France, the report features information on the treatment’s safety and tolerability, which the researchers say could help get the dapivirine ring approved for girls and women.
“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,” said Sharon Hillier, principal investigator of the Microbicide Trials Network, which conducted the new study, as well as a Phase III trial, testing the ring’s effectiveness and safety, in women from 18 to 45 in Africa.
The study enrolled 96 girls ages 15 to 17 at six U.S. sites and was conducted from July 2014 to July 2016. Participants were randomly assigned to use either the dapivirine ring or a placebo ring that felt and looked the same. Seventy-three girls were in the dapivirine group and 23 were given the placebo. The researchers asked the girls to use their assigned rings for a month at a time for six months.
No differences in safety were found between the dapivirine and placebo rings, according to Katherine Bunge, an assistant professor at the University of Pittsburgh School of Medicine and protocol co-chair for the study.
Ring usage was consistent among the girls: a point of focus for the researchers. According to self-reported data, 42 percent of participants said they removed the ring only to replace it monthly. About 87 percent of plasma samples from the dapivirine group had detectable levels of the drug, which suggests that the ring had been used the previous day. Roughly 95 percent of the rings showed drug levels that suggested consistent using during the previous month.
The participants found the ring highly acceptable, with 95 percent of the girls saying it was easy to use and 74 percent saying they were not aware of it during daily activities. While some worried that their partner would feel the ring during sex, 93 percent said they liked the ring overall.
“Adolescents and young people represent a growing share of people living with HIV worldwide,” National Institute of Allergy and Infectious Diseases director Anthony S. Fauci said in a statement. “Science has demonstrated that the HIV prevention needs of adolescents may be different than those of adults, which is why these new study findings are so important.”
Microbicide Trials Network is planning to launch another trial this year, which will collect safety data from young women and adolescent girls in Africa, who are particularly vulnerable to acquiring HIV. About 300 girls and women 16 to 21 will be enrolled at sites in Zimbabwe, Uganda, South Africa and Kenya. The study will also assess the safety of Truvada, a daily oral tablet that also contains anti-HIV drugs.
“HIV doesn’t distinguish between a 16-year-old and an 18-year-old. Access to safe and effective HIV prevention shouldn’t either,” Hillier said. “Young women of all ages deserve to be protected.”