A monthly vaginal ring that releases anti-HIV drugs was found to be safe and acceptable in an NIH-funded study of adolescent girls, according to data presented today at the 9th IAS Conference on HIV Science in Paris.
The experimental ring boasted better adherence throughout the study compared to a daily oral tablet, the researchers reported. The study is the first to test the vaginal, drug-eluting ring in girls younger than 18 years of age.
Young women ages 15 to 24 years old are at high risk for contracting HIV, according to the NIH. They represented 20% of new HIV infections among adults worldwide in 2015, despite being just 11% of the total adult population.
Ninety-six girls enrolled in the Phase II study and were randomized 3-to-1 to receive either the dapivirine ring or a placebo ring. For six months, researchers asked users to insert a new device on a monthly basis, while the investigators monitored the participant’s adherence by measuring the amount of dapivirine present in their blood samples and used rings.
The researchers reported that the drug-eluting ring was safe and acceptable to study participants and that adherence to the ring was high. They found drug levels in 87% of blood samples.
The device was rated highly among users – at 93% of study visits, participants said they liked the ring. But the young women also raised concerns that their sexual partner would feel the ring during sex and asked about the device’s cleanliness at visits.
“We are encouraged by these results of the dapivirine ring in 15- to 17-year-old girls,” principal investigator Sharon Hillier said in prepared remarks. “The study has demonstrated that the ring is safe in U.S. teens, and now we need data on the safety and acceptability of the ring in African adolescent girls. The Reach study, scheduled to launch later this year, will generate this data.”
“Adolescents and young people represent a growing share of people living with HIV worldwide,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the NIH, added. “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.”