A new report has proven a monthly vaginal ring and a daily oral emtricitabine; tenofovir disoproxil fumarate (Truvada—Gilead), both containing anti-HIV drugs, were safe and acceptable in studies of adolescents, two teams of investigators reported Tuesday at the 9th IAS Conference on HIV Science in Paris.
The experimental ring is designed for HIV prevention and the oral tablet is already used for this purpose in adults. These studies mark the first time the vaginal ring was tested in adolescent girls younger than 18 years and the first time a clinical trial of the oral tablet as pre-exposure prophylaxis (PrEP) specifically for adolescents included girls. The findings pave the way for larger trials of the vaginal ring and oral PrEP in this vulnerable age group.
“Adolescents and young people represent a growing share of people living with HIV worldwide,”
noted Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.
“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.”
The study of oral PrEP—called Choices for Adolescent Prevention Methods for South Africa, or CHAMPS PlusPills—is only the second clinical trial to report results of PrEP focused solely on adolescents.
The Principal Investigator, NIH-funded Microbicide Trials Network (MTN), Dr Sharon Hillier said,
“The study has demonstrated that the ring is safe in US 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.”
Photo credit: The Whistler
Hillier stated that an earlier NIAID-funded study called ASPIRE, which enrolled women ages from 18 to 45, tested a ring that continuously releases the experimental anti-HIV drug dapivirine in the vagina over one month.
“The results, reported in 2016, showed 27 per cent protection overall but no protection in women ages 18 to 21, likely due to low adherence.
A subsequent exploratory analysis of ASPIRE study data found that, using the ring most or all of the time reduces the risk of HIV infection in women by at least 56 per cent.’’
“Adolescent girls and young women, ages 15 to 24, are at particularly high risk for HIV infection. They accounted for 20 per cent of new HIV infections among adults globally in 2015.
The Professor and Director of reproductive infectious disease research at the University of Pittsburgh School of Medicine further said:
Overall, participants said they liked the ring at 93 per cent of study visits but were concerned about keeping the ring clean and fear of it being felt by primary sexual partner during sex.’’
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