A preliminary study examining anti-HIV drugs in a vaginal ring and oral pills for adolescents found these methods safe and acceptable in lessening the risk of young people contracting the deadly virus.
The study was presented at the ninth annual IAS Conference on HIV Science in Paris and marks the first time medication for the prevention of contracting HIV was specifically tailored and evaluated for adolescents younger than 18 years old, according to a statement by the National Institutes of Health, which in part funded the study.
“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, said in the press release. “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.”
This was the second clinical trial evaluating oral pre-exposure prophylaxis (PrEP) for the prevention of HIV — marketed as CHAMPS PlusPills but is the PrEP drug Truvada, used in adults but not evaluated for adolescents. The second phase of the clinical trial included study participants from Cape Town and Johannesburg, South Africa.
They were 99 girls and 48 boys — all evaluated as healthy, sexually active and uninfected with HIV. In addition to the CHAMPS PlusPills — which participants had to take daily for three months and up to one year — they also underwent routine HIV testing, counseling and were given information on sexually transmitted infections and how to prevent them, the NIH said in its statement.
They had access to condoms, post-exposure prophylaxis, and boys were given counseling and referrals for circumcision, which has been shown to reduce the risk of HIV infection in men, the NIH said.
Study participants had difficulty adhering to the oral medication, the researchers found, but that more reminders, clinic visits and medical information helped increase diligence to the medication program.
In a separate study in the U.S., researchers evaluated adherence to and impact of a vaginal ring insert that released PrEP medication into adolescent girls. Scientists recorded high adherence to the ring, adequate levels of the medication in the girls bloodstream and deemed it safe to the health of the patients.
“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,” said Sharon Hillier, the principal investigator of the study and professor at the University of Pittsburgh School of Medicine.
Dr. Hillier is expected to launch the REACH study later this year, which will evaluate the vaginal ring and oral Truvada in adolescent girls and young women in Africa.