Phase 2 study finds that the use of daily oral Truvada as a means of HIV prevention is safe and acceptable.
With the lofty worldwide goal of putting an end to the AIDS epidemic by 2030, researchers everywhere are working to cut back on the number of new HIV diagnoses by strengthening preventive strategies. However, given the fact that adolescents and younger individuals are representative of a growing share of those living with HIV worldwide, preventive efforts need to be tailored specifically to this population.
At the 9th International AIDS Conference on HIV Science, two teams of investigators reported findings from 2 different studies that focused on preventing HIV specifically in adolescents: a daily oral tablet and a monthly vaginal ring. This article will focus on the trial regarding the daily oral tablet.
The Choices for Adolescent Prevention Methods for South Africa, or CHAMPS PlusPills, was a phase 2 study that set out to evaluate the “safety, acceptability, and use of daily oral Truvada, which contains 2 anti-HIV drugs (tenofovir and emtricitabine), as part of an HIV prevention package” for adolescents.
This was the first time that girls were included in a clinical trial of the oral tablet as a means of pre-exposure prophylaxis (PrEP) in the adolescent population, according to the official press release.
It should be noted that as of yet, Truvada has not received approval “by any national regulatory body for use as oral PrEP in adolescents,” according to the release. However, the oral tablet is already in use as a means of prevention in adults.
A total of 148 sexually-active South African adolescents between the ages of 15 and 19 in Cape Town and Johannesburg were enrolled into the study; none of the adolescents were infected with the virus at time of enrollment and all of them were otherwise healthy. Of those 148 adolescents, 99 were girls and 49 were boys. All participants were instructed to take oral Truvada on a daily basis for the duration of at least 3 months, with the option to take it up to 1 year if they desired.
The investigators found that the majority of the participants chose to take the oral tablet, which proved “safe and tolerable” for this population. “Although the number of participants who actually took Truvada as prescribed was lower than the number who opted in and decreased over time, nearly 40% were adherent by the end of the study.” Furthermore, only 1 participant (19 years of age) out of the 148 enrolled became infected during the trial; she reportedly stopped taking the oral tablets 3 months previous to her diagnosis.
Throughout the first 3 months, the participants had monthly study visits with subsequent quarterly visits; at each of these visits, participants had the option to opt out or continue taking the tablets. The investigators monitored all participants for 1 year and analyzed blood samples for evidence that the participants were adhering to the treatment regimen. At the 3-month mark, investigators found tenofovir (evidence of adherence) in more than half, or 57% of participants; 82% of the participants opted to continue treatment. However, at the 6-month mark, tenofovir was only detected in 38% of participants and only 64% opted to continue treatment. By the end of the year, 38% of participants tested positive for tenofovir. The most commonly cited reasons for stopping treatment were either headaches or nausea.
According to the press release, all participants were given a HIV preventive package, which consisted of the following:
They were also provided with 3 “preventive components” tailored specifically for their population:
“The trend toward lower adherence to Truvada for PrEP as study visits became less frequent parallels what was observed in a study of PrEP in adolescent gay and bisexual boys, suggesting that monthly study visits may support greater adherence to oral PrEP among adolescents over time,” Protocol Chair and International AIDS Society President Linda-Gail Bekker, MBChB, PhD, commented in the press release.
Researchers hope that these results could help support the “development of evidence-based guidelines for the use of Truvada as oral PrEP in adolescents.”
The National Institute of Allergy and Infectious Diseases (NIAID) contributed funding to the study.
Feature Picture Source: National Institutes of Health