Adolescents with HIV viral suppression can safely use long-acting, injectable antiretroviral therapy (ART), which has displayed improved HIV suppression compared to oral ART in individuals with difficulty taking daily oral regimens, according to data presented at the 2024 Conference on Retroviruses and Opportunistic Infections in Denver.
Takeaways
- Long-acting injectable antiretroviral therapy (ART) shows improved HIV suppression compared to daily oral regimens, particularly beneficial for individuals struggling with adherence to daily medication schedules.
- Clinical trials evaluating long-acting cabotegravir and rilpivirine among populations lacking data, such as adolescents and those with difficulty adhering to daily oral ART, have demonstrated promising results.
- Participants receiving long-acting ART had significantly lower rates of unsuppressed HIV and treatment discontinuation because of adverse events compared to those on daily oral ART.
- Despite statistically insignificant primary endpoints in some trials, a favorable trend towards long-acting ART was observed, leading to recommendations for its widespread use based on improved efficacy in HIV suppression.
- Long-acting ART offers a safe and effective alternative for adolescents with HIV, providing them with freedom from the challenges of daily pill regimens and potentially improving treatment adherence and outcomes.
The National Institutes of Health funded research to expand upon the 2021 FDA approval of long-acting cabotegravir and rilpivirine for individuals with viral suppression. Two trials were conducted to evaluate use of the drug regimen in populations with lacking data.
In the first clinical trial, investigators assessed long-acting injectable cabotegravir and rilpivirine efficacy among individuals struggling to follow a daily oral ART regimen. Cohorts included a group of participants receiving long-acting ART and a group receiving the standard daily oral regimen.
Among patients in the long-acting ART group, 7% presented with unsuppressed HIV, vs 25% in the daily oral ART group. The odds of treatment discontinuation because of adverse events or unsuppressed HIV in these groups was 10% and 26%, respectively.
While these results were statistically significant, investigators noted that the primary endpoint of unsuppressed HIV and ART discontinuation risks was not statistically significant based on interim analysis criteria. However, a favorable trend was observed for long-acting ART over daily oral ART.
Injection site reactions were reported in over half of participants in the long-acting ART group, with 1 citing reactions as a reason for discontinuation. On February 21, 2024, the Data and Safety Monitoring Board recommended all participants be offered long-acting ART because of its improved efficacy toward HIV suppression.
“This study shows long-acting technology is safe and effective among the people with HIV who stand to benefit most from its use,” said Aadia Rana, MD, professor of medicine at the University of Alabama-Birmingham and study chair. “Offering an effective alternative for people who have struggled with taking daily ART could provide life-changing freedom from the stress of unsuppressed HIV.”
The second clinical trial evaluated the safety of the regimen in adolescents with HIV viral suppression. Participants aged 12 to 17 weeks received the regimen every 8 weeks, with data available at 24 weeks.
Viral suppression at 24 weeks was reported in all participants. Additionally, no severe adverse events were linked to the drug regimen. An injection site reaction was reported in 35% of participants, but most were mild and resolved within 7 days.
Cabotegravir and rilpivirine concentrations in adolescents were similar to those reported in adults. Investigators concluded these data support cabotegravir and rilpivirine use in virally suppressed adolescents.
“This is the first group of adolescents with HIV to have an alternative to daily pills for treatment, and the outcomes we observed have been very encouraging,” said Aditya Gaur, MD, director of the Division of HIV Medicine at St. Jude Children's Research Hospital and study co-chair.
“This study is part of the commitment to speed the evaluation of novel therapies for pediatric and adolescent populations, so that they have the opportunity to benefit as soon as possible,” Gaur added.
Reference
Long-acting HIV treatment benefits adults with barriers to daily pill taking and adolescents with suppressed HIV. National Institutes of Health. March 6 2024. Accessed March 6 2024. https://www.nih.gov/news-events/news-releases/long-acting-hiv-treatment-benefits-adults-barriers-daily-pill-taking-adolescents-suppressed-hiv
