Injectable ART given every 8 weeks safely suppresses HIV in adolescents
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Key takeaways:
- Long-acting injectable HIV treatment is approved in the United States for adults and adolescents.
- A study found that taking it every 8 weeks safely suppressed HIV in adolescents.
DENVER — Long-acting injectable ART administered every 8 weeks safely suppresses HIV in adolescents, according to research presented at the Conference on Retroviruses and Opportunistic Infections.
The long-acting combination of cabotegravir and rilpivirine has been approved by the FDA for adolescents since 2022 and can be administered as few as six times per year.
In a study lead by the International Maternal Pediatric AIDS in Adolescents Clinical Trials group (IMPAACT), researchers enrolled 144 adolescents at 18 sites in five countries, including the United States, at a median age of 15 years. All but two participants received at least one or more injections of the therapy and all but three completed visits up to 24 weeks, with no deaths or adverse events leading to discontinuation noted by the researchers.
“Just over a third of the study participants reported injection site reaction in the form of pain or redness or swelling soon after the injection, most of which resolved by seven days,” Aditya H. Gaur, MD, director of the division of HIV medicine at St. Jude Children’s Research Hospital, said at a press conference. “Despite that, when asked at 6 months about their preference of long-acting versus oral treatment, 99% of [participants] indicated their preference for long acting or oral treatment.”
The researchers recorded no virologic failures through the 24th week, though one participant was noted for having low cabotegravir concentration at that time.
Gaur said the findings marked “a good example of some concerted collaborative efforts to accelerate pediatric drug development and reduce the gap between when these compounds become approved for adults vs. in adolescence.”
“Data from this study has and will continue to inform regulatory approvals around the world such that ... access to this regimen can become much more broadly available,” Gaur added.
“The HIV community is just beginning to unpack the enormous potential of long-acting antiretroviral medications for HIV treatment and prevention, and we need population-specific data for everyone to benefit,” National Institute of Allergy and Infectious Diseases Director Jeanne M. Marrazzo, MD, MPH, said in a press release. “These findings open up new possibilities for millions of people with HIV, particularly those whose health suffers due to challenges of daily pill taking.”
References:
Gaur A, et al. Abstract 188. Presented at: Conference on Retroviruses and Opportunistic Infections; March 3-6, 2024; Denver.
Long-acting HIV treatment benefits adults with barriers to daily pill taking and adolescents with suppressed HIV. https://www.nih.gov/news-events/news-releases/long-acting-hiv-treatme. Published Mar. 6, 2024. Accessed Mar. 6, 2024.