‘Essential first step’: HIV study demonstrates potential of long-acting ART in Africa
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Key takeaways:
- Long-acting injectable ART was noninferior to daily oral treatment for HIV in an African study.
- Long-acting ART is not recommended by WHO in Africa, but new data could change that.
DENVER — Long-acting ART was shown to be safe and effective in a study conducted in sub-Saharan Africa — an “essential first step” in demonstrating its potential use to treat HIV on the continent, an expert said.
Long-acting injectable ART containing cabotegravir and rilpivirine has been approved in the United States since 2021 and can be administered as few as six times per year with a bimonthly dosing schedule.
“The CARES trial was designed to assess whether this would also work in sub-Saharan Africa in the public health approach, where you’ve got a completely different population, a completely different approach to care, with sparse viral load testing, sparse safety testing and different administration systems,” Nicholas Paton, MD, FRCP, professor of infectious diseases at the London School of Hygiene & Tropical Medicine, said during a press conference at the Conference on Retroviruses and Opportunistic Infections.
Long-acting ART has been shown to be effective and well tolerated by people with HIV, and studies have found that many people prefer an injection every 4 or 8 weeks over adhering to a daily pill regimen.
Although daily treatment regimens have been shown to be effective among people with HIV in sub-Saharan Africa, questions remain about long-acting ART because it has mostly been tested and recommended in resource-rich nations, according to Paton.
Paton and colleagues enrolled 512 participants for the phase 3b randomized, multicenter CARES trial at eight sites in Kenya, South Africa and Uganda to evaluate the efficacy, safety and tolerability of switching from daily oral ART to long-acting injectable cabotegravir and rilpivirine administered every 8 weeks.
According to the study, 97.3% of people in the long-acting group and 98.1% of people who remained on daily oral ART had maintained viral suppression at follow-up after 48 weeks. Findings showed that 9% of participants in the long-acting group experienced an adverse event compared with 4% in the daily oral group.
Most adverse events were short-term irritation or pain at the injection site — one participant discontinued long-acting ART because of an injection-site abscess. People in both groups felt satisfied with their regimen, according to surveys, but Paton said those switching to long-acting therapy increasingly felt more satisfied with the change.
He said there is more work to be done before switching patients from daily oral regimens.
“You can’t expect WHO to change guidelines and roll this out tomorrow,” Paton said. “There’s so many things to be thought of before that. But this is the essential first step — we’ve found that it works in this setting and what programs might need to do, what the costs are and what the practicalities are. But it’s very exciting that this could work in Africa.”
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Kityo C, et al. Abstract 122. Presented at: Conference on Retroviruses and Opportunistic Infections; March 3-6, 2024; Denver.
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