Infectious Disease

Long-acting ART safe, effective after 124 weeks

October 24, 2021

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Orkin does not report any relevant financial information. Please refer to the study for all relevant financial information from the other authors.

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Long-acting injectable cabotegravir plus rilpivirine was effective in maintaining viral suppression of HIV in adults with or without a one-month oral induction period, according to a study published in The Lancet HIV.

The FDA approved the once-monthly injection treatment with the Cabenuva brand in January.

Source: Adobe Stock

The long-acting injectable cabotegravir plus rilpivrine was safe, effective and well tolerated after 124 weeks. Source: Adobe Stock.

“These are the longest follow-up data from people who received long-acting injectable cabotegravir plus rilpivirine in a phase 3 clinical trial.” Chloe Orkin, MBBCh, Professor, consultant and director of HIV research at Queen Mary University of London and Barts Health, said Healio. “There is security in terms of durability.”

The new results come from the FLAIR study, an ongoing phase 3 randomized, open-label, multicenter study that previously reported improved treatment satisfaction compared to daily ART after 96 weeks.

Orkin and colleagues rated the 124-week safety, tolerability, and durability of the regimen in ART-naïve participants who were virologically suppressed with standard treatment during the 20-week induction phase. They randomly assigned participants in a 1: 1 ratio to continue the standard oral treatment or to switch to the long-acting treatment in the 100-week maintenance phase.

According to the study, randomization was stratified by sex at birth and HIV-1 RNA at baseline. Treatment group participants received cabotegravir plus rilpivirine once daily for at least 4 weeks prior to their first injection. You could choose to continue or stop cabotegravir (400 mg) plus rilpivirine (600 mg) every 4 weeks from week 100.

Study endpoints for week 124 included plasma HIV-1 RNA at least 50 copies / ml or less than 50 copies / ml, confirmed virologic failure – HIV-1 RNA measured at 200 copies / ml or more twice in a row – safety and tolerability .

According to the study, 232 (92%) of 253 participants in the extension phase switched to long-duration cabotegravir plus rilpivirine at week 100 (111 in the direct injection group and 121 in the introductory oral group). whereas 243 of the 283 who were randomly assigned to the long-acting therapy group continued the long-acting regimen into the extension phase.

Orkin and colleagues found that one participant in each extension switch group had HIV-1 RNA of 50 or more copies / ml, while 110 participants in the direct injection group and 113 in the oral introduction group in the 124. Weekly check-in remained suppressed.

The researchers said the lower rates of suppression in the oral lead-in group were due to non-virological reasons. In addition, the study showed that among those in the randomly assigned long-term effect group, 227 participants remained suppressed.

Withdrawal adverse events occurred in three participants in the extension switch population and two in the introductory oral group after 24 weeks of therapy, and in 15 in the randomly assigned long-acting group, with injection site reactions being the most common was .

“Long-acting injectable cabotegravir and rilpivrine were effective and safe over 124 weeks of treatment,” Orkin concluded. “The results were good with the people who decided against the oral introduction.”

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