In a much-anticipated decision, the U.S. Food and Drug Administration has approved Cabenuva, the long-acting injectable regimen, as a shot that can be taken every two months instead of monthly for HIV treatment.
Approved in January 2021 as the first once-monthly injectable treatment regimen for HIV, Cabenuva is for people living with HIV who have had an undetectable viral load for at least three months.
Cabenuva is actually a two-shot regimen—one shot of long-acting cabotegravir, an integrase inhibitor from ViiV Healthcare, and a shot of Janssen’s long-acting rilpivirine, a non-nucleoside reverse transcriptase inhibitor—administered into the butt muscle.
Approval of the two-month shot was based on results from the global ATLAS-2M Phase 3b, which demonstrated the dose was non-inferior to the once-monthly shot.
“Many people living with HIV face challenges with daily therapies and are interested in alternative dosing options,” said Turner Overton, MD, a professor at the University of Alabama at Birmingham’s Department of Medicine and ATLAS-2M primary investigator. “In clinical trials, approximately nine out of every ten trial participants preferred long-acting cabotegravir and rilpivirine dosed every two months compared to daily oral cabotegravir and rilpivirine taken as the oral lead-in per trial protocol. This preference data highlights the meaningful impact long-acting regimens can have on the treatment experience for the HIV community.”
Read more about the approval here.