FDA approves 2-month dosing of injectable, long-acting HIV treatment
Virologically suppressed adults can now receive HIV treatment as few as six times per year.
The FDA this week approved a 2-month dosing regimen for Cabenuva — which includes shots of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Pharmaceuticals) — for virologically suppressed adults on a stable regimen with no history of prior treatment failure or resistance to either drug.
Cabenuva was first approved in January 2021 for once-monthly dosing and remains the only long-acting HIV treatment.
The approval for the 2-month regimen was based on results from the global phase 3b ATLAS-2M trial, which demonstrated that the regimen had a similar efficacy when administered monthly or every 2 months. Participants overwhelmingly preferred the injectable regimen to oral therapy.
“Many people living with HIV face challenges with daily therapies and are interested in alternative dosing options,” Turner Overton, MD, a professor of medicine in the division of infectious diseases at the University of Alabama at Birmingham and ATLAS-2M primary investigator, said in a press release.
“In clinical trials, approximately nine out of every 10 trial participants preferred long-acting cabotegravir and rilpivirine dosed every 2 months compared to daily oral cabotegravir and rilpivirine taken as the oral lead-in per trial protocol,” Overton said. “This preference data highlights the meaningful impact long-acting regimens can have on the treatment experience for the HIV community.”