Infectious Disease

FDA approves 2-month dosing of injectable long-acting HIV treatment

February 06, 2022

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Overton does not report any relevant financial disclosures.

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Virologically suppressed adults can now only be treated for HIV six times a year.

The FDA this week approved a 2-month dosing regimen for cabenuva — which includes 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.

Source: Shutterstock.com

The FDA approved a 2-month dosing schedule of Cabenuva for HIV treatment. Source: Adobe Stock.

Cabenuva was first approved for once-monthly dosing in January 2021 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 study, which showed that the regimen had similar efficacy when administered monthly or every 2 months. Participants overwhelmingly preferred the injectable regimen over oral therapy.

“Many people living with HIV face challenges with daily therapies and are interested in alternative dosing options,” Turner Overton, MD one Professor of medicine in the Department of Infectious Diseases at the University of Alabama at Birmingham and principal investigator of ATLAS-2M, said in a press release.

“In clinical trials, approximately nine out of 10 subjects preferred long-acting cabotegravir and rilpivirine given every 2 months over daily oral cabotegravir and rilpivirine taken as the oral lead-in per study protocol,” Overton said. “These preference data underscore the important impact that long-acting therapies can have on the treatment experience for the HIV community.”

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