FDA approval of six-annual-dose HIV treatment

pharmafile | February 2, 2022 | News story | Research and Development  

ViiV Healthcare has announced the FDA approval of Cabenuva (cabotegravir, rilpivirine) for every-two-month dosing for the treatment of HIV-1 in virologically suppressed adults. The treatment is now approved for administration as few as six times a year for virologically suppressed adults living with HIV without prior treatment failure or resistance to cabotegravir or rilpivirine.

Cabenuva is the first and only complete long-acting HIV treatment regimen and was first approved by the US FDA in January 2021 as a once-monthly treatment for HIV-1 in virologically suppressed adults

“ViiV Healthcare is pleased to continue our leadership in researching and developing long-acting innovative HIV treatment options that address the evolving needs of the HIV community,” Lynn Baxter, Head of North America at ViiV Healthcare, said. “Today’s approval is a remarkable achievement given where HIV treatment was just a decade ago. We know some people living with HIV struggle with taking daily oral pills, and Cabenuva may allow them to maintain viral suppression while significantly reducing dosing to as few as six times a year.”

The US FDA approval of long-acting cabotegravir and rilpivirine for use every two months is based on the global ATLAS-2M Phase III b trial results, which demonstrated that every-two-month dosing was non-inferior to once-monthly dosing.

Turner Overton, MD, Professor, Department of Medicine at the University of Alabama at Birmingham and ATLAS-2M Primary Investigator, commented: “Many people living with HIV face challenges with daily therapies and are interested in alternative dosing options. 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.”

Cabenuva has been approved for every-two-month dosing for the treatment of HIV-1 in virologically suppressed adults (HIV-1 RNA less than 50 copies per millilitre [c/ml]), on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

Ana Ovey

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