The FDA has approved a form of HIV treatment that only needs to be taken once every two months with an injection in the buttocks.
The FDA already approved a once-a-month injection in January 2021. The shot contains cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Pharmaceuticals). At the time, its makers said they were confident that the shot could work for longer, but needed more data to back up the claim.
The once-every-two-month injection is for HIV-positive adults who are already virally suppressed, have shown no previous treatment failure or resistance to either of the drugs involved.
The FDA granted approval after results from a trial showed the injections remained efficient if given every couple of months.
The lead researcher involved with that trial, Turner Overton, MD, a professor of medicine in the division of infectious diseases at the University of Alabama at Birmingham, said in a statement, “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 10 trial participants preferred long-acting cabotegravir and rilpivirine dosed every two months compared to daily oral cabotegravir and rilpivirine.”
Viiv Healthcare is predominantly owned by GlaxoSmithKline. Lynn Baxter, Head of North America at ViiV Healthcare, said in a statement announcing the approval, “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.”
Long-acting cabotegravir and rilpivirine are already approved for use every two months in Canada under the name Cabenuva and in the EU as Vocabria and Rekambys.
Matthew Hodson, Chief Executive of HIV information organization NAM aidsmap, welcomed the news.
“For many people taking daily pills becomes an emotional burden, a constant reminder that their health is at risk without medication,” he told Queerty. “For some, who are unable to be open about their need for HIV treatment, it can create considerable obstacles to necessary adherence required for HIV medication to be effective. For many, a switch to injections just six times a year will be a liberation.”