FDA clears first long-acting HIV-prevention injectable, giving ViiV claim to historic OK
A long-acting injectable treatment for the prevention of HIV has been given the go-ahead by the FDA for use in adults and children weighing at least 77 pounds.
Apretude is first given as two injections given a month apart from each other, and then every two months after. Patients are given the option to start treatment with Apretude or the oral cabotegravir Vocabria for four weeks to assess how well to tolerate the drug.
“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” FDA director of antivirals Debra Birnkrant said. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”
About 25% of the 1.2 million people for which pre-exposure prophylaxis was recommended were prescribed the treatment for HIV prevention in the US in 2020, a number up from about 3% in 2015, the FDA said. But that requires “high levels of adherence,” and the FDA hopes that the approval of Areptude will help increase uptake in high-risk patients.
Two safety and efficacy trials were evaluated: Trial 1 in HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection, and Trial 2 in uninfected cisgender women who were at risk of acquiring HIV. Participants in trial 1 had 69% less risk of getting HIV, and those in trial 2 had a 90% risk reduction.
Participants who took Apretude started the trial with 30 mg of cabotegravir taken orally, and a placebo each day for up to five weeks. That was followed by a 600mg injection of Apretude at months one and two, then every two months after and a daily placebo tablet.
Participants who didn’t take Apretude were given Truvada and started the trial taking Truvada and a placebo daily for up to five weeks, followed by a combination of Truvada and a placebo injection.
This January, the FDA also approved Cabenuva, a combination of cabotegravir and injectable rilpivirine, as a complete regimen for the treatment of HIV-1 in patients with no known or suspected resistance to the drugs. That was the first-ever approved injectable by the FDA approved for adults infected with HIV and is administered once a month. Vocabria, which is the tablet formulation of cabotegravir, was also approved by the FDA to be taken with Edurant orally for a month before treatment starts, to ensure that the treatment will be well-tolerated. Both drugs were previously granted fast track and priority review designation from the FDA.