FDA approves HIV pre-exposure preventive injection

The US Food and Drug Administration (FDA) has approved the first injectable pre-exposure prevention treatment for HIV.

According to a news release, cabotegravir extended-release injectable suspension (Apretude, Viiv Healthcare) has been approved for use in at-risk adults and children weighing at least 77 pounds as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. It is given first as a 2-shot shot regimen administered a month apart and then one shot every 2 months following that.

Treatment can be initiated with the exteneded-release injection or with oral cabotegravir for 4 weeks to assess the drug's tolerability, the release says.

“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,” Debra Birnkrant, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, says in the release. “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.”

The release cites preliminary Centers for Disease Control and Prevention (CDC) data that show for the year 2020, among the 1.2 million persons for whome PrEP is recommended, approximately 25% were prescribed the treatment, up significnatly from the 3% in 2015. There is still room for improvement, notes CDC, as the groups most at-risk for HIV are also less likely to adhere to a daily medication regimen. The agency hopes that a long-acting injectable PrEP option will increase uptake and adherence in these groups.

In a pair of randomized, double-blind trials comparing cabotegravir extended-release injectable suspension to once-daily oral emtricitabine/renofovir, cabotegravir was shown to be more effective. Specifically, in a trial of >4500 cisgender men and transgender women who have sex with men, participants who took cabotegravir had 69% less risk of HIV infection. In the other trial of >3200 cisgender women, those who took cabotegravir were shown to have 90% less risk of getting infected with HIV, according to FDA statement.

Side effects seen more in participants who received cabotegravir compared to those who received emtricitabine/renofovir in either trial include injection site reactions, headache, pyrexia, fatigue, back pain, myalgia, and rash.

Cabotegravir extended-release injectable suspension was granted FDA priority review as well as breakthrough therapy designation.