FDA Approves Cabenuva, First Long-Acting Injectable HIV Regimen

Many people living with HIV will now be able to receive their treatment through a monthly injection rather than a daily pill.

The U.S. Food and Drug Administration Thursday approved ViiV Healthcare’s Cabenuva, an injectable regimen combining cabotegravir and rilpivirine. It’s designed as a complete regimen for treatment-experienced adults who have achieved viral suppression and have no history of treatment failure and no known or suspected resistance to either component drug.

“This is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month,” notes an FDA press release.

Having to take one or more pills daily poses adherence problems for some people with HIV, so it’s important to have the option of a monthly injection, ViiV officials and scientists say.

“FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” Lynn Baxter, who heads ViiV Healthcare’s North American operations, said in a company news release. “Cabenuva reduces the treatment dosing days from 365 days to 12 days per year. At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission.”

“Among the scientific community, we recognize the innovation behind Cabenuva is truly meaningful,” added Dr. David Wohl, professor of medicine at the University of North Carolina Institute of Global Health and Infectious Diseases. “Not only is it the first, complete long-acting regimen, which allows for a dramatic reduction in the frequency of dosing, but it also was preferred by most clinical trial participants when compared to their prior daily oral regimens. The FDA approval of Cabenuva underscores the value of community-centric research and I am pleased this new option will be available for those living with HIV.”

The FDA also approved Vocabria, a tablet formulation of cabotegravir, which should be taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.

Regulators in Canada approved Cabenuva and Vocabria for use there last March, the first approval of a long-acting injectable for HIV anywhere.