The US Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir and rilpivirine) as a complete regimen intended to treat human immunodeficiency virus type 1 (HIV-1) infection in adults. The injectable drug is designed to replace a current antiretroviral regimen in patients who are virologically suppressed on a stable antiretroviral regimen, with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
Cabenuva, a product from ViiV Healthcare, is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month. The agency also approved ViiV’s Vocabria (cabotegravir, tablet formulation), to be taken in combination with oral rilpivirine (Edurant) for one month prior to starting Cabenuva, in order to help to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.
John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, pointed out the current standard of care for HIV patients to date has involved taking pills daily to manage their condition.
“This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen. Having this treatment available for some patients provides an alternative for managing this chronic condition,” Farley said.
Prior to approval, safety and efficacy of Cabenuva were explored via two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed before initiation of treatment with Cabenuva. Researchers reported that patients in both trials continued to show virologic suppression at the conclusion of each study, with no clinically relevant change from baseline in CD4+ cell counts observed.
Lynn Baxter, head of North America for ViiV Healthcare, commented, “Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year.”
Baxter added, “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.”
David Wohl, professor of medicine at the University of North Carolina Institute of Global Health and Infectious Diseases in Chapel Hill, said Cabenuva is an innovative, “meaningful” treatment.
“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," Wohl said. "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.”
Prior to the FDA’s approval, both Cabenuva and Vocabria had been granted Fast Track and Priority Review designation by the agency. The drugs had been approved for use in adult HIV patients by Health Canada in March 2020.