ViiV Healthcare’s Cabenuva secures FDA approval for HIV treatment

ViiV Healthcare has received FDA approval for Cabenuva, a long-acting treatment regimen for HIV-1 infection in adult patients. This new therapy is poised to transform HIV care by offering a convenient, once-monthly injection that significantly reduces the burden of daily medication. Cabenuva consists of two key injectable medicines: cabotegravir, a ViiV Healthcare-developed integrase strand transfer inhibitor (INSTI), and rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen.

This approval represents a significant milestone in HIV treatment. The long-acting regimen is designed for patients who are already virologically suppressed with no history of treatment failure and who do not have known or suspected resistance to cabotegravir and rilpivirine. By reducing the frequency of dosing from 365 days to just 12 days per year, Cabenuva is set to improve the lives of individuals living with HIV, making it an innovative and highly anticipated therapy.

Lynn Baxter, Head of North America at ViiV Healthcare, emphasized the groundbreaking nature of this approval, noting that Cabenuva represents a major shift in HIV treatment by offering a new and highly convenient care option. She highlighted how this treatment significantly reduces dosing days, providing patients with an effective and less frequent treatment regimen. Baxter stressed that ViiV Healthcare’s commitment to improving the lives of people living with HIV remains at the core of their mission, and the approval of Cabenuva adds a pioneering treatment to their portfolio.

Cabenuva’s clinical success backed by extensive trials

The FDA’s approval of Cabenuva follows the positive results from the phase 3 ATLAS and FLAIR studies, which involved over 1,100 participants across 16 countries. The studies demonstrated that Cabenuva, administered once a month as an intramuscular injection, is just as effective as the daily oral three-drug regimen traditionally used to treat HIV. These trials showed that Cabenuva successfully maintained viral suppression for up to 48 weeks, confirming its potential to replace the daily regimen for those stable on antiretroviral therapy.

Before starting treatment with Cabenuva, patients were required to undergo a month-long oral dosing of cabotegravir and rilpivirine to evaluate the tolerability of each drug. Results from these studies were promising, with most participants reporting positive experiences with the regimen. Dr. David Wohl, a professor of medicine at the University of North Carolina, praised the innovation behind Cabenuva, calling it “meaningful” and highlighting its preference among clinical trial participants over daily oral regimens. Wohl noted that the regimen’s long-acting nature and reduced dosing frequency would likely result in better adherence and improved quality of life for patients.

The significance of Cabenuva in the future of HIV treatment

The approval of Cabenuva marks a pivotal moment for both ViiV Healthcare and the broader field of HIV treatment. With its monthly injection regimen, it offers a much-needed alternative for patients who struggle with daily pill regimens or who seek more flexible treatment options. ViiV Healthcare, which is majority-owned by GlaxoSmithKline (GSK), continues to solidify its leadership position in the HIV treatment space, expanding its innovative portfolio alongside Pfizer and Shionogi, its other shareholders.

The FDA’s approval of Cabenuva reflects a growing trend toward long-acting therapies that offer greater convenience without sacrificing efficacy. For those living with HIV, these innovations are not just a matter of convenience—they represent a significant step toward a better quality of life and an increased likelihood of long-term health. With this approval, ViiV Healthcare strengthens its commitment to ensuring that no individual living with HIV is left behind.