Meaningful Moment for HIV Treatment as FDA Approves ViiV's Monthly Shot

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The U.S. Food and Drug Administration (FDA) gave a greenlight for ViiV Healthcare’s Cabenuva. The drug, a combination of cabotegravir and rilpivirine, is a complete therapy for HIV-1 infection in adults who are virologically suppressed, which is defined as having HIV-1 RNA of less than 50 copies of the virus per milliliter on a stable treatment regimen, no history of treatment failure and no known or suspected resistance to either of the drugs in the combination. The shot is given as two intramuscular injections in the buttocks once a month at a specialist clinic.

ViiV Healthcare focuses on HIV and is majority-owned by GlaxoSmithKline (GSK), with Pfizer and Shionogi Limited as shareholders. Cabotegravir is a ViiV product marketed as Cabenuva, and rilpivirine is a Janssen product with a brand name Edurant. Janssen is a Johnson & Johnson company.

“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,” said Lynn Baxter, Head of North America, ViiV Healthcare. “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.”

The approval was built on the Phase III ATLAS and FLAIR trials. These involved more than 1,100 patients from 16 countries. Before beginning treatment with Cabenuva, patients took oral doses of both cabotegravir and rilpivirine for about a month to determine if the patients could tolerate it.

In the trials, Cabenuva was as effective as a daily oral three-drug regimen. The once-a-month regimen was preferred by nine out of 10 patients over the daily oral therapy.

In addition to the ATLAS and FLAIR trials, ViiV sponsored the CUSTOMIZE clinical trial. This was the first-ever, pre-approval implementation science study developed to evaluate ways to integrate Cabenuva into U.S. clinical practices.

“Among the scientific community, we recognize the innovation behind Cabenuva is truly meaningful,” said David Wohl, professor of medicine at the University of North Carolina Institute of Global Health and Infectious Diseases in Chapel Hill. “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.”

At the same time, the FDA approved ViiV’s New Drug Application (NDA) for Vocabria (cabotegravir) 30 mg oral tablets. This drug is indicated in combination with rilpivirine tablets for short-term treatment of HIV-1 in adults who are virologically stable and suppressed on a stable antiretroviral regimen who have no history of treatment failure or resistance to cabotegravir or rilpivirine.

Cabotegravir is an integrated strand transfer inhibitor (INSTI). Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI).

“With the approval of Cabenuva, we’re proud to bring a new treatment option to people living with HIV that removes the burden of taking a daily pill,” said Paul Stoffels, vice chairman of the Executive Committee and Chief Scientific Officer, J&J. “While much more remains to be done to make HIV history, today’s milestone reminds us how far medical innovation has come since the first reported cases of the virus almost 40 years ago.”