FDA approves first ER injectable drug regimen for adults living with HIV

FDA approved on Thursday cabotegravir and rilpivirine, injectable formulation (Cabenuva—ViiV Healthcare) as a complete regimen for the treatment of HIV-1 infection in adults to replace a current antiretroviral regimen in those 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. This is the first FDA-approved injectable, complete regimen for adults with HIV that is administered once a month. The agency also approved cabotegravir, tablet formulation (Vocabria—ViiV Healthcare), to be taken in combination with oral rilpivirine (Edurant) for 1 month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation. “Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition,” said John Farley, MD, MPH, director of the Office of Infectious Diseases in FDA’s Center for Drug Evaluation and Research. “This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen.” The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials involving more than 1,100 adults with HIV who were virologically suppressed prior to initiation of treatment with Cabenuva. The most frequently reported adverse reactions to the treatment were injection site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. Both Cabenuva and Vocabria received FDA Fast Track and Priority Review.