WASHINGTON—The FDA approved an injectable formulation of cabotegravir and rilpivirine (Cabenuva) for patients with HIV who are virologically suppressed on a stable antiretroviral regimen. The agency also approved a tablet version of cabotegravir (Vocabria) to be taken with oral rilpivirine (Edurant) in the month prior to starting the injectable treatment.
“Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement. “Having this treatment available for some patients provides an alternative for managing this chronic condition.”
Two randomized, open-label, controlled trials showed the safety and efficacy of the monthly jab. In these trials “1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) before initiation of treatment with [injectable cabotegravir and rilpivirine],” the FDA explained. “Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed.”
Injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash were the most common adverse side effects. Patients with a previous hypersensitivity to either cabotegravir or rilpivirine, or those whose HIV is not suppressed, should not take the new injectable formulation.
Both the injectable drug and the tablet were granted Fast Track and Priority Review designation by the FDA. The approval was granted to ViiV Healthcare.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 339
Topic ID: 338,339,284,339,125,27,192,725,925