The US Food and Drug Administration (FDA) has approved Cabenuva, an injectable formulation of cabotegravir (Vocabria) and rilpivirine (Edurant), for adults living with HIV-1 infection.
Cabenuva is the first FDA-approved injectable complete regimen for adults with HIV-1 infection. It is administered once a month.
Cabenuva would replace a current antiretroviral regimen for individuals whose condition is virologically suppressed with a stable antiretroviral regimen, whose condition is not known or suspected of being resistant to either cabotegravir or rilpivirine, and who do not have a history of treatment failure, the FDA said.
“Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition,” John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a news release.
“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,” said Farley.
The FDA also approved cabotegravir tablets (Vocabria).
Cabotegravir tablets should be taken in combination with oral rilpivirine for 1 month before starting treatment with Cabenuva to ensure that the medications are well tolerated before switching to the extended-release injectable formulation, the agency advised.
Cabenuva was shown to be safe and effective in two randomized, open-label, controlled clinical trials involving 1182 HIV-infected adults whose condition was virologically suppressed (HIV-1 RNA, <50 copies/mL) before initiation of Cabenuva.
“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,” the FDA said.
The most common adverse reactions with Cabenuva were injection site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.
Cabenuva should not be used if patients are known to have previously experienced a hypersensitivity reaction to cabotegravir or rilpivirine or for patients whose condition is not virally suppressed (HIV-1 RNA, >50 copies/mL).
Cabenuva and Vocabria were approved through a fast-track protocol and received priority review.