FDA approves first extended-release injectable, complete regimen for HIV

The US Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. This is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month. 

The agency also approved Vocabria (cabotegravir, tablet formulation), which should be taken in combination with oral rilpivirine (Edurant) for one 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. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said Dr John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Having this treatment available for some patients provides an alternative for managing this chronic condition.”

The safety and efficacy of Cabenuva were established through two randomised, open-label, controlled trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA <50 copies/milliliter) before initiation of treatment with 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 most common adverse reactions with Cabenuva were injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.

The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.