FDA Approves New Extended-Release HIV Option

The US Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir and rilpivirine) for the treatment of human immunodeficiency virus type 1 (HIV-1) in adults as a replacement for current antiretroviral regimens in patients who are virologically suppressed and with no history of treatment failure.

Cabenuva is the first FDA-approved injectable, complete regimen for HIV treatment in adults that is administered once a month. Along with Cabenuva, the FDA also approved Vocabria (cabotegravir, tablet formulation) to be taken with oral rilpivirine (Edurant) for 30 days before initiating treatment with Cabenuva.

The safety and efficacy of the drug were examined in 2 randomized, open-label, controlled clinical trials involving 1182 virologically suppressed patients. Overall, patients continued to show virologic suppression with no relevant changes in CD4+ cell count.

Common side effects included injection site reaction, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.

—Michael Potts

Reference:

US Food and Drug Administration. FDA approves first extended-release, injectable drug regimen for adults living with HIV. News release. January 21, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-extended-release-injectable-drug-regimen-adults-living-hiv