For immediate release:

The United States Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a comprehensive regimen for the treatment of human immunodeficiency virus type 1 (HIV- 1) in adults to replace a current antiretroviral regimen in people with suppressed virology. on stable antiretroviral therapy with no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine. This is the first FDA-approved complete injectable regimen for adults with HIV, administered once a month.

The FDA has also approved Vocabria (cabotegravir, tablet formulation), which must be taken in combination with oral rilpivirine (Edurant) for one month before starting treatment with Cabenuva to ensure that the drugs are well tolerated before switching. to the sustained-release injectable formulation. .

“Currently, the standard of care for HIV-positive patients includes patients who take daily pills to adequately manage their condition. This approval will allow some patients the option of receiving injections once a month instead of a daily oral treatment regimen, ”said John Farley, MD, MPH, director of the Office of Infectious Diseases at the Center for Assessment and FDA drug research. “The availability of this treatment for certain patients constitutes an alternative to manage this chronic disease.”

The safety and efficacy of Cabenuva have been established through two randomized, open-label, controlled clinical trials in 1182 HIV-infected adults with suppressed virology (HIV-1 RNA less than 50 copies / milliliter) before initiation of treatment with Cabenuva. Patients in both trials continued to show virologic suppression at the end of each study, and no clinically relevant change from baseline for CD4 + cell count was observed.

The most common side effects with Cabenuva were injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, trouble sleeping, dizziness. and skin rashes. Cabenuva should not be used in case of a known hypersensitivity reaction to cabotegravir or rilpivirine, or in patients whose virus is not suppressed (HIV-1 RNA greater than 50 copies / milliliter).

Cabenuva and Vocabria have obtained Fast Track and Priority Review designation by the FDA.

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

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, and medical devices . The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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