FDA approves first extended-release injectable drug regimen for adults living with HIV

The US Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for treating human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in people with virological suppression in a stable antiretroviral regimen, with no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine. This is the first FDA-approved injectable regimen for HIV-infected adults that is 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 formulation. prolonged release injection.

“Currently, the standard of care for HIV patients includes patients who take pills daily to properly control 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 FDA’s Drug Evaluation and Research Center. . “Having this treatment available to some patients offers an alternative to managing this chronic condition.”

The safety and efficacy of Cabenuva were established through two randomized, open and controlled clinical trials on 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies / milliliter) before starting treatment with Cabenuva. Patients in both trials continued to experience virological suppression at the conclusion of each study, and no clinically relevant changes from baseline in CD4 + cell counts were observed.

The most frequent adverse reactions with Cabenuva were reactions at the injection site, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disturbances, dizziness and skin rash. Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not experiencing viral suppression (HIV-1 RNA greater than 50 copies / milliliter).

Cabenuva and Vocabria received the designation Fast Track and Priority Review from the FDA.

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

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

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