Long-Acting HIV Rx Approved

FDA approves Cabenuva (cabotegravir and rilpivirine, injectable formulation)

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication to treat HIV.

The FDA approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) to treat human immunodeficiency virus type 1 (HIV-1) infection.

Cabenuva is the first FDA-approved HIV treatment that is injected only once per month. This long-acting medication is meant to replace daily pills for some patients.

“Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition," said Dr. John Farley, director of the FDA's Office of Infectious Diseases, in a press 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.”

Alongside this approval, the FDA also approved Vocabria (cabotegravir, tablet formulation). This drug is meant to be taken in combination with rilpivirine (Edurant) for a month before taking Cabenuva, the agency noted.

Cabenuva was approved for adults who have HIV-1, have no known resistance to cabotegravir or rilpivirine, have no history of treatment failure and are virally suppressed on a stable antiretroviral regimen. For patients with HIV, viral suppression means levels of the virus in the blood are extremely low or undetectable.

The FDA approved Cabenuva after the drug was studied in two trials of nearly 1,200 adults with HIV. The study participants were virally suppressed. And the patients remained virally suppressed after switching to once-monthly Cabenuva, the FDA noted.

Reactions at the injection site, rash, sleep disorders, nausea, muscular pain, headache, fatigue and fever were the most common adverse reactions tied to Cabenuva.

The FDA approved Cabenuva and Vocabria for ViiV Healthcare.

Talk to your health care provider about which treatment is best for you.

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Review Date: 
January 26, 2021