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FDA Approves First Injectable, Complete Regimen For HIV-infected Adults

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Thursday, the U.S. Food and Drug Administration approved first extended-release, injectable drug regimen for the treatment of HIV infection in adults.

Cabenuva (cabotegravir and rilpivirine), developed by ViiV Healthcare, is approved as a complete regimen to treat HIV infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

The FDA also approved Vocabria (cabotegravir), developed by ViiV Healthcare to be taken in combination with oral rilpivirine (Edurant), one month prior to starting treatment with Cabenuva. This is to ensure the medications are well-tolerated before switching to the extended-release injectable formulation, which is administered once a month.

"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 John Farley, director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research.

The most common adverse reactions with Cabenuva during trials were injection site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.

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