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ViiV Healthcare obtains FDA OK for HIV drug regimen


The Food and Drug Administration has given the green light to ViiV Healthcare for its new once-monthly HIV treatment. The company's Cabenuva (cabotegravir and rilpivirine, injectable formulation) was approved as a complete regimen for adults with HIV-1 — replacing a daily oral treatment regimen.

ViiV Healthcare also obtained the FDA's blessing for Vocabria (cabotegravir, tablet formulation), which should be taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.

"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. "Having this treatment available for some patients provides an alternative for managing this chronic condition."


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