Trials & Filings

Gilead’s Harvoni Approved for New Indications

Once-daily breakthrough therapy expanded for use in genotype 4, 5 and 6 chronic HCV

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By: Kristin Brooks

Managing Editor, Contract Pharma

Gilead Sciences has received approval from the FDA for Harvoni (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. Also, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received approval for chronic HCV genotype 1 infection in the U.S. in October 2014.   The approval...

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