Gilead Sciences Inc (GILD) said Friday the U.S. Food and Drug Administration approved Harvoni, the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults.
Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved under the tradename Sovaldi in December 2013.
Harvoni's efficacy has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load.
The FDA granted Harvoni a Priority Review and Breakthrough Therapy designation, which is given to investigational medicines that may offer major advances in treatment over available therapies.
Harvoni's approval is supported by data from three Phase 3 studies that evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12).
Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response rates. Trial participants in the ribavirin-free arms (n=863) achieved SVR12 rates of 94 to 99 percent.
Gilead stock is trading at $106.18, up $0.33 or 0.32%, on a volume of 10 million shares on the Nasdaq.
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