FDA expands approval of Harvoni (ledipasvir + sofosbuvir) for genotype 4, 5 and 6 chronic hepatitis C- Gilead Sciences
The FDA has approved Harvoni (ledipasvir + sofosbuvir), from Gilead Sciences, for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection. The supplemental new drug application (sNDA) approval for HCV genotypes 4–6 was supported by data from the open-label trials 1119 and ELECTRON-2. Study 1119 evaluated Harvoni for 12 weeks in patients with HCV genotype 4 or 5 who were treatment-naïve and treatment-experienced with or without cirrhosis. Results showed that 93% (41/44) of those with genotype 4 and 93% (38/41) of those with genotype 5 achieved SVR12.
Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014.
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