- The Japanese Ministry of Health, Labour and Welfare approves Gilead Sciences' (NASDAQ:GILD) Sovaldi (sofosbuvir) for the suppression of viremia in patients with chronic hepatitis C genotype 2 infection, with or without compensated cirrhosis, in combination with ribavirin for 12 weeks.
- The data supporting approval showed a 96% HCV-2 cure rate (n=135/140) in patients receiving sofosbuvir plus ribavirin for 12 weeks as defined by SVR12 (sustained virologic response 12 weeks after completing therapy).
- In Japan, 20 - 30% of the 1M HCV-infected people are genotype 2. Currently approved therapies for HCV-2 involve 24 - 48 weeks of injections with pegylated interferon.
- The company filed a New Drug Application in Japan for Harvoni (ledipasvir/sofosbuvir) on September 24, 2014.