Japan's Ministry of Health, Labor and Welfare (MHLW) has approved Gilead's ($GILD) Sovaldi (sofosbuvir) for the suppression of viremia in chronic hepatitis C virus, marking the first all-oral, interferon-free treatment regimen for genotype 2 HCV infection and the first product to be marketed by Gilead ($GILD) in Japan.
Japan has one of the highest rates of liver cancer of any industrialized country. Of the more than 1 million people chronically infected with HCV, 20% to 30% have the genotype 2 strain of the virus, Gilead said in a press release. There was no immediate response to questions on pricing or reimbursement.
Currently approved therapies in Japan for genotype 2 HCV infection involve 24 to 48 weeks of injections with pegylated interferon, which may not be suitable for many patients.
Sovaldi's approval is supported by data from a Phase III clinical trial conducted in Japan among treatment-naïve and treatment-experienced genotype 2 patients.
Approval was based on 96% of genotype 2 HCV-infected patients who received 12 weeks of an all-oral regimen of Sovaldi plus RBV 600--1,000 mg/day achieving a sustained virologic response 12 weeks after completing therapy, considered cured of HCV infection.
Gilead filed a New Drug Application in Japan for a single-tablet regimen of sofosbuvir and the NS5A inhibitor ledipasvir for the treatment of genotype 1 HCV infected patients on Sept. 24, 2014.
The ledipasvir/sofosbuvir single tablet regimen is an investigational product in Japan and its safety and efficacy have not yet been established.
- here's the release from Gilead