Gilead Sciences (GILD) said pre-market Tuesday that Japan’s Ministry of Health, Labour and Welfare has approved Epclusa for the treatment of adults with chronic hepatitis C virus (HCV) infection with decompensated cirrhosis as well as patients with chronic HCV infection without cirrhosis or with compensated cirrhosis who have had prior treatment with a direct-acting antiviral (DAA) therapy.
Epclusa’s approval in Japan was based on the results of a phase 3 clinical study in Japanese patients with HCV infection with decompensated cirrhosis, said Gilead. In that trial, 92% of patients who received Epclusa for 12 weeks achieved SVR12 and patients who attain SVR12 are considered cured of HCV, according to Gilead.
The regulatory approval was also based on data from a separate phase 3 clinical study in Japanese patients with genotype 1 or 2 HCV infection who failed prior DAA therapy, of which 97% of patients who received Epclusa with ribavirin for 24 weeks achieved SVR12. In both trials, Epclusa was generally well tolerated, the company said.