BioCentury
ARTICLE | Clinical News

Gilead reports Sovaldi data from Japanese patients

April 3, 2014 12:46 AM UTC

Gilead Sciences Inc. (NASDAQ:GILD) said once-daily oral Sovaldi sofosbuvir plus ribavirin for 12 weeks met the primary endpoint in the Japanese Phase III Study GS-US-334-0118 to treat chronic HCV genotype 2 infection. Sovaldi led to a greater proportion of patients achieving a sustained virologic response (SVR) 12 weeks after the end of treatment vs. a predefined historic control SVR12 rate. SVR12 rates were 98% in treatment-naïve patients (n=90) and 95% in treatment-experienced patients (n=63). The open-label trial enrolled 153 patients.

By mid-year, Gilead plans to submit an NDA in Japan for the nucleotide analog HCV NS5B polymerase inhibitor to treat chronic HCV genotype 2 infection. According to the company, there are about 2 million HCV-infected patients in Japan, of whom about 20-30% have HCV genotype 2 infection. ...