ARTICLE | Clinical News

Sovaldi sofosbuvir: Phase III data

April 7, 2014 7:00 AM UTC

Top-line data from the open-label, Japanese Phase III Study GS-US-334-0118 in 153 treatment-naïve or treatment-experienced patients with chronic HCV genotype 2 infection showed that once-daily 400 mg oral Sovaldi plus ribavirin for 12 weeks met the primary endpoint of a greater proportion of patients achieving an SVR 12 weeks after the end of treatment vs. a predefined historic control SVR12 rate (97% vs. undisclosed). SVR12 rates were 98% in treatment-naïve patients (n=90) and 95% in treatment-experienced patients (n=63). All patients achieved undetectable HCV RNA levels by treatment week 4 and remained undetectable through treatment week 12. Post-treatment relapse accounted for 5 virologic failures. By mid-year, Gilead plans to submit an NDA in Japan for Sovaldi to treat chronic HCV genotype 2 infection. According to Gilead, there are about 2 million HCV-infected patients in Japan, of whom about 20-30% have HCV genotype 2 infection. ...