BioCentury
ARTICLE | Clinical News

Simeprevir: Additional Phase IIa data

April 7, 2014 7:00 AM UTC

Medivir reported additional SVR data from cohort 2 of patients with HCV genotype 1 infection in the open-label, U.S. Phase IIa COSMOS trial evaluating once-daily 150 mg oral simeprevir plus once-daily 400 mg oral Sovaldi sofosbuvir with or without ribavirin for 12 or 24 weeks. In 87 evaluable treatment-naïve patients or previous null responders to peginterferon and ribavirin with advanced liver fibrosis (METAVIR scores of F3-F4) in cohort 2 of the trial, SVR12 rates were 93% for simeprevir plus Sovaldi with ribavirin for 12 weeks (n=27), 93% for simeprevir plus Sovaldi without ribavirin for 12 weeks (n=14), 93% for simeprevir plus Sovaldi with ribavirin for 24 weeks (n=30) and 100% for simeprevir plus Sovaldi without ribavirin for 24 weeks (n=16).

There were no viral breakthroughs. Relapse occurred in 3 patients with HCV genotype 1a infection within 8 weeks after the end of treatment. In cohort 2, 78% of patients had HCV genotype 1a infection, 47% had a METAVIR score of F4 (cirrhosis) and 54% were prior null responders. Data will be presented at the European Association for the Study of the Liver meeting in London this month. Medivir previously reported SVR12 data from cohort 1 of the trial and SVR4 data from cohort 2 (see BioCentury, March 11, 2013; Sept. 9, 2013; & Nov. 11, 2013). ...