Medivir AB (STO:MVIRB)(OMX: MVIR), announced today the initiation of cohort 2 in the interferon-free phase II trial combining simeprevir with sofosbuvir (GS7977) based on a safety and efficacy planned interim analysis of cohort 1 including prior null responder HCV genotype 1 infected patients without advanced hepatic fibrosis. Data from the cohort 1 study will be presented at a scientific conference during H1-2013.
Study design Simeprevir, a NS3/4A protease inhibitor is being studied with sofosbuvir, a nucleotide NS5B polymerase inhibitor, in a phase IIa, randomized, open-label study to investigate the efficacy and safety of 12 or 24 weeks of simeprevir (150 mg QD) and sofosbuvir (400 mg QD) with or without ribavirin (RBV) in HCV genotype 1 (GT1) patients.
Cohort 1 included a total of 80 HCV GT1 prior null responders to PegIFN/RBV therapy with METAVIR score F0-F2.
Cohort 2 (90 patients) will include both HCV GT1 treatment naïve and prior null responders to PegIFN/RBV patients with advanced hepatic fibrosis (METAVIR score F3 or F4). Patient screening for cohort 2 was recently initiated.