US antivirals major Gilead Sciences (Nasdaq: GILD) today announced positive findings from an open-label clinical trial (Study GS-US-334-0109) evaluating once-daily Sovaldi (sofosbuvir) 400mg tablets for the retreatment of chronic hepatitis C virus (HCV) infection among patients who failed prior therapy.
These data will be presented in two oral sessions at the 49th Annual Meeting of the European Association for the Study of the Liver (The International Liver Congress 2014) in London.
In Study GS-US-334-0109 (Oral #55), patients with genotype 1 HCV infection (n=80) received 12 weeks of treatment with once-daily Sovaldi plus weight-based ribavirin (RBV) twice-daily (1,000 or 1,200mg/day) and pegylated interferon (peg-IFN; 180mcg/week). Patients in the study had failed prior regimens containing peg-IFN, RBV and an investigational NS3 protease inhibitor, with or without investigational direct-acting antivirals (DAAs) (NS5A and/or non-nucleoside NS5B inhibitors). 45% of patients (n=36) had received more than one course of prior therapy, and 90% (n=72) had at least one viral mutation associated with HCV NS3, NS5A or NS5B drug resistance.
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