>> Interim results were presented from the Phase 2 trial of Albuferon in combination with ribavirin in patients with chronic hepatitis C who failed to respond to previous interferon alpha-based treatment regimens… Data through Week 72 are available for 71 patients who were enrolled and randomized into 3 Albuferon treatment groups (900 mcg every 2 weeks, 1200 mcg every 2 weeks, and 1200 mcg every 4 weeks). The total study duration includes 48 weeks of treatment plus 24 weeks of follow-up. All patients received Albuferon subcutaneously and received weight-based oral ribavirin daily. The overall end-of-treatment rate (ETR), defined as undetectable virus at the end of 48 weeks of treatment, was 31% (22/71) in the 900-mcg and 1200-mcg treatment groups. The primary efficacy endpoint in the Phase 2 trial in non-responders is sustained virologic response (SVR), defined as undetectable virus 24 weeks after the end of 48 weeks of treatment. The overall SVR rate in the 900-mcg and 1200-mcg Albuferon treatment groups was 21% (14/68). The overall SVR rate was 13% (5/39) in the most difficult-to-treat subgroup of genotype 1 hepatitis C patients who failed to respond to previous treatment with a combination of pegylated interferon and ribavirin. <<
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