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Human Genome Sciences Announces Albuferon(R) Meets Primary Endpoint in Phase 3 Trial in Chronic Hepatitis C
Date:12/8/2008

University of Florida, said, "Chronic hepatitis C represents a significant unmet medical need. These Phase 3 results suggest that albinterferon alfa-2b has the potential to become an important new treatment option for patients with chronic hepatitis C. Albuferon requires half as many injections as the pegylated interferons, and clinical results to date suggest that it may offer comparable efficacy, with no difference in clinically significant adverse events. The observed variation in response by geography is an unexpected finding and requires further analysis. We look forward to results from the ACHIEVE 1 trial, which is evaluating albinterferon alfa-2b in the treatment of patients with genotype 1 hepatitis C."

In the randomized, multi-center, active-controlled non-inferiority Phase 3 trial, 933 treatment-naive patients with genotypes 2 and 3 chronic hepatitis C were initially assigned to one of three treatment groups, including two groups that received albinterferon alfa-2b once every two weeks at doses of 900-mcg or 1200-mcg, and an active control group that received peginterferon alfa-2a once weekly at a dose of 180-mcg - with all patients receiving oral ribavirin daily at 800-mg in two divided doses. In January 2008, a dose modification was made and patients originally assigned to receive the 1200-mcg dose of albinterferon alfa-2b had their dose reduced to 900-mcg albinterferon alfa-2b every two weeks. The dose modification was recommended by the independent Data Monitoring Committee (DMC) for the Albuferon Phase 3 trials, following their observation during a routine review of unblinded data from both trials that serious pulmonary adverse events were higher in the 1200-mcg Albuferon treatment group. Following the dose modification, the study continued to follow all patients randomized into the trial on an intention-to-treat (ITT) basis according to their original dose assignment. The primary data analysis compares the
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SOURCE Human Genome Sciences, Inc.
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