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Human Genome Sciences Reports Positive Late-Breaker Results at EASL from ACHIEVE Phase 3 Trials of Albuferon(R) in Patients with Chronic Hepatitis C
Date:4/25/2009

scussions with regulatory authorities - and we believe that Albuferon, assuming licensure, could become a leading treatment for chronic hepatitis C."

The Phase 3 studies, known as ACHIEVE 1 and ACHIEVE 2/3, evaluated albinterferon alfa-2b vs. peginterferon alfa-2a, in combination with ribavirin, for use in the treatment of interferon-naive patients with chronic hepatitis C. ACHIEVE 1 was conducted in patients infected with genotype 1 virus, and ACHIEVE 2/3 was conducted in patients with genotypes 2 and 3 virus. The two studies treated a combined total of 2255 treatment-naive patients.

"The results of two Phase 3 trials demonstrate that 900-mcg albinterferon alfa-2b administered every two weeks provides efficacy comparable to peginterferon alfa-2a administered weekly, with a positive safety profile," said David Nelson, M.D., Professor of Medicine, Medical Director of Liver Transplantation, and Chief of the Hepatobiliary Disease Section, University of Florida. Dr. Nelson presented the results from ACHIEVE 2/3.

Stefan Zeuzem, M.D., Professor of Medicine and Chief, Department of Medicine, J.W. Goethe University Hospital, Frankfurt, Germany, presented the ACHIEVE 1 results, and said, "The data presented at EASL suggest that albinterferon alfa-2b has the potential to become an important and novel treatment option for patients with chronic hepatitis C."

Phase 3 Efficacy Findings

Based on an intention-to-treat (ITT) analysis, the data presented at EASL demonstrate that albinterferon alfa-2b met its primary efficacy endpoint of non-inferiority to peginterferon alfa-2a in both ACHIEVE 1 and ACHIEVE 2/3:

  • ACHIEVE 1: 48.2% (213/442) of patients in the 900-mcg albinterferon alfa-2b treatment group achieved sustained virologic response (SVR), vs. 51.0% (225/441) in the peginterferon alfa-2a treatment group. The primary analy
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SOURCE Human Genome Sciences, Inc.
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