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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

n-based therapy.

Overall, adverse events observed were those typically associated with interferon therapy, and most were similar for 900-mcg albinterferon alfa-2b and peginterferon alfa-2a.

About the Design of the ACHIEVE Trials

The albinterferon alfa-2b Phase 3 clinical development program included two randomized, multi-center, active-controlled non-inferiority Phase 3 trials -- ACHIEVE 1 and ACHIEVE 2/3. In ACHIEVE 1, 1331 treatment-naive patients with genotype 1 chronic hepatitis C were initially assigned to one of three treatment groups, including two groups that received subcutaneously administered 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 daily oral ribavirin concomitantly. In ACHIEVE 2/3, 933 treatment-naive patients with genotypes 2 and 3 chronic hepatitis C were initially assigned to one of three treatment groups receiving the same doses on the same schedule of administration used in the ACHIEVE 1 study.

In January 2008, a dose modification was made in both studies for patients originally assigned to receive the 1200-mcg dose of albinterferon alfa-2b. These patients had their dose reduced to 900-mcg albinterferon alfa-2b every two weeks. Following the dose modification, both ACHIEVE 1 and ACHIEVE 2/3 continued to follow all patients randomized on an intention-to-treat (ITT) basis according to their original dose assignment. The primary data analysis in both studies compared the 900-mcg albinterferon alfa-2b treatment group to the peginterferon alfa-2a treatment group. The ACHIEVE 1 trial included 48 weeks of treatment, and the ACHIEVE 2/3 trial included 24 weeks of treatment. The primary efficacy endpoint for both trials was sustained virologic response (SVR), defined as undetectable viral load (HCV RNA<10 IU/mL
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SOURCE Human Genome Sciences, Inc.
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