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Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C
Date:3/9/2009

eceive 1200-mcg albinterferon alfa-2b; and 21.6% (162/750) in patients randomized to receive 180-mcg peginterferon alfa-2a.

About the Design of the ACHIEVE 1 Trial

In the randomized, multi-center, active-controlled non-inferiority ACHIEVE 1 Phase 3 trial, 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 January 2008, a dose modification was made for patients originally assigned to receive the 1200-mcg dose of albinterferon alfa-2b. These patients had their dose modified to 900-mcg albinterferon alfa-2b every two weeks. 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 900-mcg albinterferon alfa-2b treatment group to the peginterferon alfa-2a treatment group. The trial included 48 weeks of treatment, and the primary efficacy endpoint was sustained virologic response (SVR), defined as undetectable viral load (HCV RNA<10 IU/mL) at Week 72 (24 weeks following completion of treatment). A total of 2,264 patients with chronic hepatitis C have participated in the two Phase 3 trials of albinterferon alfa-2b.

About Albinterferon Alfa-2b (Albuferon)

Albinterferon alfa-2b is a genetic fusion of human albumin and interferon alfa created using the proprietary HGS albumin-fusion technology. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for approximately 1
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SOURCE Human Genome Sciences, Inc.
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