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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

sis, which was adjusted for baseline stratification factors, showed a difference in SVR rates of -1.8% (95% CI -8.1%, 4.5%, p=0.0008 for non-inferiority).
  • ACHIEVE 2/3: 79.8% (249/312) of patients achieved SVR in the 900-mcg albinterferon alfa-2b treatment group, vs. 84.8% (263/310) in the peginterferon alfa-2a group (p=0.0086 for non-inferiority). The primary analysis, which was adjusted for baseline stratification factors, showed a difference in SVR rates of -4.8% (95% CI -10.7%, 1.1%, p=0.0086 for non-inferiority).
    • An unexpectedly high and still unexplained SVR rate for peginterferon alfa-2a in the Asian region fully accounted for the observed SVR difference between the two drugs in the ACHIEVE 2/3 study.
    • In non-Asian regions, 79.8% (174/218) of patients achieved SVR in the 900-mcg albinterferon alfa-2b treatment group, vs. 80.5% (178/221) in the peginterferon alfa-2a group. In Asia, 79.8% (75/94) of patients achieved SVR in the 900-mcg albinterferon alfa-2b treatment group, vs. 95.5% (85/89) in the peginterferon alfa-2a group.

    • Phase 3 Safety Findings

    Across the two albinterferon alfa-2b Phase 3 trials, rates of serious and/or severe adverse events were comparable in all dose groups, including 21.2% (160/755) for 900-mcg albinterferon alfa-2b, and 20.8% (156/750) for 180-mcg peginterferon alfa-2a.

    The incidence of fatality in the albinterferon alfa-2b Phase 3 trials was rare. All-cause mortality rates were 0.13% (1/755) for 900-mcg albinterferon alfa-2b every two weeks, and 0.27% (2/750) for 180-mcg peginterferon alfa-2a.

    Rates of discontinuation due to adverse events across the two studies were 8.1% (61/755) for 900-mcg albinterferon alfa-2b, vs. 3.9% (29/750) for peginterferon alfa-2a. The causes of discontinuation for both drugs were those typical for interfero
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    SOURCE Human Genome Sciences, Inc.
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