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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

primary analysis comparing the 900-mcg albinterferon alfa-2b treatment group to the peginterferon alfa-2a treatment group.

  • Based on an ITT analysis of results for the treatment group originally randomized to receive 1200-mcg albinterferon alfa-2b every two weeks, 47.3% (208/440) of patients in this treatment group achieved SVR, vs. 51.0% (225/441) in the peginterferon alfa-2a treatment group, which statistically demonstrated non-inferiority (95% CI -9.4%, 3.2%, p=0.0029, adjusted for baseline stratification factors).
  • The incidence of serious and/or severe adverse events was 28.3% (124/440) in the treatment group originally randomized to receive 1200-mcg albinterferon alfa-2b every two weeks, vs. 23.1% (102/441) in the peginterferon alfa-2a treatment group.
  • The incidence of serious and/or severe pulmonary adverse events included the following: serious and/or severe pulmonary infections were 3.2% (14/440) for 1200-mcg albinterferon alfa-2b, vs. 1.1% (5/441) for peginterferon alfa-2a; and serious and/or severe respiratory, thoracic or mediastinal disorders were 3.0% (13/440) for 1200-mcg albinterferon alfa-2b, vs. 0.5% (2/441) for peginterferon alfa-2a.
  • Overall, adverse events observed were those typically expected with interferon therapy. The incidence of discontinuations due to adverse events was 10.0% (44/440) in the treatment group originally randomized to receive 1200-mcg albinterferon alfa-2b every two weeks, vs. 4.1% (18/441) in the peginterferon alfa-2a treatment group.

Additional Safety Data of Interest from the Phase 3 Clinical Trials of Albinterferon Alfa-2b Versus Peginterferon Alfa-2a

HGS has conducted two randomized active-controlled Phase 3 clinical trials of albinterferon alfa-2b versus peginterferon alfa-2a - ACHIEVE 1 in genotype 1 chronic hepatitis C, and ACHIEVE 2/3 in genotypes 2 and 3 chronic hepatitis C.
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SOURCE Human Genome Sciences, Inc.
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