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Human Genome Sciences Announces Albuferon(R) Meets Primary Endpoint in Phase 3 Trial in Chronic Hepatitis C
Date:12/8/2008

anuary 2008, patients in the treatment group originally randomized to receive albinterferon alfa-2b 1200-mcg every two weeks had their dose modified to 900-mcg albinterferon alfa-2b every two weeks. All patients had completed at least 12 weeks of treatment at the time of the dose modification. Data from all three treatment groups in the ACHIEVE 2/3 study were analyzed according to the original dose assignment. The following topline results for the treatment group originally randomized to receive 1200-mcg albinterferon alfa-2b every two weeks did not impact the 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, 80.0% (248/310) of patients in this treatment group achieved SVR, vs. 84.8% (263/310) in the peginterferon alfa-2a treatment group, which statistically demonstrated non-inferiority (p=0.0059).
  • The incidence of severe and/or serious adverse events was comparable between the two groups, with 16.8% (52/310) in the treatment group originally randomized to receive 1200-mcg albinterferon alfa-2b every two weeks, vs. 17.5% (54/309) in the peginterferon alfa-2a treatment group.
  • The incidence of severe and/or serious pulmonary adverse events was also comparable between these groups: severe and/or serious pulmonary infections were 1.3% (4/310) in the treatment group originally randomized to receive 1200-mcg albinterferon alfa-2b, vs. 0.6% (2/309) in the peginterferon alfa-2a treatment group; severe and/or serious respiratory, thoracic or mediastinal disorders were 1.6% (5/310) in the treatment group originally randomized to receive 1200-mcg albinterferon alfa-2b, vs. 1.3% (4/309) in the peginterferon alfa-2a treatment group.
  • Overall, adverse events observed were those typicall
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SOURCE Human Genome Sciences, Inc.
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