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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

8 for non-inferiority).
  • Patients receiving 900-mcg albinterferon alfa-2b had comparable rates of serious and/or severe adverse events, vs. peginterferon alfa-2a, with 24.0% (106/442) in the albinterferon alfa-2b 900-mcg treatment group, vs. 23.1% (102/441) in the peginterferon alfa-2a treatment group.
  • Serious and/or severe pulmonary adverse events were infrequent and included the following: The rate of serious and/or severe pulmonary infections was comparable between the two groups, with 1.8% (8/442) for 900-mcg albinterferon alfa-2b, vs. 1.1% (5/441) for peginterferon alfa-2a; the rate of serious and/or severe respiratory, thoracic or mediastinal disorders was 2.5% (11/442) for 900-mcg albinterferon alfa-2b, vs. 0.5% (2/441) for peginterferon alfa-2a. Of the 11 disorders reported for 900-mcg albinterferon alfa-2b, three were classified as serious, and all three resolved off treatment.
  • Overall, adverse events observed were those typically associated with interferon therapy. The rate of discontinuations due to adverse events was 10.4% (46/442) for 900-mcg albinterferon alfa-2b, vs. 4.1% (18/441) for peginterferon alfa-2a.
  • Treatment Group Originally Randomized to Receive Albinterferon Alfa-2b 1200-mcg Every Two Weeks and Reduced to 900-mcg Following January 2008 Dose Modification, vs. Treatment Group Receiving Peginterferon Alfa-2a 180-mcg Every Week

    Due to the dose modification announced in January 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. Data from all three treatment groups in the ACHIEVE 1 study were analyzed according to the original dose assignment. The following results for the treatment group originally randomized to receive 1200-mcg albinterferon alfa-2b every two weeks did not impact the
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    SOURCE Human Genome Sciences, Inc.
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