Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic H... (Overall the two studies enrolled and ran...)

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

Date:3/9/2009

Overall, the two studies enrolled and randomized a total of 2264 treatment-naive patients.

The dose modification in January 2008 was recommended by the independent Data Monitoring Committee (DMC) based upon an interim analysis that serious pulmonary adverse events appeared to be higher in the 1200-mcg albinterferon alfa-2b treatment group.

Across the two Phase 3 trials, which have now been completed, rates of serious respiratory, thoracic or mediastinal disorders were: 0.7% (5/755) for 900-mcg albinterferon alfa-2b; 1.5% (11/750) for the group originally randomized to receive 1200-mcg albinterferon alfa-2b, and 0.0% (0/750) for peginterferon alfa-2a.
Central blinded review of chest X-rays recommended by the DMC for patients participating in the two Phase 3 trials demonstrated that the overall rates of significant interstitial findings were comparable in all three treatment groups: 4.3% (20/469) in patients randomized to receive 900-mcg albinterferon alfa-2b; 4.8% (22/454) in patients originally randomized to receive 1200-mcg albinterferon alfa-2b; and 4.5% (22/484) in patients randomized to receive 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% (1/756) in patients randomized to receive 900-mcg albinterferon alfa-2b every two weeks; 0.53% (4/751) in patients originally randomized to receive 1200-mcg albinterferon alfa-2b every two weeks; and 0.27% (2/751) in patients randomized to receive 180-mcg peginterferon alfa-2a once-weekly.

Across the two Phase 3 trials, the overall percentage of patients who had a serious and/or severe adverse event or discontinued due to an adverse event was comparable in all dose groups: 23.2% (175/755) in patients randomized to receive 900-mcg albinterferon alfa-2b; 26.0% (195/750) in patients randomized to r
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SOURCE Human Genome Sciences, Inc.
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