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Human Genome Sciences Announces Full Presentation of Quality-of-Life Results From Phase 2b Trial of Albuferon(R) for Hepatitis C
Date:11/5/2007

P., Ph.D., Monash University, Melbourne, Australia. "The results of the Phase 2b trial suggest that Albuferon may have the potential to offer a therapeutic alternative with fewer lost days of work and less impairment of health-related quality of life on treatment, compared with peginterferon alfa-2a, with at least comparable efficacy and safety. We look forward to further evaluation of Albuferon's impact on patient quality of life in the ongoing Phase 3 trials."

In the open-label, multi-center, active-controlled Phase 2b trial, 458 treatment-naive patients with genotype 1 chronic hepatitis C were randomized to four treatment groups: Albuferon 900 mcg every two weeks, Albuferon 1200 mcg every two weeks, Albuferon 1200 mcg every four weeks, and peginterferon alfa-2a 180 mcg once a week. All patients received weight-based oral ribavirin daily. The trial included 48 weeks of treatment, and the primary efficacy endpoint was SVR, defined as undetectable viral load (HCV RNA<10 IU/mL) at 24 weeks following completion of treatment. Health-related quality of life was assessed using the Short Form 36 (SF-36) health survey. SF-36 is a validated patient-reported outcomes instrument, consisting of 36 questions used to measure the health status of patients with chronic hepatitis C. The 36 questions result in an 8-scale health profile including: physical function, physical role limitations, vitality, general health perceptions, pain, social function, emotional role limitations, and mental health. Summaries of the combined physical and mental component measures were also used in the assessment.

"Strongly positive overall quality-of-life results were observed for the Albuferon treatment groups, and they were strongest among patients receiving the Albuferon 900-mcg dose every two weeks," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "This Albuferon treatment group achieved a statistically significant reduction in the number of missed w
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SOURCE Human Genome Sciences, Inc.
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