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HGS unveils positive QOL results from Phase 2B trial of Albuferon for hepatits C
Date:11/5/2007

r 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.

S trongly 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 work days compared with peginterferon alfa-2a, and also achieved statistically and clinically meaningful differences in many of the SF-36 quality-of-life domains.

Key Quality-of-Life Findings from the Phase 2b Study

Working patients in all Albuferon treatment groups recorded fewer days of missed work than was observed in the peginterferon alfa-2a treatment group. All Albuferon groups showed less impairment of health-related quality of life based on SF-36 physical and mental component summary scores.

Significantly fewer working patients taking Albuferon 900 mcg every two weeks reported missing 7 days or more of work during the month prior to their treatment visits at Weeks 12 and 24, vs. patients tak
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Contact: Jerry Parrott
301-315-2777
Edelman Public Relations
Source:Eurekalert

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