New HCV Combination Therapy Means Fewer Sick Days
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Source: Human Genome Sciences, Inc
Positive Interim Quality-of-Life Data From Phase 2B Trial of Albuferon(TM) With Ribavirin in Treatment-Naive Hepatitis C Patients
Albuferon associated with fewer missed work days and better patient-reported quality-of-life scores than pegylated interferon through week 12 –
ROCKVILLE, MD — October 16, 2006 — Human Genome Sciences, Inc. today reported 12-week interim quality-of-life results from a phase 2b clinical trial to evaluate the efficacy, safety and impact on health-related quality of life of Albuferon(TM) in combination with ribavirin in patients with genotype 1 chronic hepatitis C (HCV) who are naive to interferon alpha-based treatment regimens.
The interim results demonstrate that all Albuferon treatment groups consistently performed favorably through week 12 compared to the pegylated interferon alpha treatment group, based on patient-reported disability days and health-related quality of life as measured by the SF-36 health survey. The data were presented over this past weekend at the annual Australian Gastroenterology Week in Adelaide.
Health-related quality-of-life issues, including lost days of work and normal activity, pose a significant challenge for patients undergoing treatment for chronic hepatitis C,” said Stephen Pianko, MD, FRACP, PhD, Associate Professor of Medicine, Monash University (Melbourne, Australia). “Interim results of the current study suggest that Albuferon may have the potential to offer a therapeutic alternative with less impairment of health-related quality of life, and fewer disability days, compared with the current standard of care, with at least comparable safety and efficacy. We look forward to continuing the evaluation of Albuferon to determine its appropriate role in the treatment of hepatitis C.”
“Through week 12 of the phase 2b study, patients in the Albuferon treatment groups recorded fewer missed work days and, based on the SF-36 health assessment, reported better quality of life than patients in the pegylated interferon treatment group,” said David C. Stump, MD, Executive Vice President, Drug Development, HGS. “This result was observed in both the physical and mental component summary measures, as well as in the 8 individual domain scores. The SF-36 results in mental health suggest significantly less impairment of psychological well-being across the Albuferon treatment groups.”
About the Albuferon Phase 2B 12-Week Quality-of-Life Results
Albuferon treatment groups recorded fewer disability days and reported less impairment of health-related quality of life through week 12 of the phase 2b study than patients in the pegylated interferon treatment group. The 900- mcg Albuferon dose administered at 2-week intervals was associated with 75% fewer disability days, and the 1200-mcg Albuferon doses administered at 2-week and 4-week intervals were associated with 25% fewer disability days.
