Human Genome Sciences, Inc (HGS). has 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 in combination with ribavirin in patients with genotype 1 chronic hepatitis C (HCV) who are naïve to interferon alpha-based treatment regimens.
The interim results demonstrate that all Albuferon treatment groups consistently performed favourably 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.
Albuferon is a novel, long-acting form of interferon alpha, which was created by HGS using the company's proprietary albumin fusion technology. This technology enables scientists to improve the pharmacological properties of therapeutic proteins by fusing the gene that expresses human albumin to the gene that expresses the active protein. Albuferon results from the genetic fusion of human albumin and interferon alpha 2b. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.
"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, M.D., F.R.A.C.P., Ph.D., associate professor of medicine, Monash University (Melbourne,). "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, M.D., 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."
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 two-week intervals was associated with 75 per cent fewer disability days, and the 1200 mcg Albuferon doses administered at two-week and four-week intervals were associated with 25 per cent fewer disability days. Through week 12, based on the SF-36 health assessment, patient-reported outcomes showed that the Albuferon treatment groups consistently performed favourably compared to Pegasys in both the physical and mental component summary measures and in the 8 individual domain scores. SF 36 results in the mental health domain demonstrated significantly less impairment of psychological well-being across the Albuferon treatment groups. Of the four treatment arms in the phase 2b study, the 900 mcg Albuferon dose administered once every two weeks was significantly associated with the least negative impact on mental and physical function, bodily pain, vitality, social functioning, and mental health domains, while maintaining efficacy and safety at least comparable to pegylated interferon alpha. Less worsening of health-related quality of life also was observed in the treatment arms receiving 1200 mcg Albuferon doses administered at two-week and four-week intervals, respectively, compared to the pegylated interferon alpha treatment group, with clinically meaningful differences observed in bodily pain, mental health and social functioning.
Health-related quality of life was assessed using the short form 36 (SF 36) health survey. SF-36 is a 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.