ROCKVILLE, Maryland November 5, 2007 Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced the final quality-of-life results from a Phase 2b clinical trial of the investigational drug, Albuferon (albinterferon alfa-2b), in combination with ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C. The study demonstrated that patients in the Albuferon treatment groups reported fewer missed days of work and less impairment of health-related quality of life on treatment compared to the Pegasys (peginterferon alfa-2a) group.
The final Phase 2b quality-of-life results are being presented this week at the 58 th AASLD Annual Meeting in Boston. In two additional press releases issued by HGS today, the Company announced the full presentations at AASLD of efficacy and safety data from the Phase 2b trial of Albuferon in treatment-naive patients, and results from the Phase 2 trial of Albuferon in combination with ribavirin in patients who did not respond to prior therapy.
Patients undergoing treatment for chronic hepatitis C often find it challenging to go to work or participate in other normal daily activities, especially in the days following dose administration, said Stephen Pianko, M.D., F.R.A.C.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 Albuferons 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.
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 taking peginterferon alfa-2a. At week 12, only 4.2% of patients taking Albuferon 900 mcg every two weeks had missed 7 or more days of work the previous month, compared with 18.1% of peginterferon alfa-2a patients (p<.05). At week 24, only 5.3% of Albuferon 900-mcg patients had missed 7 or more days of work the previous month, compared with 20.3% of peginterferon alfa-2a patients (p<.05). At Week 12, working patients taking Albuferon 900-mcg every two weeks reported missing an average of 1.1 days of work during the previous month, while peginterferon alfa-2a patients reported missing an average of 4.3 work days (p<.05). At Week 24, Albuferon 900-mcg patients had missed an average of 1.6 days of work during the previous month, while peginterferon alfa-2a patients had missed an average of 4.7 work days.
At Weeks 12 and 24, the treatment group taking Albuferon 900 mcg every two weeks also reported better scores for all eight SF-36 physical and mental health domains, as well as the physical and mental summary scores, compared with peginterferon alfa-2a. Statistically significant and clinically meaningful differences were observed in the mental health, bodily pain, vitality and social functioning domains. By the Week 12 follow-up visit after the end of treatment, changes in mental health as measured by the Hospital Anxiety and Depression Scale (HADS) had recovered to baseline in 67% of the patients taking Albuferon 900 mcg, compared with 57% of the peginterferon alfa-2a patients.
The treatment group taking Albuferon 1200 mcg every two weeks also recorded fewer lost days of work and less impairment of health-related quality of life on treatment than was reported for the peginterferon alfa-2a group.
|Contact: Jerry Parrott|
Edelman Public Relations