ROCKVILLE, Ma., Nov. 5 Human Genome Sciences,Inc. (Nasdaq: HGSI) today announced the final results of a Phase 2 trial ofthe investigational drug, Albuferon(R) (albinterferon alfa-2b), in combinationwith ribavirin in patients with chronic hepatitis C who failed to respond toprevious interferon-based therapy. The results were presented yesterday inBoston at the 58th AASLD Annual Meeting in Boston.
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"The results of the Albuferon non-responder study demonstrated thatAlbuferon treatment at doses up to 1800 mcg every two weeks had an acceptablelong-term safety profile and produced an overall sustained virologic response(SVR) rate of 17% in these patients," said David Nelson, M.D., AssociateProfessor of Medicine, Medical Director of Liver Transplantation, and Chief ofthe Hepatobiliary Disease Section, University of Florida. "In the difficultto treat subgroup of genotype 1 chronic hepatitis C patients who previouslyfailed to respond to treatment with pegylated interferon and ribavirin,Albuferon treatment produced an overall SVR rate of 11%."
In the open-label, multi-center, dose-escalation Phase 2 trial,nonresponders to previous interferon-based therapy were randomized into threeAlbuferon treatment groups (900 mcg every two weeks, 1200 mcg every two weeks,and 1200 mcg every four weeks, followed by sequential escalation to 1500 mcgevery two weeks, and 1800 mcg every two weeks). A total of 115 patientsparticipated. All patients received weight-based oral ribavirin daily. Theprimary efficacy endpoint was sustained virologic response (SVR), defined asundetectable virus in the blood at 24 weeks post-48 weeks of treatment.
In two additional press releases issued by HGS today, the Companyannounced the full presentations at AASLD of efficacy and safety data, andquality-of-life data, from the Phase 2b trial of Albuferon in treatment-naivepatients. These data demonstrated that, with half the injections required bythe pegylated interferons, Albuferon provided at least comparable efficacy,comparable safety and the potential for less impairment of health-relatedquality of life and daily activity.
Key Findings from the Phase 2 Study in Non-Responders
Albuferon treatment in doses up to 1800 mcg every two weeks resulted insignificant antiviral activity in previous nonresponders to interferon-basedtreatment for chronic hepatitis C. The overall SVR rate was 17.4%. In theimportant subgroup of genotype 1 patients who were previous nonresponders totreatment with a combination of pegylated interferon and ribavirin, the SVRrate was 10.7%. SVR rates by Albuferon treatment group were: 25% for 1200mcg every four weeks; 30% for 900 mcg every two weeks; 13% for 1200 mcg everytwo weeks; 9% for 1500 mcg every two weeks; and 9% for 1800 mcg every twoweeks. These SVR results are consistent with those observed with other long-acting interferons in patient populations that have failed prior interferon-based treatment regimens.
Albuferon had an acceptable long-term safety profile at all doses,including 1500 mcg and 1800 mcg. The most common adverse events were fatigue,headache, arthralgia (joint pain), myalgia (muscle pain), insomnia, nausea,cough, and pyrexia (fever). Discontinuation rates due to adverse events were:4.2% for the 1200 mcg every four weeks group; 17.4% for the 900 mcg every twoweeks group; 4.2% for the 1200 mcg every two weeks group; 9.1% for the 1500mcg every two weeks group; and 18.2% for the 1800 mcg every two weeks group.Hematologic reductions stabilized by Week 8, were well managed with dosereductions, and returned to baseline following the completion of therapy.
"The results emerging from our Phase 2 program continue to support ourbelief that Albuferon could become an important therapeutic option forpatients with chronic hepatitis C, including those tha