"The Phase 3 data presented at EASL show that Albuferon, with half the injections, achieved a rate of sustained virologic response comparable to Pegasys,"said David C. Stump, MD, Executive Vice President, Research and Development, HGS. "Importantly, the rates of serious and/or severe adverse events were also comparable in these studies. We plan to file global marketing applications in fall 2009, following discussions with regulatory authorities—and we believe that Albuferon, assuming licensure, could become a leading treatment for chronic hepatitis C."
The Phase 3 studies, known as ACHIEVE 1 and ACHIEVE 2/3, evaluated albinterferon alfa-2b vs. peginterferon alfa-2a, in combination with ribavirin, for use in the treatment of interferon-naive patients with chronic hepatitis C. ACHIEVE 1 was conducted in patients infected with genotype 1 virus, and ACHIEVE 2/3 was conducted in patients with genotypes 2 and 3 virus. The two studies treated a combined total of 2255 treatment-naive patients.
"The results of two Phase 3 trials demonstrate that 900-mcg albinterferon alfa-2b administered every two weeks provides efficacy comparable to peginterferon alfa-2a administered weekly, with a positive safety profile," said David Nelson, MD, Professor of Medicine, Medical Director of Liver Transplantation, and Chief of the Hepatobiliary Disease Section, University of Florida. Dr. Nelson presented the results from ACHIEVE 2/3.
Stefan Zeuzem, MD, Professor of Medicine and Chief, Department of Medicine, J.W. Goethe University Hospital, Frankfurt, Germany, presented the ACHIEVE 1 results, and said, "The data presented at EASL suggest that albinterferon alfa-2b has the potential to become an important and novel treatment option for patients with chronic hepatitis C."
Phase 3 Efficacy Findings
Based on an intention-to-treat (ITT) analysis, the data presented at EASL demonstrate that albinterferon alfa-2b met its primary efficacy endpoint of non-inferiority to peginterferon alfa-2a in both ACHIEVE 1 and ACHIEVE 2/3:
· ACHIEVE 1: 48.2% (213/442) of patients in the 900-mcg albinterferon alfa-2b treatment group achieved sustained virologic response (SVR), vs. 51.0% (225/441) in the peginterferon alfa-2a treatment group. The primary analysis, which was adjusted for baseline stratification factors, showed a difference in SVR rates of -1.8% (95% CI -8.1%, 4.5%, p=0.0008 for non-inferiority).
· ACHIEVE 2/3: 79.8% (249/312) of patients achieved SVR in the 900-mcg albinterferon alfa-2b treatment group, vs. 84.8% (263/310) in the peginterferon alfa-2a group (p=0.0086 for non-inferiority). The primary analysis, which was adjusted for baseline stratification factors, showed a difference in SVR rates of -4.8% (95% CI -10.7%, 1.1%, p=0.0086 for non-inferiority).
- An unexpectedly high and still unexplained SVR rate for peginterferon alfa-2a in the Asian region fully accounted for the observed SVR difference between the two drugs in the ACHIEVE 2/3 study.
- In non-Asian regions, 79.8% (174/218) of patients achieved SVR in the 900-mcg albinterferon alfa-2b treatment group, vs. 80.5% (178/221) in the peginterferon alfa-2a group. In Asia, 79.8% (75/94) of patients achieved SVR in the 900-mcg albinterferon alfa-2b treatment group, vs. 95.5% (85/89) in the peginterferon alfa-2a group.
Phase 3 Safety Findings
· Across the two albinterferon alfa-2b Phase 3 trials, rates of serious and/or severe adverse events were comparable in all dose groups, including 21.2% (160/755) for 900-mcg albinterferon alfa-2b, and 20.8% (156/750) for 180-mcg peginterferon alfa-2a.
· The incidence of fatality in the albinterferon alfa-2b Phase 3 trials was rare. All-cause mortality rates were 0.13% (1/755) for 900-mcg albinterferon alfa-2b every two weeks, and 0.27% (2/750) for 180-mcg peginterferon alfa-2a.
· Rates of discontinuation due to adverse events across the two studies were 8.1% (61/755) for 900-mcg albinterferon alfa-2b, vs. 3.9% (29/750) for peginterferon alfa-2a. The causes of discontinuation for both drugs were those typical for interferon-based therapy.
· Overall, adverse events observed were those typically associated with interferon therapy, and most were similar for 900-mcg albinterferon alfa-2b and peginterferon alfa-2a.
Date: April 25, 2009
Source: Human Genome Sciences, Inc.