InterMune Announces Phase IV Study Shows Infergen Combination Therapy More Effective Than Rebetron for Hepatitis C
Tuesday November 5, 8:32 am ET
Infergen Plus Ribavirin Produces Higher Sustained Viral Response Rates At 72 Weeks Than Rebetron(R)
BOSTON and BRISBANE, Calif., Nov. 5 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today announced that positive preliminary results of an investigator initiated, prospective randomized Phase IV clinical trial comparing the use of Infergen® (interferon alfacon-1) plus ribavirin versus interferon alfa-2b plus ribavirin (Rebetron®) for the treatment of chronic hepatitis C infections were presented at the 53rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston. Patients treated with Infergen in combination with ribavirin achieved a higher sustained virologic response (SVR), the study's primary endpoint, compared to those patients treated with Rebetron.
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"These data suggest that the combination of consensus interferon plus ribavirin is more efficacious than Rebetron therapy," said Maria H. Sjogren, M.D., M.P.H., Chief, Department of Clinical Investigations, Walter Reed Army Medical Center in Washington, D.C. and lead investigator of the Phase IV trial. "The sustained response we observed in this trial with the Infergen combination could set a new treatment threshold for this difficult to treat U.S. patient population. As a matter of fact, the SVR is consistent to that reported for the pegylated interferons plus ribavirin but with less hematologic toxicity. These data help to provide clinical confirmation of the in vitro biologic potency of Infergen. Infergen in combination with ribavirin appears to be a viable treatment alternative. Further study comparing the use of Infergen to other treatment regimens is warranted."
In data analyzed and reported by a group at Walter Reed Army Medical Center and Kaiser Permanente Mid-Atlantic Region, 127 patients with chronic hepatitis C (128 patients randomized; one patient data point pending) were randomized to receive Infergen (15 mcg, TIW) plus ribavirin (1 g/day) or interferon alfa-2b (3MU, equivalent to 15 mcg, TIW) plus ribavirin (1g/ day) for up to 48 weeks with an additional 24 weeks of observational follow-up. Patients who were still HCV RNA positive following 24 weeks of therapy stopped treatment and were considered treatment failures. Analysis of the 127 patients who reached week 72 or who discontinued early for any reason, revealed an overall SVR rate of 57% in the Infergen plus ribavirin-treated group compared to 39% in the interferon alfa-2b plus ribavirin group (p = 0.04).
Dr. Sjogren and colleagues reported that all patients in the study received the same dose of ribavirin. However, a retrospective analysis demonstrated those patients who received the appropriate dose of ribavirin based on their weight (i.e., greater than 10.6 mg/kg per day) achieved a higher sustained viral response rate in both treatment arms: 75% SVR for the Infergen/ribavirin treated patients and an SVR rate of 52% for the Rebetron arm of the study. According to Dr. Sjogren, the side effects associated with Infergen plus ribavirin were similar to those seen with Rebetron and included flu-like symptoms, fatigue, headache, nausea, cough and mood disorders such as depressed mood, anxiety, irritability and insomnia.
"There remains a great medical need for effective therapies for the treatment of hepatitis C because approximately 50% of patients currently fail best available therapy," said Scott Harkonen, InterMune's President and CEO. "This study, which suggests that Infergen plus ribavirin makes a compelling treatment option for HCV patients, will play an important role in our efforts to broaden this drug's use in managing chronic hepatitis."
About Infergen for Hepatitis C
Infergen is a bioengineered type I interferon alfa indicated for treatment of adult patients with chronic hepatitis C infections, including therapy for patients who have never been treated with interferons and for patients following relapse or non-response to treatment with certain previous treatments. Physicians and patients can obtain additional information about Infergen by visiting infergen.com .
Hepatitis C is a liver disease caused by the hepatitis C virus that is found in the blood of people with this disease. It is the most common form of hepatitis infection in North America and Europe. According to the National Center for Infectious Diseases, there are an estimated 3.9 million (1.8%) Americans who have been infected with hepatitis C, of whom 2.7 million are chronically infected. If not detected and treated, hepatitis C may lead to chronic liver disease, including liver cancer, and ranks second to alcoholism as a cause of cirrhosis. Hepatitis C causes an estimated 8,000 to 10,000 deaths annually in the United States.
About InterMune
InterMune is a commercially driven biopharmaceutical company focused on the marketing, development and applied research of life-saving therapies for pulmonary disease, infectious disease and cancer. For additional information about InterMune, please visit www.intermune.com. |
