Hepatitis C Patients Offered New Hope With Drug Trial of Albuferon™

Thursday, December 16, 2004

EDITORS NOTE: Interviews are available with hepatitis C patients and Dr. Vijayan Balan, director of the Hepatobiliary Clinic at Mayo Clinic.

SCOTTSDALE, Ariz. – Hepatitis C patients have new options for improved treatment procedures and outcomes including a drug trial of Albuferon™, at Mayo Clinic and eight other centers in the U.S. Results from a Phase 1 / 2 clinical trial of Albuferon™ demonstrate that Albuferon™ may require less frequent dosing than pegylated interferons (IFNa), possibly with fewer side effects.

Preliminary Phase 1/2 clinical trials of Albuferon™ indicate that continued evaluation of the potential of Albuferon™ as a treatment for chronic hepatitis C is warranted in Phase 2 clinical trials. Researchers concluded that the treatment has the potential to address the unmet need for hepatitis C therapy with less frequent dosing than currently available with pegylated interferons, and it may offer improved clinical outcomes.

During the study, Albuferon™ was administered to 119 subjects with chronic hepatitis C who had failed prior IFNa-based treatment regimens. All subjects received the treatment through one or two subcutaneous (SC) injections 14 days apart. It appeared to be well tolerated with no discontinuations due to adverse reactions, which were transient and mild to moderate in severity.

"Available therapies for patients with chronic hepatitis C often have debilitating side effects that can lead to discontinuation of treatment," said Vijayan Balan, M.D., director of the Hepatobiliary Clinic at Mayo Clinic. "We are hopeful that continued study of Albuferon™ will provide these patients with treatment options that are more convenient and hopefully have fewer side effects. The clinical results are very encouraging."

An estimated 3 percent of the world's population — more than 170 million people — carries the hepatitis C virus that silently attacks their livers, often without their knowledge. In the United States alone, nearly 4 million people have been infected at one time with hepatitis C and close to 3 million are chronically infected. Over time, hepatitis C infection can lead to liver cancer, liver failure or cirrhosis — irreversible and potentially fatal scarring of the liver. It ranks second only to alcoholism as a cause of liver disease and is the leading reason for liver transplants in the United States.

The encouraging news is that new cases of hepatitis C have declined 80 percent since blood banks began screening for the virus in 1992. Although vaccines exist for hepatitis A and B, no vaccine for hepatitis C has been developed, primarily because the virus has many subtypes that change rapidly. Researchers hope to find a medication that will inhibit the growth of the virus and prevent long-term complications, such as cirrhosis and cancer, from developing.

Mayo Clinic is a private group practice of medicine dedicated to providing diagnosis and treatment of patient illnesses through a systematic focus on individual patient needs. As a leading academic medical center in the Southwest, Mayo Clinic in Scottsdale focuses on providing specialty and surgical care in more than 65 disciplines at its outpatient facility in north Scottsdale and at Mayo Clinic Hospital. The 202-licensed bed hospital is located at 56th Street and Mayo Boulevard (north of Bell Road) in northeast Phoenix, and provides inpatient care to support the medical and surgical specialties of the clinic, which is located at 134th Street and Shea Boulevard in Scottsdale.

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