Human Genome begins phase 2b study for Albuferon

By E. Janene Geiss

Philadelphia, Oct. 25 - Human Genome Sciences, Inc. announced Tuesday that it has completed enrollment, randomization and initial dosing in its phase 2b clinical trial of Albuferon in combination with ribavirin in patients with chronic hepatitis C virus genotype 1.

The trial is a randomized, open-label, multi-center, active-controlled, dose-ranging study being conducted in eight countries, company officials said in a news release.

A total of 458 patients were randomized into four treatment groups, three of which will receive Albuferon subcutaneously and the fourth will serve as the active control group, receiving weekly doses of Pegasys (peginterferon alfa-2a).

The primary objective of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin at 1,000 mg and 1,200 mg in two divided doses. The trial's endpoint is sustained virologic response defined as undetectable virus 24 weeks after completion of 48 weeks of treatment.

"The current standard of care for the treatment of chronic hepatitis C is a combination of pegylated interferon alpha and ribavirin. This combination produces cures in approximately 42-46% of all genotype 1 HCV patients completing therapy, leaving more than 50% who relapse or do not respond," said John McHutchison, coordinating center principal investigator for the phase 2b study, and professor of medicine and director, GI/Hepatology Research, Duke Clinical Research Institute and Duke University Medical Center, Durham, N.C.

Albuferon is a novel, long-acting form of interferon alpha, which is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.

Rockville, Md.-based Human Genome Sciences modified interferon alpha to improve its pharmacological properties by using the company's proprietary albumin fusion technology.

Hepatitis C is the most common chronic blood-borne infection in the developed world. It is estimated that as many as 170 million people worldwide are infected with hepatitis C virus. This includes nearly four million people in the United States.

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