Human Genome's Albuferon eliminated hepatitis C virus in 30% of patients, study says

By Angela McDaniels

Seattle, Nov. 15 - Human Genome Sciences Inc. said interim results of a phase 2 clinical trial to evaluate the safety, tolerability and efficacy of Albuferon (albumin-interferon alpha) in combination with ribavirin in patients with chronic hepatitis C demonstrate that the combination was safe, well tolerated and showed robust antiviral activity.

The 115 patient dose-escalation study is being conducted in the United States in patients who have failed to respond to any previous interferon alpha-based treatment regimen. The primary efficacy endpoint is sustained virologic response, defined as undetectable virus at 24 weeks after the end of therapy.

Patients receive doses of Albuferon ranging from 900 micrograms to 1800 micrograms subcutaneously at intervals of either 14 or 28 days, with all patients receiving oral ribavirin daily at 1000 milligrams or 1200 milligrams in two divided doses. Patients in the trial will receive 48 weeks of treatment, with an additional 24 weeks of follow-up.

At week 24, 30% of the patients had no detectable hepatitis C viral load, the company said.

The results were presented Tuesday in San Francisco at the 56th Annual Meeting of the American Association for the Study of Liver Diseases.

Human Genome Sciences has completed enrollment and initial dosing in a 458-patient phase 2b clinical trial to evaluate the efficacy and safety of Albuferon in combination with ribavirin in patients with HCV genotype 1 who have not taken interferon alpha-based treatment regimens.

Hepatitis C infection is an inflammation of the liver caused by the hepatitis C virus. It is the most common chronic blood-borne infection in the developed world, the company said, and an estimated 170 million people worldwide are infected with hepatitis C virus.

Rockville, Md.-based Human Genome Sciences develops drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.

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