Human Genome Sciences begins phase IIb hepatitis trial

The trial will evaluate the efficacy and safety of Albuferon (albumin-interferon alpha) in combination with ribavirin in patients with chronic hepatitis C virus (HCV) genotype 1 who are naive to interferon alpha-based treatment regimens. Genotype 1 accounts for nearly 70% of all HCV infections in North America and is generally regarded as the most difficult HCV genotype to treat.

The trial is being conducted in Australia, Canada, the Czech Republic, France, Germany, Israel, Poland and Romania. The primary efficacy endpoint will be sustained virologic response, defined as undetectable virus at 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,” explained Dr John McHutchison, coordinating center principal investigator for the phase IIb study, and professor of medicine and director of GI/hepatology research at Duke Clinical Research Institute and Duke University Medical Center, North Carolina.

“Clearly, chronic hepatitis C represents a significant unmet medical need,” he continued. “The preclinical and clinical evidence to date supports the continued evaluation of the potential of Albuferon to help meet this need.”

Data from a phase II clinical trial of Albuferon monotherapy in interferon alpha-naive patients with genotype 1 chronic hepatitis C demonstrated that Albuferon exhibited robust antiviral activity in genotype 1 HCV. Albuferon also proved well-tolerated with adverse events that were transient and mostly mild to moderate in severity.