Human Genome Sciences’ Albuferon effective in hepatitis trial

The data were presented at the 40th annual meeting of the European Association for the Study of the Liver (EASL) in Paris, France. The phase II clinical trial, which was conducted in Canada, was designed to evaluate the safety, tolerability, pharmacology and optimal dosing of Albuferon (albumin-interferon alpha).

The primary efficacy endpoint of the phase II study was the rate of virologic response at Day 28, defined as at least a 2-log reduction in HCV viral load compared with baseline, or undetectable HCV viral load.

The data presented show that Albuferon exhibited robust antiviral activity in genotype 1 HCV and remained in the blood substantially longer than is reported for recombinant interferon alpha and pegylated interferon alpha. Albuferon exhibited a median half-life of 148 hours, supporting dosing at intervals of 2-4 weeks. This compares to a reported mean (range) elimination half-life of 80 hours for Roche’s Pegasys and 40 hours for Schering-Plough’s PEG-Intron.

“The clinical results presented at the EASL meeting today show that Albuferon is well tolerated and exhibits a robust antiviral activity, with a pharmacokinetic profile that supports dosing at intervals of two to four weeks,” said Dr Vincent Bain, director of the liver unit and professor of gastroenterology at the University of Alberta.

“These data are strongly supportive of further evaluation of Albuferon in combination with ribavirin in a larger study over a longer period of time in treatment-naive patients.”