The top-line results from the trial comparing Albuferon in combination with ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C with Pegasys suggest that Albuferon may offer efficacy at least comparable to Roche’s drug, the company said.
HGS added that Albuferon treatment involved half the injections and possibly less impairment of quality of life. The company said that on the basis of the results, the drug will go forward to larger phase III trials.
The primary efficacy endpoint of the phase IIb trial of Albuferon was sustained virologic response (SVR), defined as undetectable viral load at 24 weeks following completion of therapy. The treatment group receiving Albuferon 900-mcg doses every two weeks achieved an SVR rate of 58.5%, vs. 57.9% for the group receiving Pegasys once every week. This Albuferon treatment group also had more favorable health- related quality-of-life scores than the Pegasys treatment group, the company said.
Among heavier patients weighing more than 75kg, who were treatment-adherent, 71.2% of those in the combined groups receiving Albuferon every two weeks achieved SVR, versus 53.3% for patients receiving Pegasys once a week. The ability to maintain efficacy in heavier patients is of particular importance in certain markets, including the US, where a large percentage of patients weigh more than 75kg.
Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement entered into in June 2006. Under the agreement, HGS and Novartis will co-commercialize Albuferon in the US, and will share clinical development costs, US commercialization costs and US profits equally.