Human Genome Sciences has announced the interim results of a Phase II clinical
trial to evaluate the safety, tolerability and efficacy of Albuferon (albumin-interferon
alpha) in combination with ribavirin (RBV) in patients with chronic hepatitis
C who failed to respond to previous interferon alpha-based treatment regimens.
The results demonstrate that Albuferon in combination with RBV was safe, well-tolerated
and showed robust antiviral activity.
The trial is a randomized, open-label, multicenter, dose-escalation study, and is being conducted in the U.S. in patients who have failed to respond to any previous interferon alpha-based treatment regimen. The study design states that approximately 50 percent of the subjects enrolled should be patients who have failed combination therapy that included pegylated interferon alpha plus ribavirin.
To date, a total of 115 patients have been enrolled and randomized into five Albuferon treatment groups that are receiving doses of Albuferon ranging from 900 mcg to 1,800 mcg. Patients are receiving Albuferon administered subcutaneously at intervals of either 14 or 28 days, with all patients receiving weight-based oral RBV daily at 1,000 mg or 1,200 mg in two divided doses. Patients in the trial will receive 48 weeks of treatment, with an additional 24 weeks of follow-up.