e trial, patients must have undergone at least 12 weeks of treatment with Peg-Intron/Rebetol therapy with no response. Patients who discontinued therapy because of adverse events alone are not eligible for this study. In addition, patients must be over 18 years of age. Nationwide enrollment is currently underway for the study. Patients will be randomized to the following treatment arms:

• Group A: Initial high induction dose of Pegasys 360 mcg/week and Copegus 1000/1200mg daily for the first 12 weeks; additional treatment period of 60 weeks with Pegasys 180 mcg/week and Copegus 1000/1200mg daily.
  
• Group B: Initial high induction dose of Pegasys 360 mcg/week and Copegus 1000/1200mg daily for the first 12 weeks; additional treatment period of 36 weeks with Pegasys 180 mcg/week and Copegus 1000/1200mg daily.
  
• Group C: Treatment period of 72 weeks with Pegasys 180 mcg/week and Copegus 1000/1200mg daily.
  
• Group D: Treatment period of 48 weeks with Pegasys 180 mcg/week and Copegus 1000/1200mg daily.

All patients will have a 24-week follow-up period to evaluate whether they have achieved a sustained virologic response. Sustained virological response refers to a patient's continued undetectable serum hepatitis C RNA levels 24 weeks after finishing a course of treatment.

"Although the two pegylated interferons in this study belong to the same class of medications, there are differences between the two," said Jensen. "We hope that the differences between the medications and the different dosing regimens will lead to a good alternative for patients who currently have no proven options."

Pegasys and Copegus combination therapy is marketed in the U.S. by Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J. Peg-Intron and Rebetol combination therapy is marketed by Schering-Plough Corporation, based in Kenilworth, NJ.

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Contact: John M. Pontarelli
jpontare@rush.edu
312-942-5949
Rush University Medical Center
23-Apr-2004

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