International study seeks 888 patients
A new study seeks to answer one of the most challenging and important questions in hepatitis C therapy today: What is the best option for patients in whom one of the most widely prescribed treatments has failed? The study will evaluate different regimens of combination therapy in patients with hepatitis C who failed to generate a sustained virological response after treatment with Peg-Intron/Rebetol therapy. Patients in the new study will receive Pegasys® (peginterferon alfa-2a) and CopegusÒ (ribavirin), already approved as a first-line treatment for patients with hepatitis C.
The REPEAT Trial (REtreatment with PEgasys in PATients Not Responding to Peg-Intron Therapy) is led in the U.S. by hepatologist Dr. Donald Jensen of Rush University Medical Center. The US portion of the study will enroll approximately 330 patients at 33 centers including Rush.
Hepatitis C, a blood-borne infectious disease of the liver, is transmitted through body fluids, primarily blood or blood products, and by sharing needles. Hepatitis C chronically infects an estimated 2.7 million Americans and 170 million people worldwide and is the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the U.S.
"Although we have seen significant improvements in hepatitis C therapy over the past few years, many patients still do not respond to treatment on their first attempt," said Dr. Donald Jensen, director of Hepatology at Rush University Medical Center and lead U.S. investigator in the REPEAT trial. "We hope that this trial will provide patients a proven option with another pegylated interferon if Peg-Intron combination therapy failed to work for them."
The REPEAT Trial is an international study enrolling approximately 888 patients at 98 centers in 14 countries worldwide. Approximately 330 patients will be enrolled at the 33 participating centers in the United States. In order to be eligible for the 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.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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