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European Union's CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
Date:9/24/2007

who fail to achieve an early response can have their therapy stopped with confidence."

In the study, failure to prior therapy was defined as relapse or non- response to one or more courses of interferon alpha plus ribavirin combination therapy (HCV-RNA positive at the end of a minimum of 12 weeks of treatment). Patients who were HCV-RNA negative at treatment week 12 continued treatment for a total of 48 weeks and were followed for 24 weeks post-treatment.

Based on results from this clinical study, the recommended duration of dosing with PEGINTRON combination therapy for retreating patients who failed previous therapy and who have undetectable virus at week 12 is 48 weeks, regardless of HCV genotype.

PEGINTRON in the European Union

PEGINTRON and REBETOL combination therapy for chronic hepatitis C was approved in the EU in March 2001. The recommended dose in the EU for combination therapy is PEGINTRON 1.5 mcg/kg once weekly plus REBETOL 800-1,400 mg daily, adjusted to body weight. The recommended duration of treatment is 24 weeks for naive patients with HCV genotype 1 and low viral load, or HCV genotype 2 or 3. The recommended duration of treatment is 48 weeks for naive patients with HCV genotype 1 and high viral load, HCV genotype 4 or HIV coinfection regardless of HCV genotype. PEGINTRON had previously received centralized marketing authorization in the EU and is marketed as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with chronic hepatitis C.

Chronic hepatitis C is estimated to affect more than 10 million people in major world markets, including 5 million in Europe. It is a leading cause of chronic liver disease and one of the most common reasons for liver transplant in Europe.

PEGINTRON in the United States

In the United States, PEGINTRON is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver di
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SOURCE Schering-Plough Corporation
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