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Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting
Date:4/26/2009

study. Relapse rates between these two arms also were not significantly different (32.7 percent (16/49) vs. 47.1 percent (32/68), respectively) and adverse events were similar among treatment groups (secondary endpoints). Early discontinuation rates were higher in the 72-week arm compared to the 48-week arm (23.3 percent (17/73) vs. 9.3 percent (8/86), respectively).

Reduced Dose and Duration of Peginterferon Alfa-2b + Weight-Based Ribavirin in European and Asian Genotype 2 and 3 Chronic Hepatitis C Patients (REDD 2/3 Trial)(4)

Shorter duration treatment of patients chronically infected with HCV genotype 2 or 3 (G2/3) with peginterferon and ribavirin has been largely unsuccessful compared with standard-duration treatment (24 weeks). The implications of a reduced peginterferon dose in G2/3 patients were unknown. The primary objective of the REDD 2/3 study was to evaluate the effect of reduced treatment duration or a reduced PEGINTRON dose on SVR and relapse rates among treatment-naive G2/3 patients in an international, multicenter, non-inferiority study. The study began as a real-world, investigator-initiated study conducted in Germany and then the patient population was expanded to include centers in Europe and Asia-Pacific. In total, 682 patients were treated. Of these, 80.2 percent were G3 and 53.1 percent had high baseline viral load (greater than or equal to 600,000 IU/mL), both negative factors for achieving SVR.

Eligible patients were randomized to one of three arms: (A) PEGINTRON (1.5 mcg/kg/wk) for 24 weeks (approved dose), (B) PEGINTRON (1.0 mcg/kg/wk) for 24 weeks (low dose) or (C) PEGINTRON (1.5 mcg/kg/wk) for 16 weeks (short duration), each in combination with weight-based REBETOL (800-1200 mg/day). Co-primary end points were non-inferiority between arms A and B and A and C. SVR rates overall were (A) 66.5 percent (153/230), (B) 64.3 percent (144/224) and (C) 56.6 percent (129/228). Neither
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