Pegasys + Ribavirin data presented by Schering & the FDA at the FDA Hearing in December 2001

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Table of Contents

Peginterferon alfa-2a (40KD) (PEGASYSĘ) in combination with ribavirin (RBV): efficacy and safety results from a phase III, randomized, double-blind, multicentre study examining effect of duration of treatment and RBV dose


Study Aims

Study Design (1)

Study Design (2)

Primary Endpoint

Main Inclusion Criteria

Main Exclusion Criteria

Patient Characteristics

Results: SVR Genotype 1

Results: SVR Genotype 1 Low Viral Titre

Results: SVR Genotype 1 High Viral Titre

Results: SVR Genotype Non-1

Sustained Virologic Response: Effect of Cirrhosis

Rate of Withdrawal From Treatment

Ribavirin Discontinuations for Adverse Events / Lab Abnormalities

Serious Adverse Events

Summary (1)

Summary (2)

Summary (3)

Study Countries

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