Table of Contents
Biologic License Supplement: Peginterferon a-2b and Ribavirin for Treatment of Chronic Hepatitis C
Objectives of Presentation
Objectives of Presentation
Objectives of Presentation
Objectives of Presentation
Phase 3 Combination Study(N= 1530)
PPT Slide
Selection of Ribavirin Dosage for Phase 3 Combination Study
Primary Efficacy Outcome: Sustained Virologic Response
Efficacy Outcomes According to Subgroup Analyses
Treatment Response in Patients with Genotype 1
Treatment Response in Patients with Genotype 2-6
Treatment Response by Geographic Location
SUBGROUP ANALYSES
Treatment Response Based on Ribavirin Weight-adjusted Dose
PPT Slide
Treatment Response by Ribavirin Weight-adjusted Dose
Treatment Response by Ribavirin Dose
Treatment Response by Ribavirin Weight-adjusted Dose
Population PK and PD analysis
SAFETY DATA SUMMARY Peginterferon and Ribavirin vs. Interferon and Ribavirin
Summary of Safety
Summary of Safety: Analyses by Ribavirin Weight-Adjusted Dose
Serious Infectious Adverse Events
Modification of Dose (IFN or Ribavirin) in PEG1.5/R Arm
Incidence of Anemia and Neutro- penia in PEG 1.5/R Arm
Conclusions (1)
Conclusions (2)
Conclusions (3)
Conclusions (4)
Conclusions (5)
Post-marketing Studies
Optimization of Ribavirin Dose and Treatment Duration
Optimization of Peginterferon Dose
Peginterferon Dose Optimization
In-treatment vs. Post-treatment Response
Effect of Food on Ribavirin Absorption
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