Biologic License Supplement: Peginterferon a-2b and Ribavirin for Treatment of Chronic Hepatitis C

12/20/01


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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

Author: marzella