Table of Contents
Pegasys® Copegus ® Hoffmann-La Roche BLA 125061
Indications and Usage
Chronic Hepatitis C: Sustained Treatment Response (SVR)
Study Drugs
Clinical Development
Clinical Development: Phase 3
PPT Slide
% SVR in Pegasys Monotherapy Studies
Rationale for Selection of Ribavirin Dose
Analysis of Phase 3 Clinical Trials
Phase 3 Protocols: Study Population
Phase 3 Protocol: Assessment of Response
NV 15801 (Study 1)
NV 15801 Clinical Protocol
Population Characteristics
Baseline Disease Characteristics
Principal Efficacy Outcomes
Percent SVR in Subgroups
Histologic Responders in Patients with Paired Biopsies
SVR by Genotype and Region
Percent SVR by Genotype
SVR by Body Weight
Adverse Events
Percent Serious Adverse Events
Number of Serious Infections
Neutropenia during Treatment and Follow-up
Lymphopenia During Treatment and Follow-up
Patient Withdrawal Numbers
Dose Modification
Serum Triglycerides
Laboratory Abnormalities by Weight
Lab Abnormalities by BMI
Summary: Efficacy
Summary: Safety
NV 15942 (Study 2)
NV 15942 Clinical Protocol
Randomization/Allocation
Population Characteristics
Baseline Disease Characteristics
Pooled Sustained Virologic Response
%SVR by Strata, Treatment Duration and Ribavirin Dose
PPT Slide
SVR by Body Weight
Pooled SVR in Patients with Cirrhosis
Pooled SVR in Genotype 4
Histologic Responders: Patients with Paired Biopsies
Percent with Adverse Events
Serious Adverse Events
Number of Serious Infections
Case Report: Infection/Neutropenia
Case Report: Infection/Neutropenia
Neutropenia during Treatment and Follow-up
Lymphopenia during Treatment and Follow-up
Number of Patients Withdrawn
% Dose Modifications – 24 weeks
% Dose Modifications - 48 weeks
Lab Abnormalities by Weight
Lab Abnormalities by BMI
Conclusions: Efficacy
Conclusions: Safety
Conclusions: Risk-Benefit HCV Genotype Non-1
Unresolved Questions
Need for Additional Studies
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