Pegasys® Copegus ® Hoffmann-La Roche BLA 125061

11/15/02


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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Number of Patients Withdrawn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

Author: Tauber