Surrogate Endpoints for Hepatitis B Trials

8/14/02


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Table of Contents

Surrogate Endpoints for Hepatitis B Trials

Potential Surrogate Endpoints

Data Source: EpivirHBV Submission

Data Source: Adefovir Submission

HBV DNA Assays

Overview

Overview

Change of Knodell Score vs Baseline

Convention

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Log10 ALT/ULN Over Time

Study 438

Study 437

LAM Studies

Study 437

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Log10 HBV DNA Over Time

Study 438

Study 437

LAM Studies

Study 437

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HBeAg Loss Over Time

Study 437

LAM Studies

Transition of HBeAg Status

Overview

Lamivudine: HBV DNA vs. Knodell

Lamivudine: HBV DNA vs. Knodell

Lamivudine: Correlation Year 1 HBV DNA vs. Knodell Score Change

Adefovir: HBV DNA vs. Knodell

Adefovir: Correlation Year 1 HBV DNA vs. Knodell Score Change

Lamivudine: ALT vs. Knodell

Lamivudine: ALT vs. Knodell

Lamivudine: Correlation ALT Change vs. Knodell Score Change

Adefovir: ALT vs. Knodell

Adefovir: Correlation ALT Change vs. Knodell Score Change

DNA, HBeAg & Knodell

Joint Prediction

Predicting Change of Knodell

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Summary

Overview

Methods

HBV DNA vs. Knodell By Trial and Treatment

ALT vs. Knodell By Trial and Treatment

HBV DNA vs Knodell: Treatment effects by Trial

HBV DNA vs Knodell: Treatment effects by Trial

ALT vs Knodell: Treatment effects by Trial

ALT vs Knodell: Treatment effects by Trial

Variability and Correlation

Variability and Correlation

Impact on relationship among treatment effects

Replication of a Single Trial

Replication of a Single Trial

Other considerations

Overview

Proportion of Treatment Effect Explained

PTE: HBV DNA vs Knodell

PTE: ALT vs Knodell

Overview

Summary

Summary

Summary

Summary

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Author: Greg Soon