Pharmaceutic Development Issues for Hepatitis B

8/14/02


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Table of Contents

Pharmaceutic Development Issues for Hepatitis B

Topics for Discussion

HBV and HIV Infection: Disease Differences and Implications for Treatment Studies

HBV and HIV Infection: Disease Differences and Implications for Treatment Studies

Hepatitis B vs. HIV Infection: Goals for combination therapy in HBV infection

Efficacy Endpoints in Hepatitis B Compensated Liver Disease

PPT Slide

Baseline Factors and HBeAg Seroconversion Multivariate Analysis of Integrated Phase III Lamivudine Data (Perrillo et al., Hepatology, July 2002)

Post-Treatment Durability of HBeAg Responses Integrated Phase III Data: LAM100 Patients, 52 Weeks of Therapy

Histology as an Efficacy Endpoint in HBV Trials: Important Findings

Histology as an Efficacy Endpoint: Problems

Relationships Among Efficacy Responses in Trials

Efficacy Endpoints in Hepatitis B Decompensated Liver Disease

PPT Slide

Child Pugh Scores 70 Lamivudine-treated patients, 50 with data ɲ months (Hann et al., DDW2000)

Biochemical Changes in Lamivudine Treated Patients 27 Non-Transplanted Patients (Perrillo et al., Hepatology 2001)

Efficacy Endpoints in HBV Trials: Conclusions

Pending Sources of New Types of Clinical Data

An Industry Perspective: Scientific Issues and Issues for Discussion Today CONTRIBUTORS

An Industry Perspective: Endpoint and Trial Design Issues Are Critical!

An Industry Perspective: Discussion Framework for the Issues

An Industry Perspective: Important Scientific Issues

A Personal Perspective: Facilitating Progress in HBV Therapeutics

Q & A

Author: Nathaniel Brown MD