Table of Contents
FDA Advisory Meeting Clinical Trial Design – Hepatitis B Treatment
TREATMENT OF CHRONIC HEPATITIS B
PPT Slide
Review of Clinical Trials of IFN and Lamivudine
Sentinel Clinical Trials of IFN and LAM in HBeAg + CHB
‘Sentinel’ Clinical Trials of IFN and LAM in HBeAg- CHB
Meta-analysis of 24 RCTs of IFN in HBeAg+ CHB
Meta-analysis of 12 Studies of IFN Rx on Long-Term Outcome of HBeAg+ Adults#
IFN Rx of HBeAg+ CHB
IFN Treatment of HBeAg - CHB
IFN Treatment of HBeAg - CHB Cumulative results of published studies
IFN Rx of HBeAg - CHB: Histologic Response
IFN Rx of HBeAg- CHB
Lamivudine Rx of HBeAg+ CHB
Lamivudine Rx of HBeAg+ CHB
Lamivudine Rx of HBeAg+ CHB
PPT Slide
PPT Slide
PPT Slide
Treatment of HBeAg - CHB
Treatment of Decompensated Cirrhosis
PPT Slide
Clinical Practice Guidelines
AASLD Practice Guidelines
PPT Slide
PPT Slide
AASLD Practice Guidelines Treatment Regimen - IFN
AASLD Practice Guidelines Treatment Regimen - Lamivudine
Issues for Future Clinical Trials
Issues for Future Clinical Trials
Issues for Future Clinical Trials
Issues for Future Clinical Trials
Issues for Future Clinical Trials
Issues for Future Clinical Trials
Issues for Future Clinical Trials
Ability of Surrogate Markers to Predict Clinical Outcome
IFN Rx of HBeAg+ CHB
Impact of HBeAg Clearance on Long-Term Clinical Outcome
Cumulative Transplant-Free Survival of Patients with HBeAg- Chronic Hepatitis
Correlation Between Week 52 HBV DNA Levels and HBeAg Seroconversion in Lamivudine Trials NUCB 3009/NUCA 3010
Correlation between Week 52 HBV DNA Levels and ALT Normalization Lamivudine Trials NUCB 3009/NUCA 3010
Correlation Between Week 52 HBV DNA Levels and Histologic Response Lamivudine Trials NUCB 3009/NUCA 3010
PPT Slide
Correlation Between Week 48 HBV DNA, ALT and Histologic Response Adefovir Trial GS-438 (e-CHB)
Issues for Future Clinical Trials
Correlation between Week 48 HBeAg loss, HBV DNA, ALT and Histologic Response
PPT Slide
PPT Slide
RCTs of IFN Treatment of HBeAg - CHB
IFN Treatment of HBeAg- Patients
Long-Term Follow-Up of HBeAg- Patients with End-of-Treatment Response to IFN
PLA
LAM
PPT Slide
LAM
PLA
LAM
PPT Slide
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