Table of Contents
Adefovir Dipivoxil 10 mg for the Treatment of Chronic Hepatitis B
Proposed Indication
Consultants
Agenda
Chronic Hepatitis B A Global Healthcare Issue
Current Therapies for Chronic Hepatitis B
Goals for New Antiviral Therapies for Chronic Hepatitis B
Adefovir Dipivoxil
In Vitro Activity of Adefovir Wild-type and Lamivudine-resistant HBV
Preclinical Pharmacology and Toxicology
Adefovir Dipivoxil 10 mg Clinical Pharmacokinetics
Adefovir Dipivoxil in Chronic Hepatitis B Dose Selection
Chronic Hepatitis B Exposure to Adefovir Dipivoxil
Clinical Efficacy and Safety
Adefovir Dipivoxil Pivotal Studies
Studies 437 and 438 Key Inclusion Criteria
Studies 437 and 438 Baseline Characteristics (ITT)
PPT Slide
Studies 437 and 438 Primary Endpoint
Studies 437 and 438 (ITT) 48 Weeks Primary Endpoint: Improvement in Liver Histology
Studies 437 and 438 Integrated 48 Weeks (ITT) Histological Improvement by Demographic Characteristics
Studies 437 and 438 Integrated 48 Weeks (ITT) Histological Improvement by Baseline HBV Characteristics
Studies 437 and 438 Secondary Endpoints
Studies 437 and 438 (ITT) 48 Weeks Necroinflammation – Ranked Assessment
PPT Slide
Studies 437 and 438 Median Change from Baseline in HBV DNA
Studies 437 and 438 (ITT) 48 Weeks Serum HBV DNA < 400 copies/mL
Studies 437 and 438 (ITT) 48 Weeks ALT Normalization
Study 437 (ITT) 48 Weeks HBeAg Loss and Seroconversion
Study 437 and 438 Efficacy Beyond 48 Weeks
Study 437 and 438 All ADV 10 mg (n=492) Efficacy Beyond 48 weeks
Studies 437 and 438 ADV 10 mg Efficacy Summary
Studies 437 and 438 Safety of Adefovir Dipivoxil 10 mg
PPT Slide
Studies 437 and 438 Integrated 0-48 Weeks Grade 1-4 Treatment-Related Adverse Eventsa
Studies 437 and 438 Integrated 0-48 Weeks Grade 3-4 Laboratory Abnormalitiesa
Studies 437 and 438 Integrated 0-48 Weeks Grade 1-4 Renal Laboratory Parameters
Studies 437 and 438 Integrated 0-48 Weeks Renal Laboratory Abnormalities
Studies 437 and 438 0-48 Weeks Renal Laboratory Abnormalities
Studies 437 and 438 Integrated ADV 10 mg Renal Laboratory Abnormalities 0-96 Weeks
Study 437 and 438 All ADV 10 mg Resolution of ? 0.3 mg/dL Increases in Serum Creatinine 0-96 Weeks (n=29)
Studies 437 and 438 Integrated 0-48 Weeks ALT Elevations > 10 x ULN
Studies 437 and 438 Integrated ADV 10 mg ALT Elevations > 10 x ULN 48-96 Weeks
Studies 437 and 438 Integrated 0-96 Weeks Adefovir Dipivoxil 10 mg Safety Summary
Adefovir Dipivoxil 30 mg Efficacy and Safety
Study 437 (ITT) Efficacy Results 48 Weeks
Study 437 Renal Laboratory Abnormalities 48 Weeks
Study 437 Assessment of Adefovir Dipivoxil 30 mg
Resistance Surveillance
Studies 437 and 438 Resistance Surveillance
Studies 437 and 438 Resistance Surveillance Results
Supportive Studies
Lamivudine Resistance
Study 435 Compassionate Access
Study 435 Mortality Rates in Advanced Liver Disease
Study 435 Baseline Characteristics
Study 435 Baseline HBV Disease Characteristics
Study 435 Median Change from Baseline in HBV DNA
Study 435 Week 48 Secondary Efficacy Endpoints
Study 435 Survival
Study 435 Patient Disposition
Study 435 Renal Laboratory Abnormalities by Week 96
Study 435 Post-Transplantation Patients with Confirmed Increases in Serum Creatinine ? 0.5 mg/dL from Baseline (n=26)
Study 435 Pre-Transplantation Patients with Confirmed Increases in Serum Creatinine ? 0.5 mg/dL from Baseline (n=15)
Adefovir Dipivoxil 10 mg Dosing Recommendations in Patients with or at risk of Renal Impairment
Study 435 Summary
Lamivudine-Resistant HBV Other Supportive Studies
PPT Slide
Study 461 ALT Normalization Week 48
Further Studies
Further Studies
Adefovir Dipivoxil for the Treatment of Chronic Hepatitis B
Proposed Indication
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