Table of Contents
FDA Presentation
Outline of FDA Presentation
Patient Demographics
Efficacy Data Assessment
Primary Endpoint: Liver Biopsy Studies 437, 438
Necroinflammatory Score Study 437
Necroinflammatory Score Study 438
Fibrosis Score Study 437
Fibrosis Scores Study 438
Secondary Endpoint: HBV DNA* Studies 437, 438
Serum HBV DNA Study 437
Serum HBV DNA Study 438
Secondary Endpoint: ALT Studies 437, 438
Serum ALT Study 437
Serum ALT Study 438
Treatment Effect on Fibrosis Study 437
Treatment Effect on Fibrosis Study 438
Assessment of Treatment Effect on Fibrosis
Comments on Ranked Assessment of Liver Biopsy
Safety Data Assessment
Adverse Event Profile Studies 437, 438
“Hepatic Flare” Studies 437, 438
Renal Safety Data
Estimated Creatinine Clearance: 0.3 versus 0.5 mg/dL Cutoff
Nephrotoxicity Study 437
Nephrotoxicity Study 438
Nephrotoxicity in Year 2 Studies 437, 438
Nephrotoxicity Study 435
Estimated Creatinine Clearance: 0.3 versus 0.5 mg/dL Cutoff
Nephrotoxicity Study 435
Nephrotoxicity Study 435
Profile of Patients with Creatinine Abnormality
Resolution of Creatinine Abnormality
Nephrotoxicity Assessment Study 435
Nephrotoxicity: Case # 1 Study 435
Nephrotoxicity: Case # 2 Study 435
PK of Adefovir in Non-CHB Patients with Renal Dysfunction
Adefovir in CHB Patients with Renal Dysfunction
Deaths
HBV Viral Resistance
Viral Resistance Issues
HBV/HIV Co-infection Study 460i
Risk-Benefit Assessment of Adefovir Treatment
Risk-Benefit Assessment of Adefovir Treatment
Questions to the Advisory Committee
1. Has the applicant demonstrated the safety of adefovir 10 mg daily dose for the treatment of CHB?
3. Based on the risk-benefit profile, does the Committee recommend approval of adefovir 10 mg daily dose for the treatment of CHB in adults?
Adefovir Review Team
PPT Slide
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