FDA Presentation

8/14/02


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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

Author: OTIS NIH | NIAID