ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING

August 6, 2002

Holiday Inn, 8120 Wisconsin Avenue, Bethesda, MD

NDA 21-449, adefovir dipivoxil tablets, Gilead Sciences, Inc., proposed for treatment of chronic hepatitis B infection

8:00 a.m. Call to Order Roy M. Gulick, M.D., M.P.H.
Chair, AVAC

Introduction of Committee

Conflict of Interest Statement Tara P. Turner, Pharm.D.
Executive Secretary, AVAC

8:10 a.m. Opening Remarks Debra B. Birnkrant, M.D.
Director
Division of Antiviral Drug Products
FDA

8:15 a.m. Sponsor Presentation Gilead Sciences, Inc.

Evaluation of Liver Histology in Zachary D. Goodman, M.D., Ph.D.
Clinical Trials for Chronic Viral Hepatitis Chief, Division of Hepatic Pathology
Armed Forces Institute of Pathology

Introduction Alan Taylor, Ph.D.
Chronic Hepatitis B Vice President, Regulatory Affairs
Pre-Clinical Gilead Sciences
Clinical Pharmacokinetics

Clinical Efficacy and Safety Carol Brosgart, M.D.
Pivotal Studies Vice President, Clinical Research
Supportive Studies Gilead Sciences
Further Studies

9:45 a.m. Break

10:15 a.m. FDA Presentation Rafia Bhore, Ph.D.
Mathematical Statistician
Division of Antiviral Drug Products

Tan T. Nguyen, M.D., Ph.D.
Medical Officer
Division of Antiviral Drug Products

11:15 a.m. Discussion of Presentations

12:00 p.m. Lunch

1:00 p.m. Open Public Hearing

Larry Kramer
Rochelle Yedvarb
Elias Anastasopoulos
Alan P. Brownstein, M.P.H. – American Liver Foundation

2:00 p.m. Charge to the Committee/Questions/Discussion

5:00 p.m. Adjourn