ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING

October 3, 2001

The Town Center Hotel –Silver Spring, Maryland

NDA 21-356, Viread™ (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., proposed for the treatment of human immunodeficiency virus (HIV) infection.

8:30 a.m. Call to Order/Welcome Roy M. Gulick, M.D., M.P.H.

Introduction of Committee

8:35 a.m. Conflict of Interest Statement Tara P. Turner, Pharm.D.

Executive Secretary, AVAC

8:45 a.m. Introduction/Opening Remarks Debra Birnkrant, M.D.

Acting Director

9:00 a.m. Sponsor Presentation Gilead Sciences, Inc.

Overview of Development Program Norbert Bischofberger, Ph.D.

Executive Vice President

Research and Development

Clinical Trial Results Jay Toole, M.D., Ph.D.

Vice President

Clinical Research

Phase IV Plans and Concluding Remarks Norbert Bischofberger, Ph.D.

9:45 a.m. FDA Presentation Kimberly Struble, Pharm.D.

Senior Regulatory Review Officer

Division of Antiviral Drug Products, FDA

James Farrelly, Ph.D.

Pharmacology Supervisor

Division of Antiviral Drug Products, FDA

10:30 a.m. Break

10:45 a.m. Questions to Presenters

12:00 p.m. Lunch

AVAC MEETING

October 3, 2001

1:00 p.m. Open Public Hearing

Yvette Delph, M.D. - Treatment Action Group (TAG)

Brett Grodeck – Santa Monica, California

Ben Cheng – Project Inform

2:00 p.m. Questions to Committee

Committee Discussion

5:00 p.m. Adjourn