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1	Valacyclovir Supplemental NDA 20- 550 ANTIVIRAL DRUGS ADVISORY COMMITTEE May 14, 2003
2	CDC STD Treatment Guidelines for Genital Herpes Simplex Virus Infections Principles of Management Chemotherapy Counseling Condoms
3	CDC STD Treatment Guidelines for Genital Herpes Simplex Virus Infections Episode Valacyclovir dosage First 1 gram po bid X 7-10d Recurrent 500 mg po bid X 3-5 days 1 gram po qd X 5 days Suppression 1g po qd 500 mg qd( < 9 episodes)
4	GSK Study HS2AB3009 N= > 1400 discordant couples Valacyclovir dose: 500 mg po qd X 8 months Condom use encouraged Primary endpoint Clinical signs/symptoms of genital herpes plus lab confirmation
5	GSK Study HS2AB3009 Issues for Discussion Trial design/endpoints Restricted patient population Applicability to other populations Screening issues Drop out rate Impact on public health guidelines Development of resistance
6	Advisory Committee Agenda 8:15 a.m. Opening Remarks 8:30 a.m. Overview of Genital Herpes 9:00 a.m. GSK Presentation 9:45 a.m. Clarifying Questions 10:00 a.m. Break 10:15 a.m. FDA Presentation Harry Haverkos, M.D. Fraser Smith, Ph.D. 11:00 a.m. Questions and Discussion 11:15 a.m. Open Public Hearing 12:15 p.m. Lunch 1:15 p.m. Charge and Questions to the Committee 4:00 p.m. Adjourn