Valacyclovir Supplemental NDA 20- 550 by omq25257

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									       Valacyclovir
 Supplemental NDA 20- 550


ANTIVIRAL DRUGS ADVISORY COMMITTEE
             May 14, 2003
   CDC STD Treatment Guidelines for Genital
       Herpes Simplex Virus Infections


 Principles of Management
  Chemotherapy
  Counseling
  Condoms
   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)
       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
        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
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

								
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