1 / 6

Valacyclovir Supplemental NDA 20- 550

ANTIVIRAL DRUGS ADVISORY COMMITTEE May 14, 2003. Valacyclovir Supplemental NDA 20- 550. CDC STD Treatment Guidelines for Genital Herpes Simplex Virus Infections. Principles of Management Chemotherapy Counseling Condoms.

kermit
Download Presentation

Valacyclovir Supplemental NDA 20- 550

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. ANTIVIRAL DRUGS ADVISORY COMMITTEE May 14, 2003 ValacyclovirSupplemental NDA 20- 550

  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 EpisodeValacyclovir 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

More Related