FDA Hepatitis C Hearing Oct 19, 2006. Jules Levin Executive Director/Founder, NATAP National AIDS Treatment Advocacy Project. Background. NATAP founded 1995 Member of ACTG & HIV RAC Committee for 5 years as NYU/Bellevue community representative 1st Coinfection peg/rbv cure.
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Executive Director/Founder, NATAP
National AIDS Treatment Advocacy Project
We need to speed up drug development process:
-- Animal & human safety studies should be accelerated
-- Phase I/II should be abbreviated
Prevent drug resistance as serial monotherapy in HIV resulted in HIV drug resistance
Accelerated Approval for advanced disease
- 7 or 14 day monotherapy depending on resistance potential followed by
- Combinations of oral agents with and without Peg & Peg/RBV
- Drug-drug interaction studies conducted before combination studies
- Coinfection studies
When is the next meeting??