Fda hepatitis c hearing oct 19 2006
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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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Fda hepatitis c hearing oct 19 2006

FDA Hepatitis C Hearing Oct 19, 2006

Jules Levin

Executive Director/Founder, NATAP

National AIDS Treatment Advocacy Project


Background
Background

  • NATAP founded 1995

  • Member of ACTG & HIV RAC Committee for 5 years as NYU/Bellevue community representative

  • 1st Coinfection peg/rbv cure.

  • Worked closely with FDA in 1995 for accelerated protease inhibitor access and approval


Natap
NATAP

  • www.NATAP.org website is a leading resource on HIV, HCV & HBV

  • Conference Coverage, Journal Publications, News

  • HIV & Hepatitis Treatment Education;

    • First HIV education forums 1995

    • First coinfection education forums 1999

    • National HIV & Hepatitis Education Forums: 25 cities; 15,000 attendees; met with local & national government officials

    • HCV & HBV coinfection in the Ryan White Care Act


Hcv drug development is accelerating
HCV drug development is accelerating

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

  • Multiple Investigational Drug Studies are important in HCV & companies need to collaborate; FDA needs to streamline process

  • HIV Drug Development Model

    Fast Track

    Accelerated Approval for advanced disease

    Expanded Access


We need to improve
We Need To Improve

  • End Stage Liver Disease, HCV/HIV coinfection, decompensated cirrhotics are in particular need

  • Can we accelerate animal & human safety & efficacy study timeline?

  • Can we start multiple investigational drug studies in phase IIb/III

  • RESISTANCE, Cross-Resistance; need Resistance Assays & databases

  • HCV/HIV coinfection is the leading cause of death & hospitalization in HIV (except for AIDS); undetected in developing world

  • TWO DISEASES: mono-infection & co-infection


Questions
Questions

  • Populations: efficacy/safety studies simultaneous with Phase II/III before approval in needy populations: coinfection, liver transplant, cirrhosis, decompensated cirrhosis

  • Control arms

  • Endpoints

  • Follow-up research


Study populations
Study Populations

  • HCV monoinfection

  • HIV coinfection: PK and efficacy studies conducted before approval

  • HBV/HCV coinfection

  • Genotype 1; genotype 2/3; genotype 4

  • Cirrhosis

  • Decompensated cirrhosis

  • Pre and post liver transplant

  • Naives

  • Ethnic/racial groups: African-Americans, Latinos

  • Null responders

  • Partial responders

  • Relapsers

  • IDUs, Substance Abusers, Alcohol users, Methadone


Endpoints
Endpoints

  • Primary endpoint SVR: 24 weeks after end of treatment

  • Secondary endpoint and non-responders: improved liver histology

  • Durability should be demonstrated with oral agents

  • Need to look at early responses: 2, 4, 8, 12 weeks


Endpoints1
Endpoints

  • Correlate SVR, biopsy and non-invasive tests although these may not be necessary


Study design
Study design

  • Study reduced dose peginteferon

  • No ribavirin

  • No pegIFN

  • Establish safety and efficacy in humans

  • Worried about Resistance using old model of adding 1 new oral agent to Peg/RBV??

  • Need to study 2 or 3 investigational oral agents in regimen

  • Switch drug or class if viral failure


Study design1
Study design

  • Problem: if VX950 looks good who will want to enroll in new drug studies

  • Standard of Care will be VX950+Peg/RBV

  • VX950 + or another PI or potent 4 to 5 log drug in combination with 1 or 2: NM283, R1626, MK0606, HCV-796

  • Substitute oral agent for ribavirin

  • Resistance profiles

  • SUGGEST:

    - 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


Follow up
Follow-Up

  • Although SVR is predictive with Peg/RBV I have concern about oral agents only. I think followup is way to address this concern

  • 3 yrs SVR follow-up

  • Long-Term Cohorts: efficacy, liver disease confirmation & safety, cancer, improved histology

  • Hepatitis C Study Consortium: independent, not NIH nor ACTG

  • Evaluate low level HCV found in SVRs

  • We need resistance databases

    When is the next meeting??


Research questions
Research Questions

  • In coinfection, affect on CD4 response to HAART

  • When to begin HAART & HCV therapy in coinfection; prevent hepatotoxicity

  • Affect of HCV on metabolics in coifected