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HIV-1 Resistance Testing in Drug Development. Antiviral Drugs Advisory Committee Meeting November 2-3, 1999. Introduction. Implications of HIV drug resistance Patient management perspective Drug development perspective Meeting Goals Origin of meeting Session objectives Acknowledgments.

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hiv 1 resistance testing in drug development

HIV-1 Resistance Testing in Drug Development

Antiviral Drugs Advisory Committee Meeting

November 2-3, 1999

introduction
Introduction
  • Implications of HIV drug resistance
    • Patient management perspective
    • Drug development perspective
  • Meeting Goals
  • Origin of meeting
  • Session objectives
  • Acknowledgments
implications of hiv drug resistance 1
Implications of HIV Drug Resistance (1)

Clinical Management Perspective

  • Critical factor affecting safe and effective use of therapeutics for HIV
    • One of the important causes of treatment failure
    • Limits options for alternative regimens
    • Exposes patients to risk of drug-induced toxicity without potential benefit
  • Public health problem of transmission of resistant virus raises additional issues
implications of hiv drug resistance 2
Implications of HIV Drug Resistance (2)

Drug Development Perspective

  • Complicates interpretation of trial results
    • Limited understanding of why patients respond or fail combination therapy in clinical trials
  • Limits ability to test new drugs in patient population with greatest need (heavily pretreated)
  • Limits ability to provide advice on the optimal use of a new drug in labeling
what are some current limitations
What are some current limitations?
  • Diverse methodologies in genotypic and phenotypic testing & uncertain correlation
  • No approved assays
  • No uniform requirements for resistance characterization in drug development or post-marketing
  • Lack of consensus regarding clinical utility and interpretation of testing
  • Incomplete understanding of relationship with cofactors
hiv resistance testing in drug development meeting goals
HIV Resistance Testing in Drug Development: Meeting Goals
  • Define what is known and what needs further study
    • Reliability of assays, interpretation of results, and strength for predicting treatment outcome
  • Discuss approaches for defining “resistance” (mutational algorithms, breakpoints) now, and in the future
  • Discuss standardized methods for analyzing data
  • Obtain guidance on use of resistance testing in drug development
  • Discuss what future initiatives should be undertaken to encourage progress
development of meeting
Development of Meeting
  • Charge from Advisory Committee Chair
  • Identification of some common goals with industry-sponsored “HIV Resistance Collaborative Group”
  • Broader solicitation of relevant information and perspective
  • Iterative approach to developing agenda (issue identification was a goal in itself!)
hiv resistance collaborative group representation
HIV Resistance Collaborative GroupRepresentation
  • Pharmaceutical companies
  • Diagnostic companies
  • ACTG virology/statistics/clinical trials
  • Academicians
  • European Health Authorities
  • FDA (CDER, CBER, CDRH)
  • Community
federal register announcement
Federal Register Announcement
  • Notification of meeting
  • Request for:
    • Data on the relationship of HIV mutation development and changes in susceptibility
    • Prospective or retrospective data on relationship between genotype or phenotype and clinical outcome
    • Proposals for resistance testing in clinical trials
    • Proposals for product labeling claims
meeting format
Meeting Format
  • Scientific workshop
    • Not product specific
    • No voting issues
  • Modular
    • Each session has specific objectives and points for committee discussion
    • Invited presentations selected to provide relevant background for discussion
  • Common theme for each session: recommendations for progress
objectives session 1 resistance technology
Objectives - Session 1:Resistance Technology
  • General principles, and exploration of performance characteristics of currently available genotypic & phenotypic assays
    • Limitations
    • Quality control issues
    • Correlation between genotype and phenotype
  • Role of assays in drug development
  • Update on proposed approach to assay regulation (CBER)
objectives session 2 clinical validation
Objectives - Session 2:Clinical Validation
  • Explore predictive value of baseline genotype or phenotype and treatment outcome
    • Prospective trials
    • Retrospective analyses using a common analysis plan
  • Discuss approaches for categorizing and analyzing resistance patterns
  • Identify additional clinical research to further define clinical utility
objectives session 3 practical considerations
Objectives - Session 3:Practical Considerations
  • Identify patient populations for whom resistance testing in drug development is most useful
  • Explore other factors to consider when resistance testing is incorporated into clinical trials
objectives session 4 potential roles in drug development
Objectives - Session 4:Potential Roles in Drug Development
  • Obtain guidance on in vitro and clinical data necessary to characterize resistance and cross-resistance potential
  • Obtain guidance on post-marketing evaluation of resistance
  • Feedback on potential scenarios for use of resistance testing to support regulatory claims
acknowledgments
HIV Resistance Collaborative Group

Invited Speakers:

Douglas Richman

Phillipe Clevenbergh

John Baxter

John Mellors

Victor DeGruttola

Michael Para

Mounir Ait-Khaled

Veronica Miller

Susan Little

Richard D’Aquila

FDA

Jeff Murray

Girish Aras

Narayana Battula

Debra Birnkrant

Gary Chikami

Andrew Dayton (CBER)

Walla Dempsey

Tom Hammerstrom

Lauren Iacono-Connors

Richard Klein

Katherine Laessig

Jonathan Ma

Lalji Mishra

Joanne Rhoads

Rhonda Stover

Kim Struble

Joseph Toerner

Acknowledgments
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