HIV-1 Resistance Testing in Drug Development Antiviral Drugs Advisory Committee Meeting November 2-3, 1999.

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Presentation transcript:

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

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) 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? 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 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 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 Pharmaceutical companies Diagnostic companies ACTG virology/statistics/clinical trials Academicians European Health Authorities FDA (CDER, CBER, CDRH) Community

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 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 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 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 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 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