Materials and Links

Background

HIV-1 drug resistance is a significant factor for treatment failure and drug susceptibility testing is recommended by U.S. and European treatment guidelines, however, the interpretation of resistance test results remains a challenge. An urgent need for a more standardized interpretation of resistance test results in the clinical setting and in the drug development process has been identified. A standardized approach for a clinical database derived definition of drug resistance for each individual drug requires extensive collaboration across academia and industry. In addition, issues related to standardization and quality assurance of technologies and reimbursement need to be addressed.

Objectives:

The Forum will convene a group of international experts (scientific committee) in the areas of genotypic and phenotypic resistance testing, technology development and standardization, database systems and analysis, cost-effectiveness and health resource utilization from academia, government agencies, pharmaceutical industry, diagnostic industry, treatment community and patient community with the goal to:

• Identify clinical databases suitable for the generation of genotypic algorithms and phenotypic cut-offs;
• Develop analytic approaches for the derivation of virologic response associated definitions of resistance for each antiretroviral drug;
• Establish collaboration amongst the various constituencies to facilitate the performance of the required analyses;
• Review current regulatory aspects related to standardization and quality assurance including laboratory as well as genotype interpretation issues;
• Present and publish the overall findings to the relevant government drug and technology approval agencies (FDA and EMEA); and
• Make recommendations for how best to establish a continuous and long-term evaluation of clinically defined HIV drug resistance.

Expected outcomes:

• A standardized data analysis plan incorporating various approaches (e.g. recursive partitioning, logistic regression, neural networks, etc) made available to be used by interested parties
• Demonstration analyses addressing specific questions
• Peer-reviewed publication of the demonstration analyses
• Advisory meeting with regulatory agencies from US and Europe
  

Status:

A standardized analysis plan has been written.

Scientific chairs:
Daniel Kuritzkes (USA)
Veronica Miller (USA)

Sub-group planning committees chairs:

Project Specific Sponsors:
Bayer, Bristol-Myers Squibb, Eurofins-Viralliance, GlaxoSmithKline, NIH, Shire, Virco, Virologic, Visible Genetics