Abstract #301419


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JSM 2002 Abstract #301419
Activity Number: 364
Type: Contributed
Date/Time: Wednesday, August 14, 2002 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section*
Abstract - #301419
Title: Genotypic and Phenotypic Resistance and Virologic Response on HIV Observational Databases: Variable Metrics and Statistical Methods
Author(s): Qiming Liao*+
Affiliation(s): GlaxoSmithKline, Inc.
Address: 5 Moore Drive, Research Triangle Park, North Carolina, 27709, USA
Keywords: HIV observational data ; Genotypic resistance ; Phenotypic resistance ; Variable metrics ; Virologic response ; Weighted average
Abstract:

Using data from HIV observational databases has the advantage of adding additional diversity and perhaps better representing the challenges faced in routine HIV disease management. However, it also creates some challenges in attempting to reasonably define genotypic resistance, phenotypic resistance, and virologic response. Use of a specific temporally defined endpoint to determine virologic response could be problematic, as length of time on particular therapy varies widely. Method of time weighted-average of HIV-1 RNA has been widely used recently, and we will compare the DAVGT and the AAUCMB (average area under the curve minus baseline). A method of weighted genotypic sensitivity score to account for the presence of primary resistance-associated mutations will be proposed. All the methods discussed above will be illustrated using HIV observational data as examples.


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Revised March 2002