JSM 2004 - Toronto

Abstract #301984

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Activity Number: 235
Type: Luncheons
Date/Time: Tuesday, August 10, 2004 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301984
Title: Issues in Choice and Analyses of Endpoints in Antiviral Drug Trials
Author(s): Victor G. De Gruttola*+
Companies: Harvard School of Public Health
Address: 665 Huntington Ave., Boston, MA, 02131,
Keywords: Antiretroviral Drug Trial ; study endpoints ; resistance mutations
Abstract:

Evaluation of efficacy of antiretroviral drugs is generally based on virological endpoints, such as viral load and development of resistance mutations. One issue that arises in defining such endpoints is how time series of viral load measurements can be summarized in a single metric. Common metrics include time to rebound and AUC. For analyses of the latter, nonparametric approaches may be preferable to standard analyses. To reduce viral genetic sequences to single metrics, resistance endpoints may be defined that are based on the drug options available to patients experiencing virological rebound. Such measures are necessary to evaluate the consequences of failing a therapy for patients' long-term prognoses.


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Revised March 2004