Application of the FDA's Snapshot Algorithm to the Statistical Review of Etravirine for the Treatment of HIV

• Activity Number: 646
• Type: Contributed
• Date/Time: Thursday, August 8, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Fraser Smith*+
• Keywords: FDA ; snapshot algorithm ; etravirine ; treatment of HIV

Abstract

The FDA Division of Antiviral Products' Snapshot Algorithm, which is used for the primary efficacy analysis of HIV RNA clinical trial data will be discussed. This algorithm is less complicated than the previously used time to loss of virologic response (TLOVR) algorithm which utilized data from every visit to consider the pattern of HIV responses to correct for intermittent spikes in HIV RNA levels. The snapshot algorithm only utilizes HIV RNA data at the visit of interest. The snapshot algorithm was used to analyze data from two pivotal phase III clinical trials of etravirine (Intellence®, TMC125) for the treatment of HIV infection for accelerated approval at Week 24. Examples of the snapshot algorithm will include the primary efficacy analysis, sensitivity analyses and analyses of important subgroups.