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Activity Number:
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324
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Type:
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Contributed
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Date/Time:
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Tuesday, August 4, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303664 |
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Title:
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A Meta-Analysis to Assess the FDA Division of Antiviral Product's Time to Loss of Virologic Response (TLOVR) Algorithm in HIV Submissions
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Author(s):
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Fraser Smith*+ and Thomas Hammerstrom and Guoxing (Greg) Soon and Susan Zhou and Baibai Chen and Yabing Mai and Kimberly Struble and Mohammad F. Huque
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Companies:
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FDA and FDA and FDA and FDA and FDA and FDA and FDA and FDA
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Address:
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CDER, 10903 New Hampshire Avenue, Silver Spring, MD, 20993-0002,
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Keywords:
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TLOVR algorithm ; snapshot approach ; HIV ; meta-analysis
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Abstract:
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The first meta-analysis of pivotal HIV study results utilizing data from 18 clinical trials involving 7 NDAs with 8046 patients of multiple NDA submissions for the treatment of HIV infection was used to determine if we can use a simplified version of the TLOVR algorithm for accelerated approval at Week 24 and possibly for traditional approval at Week 48. Analysis data sets for HIV RNA Viral Load, Demography, CD4 Counts, and Discontinuation were created. Results obtained using the TLOVR algorithm, which utilized data from every visit to consider the pattern of HIV responses, were compared to a less complicated snapshot approach which only utilized HIV RNA data at the visit of interest. Given the similarity in results between the TLOVR and snapshot approaches, it appears that correcting for intermittent spikes in HIV RNA levels with the TLOVR algorithm does not have much regulatory impact.
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