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Predictors of Response to TMC114 in POWER 1/2/3
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Reported by Jules Levin
TMC114 at IDSA Conference
Toronto, Oct 12-15, 2006
There were many presentations at IDSA updating new information with new analyses from TMC114 studies. Cal Cohen presented this in an oral talk.
Factors Influencing DRV/r* Efficacy in Treatment-experienced HIV Patients: POWER 1, 2, and 3
Pooled 48-Week Analysis
Calvin Cohen, MD, MSc1;
Ron Falcon, MD2; Alex Rinehart, PhD2;
Eric Lefebvre, MD3
1Community Research Initiative of New England, Boston, MA;
2Tibotec Therapeutics, Bridgewater, NJ;
3Tibotec, Inc., Yardley, PA
AUTHOR SUMMARY
DRV/r provides strong and durable response through Week 48
-- 61% of pts achieved ≥1 log10 VL reduction
-- 45% of pts had VL <50 copies/mL
DRV/r has a high genetic barrier to resistance
-- 92% of pts reaching <50 copies/mL at Week 24 maintained their response through Week 48
-- 79% of pts with ≥1 log10 VL reduction but VL ≥50 copies/mL at Week 24
maintained or improved their response through Week 48
Baseline FC to DRV is a strong predictor of response
-- FC 10 predicts the best virologic response
-- 70% of pts in the POWER studies had a FC 10
Baseline number of DRV-associated mutations is a strong predictor of response
-- 2 DRV-associated mutations predicts the best virologic response
-- 73% of pts in the POWER studies had 2 DRV-associated mutations
Virologic response increased as additional active agents were used with DRV/r
Study Overview:
Examination of factors influencing DRV/r response at Week 48 in POWER studies:
Phenotype (fold change in EC50)
Genotype
-- IAS-USA PI resistance-associated mutations
-- DRV-associated mutations
Active agents in optimized background regimen (OBR)
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