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POWER 2
(TMC114-C202 study)
Week 24 efficacy analysis
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Reported by Jules Levin
ICAAC Dec 16, 2005, Wash DC
T Wilkin, R Haubrich, CR Steinhart, S Becker, MA Conant, T Vangeneugden, S Spinosa-Guzman, F Godderis, P Stoffels and W Parys
Wilkin reported this information at ICAAC Dec 16, 2005.
TMC114
--HIV PI with stronger affinity for protease compared with other PIs1
--High barrier to development of resistance2
--Potent activity against wild type and a wide range of PI resistant HIV clinical isolates3
1. Dierynck I, et al. 14th IHDRW 2005. Abstract 64
2. King NM, et al. J Virol 2004;78:12012–21
3. De Meyer S, et al. Antimicrob Agents Chemother 2005;49:2314–21
POWER 2: objectives and design
One of two randomized, controlled, partially blinded, phase IIb studies
--POWER 1 (TMC114-C213)
--POWER 2 (TMC114-C202)
Objectives
--Compare ARV efficacy and safety/tolerability of different TMC114/r doses with investigator-selected control PI(s) in ARV-experienced patients
Primary endpoint
--HIV RNA reduction ≥1.0 log10 from baseline to Week 24
RESULTS
POWER 2: mean change from baseline in HIV RNA at Week 24 (NC=F)
- All TMC114/r dose groups had significantly greater mean log10 VL change from baseline than the control group
- Clear dose-response relationship shown between TMC114/r dose and mean log10 VL change from baseline
<50 copies/mL at Week 24 (ITT-TLOVR)
- Significantly more patients achieved plasma VL <50 copies/mL in the TMC114/r bid groups than in the CPI group
- Significantly more patients in the TMC114/r 600/100mg bid group achieved plasma VL<50 copies/mL than in either TMC114/r qd group
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