 |
|
|
| |
TMC-125, Potent Against NNRTI Resistant HIV
|
| |
| |
Reported by Jules Levin
13th CROI, Retrovirus Conference
Denver, Feb 5-8, 2006
Take home message for patients from this study:
The study results below show that for patients with resistance to efavirenz & nevirapine TMC-125 is effective against NNRTI resistsant HIV and potently reduced viral load. Phase III study for TMC-125 for NNRTI resistant patients is starting.
"Impact of Baseline Resistance on the
Virologic Response to TMC125 in Patients With Extensive NNRTI and PI Resistance:
Analysis of Study TMC125-C223"
J Vingerhoets, M Peeters, C Corbett, K Iveson,
K Vandermeulen, R Keen, B Woodfall and MP de Bethune
Objectives of the Current Analysis
Investigate baseline resistance parameters
Investigate virologic response associated with the number of baseline NNRTI mutations
Investigate baseline resistance parameters:
-- genotype - phenotype
-- mutations associated with increased baseline
fold change in EC50 values (FC) to TMC125
-- intent-to-treat (ITT) analysis, all subjects included
AUTHOR CONCLUSIONS
Baseline resistance to TMC-125 was low, although patients had high-level resistance to efavirenz.
Patients with 0 resistance mutations had -1.82 viral load reduction; patients with 1 mutation had -1.65 viral load reduction; patients with 2 mutations had -1.00 viral load reduction; and patients with 3 or more mutations had -0.66 viral load reduction.
INTRODUCTION
TMC125 is an NNRTI designed to have a high genetic barrier to the development of resistance1,2
Data from TMC125-C207, a 7-day Phase IIa Proof of Principle trial with functional monotherapy in NNRTI-resistant subjects, showed a mean change in log10 viral load of -0.9 3
Data from the 24 week primary analysis of the Phase IIb trial TMC125-C223 in heavily pre-treated subjects with substantial NNRTI and PI resistance were presented recently4,5
1. Andries et al. Antimicrob Agents Chemother 2004; 48:4680-6
2. Vingerhoets et al. Journal of Virology 2005; 79:12773-82
3. Gazzard et al. AIDS 2003; 17:49-54
4. Nadler J et al. 10th EACS 2005, Ireland, LBPS3/7A
5. Grossman H et al. 45th ICAAC 2005, Washington DC US, H-416c
|
|
| |
| |
|
|
|
|
|
