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Interim analysis of a double- blind, placebo-controlled study with TMC207 in patients with Multi-Drug Resistant (MDR) Tuberculosis: effective and safe
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Reported by Jules Levin
ICAAC Oct 2008
AH Diacon*, A Pym**, MP Grobusch, M Bogoshi, R Krause, C Pistoriusº, T De Marez, N Lounis, R van Heeswijk, P Meyvisch, K de Beule, K Andries, DF Mc Neeley
*Stellenbosch University, **Medical Research Council Durban, University of the Witwatersrand and NHLS, Aurum Health, and ºQdotPharma, South Africa, and Tibotec
AUTHOR CONCLUSIONS
TMC207 was safe and well-tolerated over 8 weeks
Dosing regimen validated for Stage
- 400 mg qd for 2 weeks followed by 200 mg tiw
Addition of TMC207 to a 5-drug MDR-TB regimen resulted
- In faster culture conversion within 8 weeks
- In a higher conversion rate at week 8: 47.5% TMC207 vs 8.7% placebo
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