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  Infectious Disease Societyof America (IDSA)
47th Annual Meeting
Philadelphia, PA
October 29 - November 1, 2009 		Back grey_arrow_rt.gif
 
 
 
(IDSA) TMC278 25mg qd has no effect on corrected QT
interval in HIV-negative volunteers
 
 
  Reported by Jules Levin
47th Annual Meeting of the Infectious Diseases Society of America,Philadelphia, Pennsylvania, USA. October 29-November 1 2009
 
Simon Vanveggel,1 Annemie Buelens,1 Herta Crauwels,1 Rolf van Heeswijk,1 Lorant Leopold,2 Marita Stevens,1 Katia Boven2 1Tibotec BVBA, Mechelen, Belgium; 2Tibotec Inc., Yardley, PA, USA

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INTRODUCTION
 
· TMC278 is a next-generation NNRTI being investigated in treatment-naïve, HIV-1-infected patients.
 
· In a Phase IIb trial in this population, all doses of once-daily oral TMC278 (25mg, 75mg and 150mg) had similar efficacy to efavirenz (EFV) 600mg qd over 96 weeks.1
 
· In the current thorough QT (TQT) trial, the potential for TMC278 to affect the corrected QT (QTc) interval at the selected Phase III oral dose of 25mg qd was assessed at steady-state.
 
· In the Phase IIb trial, QTc prolongation was observed in all treatment groups: TMC278 or EFV combined with two NRTIs,1 so the effect of EFV 600mg qd on QTc interval was also investigated in this study.
 
· In a prior TQT trial, TMC278 75mg qd and 300mg qd prolonged the QTc interval in a dose- and plasma-concentration-dependent manner.

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REFERENCE
 
1. Molina J-M, et al. HIV9 2008. Abstract P002.