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TMC278 25mg qd has no effect on corrected QT interval in a study in HIV-negative volunteers
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Reported by Jules Levin
EACS Nov 13 2009 Cologne Germany
S Vanveggel,1 A Buelens,1 HM Crauwels,1 RPG van Heeswijk,1 L Leopold,2 M Stevens,1 K Boven2
1Tibotec BVBA, Mechelen, Belgium; 2Tibotec Inc., Yardley, PA, USA
INTRODUCTION
In a Phase IIb trial, all oral once-daily doses of the next-generation NNRTI, TMC278 (25mg, 75mg and 150mg), had similar efficacy to efavirenz (EFV) 600mg qd over 96 weeks in treatment-naïve, HIV-1-infected patients.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 and therefore 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.
Reference
1. Molina J-M, et al. HIV9 2008. Abstract P002.
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