Cumulative Fraction of Response for Once- and Twice-Daily Delamanid in Patients with Pulmonary Multidrug-Resistant Tuberculosis
Suresh Mallikaarjun, Moti Chapagain, T. Sasaki, Norimitsu Hariguchi, Devyani Deshpande, Shashikant Srivastava, Alexander Berg, Kuniko Hirota, Yusuke Inoue, Makoto Matsumoto, Jeffrey Hafkin, Lawrence Geiter, Xiaofeng Wang, Tawanda Gumbo, Yongge Liu
Abstract
/MIC of 171. Finally, the CFRs for the currently approved 100-mg BID dose were determined to be above 95% in two MDR-TB clinical trials. The CFR for the 200-mg QD dose, evaluated in a trial in which delamanid was administered as 100 mg BID for 8 weeks plus 200 mg QD for 18 weeks, was 89.3% based on the mouse PDT and >90% on the other PDTs. QTcF (QTc interval corrected for heart rate by Fridericia's formula) prolongation was approximately 50% lower for the 200 mg QD dose than the 100 mg BID dose. In conclusion, while CFRs of 100 mg BID and 200 mg QD delamanid were close to or above 90% in patients with MDR-TB, more-convenient once-daily dosing of delamanid is feasible and likely to have less effect on QTcF prolongation.