To determine the safety and efficacy of bedaquiline for Chinese multidrug-resistant tuberculosis patients based on serum concentration monitoring and identify factors associated with QTc prolongation occurring during treatment.
We collected data from 35 patients who received treatment regimens containing bedaquiline for multidrug-resistant tuberculosis (MDR-TB) from May 2018 to December 2020. Blood samples were collected, and serum concentrations of bedaquiline were measured using high-performance liquid chromatography-mass spectrometry.
After completing the 24-week bedaquiline treatment course, 80.0% of the patients’ sputum cultures turned negative. The median time to sputum culture conversion was 75.5 days (interquartile range, 52-126). The median serum concentration of bedaquiline was 0.586 ± 0.288 µg/ml during treatment and 0.205 ± 0.145 µg/ml 16 weeks after bedaquiline discontinuation. Bedaquiline remained detectable 52 weeks after discontinuation. Combination with clofazimine (CFZ) during bedaquiline treatment significantly increased cardiac QTc prolongation. When QTc prolongation occurred, serum potassium levels decreased by 10.71% from baseline, while serum sodium levels increased by 1.07% from baseline.
Bedaquiline had good treatment outcomes for Chinese MDR-TB patients. Combination with clofazimine increased the risk of QTc prolongation. Serum electrolytes (potassium and sodium) should be measured regularly during treatment of MDR-TB with regimens containing bedaquiline.

Copyright © 2021. Published by Elsevier Ltd.