Background: The final treatment outcomes of Korean multidrug-resistant tuberculosis (MDR-TB) patients treated with bedaquiline in the C209 trial have not yet been reported. Therefore, a subgroup analysis of the Korean population from the C209 trial was performed, and the results were compared with those of the overall C209 study population.
Methods: In the C209 trial, MDR-TB patients were treated with bedaquiline for 24 weeks in combination with background anti-TB drugs, and were followed-up until week 120 after bedaquiline treatment initiation.
Results: With the exception of drug susceptibility patterns, the baseline clinical characteristics of both groups were similar. The proportions of pre-extensively drug-resistant TB to extensively drug-resistant TB (pre-XDR-TB/XDR-TB) were 61.9 and 35.2% in the Korean and the overall C209 populations, respectively. Aminoglycosides, later-generation fluoroquinolones, cycloserine, and linezolid were the most common concomitant drugs used during bedaquiline treatment. The culture conversion rates of both groups were similar at week 24 (end of bedaquiline treatment; 80.0% vs. 79.5%) and 120 (75.0% vs. 72.2%). Additionally, the frequency and type of adverse events during treatment were similar in both groups, and 1 patient (5.0%) died due to a cause unrelated to bedaquiline treatment.
Conclusions: Bedaquiline showed similar efficacy and safety in Korean patients with MDR-TB, despite their advanced drug-resistance profiles, possibly due to other concomitant drugs such as linezolid.
Keywords: Bedaquiline; Clinical trial; Korea; Multidrug-resistant tuberculosis; Treatment outcome.
Copyright © 2019 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.