BACKGROUND: Multidrug- and extensively drug-resistant tuberculosis (MDR/XDR-TB) continues to be a challenge in China. Bedaquiline (BDQ) is associated with accelerated sputum culture conversion and favourable treatment outcomes when added to a preferred background regimen. This post-hoc study aimed to assess the outcomes of BDQ treatment in Chinese patients with MDR/XDR-TB.METHODS: Data from 51 Chinese patients who participated in a global Phase 2, open-label, single-arm study (TMC207-C209) were analysed for effectiveness and safety of the BDQ-containing regimen.RESULTS: During the 24-week BDQ treatment, adverse events (AEs) occurred in 48 patients (94.1%), with the most common AE being hyperuricemia. Drug-induced liver injury (DILI) was reported in 13 patients (25.5%); serious DILI was reported in one patient (2.0%). Seven (13.7%) AEs were considered to be possibly related to BDQ by the investigators. Only one Grade 1 QTc prolongation was reported; no QTcF >500 ms was reported. One death occurred after BDQ treatment due to progressive TB. The median time to sputum culture conversion was 85 days based on the 24-week data. The sputum culture conversion rate was 82% at 24 weeks and 78% at 120 weeks; 66% of patients achieved a cure.CONCLUSIONS: BDQ was well-tolerated and effective for treating MDR-TB among Chinese patients.

Objectives: We carried out a randomized multicentre study in China to investigate whether the clofazimine would improve the efficacy of the standardized regimen in patients with multidrug-resistant tuberculosis (MDR-TB). Methods: Patients with MDR-TB managed in 17 TB specialist hospitals in China between September 2009 and September 2011 were randomly assigned to the treatment groups at enrolment. In the intervention group, 100 mg clofazimine per day was added to the standardized regimen. The primary outcome was the proportion of patients with successful outcomes. Results: From the 156 patients that were screened, 74 were assigned to the control group and 66 to the clofazimine group. Of the 66 cases analysed for clinical outcome in the clofazimine group, 36 patients were cured, and seven completed treatment, yielding a favourable outcome rate of 65.1%. The proportion of patients with favourable outcomes receiving the control regimen was 47.3% (35/74), which was significantly lower than that in the clofazimine group (p 0.034, relative risk 0.661, 95% CI 0.243-0.949). Conclusions: The addition of clofazimine to the standard regimen improved the treatment of MDR-TB. (C) 2018 Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases.