Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis in China.

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.