PMID- 32912383
OWN - NLM
STAT- MEDLINE
DCOM- 20210427
LR  - 20210427
IS  - 1815-7920 (Electronic)
IS  - 1027-3719 (Linking)
VI  - 24
IP  - 8
DP  - 2020 Aug 1
TI  - Bedaquiline in the treatment of multidrug- and extensively drug-resistant 
      tuberculosis in China.
PG  - 789-794
LID - 10.5588/ijtld.19.0586 [doi]
AB  - 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.
FAU - Han, X
AU  - Han X
AD  - Beijing Chest Hospital, Capital Medical University, Beijing.
FAU - Chen, X
AU  - Chen X
AD  - Fuzhou Pulmonary Hospital, Fuzhou, Fujian.
FAU - Sha, W
AU  - Sha W
AD  - Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai.
FAU - Zhang, X
AU  - Zhang X
AD  - The Second Hospital of Nanjing, Nanjing, Jiangsu.
FAU - Qiu, L
AU  - Qiu L
AD  - Shandong Chest Hospital, Jinan, Shandong.
FAU - Wang, J
AU  - Wang J
AD  - Beijing Chest Hospital, Capital Medical University, Beijing.
FAU - Wu, G
AU  - Wu G
AD  - Fuzhou Pulmonary Hospital, Fuzhou, Fujian.
FAU - Yao, L
AU  - Yao L
AD  - Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai.
FAU - Lv, Y
AU  - Lv Y
AD  - Shandong Chest Hospital, Jinan, Shandong.
FAU - Zhang, X
AU  - Zhang X
AD  - The Second Hospital of Nanjing, Nanjing, Jiangsu.
FAU - Zhou, J
AU  - Zhou J
AD  - Xi an Janssen Pharmaceuticals, Beijing.
FAU - Tang, S
AU  - Tang S
AD  - Beijing Chest Hospital, Capital Medical University, Beijing, Shanghai Pulmonary 
      Hospital, Tongji University School of Medicine, Shanghai.
FAU - Chu, N
AU  - Chu N
AD  - Beijing Chest Hospital, Capital Medical University, Beijing, Beijing Tuberculosis 
      and Thoracic Tumor Research Institute, Beijing, China.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - France
TA  - Int J Tuberc Lung Dis
JT  - The international journal of tuberculosis and lung disease : the official journal 
      of the International Union against Tuberculosis and Lung Disease
JID - 9706389
RN  - 0 (Antitubercular Agents)
RN  - 0 (Diarylquinolines)
RN  - 78846I289Y (bedaquiline)
SB  - IM
MH  - Antitubercular Agents/adverse effects
MH  - China
MH  - Diarylquinolines/adverse effects
MH  - *Extensively Drug-Resistant Tuberculosis/drug therapy
MH  - Humans
MH  - Treatment Outcome
MH  - *Tuberculosis, Multidrug-Resistant/drug therapy
EDAT- 2020/09/12 06:00
MHDA- 2021/04/28 06:00
CRDT- 2020/09/11 05:32
PHST- 2020/09/11 05:32 [entrez]
PHST- 2020/09/12 06:00 [pubmed]
PHST- 2021/04/28 06:00 [medline]
AID - 10.5588/ijtld.19.0586 [doi]
PST - ppublish
SO  - Int J Tuberc Lung Dis. 2020 Aug 1;24(8):789-794. doi: 10.5588/ijtld.19.0586.