PMID- 32553316
OWN - NLM
STAT- MEDLINE
DCOM- 20210419
LR  - 20210419
IS  - 0019-5707 (Print)
IS  - 0019-5707 (Linking)
VI  - 67
IP  - 2
DP  - 2020 Apr
TI  - Early treatment outcome of bedaquiline plus optimised background regimen in drug 
      resistant tuberculosis patients.
PG  - 222-230
LID - S0019-5707(20)30041-X [pii]
LID - 10.1016/j.ijtb.2020.03.002 [doi]
AB  - AIMS: Bedaquiline (BDQ) has been recently approved for drug resistant 
      tuberculosis with active drug safety monitoring under programmatic condition. The 
      present study was conducted to evaluate safety, tolerability and efficacy of 
      bedaquiline plus optimised background regimen. METHODS: A prospective study was 
      conducted on cohort of pre-extensively drug resistant (XDR) and XDR pulmonary TB 
      patients. Eligible patients were closely monitored for cardiac safety, adverse 
      events (AEs), clinical and microbiological improvement during BDQ (6 months) and 
      post BDQ phase for twelve months. RESULTS: Of 127 patients enrolled, a 
      significant increase in mean QTc interval was observed on 13th day and 3rd week 
      as compared to baseline (p < 0.0001). Mean maximum increase of QTc was 37.92ms 
      (95% CI, 14.1-61.74ms). Concomitant anti-TB medications, age, gender, low body 
      mass index (BMI) had significant effect on QTc prolongation (p < 0.0001, 
      p < 0.05). However, none of the patient required discontinuation of BDQ. Majority 
      of AEs (86.3%) were non-serious and not preventable 108 (87.1%). The median time 
      for sputum-culture conversion was 40.89 +/- 3.5 days (95% CI, 34-48 days) and the 
      treatment outcome was successful in 102 (80.3%) patients with negative sputum 
      culture conversion. CONCLUSIONS: Bedaquiline containing regimen achieved 
      favourable outcome. Although, bedaquiline along with concomitant anti-TB 
      medications has the potential to prolong QTc interval, the benefit certainly 
      outweighs the risk. This calls for a through pre-treatment cardiovascular and 
      biochemical evaluation as a preventive measure and appropriate selection of 
      patients for safe use of BDQ and successful outcome.
CI  - Copyright (c) 2020 Tuberculosis Association of India. Published by Elsevier B.V. 
      All rights reserved.
FAU - Barvaliya, Sandip V
AU  - Barvaliya SV
AD  - Department of Pharmacology, B. J. Medical College & Civil Hospital, Ahmedabad, 
      380016, India.
FAU - Desai, Mira K
AU  - Desai MK
AD  - Department of Pharmacology, B. J. Medical College & Civil Hospital, Ahmedabad, 
      380016, India.
FAU - Panchal, Jigar R
AU  - Panchal JR
AD  - Department of Pharmacology, B. J. Medical College & Civil Hospital, Ahmedabad, 
      380016, India. Electronic address: doc.jigarpanchal@gmail.com.
FAU - Solanki, Rajesh N
AU  - Solanki RN
AD  - Department of Pulmonary Medicine, B. J. Medical College & Civil Hospital, 
      Ahmedabad, 380016, India.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20200324
PL  - India
TA  - Indian J Tuberc
JT  - The Indian journal of tuberculosis
JID - 0373027
RN  - 0 (Antitubercular Agents)
RN  - 0 (Diarylquinolines)
RN  - 78846I289Y (bedaquiline)
SB  - IM
MH  - Adult
MH  - Antitubercular Agents/*therapeutic use
MH  - Culture Techniques
MH  - Diarrhea/chemically induced
MH  - Diarylquinolines/*therapeutic use
MH  - Drug Eruptions
MH  - Drug Therapy, Combination
MH  - Extensively Drug-Resistant Tuberculosis/*drug therapy
MH  - Female
MH  - Humans
MH  - Long QT Syndrome/chemically induced
MH  - Male
MH  - Pigmentation Disorders/chemically induced
MH  - Skin Pigmentation
MH  - Sputum
MH  - Treatment Outcome
MH  - Tuberculosis, Multidrug-Resistant/drug therapy
MH  - Tuberculosis, Pulmonary/*drug therapy
MH  - Vomiting/chemically induced
OTO - NOTNLM
OT  - Bedaquiline
OT  - Drug resistant tuberculosis
OT  - Drug susceptibility tests
COIS- Declaration of Competing Interest The authors have none to declare.
EDAT- 2020/06/20 06:00
MHDA- 2021/04/20 06:00
CRDT- 2020/06/20 06:00
PHST- 2019/07/29 00:00 [received]
PHST- 2019/11/20 00:00 [revised]
PHST- 2020/03/06 00:00 [accepted]
PHST- 2020/06/20 06:00 [entrez]
PHST- 2020/06/20 06:00 [pubmed]
PHST- 2021/04/20 06:00 [medline]
AID - S0019-5707(20)30041-X [pii]
AID - 10.1016/j.ijtb.2020.03.002 [doi]
PST - ppublish
SO  - Indian J Tuberc. 2020 Apr;67(2):222-230. doi: 10.1016/j.ijtb.2020.03.002. Epub 
      2020 Mar 24.