PMID- 34466629
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240404
IS  - 2328-8957 (Print)
IS  - 2328-8957 (Electronic)
IS  - 2328-8957 (Linking)
VI  - 8
IP  - 8
DP  - 2021 Aug
TI  - QT Interval Prolongation in People Treated With Bedaquiline for Drug-Resistant 
      Tuberculosis Under Programmatic Conditions: A Retrospective Cohort Study.
PG  - ofab413
LID - 10.1093/ofid/ofab413 [doi]
LID - ofab413
AB  - BACKGROUND: Bedaquiline has a black-box warning of the risk of arrhythmias and 
      sudden death. This study aimed to determine the incidence of QTc prolongation and 
      cardiac events in patients receiving bedaquiline for drug-resistant tuberculosis 
      (DR-TB) under programmatic conditions. METHODS: Retrospective cohort study of 
      patients receiving bedaquiline at a DR-TB hospital in KwaZulu Natal, South Africa 
      from September 2017 to February 2019. The primary outcome, a prolonged QT 
      interval corrected using the Fridericia formula (QTcF), was defined as QTcF >500 
      ms, QTcF change >60 ms from baseline, or both. RESULTS: Among 420 patients (66.2% 
      male, median age 36 years), the median QTcF was 406.4 (interquartile range [IQR], 
      389.1-421.3) ms at baseline, increasing to 430.5 (IQR, 414.4-445.1) ms by 3 
      months and 434.0 (IQR, 419.0-447.9) ms at 6 months. Eighteen of 420 patients 
      (4.3%) had a QTcF >500 ms and 110 of 420 patients (26.2%) had a QTcF change >60 
      ms. There were no recorded arrhythmias or cardiac deaths. Odds of prolonged QTcF 
      were increased with concomitant azoles (adjusted odds ratio [aOR], 5.61 [95% 
      confidence interval (CI), 2.26-13.91]; P < .001) and an inverse association with 
      HIV-positive status (aOR, 0.34 [95% CI, .15-.75]; P = .008) and hypertension 
      (aOR, 0.13 [95% CI, .02-.86]; P = .02). After prolongation, the QTcF declined to 
      <500 ms, whether drugs were interrupted or not. CONCLUSIONS: We observed a modest 
      prolongation of QTcF, maximal at week 15; there were no recorded arrhythmias or 
      related deaths.
CI  - (c) The Author(s) 2021. Published by Oxford University Press on behalf of 
      Infectious Diseases Society of America.
FAU - Isralls, Sharon
AU  - Isralls S
AUID- ORCID: 0000-0003-4206-8022
AD  - London School of Hygiene and Tropical Medicine, London, United Kingdom.
FAU - Baisley, Kathy
AU  - Baisley K
AUID- ORCID: 0000-0003-1849-6625
AD  - London School of Hygiene and Tropical Medicine, London, United Kingdom.
AD  - Africa Health Research Institute, Durban, South Africa.
FAU - Ngam, Eric
AU  - Ngam E
AD  - University of KwaZulu-Natal, Durban, South Africa.
FAU - Grant, Alison D
AU  - Grant AD
AUID- ORCID: 0000-0002-2437-5195
AD  - Africa Health Research Institute, Durban, South Africa.
AD  - Tuberculosis Centre, London School of Hygiene and Tropical Medicine, London, 
      United Kingdom.
AD  - School of Laboratory Medicine and Medical Sciences, College of Health Sciences, 
      University of KwaZulu-Natal, Durban, South Africa.
AD  - School of Public Health, University of the Witwatersrand, Johannesburg, South 
      Africa.
FAU - Millard, James
AU  - Millard J
AUID- ORCID: 0000-0001-6427-552X
AD  - Africa Health Research Institute, Durban, South Africa.
AD  - Wellcome Trust Liverpool Glasgow Centre for Global Health Research, Liverpool, 
      United Kingdom.
AD  - Institute of Infection and Global Health, University of Liverpool, Liverpool, 
      United Kingdom.
LA  - eng
GR  - WT_/Wellcome Trust/United Kingdom
GR  - MR/R010161/1/MRC_/Medical Research Council/United Kingdom
PT  - Journal Article
DEP - 20210801
PL  - United States
TA  - Open Forum Infect Dis
JT  - Open forum infectious diseases
JID - 101637045
PMC - PMC8403230
OTO - NOTNLM
OT  - QT interval prolongation
OT  - bedaquiline
OT  - tuberculosis
EDAT- 2021/09/02 06:00
MHDA- 2021/09/02 06:01
PMCR- 2021/08/01
CRDT- 2021/09/01 07:26
PHST- 2021/05/17 00:00 [received]
PHST- 2021/07/30 00:00 [accepted]
PHST- 2021/09/01 07:26 [entrez]
PHST- 2021/09/02 06:00 [pubmed]
PHST- 2021/09/02 06:01 [medline]
PHST- 2021/08/01 00:00 [pmc-release]
AID - ofab413 [pii]
AID - 10.1093/ofid/ofab413 [doi]
PST - epublish
SO  - Open Forum Infect Dis. 2021 Aug 1;8(8):ofab413. doi: 10.1093/ofid/ofab413. 
      eCollection 2021 Aug.