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Programme","award":["TB\/HIV\/AIDS-01-2014"],"award-info":[{"award-number":["TB\/HIV\/AIDS-01-2014"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,12,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Bedaquiline improves treatment outcomes in patients with rifampin-resistant (RR) tuberculosis but prolongs the QT interval and carries a black-box warning from the US Food and Drug Administration. The World Health Organization recommends that all patients with RR tuberculosis receive a regimen containing bedaquiline, yet a phase 3 clinical trial demonstrating its cardiac safety has not been published.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted an observational cohort study of patients with RR tuberculosis from 3 provinces in South Africa who received regimens containing bedaquiline. We performed rigorous cardiac monitoring, which included obtaining electrocardiograms in triplicate at 4 time points during bedaquiline therapy. Participants were followed up until the end of therapy or 24 months. Outcomes included final tuberculosis treatment outcome and QT interval prolongation (QT prolongation), defined as any QT interval corrected by the Fridericia method (QTcF) &amp;gt;500 ms or an absolute change from baseline (\u0394QTcF) &amp;gt;60 ms.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We enrolled 195 eligible participants, of whom 40% had extensively drug-resistant tuberculosis. Most participants (97%) received concurrent clofazimine. Of the participants, 74% were cured or successfully completed treatment, and outcomes did not differ by human immunodeficiency virus status. QTcF continued to increase throughout bedaquiline therapy, with a mean increase (standard deviation) of 23.7 (22.7) ms from baseline to month 6. Four participants experienced a QTcF &amp;gt;500 ms and 19 experienced a \u0394QTcF &amp;gt;60 ms. Older age was independently associated with QT prolongation. QT prolongation was neither more common nor more severe in participants receiving concurrent lopinavir-ritonavir.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Severe QT prolongation was uncommon and did not require permanent discontinuation of either bedaquiline or clofazimine. Close monitoring of the QT interval may be advisable in older patients.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciab335","type":"journal-article","created":{"date-parts":[[2021,4,17]],"date-time":"2021-04-17T01:13:53Z","timestamp":1618622033000},"page":"2083-2092","source":"Crossref","is-referenced-by-count":48,"title":["Effectiveness and Cardiac Safety of Bedaquiline-Based Therapy for Drug-Resistant Tuberculosis: A Prospective Cohort Study"],"prefix":"10.1093","volume":"73","author":[{"given":"James C M","family":"Brust","sequence":"first","affiliation":[{"name":"Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine & Montefiore Medical Center, Bronx, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neel R","family":"Gandhi","sequence":"additional","affiliation":[{"name":"Departments of Epidemiology & Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, 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V","family":"Omar","sequence":"additional","affiliation":[{"name":"Centre for Tuberculosis, National Institute for Communicable Diseases, Johannesburg, South Africa"},{"name":"Department of Molecular Medicine & Haematology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nazir A","family":"Ismail","sequence":"additional","affiliation":[{"name":"Centre for Tuberculosis, National Institute for Communicable Diseases, Johannesburg, South Africa"},{"name":"Department of Molecular Medicine & Haematology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela","family":"Campbell","sequence":"additional","affiliation":[{"name":"Departments of Epidemiology & Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, 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Italian Multidrug-Resistant Tuberculosis Outbreak Study Group","volume":"12","author":"Moro","year":"1998","journal-title":"AIDS"},{"key":"2021121022423945500_CIT0012","doi-asserted-by":"crossref","first-page":"1701462","DOI":"10.1183\/13993003.01462-2017","article-title":"Cardiac safety of bedaquiline: a systematic and critical analysis of the evidence","volume":"50","author":"Pontali","year":"2017","journal-title":"Eur Respir J"},{"key":"2021121022423945500_CIT0013","doi-asserted-by":"crossref","first-page":"943","DOI":"10.1164\/rccm.201410-1801OC","article-title":"Bactericidal activity of pyrazinamide and clofazimine alone and in combinations with pretomanid and bedaquiline","volume":"191","author":"Diacon","year":"2015","journal-title":"Am J Respir Crit Care Med"},{"key":"2021121022423945500_CIT0014","doi-asserted-by":"crossref","first-page":"402","DOI":"10.1016\/S0140-6736(20)31316-7","article-title":"Mortality in adults with multidrug-resistant tuberculosis and HIV by 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