{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T13:41:09Z","timestamp":1791726069514,"version":"4.3.4"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2022,3,4]],"date-time":"2022-03-04T00:00:00Z","timestamp":1646352000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Harvard Medical School Center for Global Health Delivery"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,10,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Concomitant use of bedaquiline (Bdq) and delamanid (Dlm) for multi-drug\/rifampicin resistant tuberculosis (MDR\/RR-TB) has raised concerns about a potentially poor risk-benefit ratio. Yet this combination is an important alternative for patients infected with strains of TB with complex drug resistance profiles or who cannot tolerate other therapies. We assessed safety and treatment outcomes of MDR\/RR-TB patients receiving concomitant Bdq and Dlm, along with other second-line anti-TB drugs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a multi-centric, prospective observational cohort study across 14 countries among patients receiving concomitant Bdq-Dlm treatment. Patients were recruited between April 2015 and September 2018 and were followed until the end of treatment. All serious adverse events and adverse events of special interest (AESI), leading to a treatment change, or judged significant by a clinician, were systematically monitored and documented.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 472 patients received Bdq and Dlm concomitantly. A large majority also received linezolid (89.6%) and clofazimine (84.5%). Nearly all (90.3%) had extensive disease; most (74.2%) had resistance to fluoroquinolones. The most common AESI were peripheral neuropathy (134, 28.4%) and electrolyte depletion (94, 19.9%). Acute kidney injury and myelosuppression were seen in 40 (8.5%) and 24 (5.1%) of patients, respectively. QT prolongation occurred in 7 patients (1.5%). Overall, 78.0% (358\/458) had successful treatment outcomes, 8.9% died, and 7.2% experienced treatment failure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Concomitant use of Bdq and Dlm, along with linezolid and clofazimine, is safe and effective for MDR\/RR-TB patients with extensive disease. Using these drugs concomitantly is a good therapeutic option for patients with resistance to many anti-TB drugs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciac176","type":"journal-article","created":{"date-parts":[[2022,3,1]],"date-time":"2022-03-01T15:10:34Z","timestamp":1646147434000},"page":"1307-1314","source":"Crossref","is-referenced-by-count":38,"title":["Safety and Effectiveness Outcomes From a 14-Country Cohort of Patients With Multi-Drug Resistant Tuberculosis Treated Concomitantly With Bedaquiline, Delamanid, and Other Second-Line Drugs"],"prefix":"10.1093","volume":"75","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0302-9063","authenticated-orcid":false,"given":"Helena","family":"Huerga","sequence":"first","affiliation":[{"name":"Field Epidemiology Department, Epicentre , Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uzma","family":"Khan","sequence":"additional","affiliation":[{"name":"Interactive Research and Development (IRD) Global , Singapore , Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathieu","family":"Bastard","sequence":"additional","affiliation":[{"name":"Field Epidemiology Department, Epicentre , Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carole D","family":"Mitnick","sequence":"additional","affiliation":[{"name":"Department of Global Health and Social Medicine, Harvard Medical School , Boston, Massachusetts , USA"},{"name":"Partners In Health , Boston, Massachusetts , USA"},{"name":"Division of Global Health Equity, Brigham and Women\u2019s Hospital , Boston, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Lachenal","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Unit, M\u00e9decins Sans Fronti\u00e8res , Geneva , Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Palwasha Y","family":"Khan","sequence":"additional","affiliation":[{"name":"Interactive Research and Development (IRD) Global , Singapore , Singapore"},{"name":"Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine , London , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kwonjune J","family":"Seung","sequence":"additional","affiliation":[{"name":"Department of Global Health and Social Medicine, Harvard Medical School , Boston, Massachusetts , USA"},{"name":"Partners In Health , Boston, Massachusetts , USA"},{"name":"Division of Global Health Equity, Brigham and Women\u2019s Hospital , Boston, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nara","family":"Melikyan","sequence":"additional","affiliation":[{"name":"Field Epidemiology Department, Epicentre , Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saman","family":"Ahmed","sequence":"additional","affiliation":[{"name":"Interactive Research and Development (IRD) , Karachi , Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael L","family":"Rich","sequence":"additional","affiliation":[{"name":"Department of Global Health and Social Medicine, Harvard Medical School , Boston, Massachusetts , USA"},{"name":"Partners In Health , Boston, Massachusetts , USA"},{"name":"Division of Global Health Equity, Brigham and Women\u2019s Hospital , Boston, Massachusetts , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francis","family":"Varaine","sequence":"additional","affiliation":[{"name":"Medical Department, M\u00e9decins Sans Fronti\u00e8res , Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elna","family":"Osso","sequence":"additional","affiliation":[{"name":"Department of Global Health and Social Medicine, Harvard Medical School , Boston, Massachusetts , USA"},{"name":"Pharmacovigilance Unit, M\u00e9decins Sans Fronti\u00e8res , Geneva , Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makhmujan","family":"Rashitov","sequence":"additional","affiliation":[{"name":"Partners In Health , Almaty , Kazakhstan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naseem","family":"Salahuddin","sequence":"additional","affiliation":[{"name":"Indus Hospital and Health Network (IHHN) , Karachi , Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gocha","family":"Salia","sequence":"additional","affiliation":[{"name":"Medical Department, M\u00e9decins Sans Fronti\u00e8res , Tbilisi , Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Epifanio","family":"S\u00e1nchez","sequence":"additional","affiliation":[{"name":"Hospital Nacional Sergio Bernales Hospital , Lima , 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