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Adverse events are a concern to prescribers but have not been systematically studied at the standard dose, and the relationship between linezolid exposure and clinical toxicity is not completely elucidated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and methods<\/jats:title>\n                    <jats:p>We conducted an observational cohort study to describe the incidence and determinants of linezolid toxicity, and to determine a drug exposure threshold for toxicity, among patients with rifampicin-resistant TB in South Africa. Linezolid exposures were estimated from a population pharmacokinetic model. Mixed-effects modelling was used to analyse toxicity outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>One hundred and fifty-one participants, 63% HIV positive, were enrolled and followed for a median of 86 weeks. Linezolid was permanently discontinued for toxicity in 32 (21%) participants. Grade 3 or 4 linezolid-associated adverse events occurred in 21 (14%) participants. Mean haemoglobin concentrations increased with time on treatment (0.03 g\/dL per week; 95% CI 0.02\u20130.03). Linezolid trough concentration, male sex and age (but not HIV positivity) were independently associated with a decrease in haemoglobin &amp;gt;2 g\/dL. Trough linezolid concentration of 2.5 mg\/L or higher resulted in optimal model performance to describe changing haemoglobin and treatment-emergent anaemia (adjusted OR 2.9; 95% CI 1.3\u20136.8). SNPs 2706A &amp;gt; G and 3010G &amp;gt; A in mitochondrial DNA were not associated with linezolid toxicity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Permanent discontinuation of linezolid was common, but linezolid-containing therapy was associated with average improvement in toxicity measures. HIV co-infection was not independently associated with linezolid toxicity. Linezolid trough concentration of 2.5 mg\/L should be evaluated as a target for therapeutic drug monitoring.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jac\/dkac019","type":"journal-article","created":{"date-parts":[[2022,1,24]],"date-time":"2022-01-24T23:12:44Z","timestamp":1643065964000},"page":"1146-1154","source":"Crossref","is-referenced-by-count":43,"title":["Linezolid toxicity in patients with drug-resistant tuberculosis: a prospective cohort study"],"prefix":"10.1093","volume":"77","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3508-6719","authenticated-orcid":false,"given":"Sean","family":"Wasserman","sequence":"first","affiliation":[{"name":"Wellcome Centre for Infectious Diseases Research in Africa, Institute for Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa"},{"name":"Division of Infectious Diseases and HIV Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James C. M.","family":"Brust","sequence":"additional","affiliation":[{"name":"Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine & Montefiore Medical Center, Bronx, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2134-8749","authenticated-orcid":false,"given":"Mahmoud T.","family":"Abdelwahab","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Little","sequence":"additional","affiliation":[{"name":"Department of Statistical Sciences, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Denti","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, University of Cape Town, Cape Town, South 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