{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T11:34:40Z","timestamp":1781782480077,"version":"3.54.5"},"reference-count":40,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2024,10,10]],"date-time":"2024-10-10T00:00:00Z","timestamp":1728518400000},"content-version":"vor","delay-in-days":9,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000691","name":"Academy of Medical Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000691","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>We compared performance of the Roussel Uclaf Causality Assessment Method (RUCAM) with multidisciplinary expert panel review in identifying a drug\u2010induced liver injury (DILI) due to antituberculosis therapy (ATT) and\/or antiretroviral therapy (ART).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Cases were drawn from a prospective registry of hospitalised adults with suspected DILI due to ATT and\/or ART in Cape Town, South Africa. Participants had to fulfil American Thoracic Society criteria for ATT interruption (alanine transaminase [ALT] \u22655 times upper limit of normal [ULN]\/ALT \u22653 times [ULN] and symptomatic). Causality assessment by expert panel review served as reference standard. The panel ranked potentially implicated drugs as certain, probable, possible or unlikely causes guided by World Health Organization Uppsala Monitoring Centre criteria. The RUCAM was performed for each potentially implicated drug. We calculated sensitivity and specificity of the RUCAM in identifying a probable\/certain drug cause for liver injury.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We included 48 participants. All were people with HIV (PWH). Twenty\u2010seven were on concomitant ART and ATT, with a median of six potentially hepatotoxic drugs per case. Sensitivity and specificity of the RUCAM in identifying a probable\/certain drug cause of liver injury compared with expert panel review was 7% and 100% respectively. Implicated drugs (times ranked probable\/certain by panel) were isoniazid (18\/0), pyrazinamide (17\/0), rifampicin (15\/1), efavirenz (6\/4) and lopinavir\/ritonavir (1\/0).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>PWH with liver injury received multiple potentially implicated drugs, which may increase liver injury risk and complicate causality assessment. Compared with expert panel review, the RUCAM had low sensitivity in detecting probable or certain drug causes of liver injury.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5883","type":"journal-article","created":{"date-parts":[[2024,10,10]],"date-time":"2024-10-10T12:51:19Z","timestamp":1728564679000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Liver Injury in People With <scp>HIV<\/scp> on Antituberculosis and\/or Antiretroviral Therapy\u2014Assessing Causality Using the Updated Roussel Uclaf Causality Assessment Method"],"prefix":"10.1002","volume":"33","author":[{"given":"H.\u00a0M.","family":"Gunter","sequence":"first","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Tatz","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Maartens","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.\u00a0W.","family":"Spearman","sequence":"additional","affiliation":[{"name":"Division of Hepatology, Department of Medicine Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"U.","family":"Mehta","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital  Cape Town South Africa"},{"name":"Centre for Infectious Disease Epidemiology and Research, School of Public Health, University of Cape Town  Cape Town South\u00a0Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1892-4207","authenticated-orcid":false,"given":"K.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,10,10]]},"reference":[{"key":"e_1_2_11_2_1","volume-title":"WHO Global Lists of High Burden Countries for Tuberculosis (TB), TB\/HIV and TB (MDR\/RR\u2010TB), 2021\u20132025","author":"World Health Organization","year":"2021"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/0041\u20103879(77)90022\u20108"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2010.08.024"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12567"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000003437"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.7196\/SAMJ.5650"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/0895-4356(93)90101-6"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23577"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.5009\/gnl15114"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/0895\u20104356(93)90102\u20107"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13593"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e32814e6b08"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.7861\/clinmedicine.16\u20106\u2010s104"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/cld.365"},{"key":"e_1_2_11_16_1","unstructured":"World Health Organization \u201cThe Use of the WHO\u2010UMC System for Standardised Case Causality Assessment \u201dhttps:\/\/who\u2010umc.org\/media\/164200\/who\u2010umc\u2010causality\u2010assessment_new\u2010logo.pdf."},{"key":"e_1_2_11_17_1","first-page":"317","article-title":"Standardization of Definitions and Criteria of Causality Assessment of Adverse Drug Reactions. 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