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Drug rechallenge following drug-induced liver injury

Hunt, Christine M., Papay, Julie I., Stanulovic, Vid, Regev, Arie·2017·Hepatology
DOI 10.1002/hep.29152
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Abstract

Drug‐induced hepatocellular injury is identified internationally by alanine aminotransferase (ALT) levels equal to or exceeding 5× the upper limit of normal (ULN) appearing within 3 months of drug initiation, after alternative causes are excluded. Upon withdrawing the suspect drug, ALT generally decrease by 50% or more. With drug readministration, a positive rechallenge has recently been defined by an ALT level of 3‐5× ULN or greater. Nearly 50 drugs are associated with positive rechallenge after drug‐induced liver injury (DILI): antimicrobials; and central nervous system, cardiovascular and oncology therapeutics. Drugs associated with high rates of positive rechallenge exhibit multiple risk factors: daily dose >50 mg, an increased incidence of ALT elevations in clinical trials, immunoallergic clinical injury, and mitochondrial impairment in vitro . These drug factors interact with personal genetic, immune, and metabolic factors to influence positive rechallenge rates and outcomes. Drug rechallenge following drug‐induced liver injury is associated with up to 13% mortality in prospective series of all prescribed drugs. In recent oncology trials, standardized systems have enabled safer drug rechallenge with weekly liver chemistry monitoring during the high‐risk period and exclusion of patients with hypersensitivity. However, high positive rechallenge rates with other innovative therapeutics suggest that caution should be taken with rechallenge of high‐risk drugs. Conclusion : For critical medicines, drug rechallenge may be appropriate when 1) no safer alternatives are available, 2) the objective benefit exceeds the risk, and 3) patients are fully informed and consent, can adhere to follow‐up, and alert providers to hepatitis symptoms. To better understand rechallenge outcomes and identify key risk factors for positive rechallenge, additional data are needed from controlled clinical trials, prospective registries, and large health care databases. (H epatology 2017;66:646–654).

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Research works printed but not linked: 55

  1. 2002, Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States, Ann Intern Med, 137, 947, 10.7326/0003-4819-137-12-200212170-00007 · DOI · Paper page
  2. 2015, Population‐representative incidence of drug‐induced acute liver failure based on an analysis of an integrated health care system, Gastroenterology, 148, 1353, 10.1053/j.gastro.2015.02.050 · DOI
  3. 2015, Features and outcomes of 899 patients with drug‐induced liver injury: the DILIN prospective study, Gastroenterology, 148, 1340, 10.1053/j.gastro.2015.03.006 · DOI · Paper page
  4. 2015, Drug‐induced liver injury associated with stevens‐Johnson syndrome/toxic epidermal necrolysis: patient characteristics, causes, and outcome in 36 cases, Hepatology, 63, 993
  5. 2011, Case definition and phenotype standardization in drug‐induced liver injury, Clin Pharmacol Ther, 89, 806, 10.1038/clpt.2011.58 · DOI · Paper page
  6. 2005, Recognizing drug‐induced liver injury: current problems, possible solutions, Toxicol Pathol, 33, 155, 10.1080/01926230590522356 · DOI
  7. 2010, Oral medications with significant hepatic metabolism at higher risk for hepatic adverse events, Hepatology, 51, 615, 10.1002/hep.23317 · DOI
  8. 1993, Causality assessment of adverse reactions to drugs—I. A novel method based on the conclusions of international consensus meetings: application to drug‐induced liver injuries, J Clin Epidemiol, 46, 1323, 10.1016/0895-4356(93)90101-6 · DOI · Paper page
  9. 1993, Causality assessment of adverse reactions to drugs—II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge, J Clin Epidemiol, 46, 1331, 10.1016/0895-4356(93)90102-7 · DOI · Paper page
  10. 1999, Accuracy of hepatic adverse drug reaction reporting in one English health region, BMJ, 319, 1541, 10.1136/bmj.319.7224.1541 · DOI
  11. 2015, Characterisation of liver chemistry abnormalities associated with pazopanib monotherapy: a systematic review and meta‐analysis of clinical trials in advanced cancer patients, Eur J Cancer, 51, 1293, 10.1016/j.ejca.2015.03.019 · DOI
  12. 2010, Safety of 3 different reintroduction regimens of antituberculosis drugs after development of antituberculosis treatment–induced hepatotoxicity, Clin Infect Dis, 50, 833, 10.1086/650576 · DOI
  13. 2001, The management of anti‐tuberculosis drug‐induced hepatotoxicity, Int J Tuberc Lung Dis, 5, 65
  14. 1971, Post‐halothane jaundice in relation to previous administration of halothane, Br Med J, 3, 18, 10.1136/bmj.3.5765.18 · DOI
  15. 2009, Rechallenge in drug‐induced liver injury: the attractive hazard, Expert Opin Drug Saf, 8, 709, 10.1517/14740330903397378 · DOI · Paper page
  16. 2009, Drug‐induced liver injury following positive drug rechallenge, Regul Toxicol Pharmacol, 54, 84, 10.1016/j.yrtph.2009.03.003 · DOI
  17. 2010, The evaluation of drug rechallenge: the casopitant phase III program, Regul Toxicol Pharmacol, 58, 539, 10.1016/j.yrtph.2010.09.014 · DOI
  18. 2016, Categorization of drugs implicated in causing liver injury: critical assessment based on published case reports, Hepatology, 63, 590, 10.1002/hep.28323 · DOI · Paper page
  19. 2012, A pre‐marketing ALT signal predicts post‐marketing liver safety, Regul Toxicol Pharmacol, 63, 433, 10.1016/j.yrtph.2012.05.016 · DOI
  20. 2010, Mitochondrial and immunoallergic injury increase risk of positive drug rechallenge after drug‐induced liver injury: a systematic review, Hepatology, 52, 2216, 10.1002/hep.24022 · DOI
  21. 2014, Human drug‐induced liver injury severity is highly associated with dual inhibition of liver mitochondrial function and bile salt export pump, Hepatology, 60, 1015, 10.1002/hep.27206 · DOI · Paper page
  22. 2008, Relationship between daily dose of oral medications and idiosyncratic drug‐induced liver injury: search for signals, Hepatology, 47, 2003, 10.1002/hep.22272 · DOI
  23. 2013, Reduced mitochondrial DNA content and heterozygous nuclear gene mutations in patients with acute liver failure, J Pediatr Gastroenterol Nutr, 57, 438, 10.1097/MPG.0b013e31829ef4b4 · DOI
  24. 2016, Deep sequencing reveals novel genetic variants in children with acute liver failure and tissue evidence of impaired energy metabolism, PloS One, 11, e0156738, 10.1371/journal.pone.0156738 · DOI
  25. 2009, Outcome of liver transplantation for drug‐induced acute liver failure in the United States: analysis of the United Network for Organ Sharing database, Liver Transpl, 15, 719, 10.1002/lt.21692 · DOI
  26. 2015, Drug‐induced liver injury: interactions between drug properties and host factors, J Hepatol, 63, 503, 10.1016/j.jhep.2015.04.016 · DOI
  27. 2016, Outcomes in adults with acute liver failure between 1998 and 2013: an observational cohort study, Ann Intern Med, 164, 724, 10.7326/M15-2211 · DOI · Paper page
  28. 2012, Genetic association studies in drug‐induced liver injury, Drug Metab Rev, 44, 116, 10.3109/03602532.2011.605790 · DOI
  29. 2002, Association between presence of HLA‐B* 5701, HLA‐DR7, and HLA‐DQ3 and hypersensitivity to HIV‐1 reverse‐transcriptase inhibitor abacavir, Lancet, 359, 727, 10.1016/S0140-6736(02)07873-X · DOI · Paper page
  30. 1995, Drug‐induced “allergic hepatitis, Clin Rev Allergy Immunol, 13, 223, 10.1007/BF02771763 · DOI
  31. 2002, Epidemiology and individual susceptibility to adverse drug reactions affecting the liver, Semin Liver Dis, 22, 145, 10.1055/s-2002-30105 · DOI
  32. 2002, Halothane, isoflurane and sevoflurane inhibit NADH: ubiquinone oxidoreductase (complex I) of cardiac mitochondria, J Physiol, 544, 687, 10.1113/jphysiol.2002.025015 · DOI
  33. 2004, Inhibitory effects of halothane on the thermogenic pathway in brown adipocytes: localization to adenylyl cyclase and mitochondrial fatty acid oxidation, Biochem Pharmacol, 68, 463, 10.1016/j.bcp.2004.03.028 · DOI
  34. 2007, The significance of mitochondrial toxicity testing in drug development, Drug Discov Today, 12, 777, 10.1016/j.drudis.2007.07.013 · DOI
  35. 2016, P450 3A‐catalyzed O‐dealkylation of lapatinib induces mitochondrial stress and activates Nrf2, Chem Res Toxicol, 29, 784, 10.1021/acs.chemrestox.5b00524 · DOI
  36. 2014, Prospective validation of HLA‐DRB1* 07: 01 allele carriage as a predictive risk factor for lapatinib‐induced liver injury, J Clin Oncol, 32, 2296, 10.1200/JCO.2013.52.9867 · DOI
  37. 2012, Human metabolism of lapatinib, a dual kinase inhibitor: implications for hepatotoxicity, Drug Metab Dispos, 40, 139, 10.1124/dmd.111.040949 · DOI
  38. 2009, Pharmacometabonomic identification of a significant host‐microbiome metabolic interaction affecting human drug metabolism, Proc Natl Acad Sci U S A, 106, 14728, 10.1073/pnas.0904489106 · DOI · Paper page
  39. 2016, Mechanisms of adaptation and progression in idiosyncratic drug induced liver injury, clinical implications, Liver Int, 36, 158, 10.1111/liv.12988 · DOI
  40. 2017, New approaches to investigate drug‐induced hypersensitivity, Chem Res Toxicol, 30, 239, 10.1021/acs.chemrestox.6b00333 · DOI
  41. 2012, Prediction of liver injury induced by chemicals in human with a multiparametric assay on isolated mouse liver mitochondria, Toxicol Sci, 129, 332, 10.1093/toxsci/KFS197 · DOI
  42. 2016, Effects of 31 FDA approved small‐molecule kinase inhibitors on isolated rat liver mitochondria, Arch Toxicol
  43. 2015, Minimizing DILI risk in drug discovery—a screening tool for drug candidates, Toxicol In Vitro, 30, 429, 10.1016/j.tiv.2015.09.019 · DOI · Paper page
  44. 2015, Evaluation of multiple mechanism‐based toxicity endpoints in primary cultured human hepatocytes for the identification of drugs with clinical hepatotoxicity: results from 152 marketed drugs with known liver injury profiles, Chem Biol Interact, 255, 3
  45. 2012, Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds, Chem Res Toxicol, 25, 2067, 10.1021/tx300075j · DOI
  46. 2015, Combined nivolumab and ipilimumab or monotherapy in untreated melanoma, N Engl J Med, 373, 23, 10.1056/NEJMoa1504030 · DOI · Paper page
  47. 2016, Can rechallenge be done safely after mild or moderate drug‐induced liver injury?, Hepatology, 63, 691, 10.1002/hep.28353 · DOI
  48. 2016, HLA‐B* 57: 01 Confers susceptibility to pazopanib‐associated liver injury in patients with cancer, Clin Cancer Res, 22, 1371, 10.1158/1078-0432.CCR-15-2044 · DOI
  49. 2002, Evaluation of clinical and immunogenetic risk factors for the development of hepatotoxicity during antituberculosis treatment, Am J Respir Crit Care Med, 166, 916, 10.1164/rccm.2108091 · DOI
  50. 2003, In vitro studies on the toxicity of isoniazid in different cell lines, Hum Exp Toxicol, 22, 607, 10.1191/0960327103ht401oa · DOI
  51. 2016, Mechanism of isoniazid‐induced hepatotoxicity: then and now, Br J Clin Pharmacol, 81, 1030, 10.1111/bcp.12885 · DOI
  52. 2013, Genetic characterization to improve interpretation and clinical management of hepatotoxicity caused by tyrosine kinase inhibitors, Pharmacogenomics, 14, 541, 10.2217/pgs.13.24 · DOI
  53. 2015, Clinical pattern of tolvaptan‐associated liver injury in subjects with autosomal dominant polycystic kidney disease: analysis of clinical trials database, Drug Saf, 38, 1103, 10.1007/s40264-015-0327-3 · DOI
  54. 2013, Intentional rechallenge: does the benefit outweigh the risk?, Drug Saf, 36, 155, 10.1007/s40264-013-0020-3 · DOI
  55. 2013, Idiosyncratic adverse drug reactions: current concepts, Pharmacol Rev, 65, 779, 10.1124/pr.113.007450 · DOI

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Metadata

Authors
Hunt, C. M., Papay, J. I., Stanulovic, V., & Regev, A.
Affiliations
  • Department of Medicine,Duke University Medical Center,Durham,NC
  • Global Patient Safety,UCB BioSciences,Research Triangle Park,NC
  • Accelsiors Clinical Research Organization and Consultancy,Budapest,Hungary
  • Global Patient Safety,Eli Lilly and Company,Indianapolis,IN
ORCID
Hunt, Christine M.
Venue
Hepatology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2017-06-26
Volume
66
Issue
2
Pages
646-654
ISSN
  • 0270-9139
  • 1527-3350
DOI
10.1002/hep.29152
Cited by
72
References
2
Language
en
Licence

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