Latest advances in predicting DILI in human subjects: Focus on biomarkers

Expert Opinion on Drug Metabolism and Toxicology

Volumn 8, Issue 12, 2012, Pages 1521-1530

  Hawkins, Maiyen Tran ^a   Lewis, James H ^a  

^a GEORGETOWN UNIVERSITY HOSPITAL   (United States)

Author keywords

Biomarkers; Drug induced liver injury; Hepatotoxicity; Pharmacogenetics

Indexed keywords

ABACAVIR; ALLOPURINOL; AMOXICILLIN PLUS CLAVULANIC ACID; APOLIPOPROTEIN E; BIOLOGICAL MARKER; FLUCLOXACILLIN; GAMMA INTERFERON; GLUCURONOSYLTRANSFERASE 1A1; GLUTATHIONE TRANSFERASE M1; GLUTATHIONE TRANSFERASE T1; HLA ANTIGEN CLASS 2; HLA B ANTIGEN; HLA B57 ANTIGEN; HLA DQA1 ANTIGEN; HLA DRB1 ANTIGEN; HLA DRB5 ANTIGEN; INTERLEUKIN 1ALPHA; INTERLEUKIN 6; ISONIAZID; LAPATINIB; LUMIRACOXIB; METHYLDOPA; NITROFURANTOIN; PARACETAMOL; PAZOPANIB; TROGLITAZONE; TUBERCULOSTATIC AGENT; TUMOR NECROSIS FACTOR ALPHA; UNINDEXED DRUG; XIMELAGATRAN;

ACETYLATOR PHENOTYPE; DRUG HYPERSENSITIVITY; GENETIC ASSOCIATION; GENETIC POLYMORPHISM; GENOTYPE; HIGH RISK PATIENT; HUMAN; LIVER TOXICITY; METABOLOMICS; NONHUMAN; PHARMACOGENETICS; PREDICTION; PROTEOMICS; REVIEW; RISK ASSESSMENT; SKIN TOXICITY; STEVENS JOHNSON SYNDROME; TOXIC EPIDERMAL NECROLYSIS; TOXIC HEPATITIS; VALIDATION PROCESS;

ANTITUBERCULAR AGENTS; APOLIPOPROTEINS E; ARYLAMINE N-ACETYLTRANSFERASE; AZETIDINES; BENZYLAMINES; BIOLOGICAL MARKERS; DICLOFENAC; DRUG-INDUCED LIVER INJURY; FLOXACILLIN; HLA-B ANTIGENS; HUMANS; LIVER; METABOLOMICS; PHARMACOGENETICS; POLYMORPHISM, GENETIC; PROTEOMICS; RISK FACTORS;

ANIMALIA;

EID: 84869434683     PISSN: 17425255     EISSN: 17447607     Source Type: Journal    
DOI: 10.1517/17425255.2012.724060     Document Type: Review

References (85)

1. Przybylak KR, Cronin MT. In silico models for drug-induced liver injury-current status. Expert Opinion: Drug Metab Toxicol 2012;8:201-17
2. Amacher D. The discovery and development of proteomic safety biomarkers for the detection of drug-induced liver toxicity. Toxicol Apply Pharmacol 2010;245:134-42
3. Cheng F, Theodorescu D, Shulman I, Lee J. In vitro transcriptomic prediction of hepatotoxicity for early drug discovery. J Theor Biol 2011;290:27-36
4. Bauman J, Kelly J, Tripathy S, et al. Can in vitro metabolism-dependent binding data distinguish hepatotoxic from nonhepatotoxic drugs? An analysis using human hepatocytes and liver S-9 fraction. Chem Res Toxicol 2009;2:332-40
5. Mandenius C, Andersson T, Alves P, et al. Toward preclinical predictive drug testing for metabolism and hepatotoxicity by using in vitro models derived from human embryonic stem cells and human cell lines-a report of the Vitrocellomics EU-project. Altern Lan Anim 2011;2:147-71
6. Liu Z, Shi Q, Ding D, et al. Translating clinical findings into knowledge in drug safety evaluation-drug induced liver injury prediction systems (DILIps). PLoS Comput Biol 2011;7:e1002310
7. Shi Q, Hong H, Senoir J, Tong W. Biomarkers for drug-induced liver injury. Expert Rev Gastroenterol Hepatol 2010;4:225-34
8. Zhang M, Chen M, Tong W. Is toxicogenomics a more reliable and sensitive biomarker than conventional indicators from rats to predict drug-induced injury in humans. Chem Res Toxicol 2012;25:122-9
9. Liss G, Rattan S, Lewis J. Predicting and preventing acute drug-induced liver injury: what's new in 2010. Expert Opinion: Drug Metab Toxicol 2010;9:1-15
10. Graham D, Drinkard C, Shatin D, et al. Liver enzyme monitoring in patients treated with troglitazone. JAMA 2001;286:831-3
11. Guidance for Industry. Drug-Induced Liver Injury: Pre-marketing Clinical Evaluation. July 2009. U.S. Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research. Center for Biologics Evaluation and Research. Accessed from http://www.fda.gov/Drugs/ GuidanceComlianceRegulatory Information/guidances/default.htm [Last accessed 25 June 2012]
12. Zimmerman HJ. Hepatotoxicity. The adverse effects of drugs and other chemicals on the liver. 2nd edition. Lippincott Williams & Wilkins; Philadelphia:1999
13. Singla R, Sharma S, Mohan A, et al. Evaluation of risk factors for antituberculosis treatment induced hepatotoxicity. Indian J Med Res 2010;132:81-6
14. Bjornsson E, Olsson R. Outcome and prognostic markers in severe drug-induced liver disease. Hepatology 2005;42:481-90
15. Devarbhavi H, Dierkhising R, Kremers W, et al. Single-center experience with drug-induced liver injury from India: causes, outcome, prognosis, and predictors of mortality. Am J Gastroenterol 2010;105:2396-404
16. Andrade R, Lucena MI, Fernandez C, et al. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology 2005;129:512-21
17. Chalasani N, Fontana RJ, Bonjovsky HL, et al. Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the united States. Gastroenterology 2008;135:1924-34
18. Lucena M, Andrade R, Kaplowitz N, et al. Phenotypic characterization of idiosyncratic drug-induced liver injury: the influence of age and sex. Hepatology 2009;49:2001-9
19. Reuben A, Koch DG, Lee WM, et al. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology 2010;52:2065-76
20. Lammert C, Einarsson S, Saha C, et al. Relationship between daily dose of oral medications and idiosyncratic drug-induced liver injury: search for signals. Hepatology 2008;47:2003-9
21. Stepan A, Walker D, Bauman J, et al. Structural alert/reactive metabolite concept as applied in medicinal chemistry to mitigate the risk of idiosyncratic drug toxicity: a perspective based on the critical examination of trends in the top 200 drugs marketed in the Unites States. Chem Res Toxicol 2011;24:1345-410
22. Laverty H, Antoine D, Benson C, et al. The potential of cytokines as safety biomarkers for drug-induced liver injury. Eur J Clin Pharmacol 2010;66:961-76
23. Cosgrove B, Alexopoulos L, Hang T, et al. Cytokine-associated drug toxicity in human hepatocytes is associated with signaling network dysregulation. Mol Biosyst 2010;6:1195-206
24. Daly AK, Donaldson PT, Bhatnagar P, et al. HLA-B*5701 genotype is a major determinant of drug-induced liver injury due to flucloxacillin. Nat Genet 2009;41:816-19
25. Daly AK. Drug-induced liver injury: past, present, and future. Pharmacogenomics 2010;5:607-11
26. Daly AK, Day CP. Genetic association studies in drug-induced liver injury. Semin Liver Dis 2009;29:400-11
27. Watkins PB. Biomarkers for the diagnosis and management of drug-induced liver injury. Semin Liver Dis 2009;4:393-9
28. Russman S, Jetter A, Kullak-Ublick G. Pharmacogenetics of drug-induced liver injury. Hepatology 2010;52:748-861
29. Lucena M, Molokhia M, Shen Y, et al. Susceptibility to amoxicillin-clavulanate-induced liver injury is influenced by multiple HLA class I and II alleles. Gastroenterology 2011;141:338-47
30. Donaldson PT, Daly AK, Henderson J, et al. Human leucocyte antigen class II genotype in susceptibility and resistance to co-amoxiclav-induced liver injury. J Hepatol 2010;53:1049-53
31. Daly AK. Using the genome-wide association studies to identify genes important in serious adverse drug reactions. Annu Rev Pharmacol Toxicol 2012;52:21-35
32. Spraggs C, Parham L, Hunt C, et al. Lapatinib-induced liver injury characterized by class II HLA and Gilbert's syndrome genotypes. Clin Pharm Ther 2012;91:647-52
33. Keisu M, Andersson TB. Drug-induced liver injury in humans: the case of ximelagatran. Handb Exp Pharmacol 2010;196:407-18
34. Mallal S, Phillips E, Carosi G, et al. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med 2008;358:568-79
35. Phillips E, Mallal S. Successful translation of pharmacogenetics into the clinic: the abacavir example. Mol Diagn Ther 2009;13:1-9
36. Phillips E, Mallal S. Pharmacogenetics of drug hypersensitivity. Pharmacogenomics 2010;11:973-87
37. Berka N, Gill J, Liacini A, et al. Human leukocyte antigen (HLA) and pharmacogenetics: screening for HLA-B*57:01 among human immunodeficiency virus-positive patients from southern Alberta. Hum Immunol 2012;73:164-7
38. Overview: abacavir. Accessed from http://livertox.nlm.nih.gov/abacavir. htm [Last accessed 7 August 2012]
39. Martin M, Klein T, Dong B, et al. Clinical pharmacogenetics implementation consortium guidelines for HLA-B genotype and abacavir dosing. Clin Pharmacol Ther 2012;91:734-8
40. Soni S, Churchill D, and Gilleece Y. Abacavir-induced hepatotoxocity: a report of two cases. AIDS 2008;30:2557-8
41. Teixera R, Morato R, Cabello P, et al. Genetic polymorphisms of NAT2, CYP2E1 and GST enzymes and the occurrence of antituberculosis drug-induced hepatitis in Brazilian TB patients. Mem Inst Oswaldo Cruz 2011;106:716-24
42. Chang J, Liu E, Lee C, et al. UGTA1 polymorphisms associated with risk of induced liver disorders by anti-tuberculosis medications. Int J tuberc Lung Dis 2012;16:376-8
43. An H, Wu X, Wang Z, et al. NAT 2 and CYPE1 polymorphisms associated with antituberculosis drug-induce hepatotoxicity in Chinese patients. Clin Exp Pharmacol Physiol 2012;39:535-43
44. Tang S, Lv X, Zhang Y, et al. CYP2E1, GSTM1, and GSTT1 genetic polymorphisms and susceptibility to antituberculosis drug-induced hepatotoxicity: a nested case-control study. J Clin Pharm Ther [Epub ahead of print]
45. Ben Mahmoud L, Ghozzi H, Kamoun A, et al. Polymorphism of the N-acetyltransferase 2 gene as a susceptibility risk factor for antituberculosis drug-induced hepatotoxicity in Tunisian patients with tuberculosis. Pathol Bio (Paris) 2011;[Epub ahead of print]
46. An H, Wu X, Wang Z, et al. The associations of polymorphism of N-acetyltransferase 2 gene is associated with antituberculosis drug-induced hepatotoxicity in tuberculosis patients. Zhonghua Yu Fang Yi Xue Za Zhi 2011;45:36-40
47. Nanashima K, Mawatari T, Tahara N, et al. Genetic variants in antioxidant pathway: risk factors for hepatoxicity for tuberculosis patients. Tuberculosis (Edinb) 2012;92:253-9
48. Park W, Kim W, Lee K, et al. Antituberculosis drug-induced liver injury in chronic hepatitis and cirrhosis. J of Infect 2010;61:323-9
49. Winnike J, Wright F, Macdonald J, et al. Use of pharmaco-metabonomics for early prediction of acetaminophen-induced hepatotoxicity in humans. Clin Pharmacol Ther 2010;88:45-51
50. Buchard A, Eefsen M, Semb S, et al. The role of the glutathione S-transferase genes GSTT1, GSTM1, and GSTP1 in acetaminophen-poisoned patients. Clin Toxicol 2012;50:27-33
51. Zimmerman H, Maddrey W. Acetominophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure. Hepatology 1995;22:767-73
52. Khalid S, Lane J, Navarro V, Garcia-Tsao G. Use of over-the-counter analgesics is not associated with acute decompensation in patients with cirrhosis. Clin Gastroenterol Hepatol 2009;7:994-9
53. Rumack B. and Bateman D. Acetominophen and acetylcysteine dose and duration: past, present, and future. Clin Toxicol 2012;50:91-8
54. Waters N. The role of metabonomics at the interface between drug metabolism and safety assessment. Curr Drug Metab 2010;11:686-92
55. O'Connell T, Watkins P. The application of metabonomics to predict drug-induced liver injury. Clin Pharmacol Ther 2010;88:394-9
56. Leung L, Kalgutkar A, and Obach R. Metabolic activation in drug-induced liver injury. Drug Metab Rec 2012;44:18-33
57. Amacher DE. The primary role of hepatic metabolism in idiosyncratic drug-induced liver injury. Expert Opinion: Drug Metab Toxicol 2012;8:335-47
58. McBurney RN, Hines WM, Vontungeln LS, et al.The liver toxicity biomarker study phase I. Markers for the effects of tolcapone or entecapone. Toxicol Pathol 2012. [Epub ahead of print]
59. Huang J, Shi W, Zhang J, et al. Genomic indicators in the blood predict drug-induced liver injury. Pharmacogenomics J 2010;10:267-77
60. McBurney RN, Hines W, Von Tungelin LS, et al. The liver toxicity biomarker study: phase design and preliminary results. Toxicology Pathol 2009;37:52-64
61. Xu J, Dunn M, Smith A, et al. Assessment of hepatotoxicity potential of drug candidate molecules including kinase inhibitors by hepatocyte imaging assay technology and bile flux imaging assay technology. Methods mol Biol 2012;795:83-107
62. Van Summeren A, Renes J, van Delft J, et al. Proteomics in the search for mechanisms and biomarkers of drug-induced hepatotoxicity. Toxicol In Vitro 2012;26:373-85
63. Kostenko L, Kjer-Neilsen L, Nicholson I, et al. Rapid screening for the detection for HLA-B57 and HLA B58 in prevention of drug hypersensitivity. Tissue Antigens 2011;78:11-20
64. Kauf TL, Farkouh RA, Earnshaw SR, et al. Economic efficiency of genetic screening to inform the use of abacavir sulfate in the treatment of HIV. Pharmacoeconomics 2010;28:1025-39
65. Charneira C, Godinho A, Conceicao Oliveria M, et al. Reactive aldehyde metabolites from the anti-HIV drug Abacavir: amino acid adducts as possible factors in Abacavir toxicities. Chem Res Toxicol 2011;24:2129-41
66. Ostrov DA, Grant BJ, Pompeu YA, et al. Drug hypersensitivity caused by alteration of the MHC-presented self-peptide repertoire. Proc Natl Acad Sci USA 2012;[epub ahead of print]
67. Krawczyk M, Mullenbach R, Weber S, et al. Genome-wide association studies and genetic risk assessment of liver diseases. Nat Rev Gastroenterol Hepatol 2010;7:669-80
68. Bell L, Theodorakis J, Vuppalanchi R, et al. Serum proteomics and biomarker discovery across the spectrum of nonalcoholic fatty liver disease. Hepatology 2010;51:111-20
69. Bell L, Vuppalanchi R, Watkins P, et al. Serum proteomic profiling in patients with drug-induced liver injury. Alimentary Pharmacology and Therapeutics 2012;35:600-12
70. Ferre N, Martinez-Clemente M, Lopez-Parra M, et al. Increased susceptibility to exacerbated liver injury in hypercholesterolemic ApoE-deficient mice: potential involvement of oxysterols. Am J Physiol Gastrointest Liver Physiol 2009;296:G553-62
71. Van Summeren A, Renes J, Bouwman FG, et al. Proteomics investigations of drug-induced hepatotoxicity in HepG2 cells. Toxicol Sci 2011;120:109-22
72. Jaeschke H, McGill M, Ramachandran A. Letter to the Editor: pathophysiology relevance of proteomics investigations of drug-induced hepatotoxicity in HepG2 cells. Toxicol Sci 2011;121:428-30
73. Luo Y, Rana P, and Will Y. Palmitate increases the susceptibility of cells to drug-induced toxicity: an invitro method to identify drugs with potential contraindications in patients with metabolic disease. Toxicol Sci [Epub ahead of print]
74. Clayton T, Lindon J, Cloarec O, et al. Pharmaco-metabonomics phenotyping and personalized drug treatment. Nature 2006;440:1073-7
75. Lee S-W, Chung L S-C, Huang H-H, et al. NAT2 and CYP2E1 polymorphisms and susceptibility to first-line anti-tuberculosis drug-induced hepatitis. Int J Tuberc Lung Dis 2010;14:622-6
76. Kim S, Kim S, Yoon H, et al. TNF-alpha genetic polymorphism-308G/A and antituberculosis drug-induced hepatitis. Liver International 2011;1-6
77. Yimer G, Ueda N, Habtewold A, et al. Pharmacogenetic & pharmacokinetic biomarker for efavirenz based ARV and rifampin based anti-TB drug induced liver injury in TB-HIV infected patients. PLoS One 2011;6:1-8
78. Henderson C, Wolf C, Kitteringham N, et al. Increased resistance to acetaminophen toxicity in mice lacking glutathione S-transferase Pi. Proc Natl Acad Sci 2000;23:12741-5
79. Usui T, Hashizume T, Katsumata T, et al. In vitro investigation of the glutathione transferase M1 and T1 null genotypes as risk factors for troglitazone-induced liver injury. Drug Metab Dispos 2011;39:1303-10
80. Starkey Lewis PJ, Dear J, Platt V, et al. Circulative microRNAs as potential markers of human drug-induced liver injury. Hepatology 2011;54:1767-76
81. Adebayo D, Mookerjee RP, Jalan R. Mechanistic biomarkers in acute liver injury: are we there yet? J Hepatol 2012;56:1003-5
82. Lewis JH. The adaptive response (drug tolerance) helps prevent drug-induced liver disease. Gastroenterology & Hepatology 2012;8:5-333-6
83. Lee MH, Stocker SL, Anderson J, et al. Initiating allopurinol therapy: do we need to know the patient's human leucocyte antigen status? Intern Med J 2012;42:411-16
84. Xu C, Reck B, Xue Z, et al. Pazopanib-induced hyperbilirubinemia is associated with Gilbert's syndrome UGT1A1 polymorphism. Br J Cancer 2010;102:1371-7
85. Singer JB, Lewitzky S, Leroy E, et al. A genome-wide study identifies HLA alleles associated with lumiracoxib-related liver injury. Nat Genet 2010;42:711-14