Drug-drug interactions with oral anti-HCV agents and idiosyncratic hepatotoxicity in the liver transplant setting

Journal of Hepatology

Volumn 60, Issue 4, 2014, Pages 872-884

  Tischer, Sarah ^a   Fontana, Robert J ^b  

^a UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

Author keywords

Antiviral therapy; Calcineurin inhibitors; Cytochrome P450; Hepatitis C; Immunosuppression

Indexed keywords

ABT 267; ABT 333; ABT 450; ANTIBIOTIC AGENT; ANTIVIRUS AGENT; BI 20335; BI 207127; BOCEPREVIR; CALCINEURIN INHIBITOR; CREATININE; CYCLOSPORIN; DACLATASVIR; DELEOBUVIR; FALDAPREVIR; GANCICLOVIR; IMMUNOSUPPRESSIVE AGENT; LEDIPASVIR; MAMMALIAN TARGET OF RAPAMYCIN INHIBITOR; RITONAVIR; SIMEPREVIR; SOFOSBUVIR; TACROLIMUS; TELAPREVIR; UNCLASSIFIED DRUG; VALGANCICLOVIR; ANTIINFECTIVE AGENT; MTOR PROTEIN, HUMAN; N-(3-AMINO-1-(CYCLOBUTYLMETHYL)-2,3-DIOXOPROPYL)-3-(2-((((1,1-DIMETHYLETHYL)AMINO)CARBONYL)AMINO)-3,3-DIMETHYL-1-OXOBUTYL)-6,6-DIMETHYL-3-AZABICYCLO(3.1.0)HEXAN-2-CARBOXAMIDE; OLIGOPEPTIDE; PROLINE; TARGET OF RAPAMYCIN KINASE;

ACUTE GRAFT REJECTION; ANEMIA; ANORECTAL DISEASE; ANTIVIRAL THERAPY; ARTICLE; BLOOD TRANSFUSION REACTION; CREATININE BLOOD LEVEL; DRUG BLOOD LEVEL; DRUG DRUG INTERACTION; DRUG EFFICACY; DRUG FATALITY; DRUG INTERACTION; DRUG MONITORING; DRUG SAFETY; GENOTYPE; GRAFT RECIPIENT; HEPATITIS C; HIGH RISK POPULATION; HISTOPATHOLOGY; HOSPITAL INFECTION; HOSPITALIZATION; HUMAN; INFECTION; KIDNEY FAILURE; LEUKOPENIA; LIVER GRAFT; LIVER TOXICITY; NEPHROTOXICITY; NEUTROPENIA; OUTCOME ASSESSMENT; PATIENT SAFETY; PRIORITY JOURNAL; PRURITUS; RASH; SIDE EFFECT; THROMBOCYTOPENIA; TOXIC HEPATITIS; ADVERSE EFFECTS; ANALOGS AND DERIVATIVES; ANTAGONISTS AND INHIBITORS; DRUG-INDUCED LIVER INJURY; HEPATITIS C, CHRONIC; LIVER TRANSPLANTATION; METABOLISM; ORAL DRUG ADMINISTRATION; RISK FACTOR;

ADMINISTRATION, ORAL; ANTI-BACTERIAL AGENTS; ANTIVIRAL AGENTS; CALCINEURIN INHIBITORS; DRUG INTERACTIONS; DRUG-INDUCED LIVER INJURY; HEPATITIS C, CHRONIC; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LIVER TRANSPLANTATION; OLIGOPEPTIDES; PROLINE; RISK FACTORS; TACROLIMUS; TOR SERINE-THREONINE KINASES;

EID: 84896399288     PISSN: 01688278     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jhep.2013.11.013     Document Type: Note

References (149)

1. S. Zhou, S. Yung Chan, B. Cher Goh, E. Chan, W. Duan, and M. Huang et al. Mechanism-based inhibition of cytochrome P450 3A4 therapeutic drugs Clin Pharmacokinet 44 2005 279 304
2. S. Zhou, E. Chen, L.Y. Lim, U.A. Boelsterli, S.C. Li, and J. Want et al. Therapeutic drugs that behave as mechanism-based inhibitor of cytochrome P450 3A4 Curr Drug Metab 5 2004 415 442
3. D.A. Flockart, and J.E. Tanus-Santos Implications of cytochrome P540 interactions when prescribing medications for hypertension Arch Intern Med 1 2002 405 412
4. K. Knops, E. Levthchenko, B. van den Heuvel, and D. Kuypers From gut to kidney: transporting and metabolizing calcineurin-inhibitors in solid organ transplantation Int J Pharm 452 2013 14 35
5. T.R. Srinivas, H.U. Meier-Kriesche, and B. Kaplan Pharmacokinetic principles of immunosuppressive drugs Am J Transplant 5 2005 207 217
6. S. Yu, L. Wu, S. Yan, G. Jiang, H. Xie, and S. Zheng Influence of CYP3A5 gene polymorphisms of donor rather than recipient to tacrolimus individual dose requirement in liver transplantation Transplantation 81 2006 46 51
7. A.H. Saad, D.D. DePestel, and P.L. Carver Factors influencing the magnitude and clinical significance of drug interactions between azole antifungals and select immunosuppressants Pharmacotherapy 26 2006 1730 1744
8. M.F. Herbert, J.M. Park, Y.L. Chen, S. Akhtar, and A.M. Larson Effects of St. John's wort (Hypericum perforatum) on tacrolimus pharmacokinetics in healthy volunteers J Clin Pharmacol 44 2004 89 94
9. J.R. Burton, and G.T. Everson Management of the transplant recipient with hepatitis C Clin Liver Dis 17 2013 73 91
10. E.J. Gane, N.V. Naoumov, K.P. Qian, M.U. Mondelli, G. Maertens, and B.C. Portmann et al. A longitudinal analysis of hepatitis C virus replication following liver transplantation Gastroenterology 110 1996 167 177
11. M. Berenguer, L. Ferrell, J. Watson, M. Prieto, M. Kim, and M. Rayon et al. HCV related fibrosis progression following liver transplantation: increase in recent years J Hepatol 32 2000 674 684
12. P. Guillouche, and C. Feray Systematic review: anti-viral therapy of recurrent hepatitis C after liver transplantation Aliment Pharmacol Ther 33 2011 163 174
13. M. Berenguer, V. Aguilera, A. Rubin, C. Ortiz, M. Jimenez, and M. Prieto Comparison of two non-contemporaneous HCV-liver transplant cohorts: strategies to improve the efficacy of antiviral therapy J Hepatol 56 2012 1310 1316
14. P. Sharma, J.A. Marrero, R.J. Fontana, J.K. Greenson, H. Conjeevaram, and G.L. Su et al. Sustained virologic response to therapy of recurrent hepatitis C after liver transplantation is related to early virologic response and dose adherence Liver Transpl 13 2007 1100 1108
15. J. Levitsky, M.I. Fiel, J.P. Norvell, E. Wang, K.D. Watt, and M.P. Curry et al. Risk for immune-mediated graft dysfunction in liver transplant recipients with recurrent HCV infection treated with pegylated Interferon Gastroenterology 142 2012 1132 1139
16. N. Selzner, M. Guindi, E.L. Renner, and M. Berenguer Immune-mediated complications of the graft in interferon-treated hepatitis C positive liver transplant recipients J Hepatol 55 2011 207 217
17. P. Sharma, A. Hosmer, H. Appelman, B. McKenna, M. Jafri, and P. Sullivan et al. Immunological dysfunction during or after antiviral therapy for recurrent hepatitis C reduces graft survival Hepatol Int 2013 10.1007/s12072-013-9436-1
18. F.P. Picciotto, G. Tritto, A.G. Lanza, L. Addaario, M. De Luca, and G.G. Di Costanzo et al. Sustained virological response to antiviral therapy reduces mortality in HCV reinfection after liver transplantation J Hepatol 46 2007 459 465
19. B.J. Veldt, J.J. Poterucha, K.D.S. Watt, R.H. Wiesner, J.E. Hay, and W.K. Kremers et al. Impact of pegylated interferon and ribavirin treatment on graft survival in liver transplant patients with recurrent HCV infection Am J Transpl 8 2008 1 8
20. I.M. Jacobson, J.G. McHutchison, G. Dusheiko, A.M. DiBisceglie, R. Reddy, and N.H. Bzowej et al. Telaprevir for previously untreated chronic hepatitis C virus infection N Engl J Med 364 2011 2405 2416
21. F. Poordad, J. McCone, B.R. Bacon, S. Bruno, M.P. Manns, and M.S. Sulkowski et al. Boceprevir for untreated chronic HCV genotype 1 infection N Engl J Med 364 2011 1195 1206
22. M.G. Ghany, D.R. Nelson, D.B. Strader, D.L. Thomas, and L.B. Seeff An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases Hepatology 54 2011 1434 1444
23. K.E. Sherman, S.L. Flamm, N.H. Afdhal, D.R. Nelson, M.S. Sulkowski, and G.T. Everson et al. Response-guided telaprevir combination treatment for hepatitis virus infection N Engl J Med 365 2011 1014 1024
24. B.R. Bacon, S.C. Gordon, E. Lawitz, P. Marcellin, J.M. Vierling, and S. Zeuzem et al. Boceprevir for previously treated chronic HCV genotype 1 infection N Engl J Med 364 2011 1207 1217
25. S. Zeuzem, P. Andreone, S. Pol, E. Lawitz, M. Diago, and S. Roberts et al. Telaprevir for retreatment of HCV infection N Engl J Med 364 2011 2417 2428
26. Boceprevir [package insert]. Whitehouse Station, NJ: Merck Laboratories; 2013.
27. Telaprevir [package insert]. Boston, MA: Vertex Pharmaceuticals; 2011.
28. G.W. McCaughan New therapies against HCV: expected risks and challenges associated with their use in the liver transplant setting J Hepatol 57 2012 1361 1367
29. J. Wilby, E. Grenya, and J. Ford et al. A review of drug interaction with boceprevir and telaprevir: implications for HIV and transplant patients Ann Hepatol 11 2012 179 185
30. J.J. Kiser, J.R. Burton, P.L. Anderson, and G.T. Everson Review and management of drug interaction with boceprevir and telaprevir Hepatology 55 2012 1620 1628
31. D. Burger, D. Back, P. Buggisch, M. Buti, A. Craxi, and G. Foster et al. Clinical management of drug-drug interactions in HCV therapy: challenges and solutions J Hepatol 58 2013 792 800
32. J.J. Kiser, J.R. Burton, and G.T. Everson Drug-drug interactions during antiviral therapy for chronic hepatitis C Nat Rev Gastroenterol Hepatol 2013 10.1038/nrgastro.2013.10
33. J.E. Lee, R. van Heeswijk, K. Alves, F. Smith, and V. Garg Effect of the hepatitis C virus protease inhibitor telaprevir on the pharmacokinetics of amlodipine and atorvastatin Antimicrob Agents Chemother 55 2011 4569 4574
34. A.S. Rangnekar, and R.J. Fontana Managing drug-drug interactions with boceprevir and telaprevir Clin Liver Dis 1 2012 35 40
35. E.G. Huloskotte, H.P. Feng, F. Xuan, S. Gupta, M.G. Van Zutven, and E. O'Mara et al. Pharmacokinetic evaluation of the interaction between the hepatitis C virus protease inhibitor boceprevir and the 3-hydroxy-3-methylguaryl coenzyme a reductase inhibitors atorvastatin and pravastatin Antimicrob Agents Chemother 57 2013 2582 2588
36. V. Garg, G. Chandorkar, F. Farmer, F. Smith, K. Alves, and P.G. Rolf et al. Effect of telaprevir on the pharmacokinetics of midazolam and digoxin J Clin Pharmacol 52 2012 1566 1573
37. V. Garg, R. van Heeswijk, Y. Yang, R. Kaufman, F. Smith, and N. Adda The pharmacokinetic interaction between oral contraceptives containing ethinyl estradiol and norethindrone and the HCV protease inhibitor telaprevir J Clin Pharmacol 52 2012 1574 1583
38. K.R. Reddy, and G.T. Everson Treatment of chronic hepatitis C with protease inhibitor-based therapy after liver transplantation Hepatology 58 2013 1181 1183
39. E. Hulskotte, S. Gupta, F. Xuan, M. van Zutven, E. O'Mara, and H.P. Feng et al. Pharmacokinetic interaction between the hepatitis C virus and protease inhibitor boceprevir and cyclosporine and tacrolimus in health volunteers Hepatology 56 2012 1622 1630
40. V. Garg, R. van Heeswijk, J.E. Lee, K. Alves, P. Nakarini, and X. Luo Effect of telaprevir on the pharmacokinetics of cyclosporine and tacrolimus Heptology 54 2011 20 27
41. E.G. Hulskotte, H.P. Feng, F. Xuan, W.H. Ling, T. Zhu, and S. Rasmussen et al. Pharmacokinetics interactions between the HCV protease inhibitor boceprevir and sirolimus in healthy subject J Hepatol S58 2013 S190 [Abstract 463]
42. A. Coilly, V. Furlan, B. Roche, C. Barau, C. Noel, and L. Bonhomme-Faivre et al. Practical management of boceprevir and immunosuppressive therapy in liver transplant recipients with hepatitis C virus recurrence Antimicrob Agents Chemother 56 2012 5728 5734
43. R.J. Fontana, R. Qiu, M.W. Russo, E.M. Yoshida, K.A. Brown, and J. Levitsky et al. Twice daily telaprevir in combination with peginterferon alfa-2a/ribavirin in genotype 1 HCV liver transplant recipients: interim Week 16 Calcineurin inhibitor, telaprevir, and ribavirin pharmacokinetics from the prospective, multicenter, REFRESH study Hepatology 53 2013 #1736 [Abstract]
44. J.G. O'Leary, G.J. McKenna, G.B. Klintlmalm, and G.L. Davis Effect of telaprevir on the pharmacokinetics of sirolimus in liver transplant recipients Liver Transpl 19 2013 463 465
45. P. Jumes, H.P. Feng, M. Chatterjee, F. Xuan, S.M. Connolly, and J.A. Wagner et al. Pharmacokinetic interaction between the HCV protease inhibitor boceprevir and prednisone in healthy volunteers Hepatology 56 2012 1076A [Abstract]
46. S. Pungpapong, B.A. Aqel, L. Koning, J.L. Murphy, T.M. Henry, and K.L. Ryland et al. Multicenter experience using telaprevir or boceprevir with peginterferon and ribavirin to treat hepatitis C genotype 1 after liver transplantation Liver Transpl 19 2013 690 700
47. A. Coily, B. Roche, J. Dumortier, V. Leroy, D. Botta-Fridlund, and R. Sylvie et al. Safety and efficacy of protease inhibitors to treat hepatitis C after liver transplantation: a multicenter experience J Hepatol 2013 10.1016/j.jhep.2013.08.018
48. K. Brown, R.J. Fontana, M.W. Russo, J. Levitsky, E. Yoshida, and H. Vargas et al. Twice daily telaprevir in combination with peginterferon alfa-2a/ribavirin in genotype 1 HCV liver transplant recipients: interim Week 16 Safety and Efficacy results of the Prospective, Multicenter REFRESH Study Hepatology 58 2013 #3 [Abstract]
49. C.R. Werner, D.P. Egetmeyr, U.M. Lauer, S. Nadalin, A. Konigsrainer, and N.P. Malek et al. Telaprevir-based triple therapy in liver transplant patients with hepatitis C virus: a 12-week pilot study providing safety and efficacy data Liver Transpl 18 2012 1464 1470
50. A.P. De Oliverira Pereira, H.J. Shin, A. Safdar, H. Tobias, B. Gelb, and G. Morgan et al. Post liver transplant therapy with telaprevir for recurrent hepatitis C Am J Transplant 12 2012 1369 [Abstract]
51. G. Burton, and T. Everson Initial experience with telaprevir for treating hepatitis C virus in liver transplant recipients: virologic response, safety and tolerability Am J Transplant 12 2012 LB01 [Abstract]
52. J. O'Leary, E. Verna, J. Burton, J. Lai, V. Saxena, and J. Levistky et al. A high rate of eRVR with protease inhibitor-triple HCV therapy in liver transplant recipients: a multicenter study from CRUSH-C Am J Transplant S5 2013 32 [Abstract]
53. Y.H. Oo, and D.J. Mutimer Rapid recovery of cytochrome P450 3A4 after protease inhibitor withdrawal in post-liver transplant patients Liver Transpl 18 2012 1264 1265
54. S.P. Nair Protease inhibitor therapy post-liver transplantation in the treatment of hepatitis c virus infection Gastroenterol Hepatol 9 2013 368 390
55. A. Coilly, B. Roche, and D. Samuel Current management and perspectives for HCV recurrent after liver transplantation Liver Int 33 2013 56 62
56. S. Mauss, D. Hueppe, and U. Alshuth Renal impairment is frequent in chronic hepatitis C patients under triple therapy with telaprevir or boceprevir Hepatology 2013 10.1001/hep26602
57. A. Kunze, J. Huwyler, G. Camenisch, and H. Gutmann Interaction of the antiviral drug telaprevir with renal and hepatic drug transporters Biochem Pharmacol 84 2012 1096 1102
58. C. Herold Quantitative testing of liver function in relation to fibrosis in patients with chronic hepatitis B and C Liver 21 2001 260 265
59. R.F. Frey Liver disease selectively modulates cytochrome P450-mediated metabolism Clin Pharmacol Ther 80 2006 235 245
60. M. Kugelmas et al. Hepatitis C virus therapy, hepatocyte drug metabolism, and risk for acute cellular rejection Liver Transpl 9 2003 1159 1165
61. F. Poordad, E. Lawitz, K.V. Kowdley, D.E. Cohen, T. Podsadecki, and S. Siggelkow et al. Exploratory study of oral combination antiviral therapy for hepatitis C N Engl J Med 368 2013 45 53
62. K.V. Kowdley, E. Lawitz, F. Poordad, D.E. Cohen, D.R. Nelson, and S. Zeuzem et al. A 12 week interferon-free treatment regimen with ABT-450/R, ABT-267, ABT-333, and ribavirin achieves SVR12 rates of 99% in treatment naïve patients and 93% in prior null-responders with HCV genotype 1 infection Hepatology 56 2012 1515A [Abstract]
63. C.M. Lange, and S. Zeuzem Perspectives and challenges of interferon-free therapy for chronic hepatitis C J Hepatol 58 2013 583 592
64. M. Manns, P. Marcellin, F. Poordad, E. Stanislau Alfonso de Araujo, M. Buti, and Y. Horsmans et al. Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naive patients: results from QUEST-2 a phase III trial J Hepatol 58S 2013 S568 [Abstract]
65. I. Jacobson, G.J. Dore, G.R. Foster, M.N. Fried, M.I. Radi, and V.V. Rafalskiy et al. Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naïve patients: results from QUEST-1 a phase III trial J Hepatol 58S 2013 S574 [Abstract]
66. M.S. Sulkowski, T. Asselah, J. Lalezari, P. Ferenci, H. Fainbohm, and B. Leggett et al. Faldaprevir combined with peginterferon alfa-2a and ribavirin in chronic hepatitis C virus genotype1 HCV: SILEN-C1 trial Hepatology 57 2013 2143 2154
67. M.S. Sulkowski, M. Bourliere, J.P. Bronowicki, T. Asselah, J.M. Pawlostsky, and S.D. Sharfran et al. Faldaprevir combined with peginterferon alfa-2a and ribavirin in chronic hepatitis C virus genotype-1 patients with prior nonresponse: SILEN-C2 Trial Hepatology 57 2013 2155 2163
68. K.V. Kowdley, E. Lawitz, I. Crespo, T. Hassanien, M.N. Davis, and M. DeMicco et al. Sofosbuvir with pegylated interferon alfa-2 a and ribavirin for treatment-naïve patients with hepatitis C genotype 1 (ATOMIC): an open-label, randomized, multicenter phase 2 trial Lancet 381 2013 2100 2107
69. S. Pol, R.H. Ghalib, V.K. Rustgi, C. Martorell, G.T. Everson, and H.A. Tatum et al. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomized, parallel-group, double-placebo, placebo-controlled, dose-finding, phase 2a trial Lancet Infect Dis 12 2012 671 677
70. M.W. Fried, G.J. Dore, R. Flisiak, P. Ferenci, I. Jacobson, and P. Marcellin et al. Once-daily simeprevir (TMC 435) with pegylated interferon and ribavirin in treatment-naïve genotype I hepatitis C: the randomized PILLAR study Hepatology 58 2013 1918 1929
71. S. Zeuzem, V. Soriano, T. Asselah, J.P. Bronowicki, A.W. Lohse, and B. Mullhaupts et al. Faldaprevir and deleobuvir for HCV genotype 1 infection N Engl J Med 369 2013 630 639
72. A.S. Lok, D.F. Gardiner, E. Lawitz, C. Martorell, G.T. Everson, and R. Ghalib et al. Preliminary study of two antiviral agents for hepatitis C Genotype 1 N Engl J Med 366 2012 216 224
73. J.J. Feld et al. Up to 100% SVR4 rates with ritonavir-boosted danoprevir (DNRr), mericitabine (MCB), and ribavirin (R) ± peginterferon alfa-2a (40KD) (P) in HCV genotype 1-infected partial and null responders: results from MATTERHORN study Hepatology 56 2012 231A [Abstract]
74. E. Lawitz, A. Mangia, D. Wyles, M. Rodriguez-Torres, T. Hassanein, and S.C. Gordon et al. Sofosbuvir for previously untreated chronic hepatitis C infection N Engl J Med 368 2013 1878 1887
75. I.M. Jacobson, S.C. Gordon, and K.V. Kowdley et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options N Engl J Med 368 2013 1867 1877
76. A. Thompson, S. Han, M.L. Shiffman, L. Rossaro, R. Ghalib, and K. Beavers et al. GS-5885 (Ledipasvir) + GS-9451 + peginterferon and ribavirin for 6 or 12 weeks achieves high SVR12 rates in treatment naïve genotype 1 IL28B CC patients J Hepatol 58S 2013 S29 [Abstract]
77. E. Lawitz, D. Gruener, J.M. Hill, T. Marbury, S. Komjathy, and M. DeMicco et al. A phase I, randomized, placebo controlled, 3-day dose -ranging study of GS-5885: an NS5A inhibitor, in patients with genotype 1 hepatitis C J Hepatol 57 2012 24 31
78. S. Ouwerkerk-Mahadevan, A. Simion, S. Mortier, M. Peeters, and M. Beumont No clinically significant interaction between the investigational HCV protease inhibitor, TMC435 and the immunosuppressives cyclosporine and tacrolimus Hepatology 58 2012 213A [Abstract]
79. K.V. Kowdley, E. Lawitz, F. Poordad, D.E. Cohen, D.R. Nelson, and S. Zeuzem et al. A 12 week interferon-free treatment regimen with ABT-450/R, ABT-267, ABT-333, and ribavirin achieves SVR12 rates of 99% in treatment naïve patients and 93% in prior null-responders with HCV genotype 1 infection J Hepatol 56S 2012 S478 [Abstract]
80. R. Sane, L. Podila, A. Mathur, K. Mease, and M. Taub et al. Mechanisms of isolated unconjugated hyperbilirubinemia induced by the HCV NS3/4A protease inhibitor, BI201335 J Hepatol 54 2011 S488 [Abstract]
81. M.T. Huisman, J. Snoeys, J. Monbaliu, M. Martens, V. Sekar, and A. Raoof In vitro studies investigating the mechanism of interaction between TMC435 and hepatic transporters Hepatology 52 2010 461A [Abstract]
82. R.J. Fontana, E.A. Hughes, H. Appelman, R. Hindes, D. Dimitrova, and M. Bifano Case report of successful peginterferon, ribavirin, and daclatasvir therapy for recurrent cholestatic hepatitis C after liver transplantation Liver Transpl 18 2012 1053 1059
83. R.J. Fontana, E.A. Hughes, M. Bifano, H. Appelman, D. Dimitrova, and R. Hindes et al. Sofosbuvir and daclatasvir combination therapy in a liver transplant recipient with severe recurrent cholestatic hepatitis C Am J Transpl 13 2013 1601 1605
84. E. Charlton Gane, M.P. Manns, R.S. Brown, M.P. Curry, and P. Kwo et al. Sofosbuvir and ribavirin for the treatment of established recurrent hepatitis C infection after liver transplantation: Preliminary results of a prospective, multicenter study Hepatology 58 2013 #LB2 [Abstract]
85. V. Sekar, R. Verloes, P. Meyvisch, K. Spittaels, S.H. Akuma, and D.G. DeSmedt TMC435 and drug interactions: evaluation of the metabolic interactions of TMC435 via cytochrome P450 (CYP) enzymes in health volunteers J Hepatol 52 2010 S416 [Abstract]
86. S. Ouwerkerk-Mahadevan, A. Simon, S. Mortier, M. Peeters, and M. Beumont No clinically significant interaction between the investigational HCV protease inhibitor, TMC435 and the immunosuppressives cyclosporine and tacrolimus Hepatology 56 2012 213A [Abstract]
87. M.P. Manns, M. Bourliere, and Y. Benhamou et al. Potency, safety, and pharmacokinetics of the NS3/4A protease inhibitor BI210335 in patients with chronic HCV genotype 1 infection J Hepatol 54 2011 1114 1122
88. E. Dumas, A. Lawal, R. Menon, T. Podsadecki, W. Awni, and S. Dutta et al. Pharmacokinetics, safety and tolerability of the HCV NS5A inhibitor ABT-267 following single and multiple doses in healthy adult volunteers J Hepatol 54 2011 S475 [Abstract 1024]
89. C. Maring, R. Wagner, D. Hutchinsom, C. Flentge, and W. Kati et al. Preclinical potency and ADME characterization of ABT-333, a novel non-nucleoside HCV polymerase inhibitor J Hepatol 50 2009 S346 S347 [Abstract]
90. R.J. Fontana, L.B. Seeff, R.J. Andrade, E. Bjornsson, C.P. Day, and J. Serrano et al. Standardization of nomenclature and causality assessment in drug-induced liver injury: summary of a clinical research workshop Hepatology 52 2010 730 742
91. J.P. Molleston, R.J. Fontana, M.J. Lopez, D.E. Kleiner, J. Gu, and N. Chalasani Characteristics of idiosyncratic drug-induced liver injury in children: results from the DILIN Prospective study JPGN 53 2011 182 189
92. G. Ostapowicz, R.J. Fontana, and F.V. Schiodt et al. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States Ann Intern Med 137 2002 947 954
93. A. Reuben, D.G. Koch, and W.M. Lee Drug induced acute liver failure: results of a US multicenter, prospective study Hepatology 52 2010 2065 2076
94. P.G. Aithal, and C.P. Day The natural history of histologically proved drug induced liver disease Gut 44 1999 731 735
95. E. Bjornsson, and L. Davidsdottir The long-term follow-up after idiosyncratic drug-induced liver injury with jaundice J Hepatol 50 2009 511 517
96. M.B. De Valle, A.V. Klinteberg, N. Alem, R. Olsson, and E. Björnsson Drug-induced liver injury in a Swedish University hospital out-patient hepatology clinic Aliment Pharmacol Ther 24 2006 1187 1195
97. M.V. Galan, J.A. Potts, A.L. Silverman, and S.C. Gordon The burden of acute non-fulminant drug-induced hepatitis in a United States tertiary referral center J Clin Gastroenterol 39 2005 64 67
98. C. Sgro, F. Clinard, K. Quazir, H. Chanay, C. Allard, and C. Guilleminet et al. Incidence of drug-induced hepatic injuries: a french population-based study Hepatology 36 2002 451 455
99. E.S. Bjornsson, O.M. Bergmann, H.K. Bjornsson, R.B. Kvaran, and S. Olafsson Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland Gastroenterology 144 2013 1419 1425
100. N. Chalasani, R.J. Fontana, H.L. Bonkovsky, P.B. Watkins, T. Davern, and J. Serrano et al. Causes, clinical features, and outcomes from a prospective study of drug induced liver injury in the United States Gastroenterology 135 2008 1924 1934
101. R.J. Andrade, M.I. Lucena, and M.C. Fernandez et al. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period Gastroenterology 129 2005 512 521
102. H. Takikawa, Y. Murata, N. Horiike, H. Fukui, and M. Onji Drug-induced liver injury in Japan: an analysis of 1676 cases between 1997 and 2006 Hepatol Res 39 2009 427 431
103. V.K. Agarwal, M.G. Mchutchison, and J.H. Hoofnagle Important elements for the diagnosis of drug induced liver injury Clin Gastroenterol Hepatol 8 2010 463 470
104. A.H. Harrill, J. Roach, and I. Fier et al. The effects of heparins on the liver: application of mechanistic biomarkers in a randomized study in healthy volunteers Clin Pharm Ther 92 2012 214 220
105. G. Danan, and C. Benichou 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 1993 1323 1330
106. D.C. Rockey, L.B. Seeff, J. Rochon, N. Chalasani, M. Bonacini, and R.J. Fontana et al. Comparison between expert opinion and RUCAM for assignment of causality in drug-induced liver injury Hepatology 51 2010 2117 2126
107. J.H. Hoofnagle, J. Serrano, J.E. Knoben, and V.J. Navarro LiverTox: a website on drug induced liver injury Hepatology 57 2013 873 874
108. M. Chen, J. Borlak, and W. Tong High lipophilicity and high daily dose of oral medications are associated with significant risk for drug-induced liver injury Hepatology 58 2013 388 396
109. R.J. Fontana, P.B. Watkins, H.L. Bonkovsky, N. Chalasani, T. Davern, and J. Serrano et al. Rationale, design and conduct of the drug induced liver injury network prospective study Drug Saf 32 2009 55 68
110. J. Neuberger Recurrent primary biliary cirrhosis Liver Transpl 9 2003 4
111. M.A. Heneghan, B.C. Portmann, S.M. Norris, R. Williams, P. Muiseauan, and M. Rela et al. Graft dysfunction mimicking autoimmune hepatitis following liver transplantation in adults Hepatology 34 2001 464 470
112. M. Guido, and P. Burra De novo autoimmune hepatitis after liver transplantation Semin Liver Dis 31 2011 71 81
113. T.J. Davern, N. Chalasani, R.J. Fontana, P.H. Hayashi, P. Protiva, and D.E. Kleiner et al. Role of acute hepatitis E in suspected drug-induced liver injury Gastroenterology 141 2011 1665 1672
114. N. Kamar, C. Garrouste, E.B. Haagsma, V. Garrigue, S. Pischke, and C. Chauvet et al. Factors associated with chronic hepatitis in patients with hepatitis E virus infection who have received solid organ transplants Gastroenterology 140 2011 1481 1489
115. W.M. Wong, P.C. Wu, M.F. Yuen, C.C. Cheng, W.W. Yew, and P.C. Wong et al. Antituberculosis drug-related liver dysfunction in chronic hepatitis B infection Hepatology 31 2000 201 206
116. M.S. Sulkowski, D.L. Thomas, R.E. Chaisson, and R.D. Moore Hepatotoxicity associated with antiretroviral therapy in adults infected with human immunodeficiency virus and the role of hepatitis C or B virus infection JAMA 283 2000 74 80
117. W. Zhenglu, L. Hui, Z.H. Shuying, C. Wenjuan, and S.H. Zhongyang A clinical-pathological analysis of drug-induced hepatic injury after liver transplantation Transplant Proc 39 2007 3287 3291
118. S. Sembera, C. Lammert, J.A. Talwalkar, S.O. Sanderson, J.J. Poterucha, and J.E. Hay et al. Frequency and clinical presentation and outcomes of drug-induced liver injury after liver transplantation Liver Transpl 18 2012 803 810
119. F. Hanses, S. Zierhut, J. Scholmerich, B. Salzberger, and C.E. Wrede Severe and long-lasting cholestasis after high dose co-trimoxazole treatment for pneumocystis pneumonia in HIV-infected patients - A report of two cases Int J Infect Dis 13 2009 e467 e469
120. C. Legendre, S. Caillat-Zucman, D. Samuel, S. Morelon, H. Bismuth, and F. Bach et al. Transfer of symptomatic peanut allergy to the recipient of a combined liver-and-kidney transplant N Eng J Med 337 1997 822 825
121. M. Schwab, E. Schaeffeler, C. Marx, C. Fischer, T. Lang, and C. Behrens et al. Azathioprine therapy and adverse drug reactions in patients with inflammatory bowel disease: impact of thiopurine s-methyltransferase polymorphism Pharmacogenetics 12 2002 429 436
122. Y. Horsmans, J. Rahler, and A.P. Geubel Reversible cholestasis with bile duct injury following azathioprine therapy. A case report Liver 11 1991 89 93
123. M. Sterneck, R. Wiesner, N. Ascher, J. Roberts, L. Ferrell, and J. Ludwig et al. Azathioprine hepatotoxicity after liver transplantation Hepatology 14 1991 806 810
124. E. Gane, B. Portmann, R. Sazena, P. Wong, J. Ramage, and R. Williams Nodular regenerative hyperplasia of the liver graft after liver transplantation Hepatology 20 1994 88 94
125. C. Kamphues, R. Bova, C. Rocken, R. Neuhaus, J. Pratschke, and P. Neuhaus et al. Safety of mycophenolate mofetil monotherapy in patients after liver transplantation Ann Transplant 14 2009 40 46
126. S.P. Dourakis, K. Boki, A. Soultati, E. Cherouvim, and I. Delladetsima Acute hepatitis following mycophenolate mofetil administration for ANCA-positive vasculitis Scand J Rheumatol 36 2007 237 239
127. A. Loupy, D. Anglicheau, M.F. Mamzer-Bruneel, F. Martinez, E. Thervet, and C. Legendre et al. Mycophenolate sodium-induced hepatotoxicity: first report Transplantation 82 2006 581
128. N. Taniai, K. Akimaru, Y. Ishikawas, T. Kanada, D. Kakinuma, and Y. Mizuguchi et al. Hepatotoxicity caused by both tacrolimus and cyclosporine after living donor liver transplantation J Nippon Med Sch 75 2008 187 191
129. G.B. Klintmalm, S. Iwatsuki, and T.E. Starzl Cyclosporine a hepatotoxicity in 66 renal allograft recipients Transplantation 32 1981 488 489
130. T. Oto, M. Okazaki, K. Takata, M. Egi, M. Yamane, and S. Toyooka et al. Calcineurin inhibitor-related cholestasis complicating lung transplantation Ann Thorac Surg 89 2010 1664 1665
131. M.L. Lorber, C.T. Van Buren, S.M. Flechner, C. Williams, and B.D. Kahan Hepatobiliary and pancreatic complications of cyclosporine therapy in 466 renal transplant recipients Transplantation 43 1987 35 40
132. D. Moran, J.M. De Buitrago, E. Fernandez, A.J. Galan, M.E. Munoz, and R. Jimenez Inhibition of biliary glutathione secretion of cyclosporine a in the rate possible mechanisms and role in the cholestasis induced by the drug J Hepatol 29 1998 68 77
133. J. Jacques, Z. Dickson, P. Carrier, M. Essiq, A. Guillaudeau, and C. Lacour et al. Severe sirolimus-induced acute hepatitis in a renal transplant recipient Transpl Int 23 2010 967 970
134. G.W. Neff, P. Ruiz, J.R. Madaraiaga, S. Nishida, M. Montalbano, and D. Meyer et al. Sirolimus-associated hepatotoxicity in liver transplantation Ann Pharmacother 38 2004 1593 1596
135. G.J. Chang, H.D. Mahanty, D. Quan, C.E. Freise, N.L. Ascher, and J.P. Roberts et al. Experience with the use of sirolimus in liver transplantation - Use in patients for whom calcineurin inhibitors are contraindicated Liver Transpl 6 2000 734 740
136. M. Studniarz, P. Czubkowski, J. Cielecka-Kuszyk, I. Jankowska, M. Teisseyre, and D. Kaminska et al. Amoxicillin/clavulanic acid-induced cholestatic liver injury after pediatric liver transplantation Ann Transplant 17 2012 128 131
137. R.R. Mainra, and S.E. Card Trimethoprim-sulfamethoxasole associated hepatotoxicity - part of a hypersensitivity syndrome Can J Clin Pharmacol 10 2003 175 178
138. M.G. Neuman, K.K. McKinney, R.M. Nanau, V. Kong, I. Malkiewicz, and T. Mazulli et al. Drug induced severe adverse reaction enhanced by human herpes virus-6 reactivation Transl Res 161 2013 430 440
139. J.A. Bronstein, P. Gros, E. Hernandez, P. Larroque, and C. Molinie Fatal acute hepatic necrosis due to dose-dependent fluconazole hepatotoxicity Clin Infect Dis 25 1997 1266 1267
140. M. Cruciani, C. Mengoli, M. Malena, O. Bosco, G. Serpelloni, and P. Grossi Antifungal prophylaxis in liver transplant patients: a systematic review and meta-analysis Liver Transpl 12L 2006 850 855
141. P. Ichai, F. Saliba, F. Antoun, D. Azoulay, M. Sebagh, and T.M. Antonini et al. Acute liver failure due to anti-tubercular therapy: strategy for antitubercular treatment before and after liver transplantation Liver Transpl 16 2010 1136 1146
142. M. Jafri, A.G. Singal, D. Kaul, and R.J. Fontana Detection and management of latent tuberculosis in liver transplant patients Liver Transpl 17 2011 306 314
143. R.H. Rubin Management of tuberculosis in the transplant recipient Am J Transplant 5 2005 2599 2600
144. R.S. Cvetkovic, and K. Wellington Valganciclovir: a review of its use in the management of CMV infectin and disease in immunocompromised patients Drugs 65 2005 859
145. R. Teschke, X. Glass, and J. Schulze Herbal hepatotoxicity by greater celandine (Chelidonium majus): Causality assessment of 22 spontaneous reports Regul Toxicol Pharmacol 61 2011 282 291
146. C.A. Apestegui, O. Julliard, O. Ciccarelli, D.K. Duc, and J. Lerut Energy drinks: another red flag for the liver allograft Liver Transpl 17 2011 1117 1118
147. U. Herden, L. Fischer, H. Schafer, B. Nashan, V. Baehr, and M. Sterneck Sorafenib-induced severe acute hepatitis in a stable liver transplant recipient Transplantation 90 2010 98 99
148. J.M. Von Vital, A. Karaschristos, A. Singhal, R. Thomas, and A. Jain Acute amiodarone hepatotoxicity after liver transplantation Transplantation 91 2011 e62 e64
149. A.E. Ritz Bravo, J. Drewe, and R.G. Schlienger et al. Hepatotoxicity during rapid intravenous loading with amiodarone: Description of three cases and review of the literature Crit Care Med 33 2005 128