Outcome of recurrent hepatitis C virus after liver transplantation in a randomized trial of tacrolimus monotherapy versus triple therapy

Liver Transplantation

Volumn 15, Issue 12, 2009, Pages 1783-1791

  Manousou, Pinelopi ^a   Samonakis, Dimitrios ^a   Cholongitas, Evangelos ^a   Patch, David ^a   O'Beirne, James ^a   Dhillon, Amar P ^b   Rolles, Keith ^a   McCormick, Aiden ^c   Hayes, Peter ^d   Burroughs, Andrew K ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b ROYAL FREE HOSPITAL   (United Kingdom)

^c ST VINCENT S UNIVERSITY HOSPITAL   (Ireland)

^d ROYAL INFIRMARY OF EDINBURGH   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; AZATHIOPRINE; CYCLOSPORIN; GANCICLOVIR; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISOLONE; STEROID; TACROLIMUS; VALGANCICLOVIR;

ACUTE GRAFT REJECTION; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; CHRONIC GRAFT REJECTION; CLINICAL TRIAL; CREATININE BLOOD LEVEL; DISEASE COURSE; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FEMALE; GRAFT SURVIVAL; HEPATITIS C; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY DYSFUNCTION; KIDNEY FUNCTION; LIVER BIOPSY; LIVER FUNCTION; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MORTALITY; MULTIPLE ORGAN FAILURE; NEUROTOXICITY; OUTCOME ASSESSMENT; POSTOPERATIVE PERIOD; PREOPERATIVE PERIOD; PRIORITY JOURNAL; RECURRENT DISEASE;

ADOLESCENT; ADULT; AGED; AZATHIOPRINE; BIOPSY; CHILD; DRUG THERAPY, COMBINATION; FEMALE; GRAFT REJECTION; GRAFT SURVIVAL; HEPATITIS C; HUMANS; HYPERTENSION, PORTAL; IMMUNOSUPPRESSIVE AGENTS; KAPLAN-MEIERS ESTIMATE; LIVER CIRRHOSIS; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; PREDNISOLONE; PROPORTIONAL HAZARDS MODELS; RECURRENCE; RISK ASSESSMENT; RISK FACTORS; SEVERITY OF ILLNESS INDEX; TACROLIMUS; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 71249159640     PISSN: 15276465     EISSN: 15276473     Source Type: Journal    
DOI: 10.1002/lt.21907     Document Type: Article

References (60)

1. Berenguer M, Lopez-Labrador FX, Wright TL. Hepatitis C and liver transplantation. J Hepatol 2001;35:666-678.
2. Gane E. The natural history and outcome of liver transplantation in hepatitis C virus-infected recipients. Liver Transpl 2003;9:S28-S34. (Pubitemid 37408000)
3. Forman LM, Lewis JD, Berlin JA, Feldman HI, Lucey MR. The association between hepatitis C infection and survival after orthotopic liver transplantation. Gastroenterology 2002;122:889-896. (Pubitemid 34267271)
4. Berenguer M, Ferrell L, Watson J, Prieto M, Kim M, Rayon M, et al. HCV-related fibrosis progression following liver transplantation: increase in recent years. J Hepatol 2000; 32:673-684. (Pubitemid 30180389)
5. Kalambokis G, Manousou P, Samonakis D, Grillo F, Dhillon AP, Patch DW, et al. Clinical outcome of HCV-related graft cirrhosis and prognostic value of hepatic venous pressure gradient. Transpl Int 2009;22:172-181.
6. Berenguer M, Prieto M, San Juan F, Rayon JM, Martinez F, Carrasco D, et al. Contribution of donor age to the recent decrease in patient survival among HCV-infected liver transplant recipients. Hepatology 2002;36:202-210. (Pubitemid 34700779)
7. Neumann UP, Berg T, Bahra M, Puhl G, Guckelberger O, Langrehr JM, et al. Long-term outcome of liver transplants for chronic hepatitis C: a 10-year follow-up. Transplantation 2004;77:226-231. (Pubitemid 38155751)
8. Samonakis DN, Triantos CK, Thalheimer U, Quaglia A, Leandro G, Teixeira R, et al. Immunosuppression and donor age with respect to severity of HCV recurrence after liver transplantation. Liver Transpl 2005;11:386-395. (Pubitemid 40533206)
9. Oo YH, Dudley T, Nightingale P, Haydon G, Mutimer D. Tacrolimus and cyclosporin doses and blood levels in hepatitis C and alcoholic liver disease patients after liver transplantation. Liver Transpl 2008;14:81-87. (Pubitemid 351167993)
10. Everson GT. Impact of immunosuppressive therapy on recurrence of hepatitis C. Liver Transpl 2002; 8(suppl 1):S19-S27. (Pubitemid 35154039)
11. Papatheodoridis GV, Davies S, Dhillon AP, Teixeira R, Goulis J, Davidson B, et al. The role of different immunosuppression in the long-term histological outcome of HCV reinfection after liver transplantation for HCV cirrhosis. Transplantation 2001;72:412-418. (Pubitemid 32769624)
12. Foxton MR, Quaglia A, Muiesan P, Heneghan MA, Portmann B, Norris S, et al. The impact of diabetes mellitus on fibrosis progression in patients transplanted for hepatitis C. Am J Transplant 2006;6:1922-1929. (Pubitemid 44024965)
13. Berenguer M, Prieto M, Cordoba J, Rayon JM, Carrasco D, Olaso V, et al. Early development of chronic active hepatitis in recurrent hepatitis C virus infection after liver transplantation: association with treatment of rejection. J Hepatol 1998;28:756-763. (Pubitemid 28223478)
14. Berenguer M, Crippin J, Gish R, Bass N, Bostrom A, Netto G, et al. A model to predict severe HCV-related disease following liver transplantation. Hepatology 2003;38:34-41. (Pubitemid 36775793)
15. Roche B, Samuel D. Risk factors for hepatitis C recurrence after liver transplantation. J Viral Hepat 2007;14(suppl 1):89-96. (Pubitemid 47624117)
16. Berenguer M, Royuela A, Zamora J. Immunosuppression with calcineurin inhibitors with respect to the outcome of HCV recurrence after liver transplantation: results of a meta-analysis. Liver Transpl 2007;13:21-29. (Pubitemid 46099970)
17. Henry SD, Metselaar HJ, Van Dijck J, Tilanus HW, Van Der Laan LJ. Impact of steroids on hepatitis C virus replication in vivo and in vitro. Ann N Y Acad Sci 2007;1110: 439-447. (Pubitemid 350043033)
18. Segev DL, Sozio SM, Shin EJ, Nazarian SM, Nathan H, Thuluvath PJ, et al. Steroid avoidance in liver transplantation: meta-analysis and meta-regression of randomized trials. Liver Transpl 2008;14:512-525.
19. Kakumu S, Takayanagi M, Iwata K, Okumura A, Aiyama T, Ishikawa T, et al. Cyclosporine therapy affects aminotransferase activity but not hepatitis C virus RNA levels in chronic hepatitis C. J Gastroenterol Hepatol 1997;12:62-66. (Pubitemid 27100168)
20. Berenguer M. Recurrent hepatitis C: worse outcomes established, interventions still inadequate. Liver Transpl 2007;13:641-643. (Pubitemid 46796531)
21. O'Grady JG, Burroughs A, Hardy P, Elbourne D, Truesdale A. Tacrolimus versus microemulsified ciclosporin in liver transplantation: the TMC randomised controlled trial. Lancet 2002;360:1119-1125.
22. Vivarelli M, Burra P, Barba GL, Canova D, Senzolo M, Cucchetti A, et al. Influence of steroids on HCV recurrence after liver transplantation: a prospective study. J Hepatol 2007;47:793-798. (Pubitemid 350051119)
23. Fraser GM, Grammoustianos K, Reddy J, Rolles K, Davidson B, Burroughs AK. Long-term immunosuppression without corticosteroids after orthotopic liver transplantation: a positive therapeutic aim. Liver Transpl Surg 1996; 2:411-417. (Pubitemid 26386859)
24. Raimondo ML, Burroughs AK. Single-agent immunosuppression after liver transplantation: what is possible? Drugs 2002;62:1587-1597.
25. Rolles K, Davidson BR, Burroughs AK. A pilot study of immunosuppressive monotherapy in liver transplantation: tacrolimus versus microemulsified cyclosporin. Transplantation 1999;68:1195-1198.
26. Margarit C, Bilbao I, Castells L, Lopez I, Pou L, Allende E, et al. A prospective randomized trial comparing tacrolimus and steroids with tacrolimus monotherapy in liver transplantation: the impact on recurrence of hepatitis C. Transpl Int 2005;18:1336-1345. (Pubitemid 41726729)
27. Pirenne J, Aerts R, Koshiba T, Van Gelder F, Roskams T, Schetz M, et al. Steroid-free immunosuppression during and after liver transplantation - a 3-yr follow-up report. Clin Transplant 2003;17:177-182. (Pubitemid 36748462)
28. Freedman LS. Tables of the number of patients required in clinical trials using the logrank test. Stat Med 1982;1:121-129.
29. Lao WC, Lee D, Burroughs AK, Lanzani G, Rolles K, Emery VC, et al. Use of polymerase chain reaction to provide prognostic information on human cytomegalovirus disease after liver transplantation. J Med Virol 1997;51:152-158. (Pubitemid 27157794)
30. Ishak K, Baptista A, Bianchi L, Callea F, De Groote J, Gudat F, et al. Histological grading and staging of chronic hepatitis. J Hepatol 1995;22:696-699.
31. Neumann UP, Berg T, Bahra M, Seehofer D, Langrehr JM, Neuhaus R, et al. Fibrosis progression after liver transplantation in patients with recurrent hepatitis C. J Hepatol 2004;41:830-836. (Pubitemid 39434314)
32. Datta GS, Hudson M, Burroughs AK, Morris R, Rolles K, Amlot P, et al. Grading of cellular rejection after orthotopic liver transplantation. Hepatology 1995;21:46-57.
33. Groszmann RJ, Wongcharatrawee S. The hepatic venous pressure gradient: anything worth doing should be done right. Hepatology 2004;39:280-282. (Pubitemid 38222164)
34. Ripoll C, Groszmann R, Garcia-Tsao G, Grace N, Burroughs A, Planas R, et al. Hepatic venous pressure gradient predicts clinical decompensation in patients with compensated cirrhosis. Gastroenterology 2007;133:481-488.
35. Garcia-Tsao G, Groszmann RJ, Fisher RL, Conn HO, Atterbury CE, Glickman M. Portal pressure, presence of gastroesophageal varices and variceal bleeding. Hepatology 1985;5:419-424. (Pubitemid 15065948)
36. Morali GA, Sniderman KW, Deitel KM, Tobe S, Witt-Sullivan H, Simon M, et al. Is sinusoidal portal hypertension a necessary factor for the development of hepatic ascites? J Hepatol 1992;16:249-250.
37. Casado M, Bosch J, Garcia-Pagan JC, Bru C, Banares R, Bandi JC, et al. Clinical events after transjugular intrahepatic portosystemic shunt: correlation with hemodynamic findings. Gastroenterology 1998;114:1296-1303. (Pubitemid 28243916)
38. Kidd IM, Fox JC, Pillay D, Charman H, Griffiths PD, Emery VC. Provision of prognostic information in immunocompromised patients by routine application of the polymerase chain reaction for cytomegalovirus. Transplantation 1993;56:867-871. (Pubitemid 23321520)
39. Mattes FM, Hainsworth EG, Geretti AM, Nebbia G, Prentice G, Potter M, et al. A randomized, controlled trial comparing ganciclovir to ganciclovir plus foscarnet (each at half dose) for preemptive therapy of cytomegalovirus infection in transplant recipients. J Infect Dis 2004;189: 1355-1361. (Pubitemid 38543583)
40. Samonakis DN, Mela M, Quaglia A, Triantos CK, Thalheimer U, Leandro G, et al. Rejection rates in a randomised trial of tacrolimus monotherapy versus triple therapy in liver transplant recipients with hepatitis C virus cirrhosis. Transpl Infect Dis 2006;8:3-12.
41. Lake JR. The role of immunosuppression in recurrence of hepatitis C. Liver Transpl 2003;9:S63-S66.
42. Berenguer M. Host and donor risk factors before and after liver transplantation that impact HCV recurrence. Liver Transpl 2003;9:S44-S47. (Pubitemid 37408002)
43. Wiesner RH, Sorrell M, Villamil F. Report of the first International Liver Transplantation Society expert panel consensus conference on liver transplantation and hepatitis C. Liver Transpl 2003;9:S1-S9. (Pubitemid 37407996)
44. Samonakis DN, Cholongitas E, Thalheimer U, Kalambokis G, Quaglia A, Triantos CK, et al. Hepatic venous pressure gradient to assess fibrosis and its progression after liver transplantation for HCV cirrhosis. Liver Transpl 2007;13: 1305-1311. (Pubitemid 47457059)
45. Blasco A, Forns X, Carrion JA, Garcia-Pagan JC, Gilabert R, Rimola A, et al. Hepatic venous pressure gradient identifies patients at risk of severe hepatitis C recurrence after liver transplantation. Hepatology 2006;43:492-499.
46. Wali M, Harrison RF, Gow PJ, Mutimer D. Advancing donor liver age and rapid fibrosis progression following transplantation for hepatitis C. Gut 2002;51:248-252. (Pubitemid 34791456)
47. Brillanti S, Vivarelli M, De Ruvo N, Aden AA, Camaggi V, D'Errico A, et al. Slowly tapering off steroids protects the graft against hepatitis C recurrence after liver transplantation. Liver Transpl 2002;8:884-888. (Pubitemid 35154016)
48. Llado L, Fabregat J, Castellote J, Ramos E, Xiol X, Torras J, et al. Impact of immunosuppression without steroids on rejection and hepatitis C virus evolution after liver transplantation: results of a prospective randomized study. Liver Transpl 2008;14:1752-1760.
49. Germani G, Pleguezuelo M, Villamil F, Vaghjiani S, Tsochatzis E, Andreana L, et al. Azathioprine in liver transplantation: a re-evaluation of its use and a comparison with mycophenolate mofetil. Am J Transplant 2008;9: 1725-1731.
50. Bahra M, Neumann UI, Jacob D, Puhl G, Klupp J, Langrehr JM, et al. MMF and calcineurin taper in recurrent hepatitis C after liver transplantation: impact on histological course. Am J Transplant 2005;5:406-411. (Pubitemid 40179529)
51. Walter T, Dumortier J, Guillaud O, Hervieu V, Paliard P, Scoazec JY, et al. Rejection under alpha interferon therapy in liver transplant recipients. Am J Transplant 2007;7: 177-184. (Pubitemid 44952871)
52. Eid AJ, Brown RA, Paya CV, Razonable RR. Association between toll-like receptor polymorphisms and the outcome of liver transplantation for chronic hepatitis C virus. Transplantation 2007;84:511-516.
53. Hunt J, Gordon FD, Lewis WD, Pomfret E, Pomposelli JJ, Jenkins RL, et al. Histological recurrence and progression of hepatitis C after orthotopic liver transplantation: influence of immunosuppressive regimens. LiverTranspl2001;7: 1056-1063.
54. Belli LS, Burroughs AK, Burra P, Alberti AB, Samonakis D, Camma C, et al. Liver transplantation for HCV cirrhosis: improved survival in recent years and increased severity of recurrent disease in female recipients: results of a long term retrospective study. Liver Transpl 2007;13:733-740. (Pubitemid 46796545)
55. Singh N, Gayowski T, Ndimbie OK, Nedjar S, Wagener MM, Yu VL. Recurrent hepatitis C virus hepatitis in liver transplant recipients receiving tacrolimus: association with rejection and increased immunosuppression after transplantation. Surgery 1996;119:452-456. (Pubitemid 26115840)
56. Baiocchi L, Angelico M, Petrolati A, Perrone L, Palmieri G, Battista S, et al. Correlation between liver fibrosis and inflammation in patients transplanted for HCV liver disease. Am J Transplant 2008;8:673-678. (Pubitemid 351287539)
57. Stangl JR, Carroll KL, Illichmann M, Striker R. Effect of antimetabolite immunosuppressants on Flaviviridae, including hepatitis C virus. Transplantation 2004;77:562-567.
58. Zekry A, Gleeson M, Guney S, McCaughan GW. A prospective cross-over study comparing the effect of mycophenolate versus azathioprine on allograft function and viral load in liver transplant recipients with recurrent chronic HCV infection. Liver Transpl 2004;10:52-57. (Pubitemid 38885893)
59. Abraldes JG, Tarantino I, Turnes J, Garcia-Pagan JC, Rodes J, Bosch J. Hemodynamic response to pharmacological treatment of portal hypertension and long-term prognosis of cirrhosis. Hepatology 2003;37:902-908. (Pubitemid 36397403)
60. Burroughs AK, Groszmann R, Bosch J, Grace N, Garcia- Tsao G, Patch D, et al. Assessment of therapeutic benefit of antiviral therapy in chronic hepatitis C: is hepatic venous pressure gradient a better end point? Gut 2002;50: 425-427.