Antiviral prophylaxis for the prevention of chronic hepatitis C virus in patients undergoing liver transplantation

Cochrane Database of Systematic Reviews

Volumn 2013, Issue 12, 2013, Pages

  Gurusamy, Kurinchi Selvan ^a   Tsochatzis, Emmanuel ^b   Toon, Clare D ^c   Davidson, Brian R ^a   Burroughs, Andrew K ^d  

^a ROYAL FREE HOSPITAL   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

^c WEST SUSSEX COUNTY COUNCIL   (United Kingdom)

^d ROYAL FREE LONDON NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

HEPATITIS C ANTIBODY; INTERFERON; PEGINTERFERON; PLACEBO; RIBAVIRIN; ALPHA2B INTERFERON; ANTIVIRUS AGENT; MACROGOL DERIVATIVE; PEGINTERFERON ALPHA2B; ALPHA INTERFERON; RECOMBINANT PROTEIN;

ANEMIA; CHEMOPROPHYLAXIS; CHRONIC HEPATITIS C; DATA EXTRACTION; DATA SYNTHESIS; DRUG MEGADOSE; GRAFT SURVIVAL; HEPATITIS C VIRUS GENOTYPE 1; HUMAN; INFECTION PREVENTION; LEUKOPENIA; LIVER FIBROSIS; LIVER GRAFT REJECTION; LIVER TRANSPLANTATION; LOW DRUG DOSE; MORTALITY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT DISEASE; REVIEW; RISK BENEFIT ANALYSIS; SENSITIVITY ANALYSIS; STUDY DESIGN; SURGICAL PATIENT; SURVIVAL RATE; SYSTEMATIC REVIEW; GENETICS; GENOTYPE; GRAFT REJECTION; HEPATITIS C; HEPATITIS C VIRUS; META ANALYSIS;

ANTIVIRAL AGENTS; GENOTYPE; GRAFT REJECTION; GRAFT SURVIVAL; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; INTERFERON ALFA-2B; LIVER TRANSPLANTATION; POLYETHYLENE GLYCOLS; RECURRENCE; RIBAVIRIN; INTERFERON-ALPHA; RECOMBINANT PROTEINS;

EID: 84897368213     PISSN: 14651858     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD006573.pub3     Document Type: Review

References (89)

1. Belli LS, Alberti AB, Rondinara GF, de Carlis L, Corti A, Mazza E, et al.Early ribavirin treatment and avoidance of corticosteroids in hepatitis C virus (HCV)-positive liver transplant recipients: interim report of a prospective randomized trial. Transplantation Proceedings 2001; Vol. 33, issue 1-2:1353-4.
2. Alpert E, Levy GA, Marotta P, Deschenes M, Yoshida E, Peck-Radosavljevic M, et al.Peginterferon alfa-2a for hepatitis C after liver transplantation: two randomized, controlled trials (vol 41, pg 289, 2004). Hepatology 2005;42(2):506.
3. Chalasani N, Manzarbeitia C, Ferenci P, Vogel W, Fontana RJ, Voigt M, et al.Peginterferon alfa-2a for hepatitis C after liver transplantation: two randomized, controlled trials. Hepatology 2005;41(2):289-98.
4. Manzarbeitia C, Tepermann L, Chalasani N, Sheiner P, Wiesner R, Marks IM, et al.40 KDA peginterferon alfa-2a (PEGASYS) as a prophylaxis against hepatitis C infection recurrence after liver transplantation (LT): preliminary results of a randomized multicenter trial (abstract). Hepatology 2001;34(4 Pt 2):406A.
5. Vogel W, Ferenci P, Fontana R, Arbor A, Saab S, LaBrecque D, et al.Peginterferon alfa-2A (40 kd) (PEGASYS) in liver transplant recipients with established recurrent hepatitis C: interim results of an ongoing randomized multicenter trial [abstract]. Hepatology 2002;36(4 Pt 2):312A.
6. Bzowej N, Nelson DR, Terrault NA, Everson GT, Teng LL, Prabhakar A, et al.PHOENIX: a randomized controlled trial of peginterferon alfa-2a plus ribavirin as a prophylactic treatment after liver transplantation for hepatitis C virus. Liver Transplantation 2011;17(5):528-38.
7. Bzowej N, Nelson DR, Terrault NA, Everson GT, Teng LL, Prabhakar A, et al.Phoenix: a randomized controlled trial of peginterferon alfa-2a/ribavirin prophylactic treatment after liver transplant for hepatitis C. Liver Transplantation 2010;16(Suppl 1):S118.
8. Bzowej NH, Nelson D, Terrault N, Everson GT, Teng LL, Prabhakar A, et al.A randomized controlled trial of the efficacy, tolerability, and safety of prophylactic treatment with peginterferon alfa-2a plus ribavirin after orthotopic liver transplantation (OLT) for hepatitis C: The PHOENIX Study. Hepatology 2009;50(4 Suppl):547a.
9. Bzowej NH, Nelson D, Thommes JA, Hamzeh FM, Charlton M. A randomized controlled trial of prophylactically administered peginterferon alfa-2A plus ribavirin vs no prophylaxis following orthotopic liver transplantation (OLT) for hepatitis C: a report of initial safety and tolerability. Hepatology 2006; Vol. 44, issue 4 Suppl 1:188A.
10. Charlton MR, Bzowej N, Rossi S, Nelson DR. Prophylactic peginterferon alfa-2a/ribavirin vs no prophylaxis following orthotopic liver transplantation (OLT) for hepatitis C: 24-week virologic and safety responses. Hepatology 2007;46(4 Suppl 1):244a.
11. Chung RT, Gordon FD, Curry MP, Schiano TD, Emre S, Corey K, et al.Human monoclonal antibody MBL-HCV1 delays HCV viral rebound following liver transplantation: a randomized controlled study. American Journal of Transplantation 2013;13(4):1047-54.
12. Davis GL, Nelson DR, Terrault N, Pruett TL, Schiano TD, Fletcher CV, et al.A randomized, open-label study to evaluate the safety and pharmacokinetics of human hepatitis C immune globulin (Civacir) in liver transplant recipients. Liver Transplantation 2005;11(8):941-9.
13. Mazzaferro V, Schiavo M, Caccamo L, Tagger A, Morabito A, Lavezzo B, et al.Prospective randomized trial on early treatment of HCV infection after liver transplantation in HCV-RNA positive patients. Liver Transplantation 2003;9(6):C36.
14. Reddy R, Fried M, Dickson R, Martin P, Schiff E, Torres M, et al.Interferon alfa-2b and ribavirin vs. placebo as early treatment in patients transplanted for hepatitis C end-stage liver disease: results of a multicenter, randomized trial. Gastroenterology 2002;122(4 Suppl 1):A632.
15. Schiano TD, Charlton M, Younossi Z, Galun E, Pruett T, Tur-Kaspa R, et al.Monoclonal antibody HCV-Ab(XTL)68 in patients undergoing liver transplantation for HCV: results of a phase 2 randomized study. Liver Transplantation 2006;12(9):1381-9.
16. Sheiner PA, Boros P, Klion FM, Thung SN, Schluger LK, Lau JYN, et al.The efficacy of prophylactic interferon alfa-2b in preventing recurrent hepatitis C after liver transplantation. Hepatology 1998;28(3):831-8.
17. Sheiner PA, Boros P, Thung SN, Klion FM, Emre S, Guy SR, et al.Prophylactic interferon-alpha2b reduces the incidence of recurrent hepatitis after liver transplantation for hepatitis C. 16th Annual Meeting of American Society of Transplant Physicians (ASTP). 1997:262.
18. Shergill AK, Khalili M, Straley S, Bollinger K, Roberts JP, Ascher NA, et al.Applicability, tolerability and efficacy of preemptive antiviral therapy in hepatitis C-infected patients undergoing liver transplantation. American Journal of Transplantation 2005;5(1):118-24.
19. Terrault NA, Khalili M, Straley S, Bollinger K, Bass N, Roberts JP, et al.Efficacy and tolerability of preemptive interferon (IFN) versus IFN plus ribavirin (RBV) treatment in hepatitis C virus (HCV) infected liver transplant recipients [AASLD abstract]. Hepatology 2003;38(4 Suppl 1):158a-9a.
20. Singh N, Gayowski T, Wannstedt CF, Shakil AO, Wagener MM, Fung JJ, et al.Interferon-alpha for prophylaxis of recurrent viral hepatitis C in liver transplant recipients: a prospective, randomized, controlled trial. Transplantation 1998; Vol. 65, issue 1:82-6.
21. Willems B, Ede M, Marotta P, Wall W, Greig P, Lilly L, et al.Anti-HCV human immunoglobulins for the prevention of graft infection in HCV-related liver transplantation, a pilot study [abstract]. Journal of Hepatology 2002;36(Suppl 1):32.
22. Beckebaum S, Cicinnati VR, Karliova M, Dirsch O, Erim Y, Frilling A, et al.Daily interferon alpha-2B and ribavirin combination therapy for liver transplant patients with chronic hepatitis C infection. Transplantation Proceedings 2003;35(6):2080-1.
23. Boillot O, Berger F, Rasolofo E, Mion F, Chevallier P, Gille D, et al.Effects of early interferon alfa therapy for hepatitis C virus infection recurrence after liver transplantation. Transplantation Proceedings 1995; Vol. 27, issue 4:2501.
24. Casanovas TT, Casais ALA, Samuel D, Bizollon T, Trepo C. Chronic hepatitis C after liver transplantation: a randomized study (5) (multiple letters). Gastroenterology 2004;126(1):373-4.
25. Castedal M, Siewert DA, Olausson M, Friman S. Combination therapy of interferon alpha-2B and ribavirin for recurrent hepatitis C after liver transplantation. Transplantation Proceedings 2003;35(2):820-1.
26. Catalano G, Urbani L, Oliveri F, Iaria G, Biancofiore G, Mosca F, et al.Recurrence of hepatitis C in liver transplants from elderly donors aged more than 75 years. Transplantation Proceedings 2003;35(3):1034.
27. Ceccherini NL, Giannotti A, Malizia T, Ciccorossi P, Olivieri F, Vanni M, et al.Recurrence of HCV infection in liver transplant patients: evaluation of IgM anti-HCV and IgM anti-CMV. Transplantation Proceedings 2003;35(3):1030-1.
28. Charlton M. Pre-emptive treatment of recurrent hepatitis C infection. Liver Transplantation 2002;8(10 Suppl 1):S50-S54.
29. Everson GT, Terrault N, Lok AS, Brown RS, Saab S, Shiffman ML, et al.Interim analysis of a controlled trial of pre-transplant peginterferon alfa-2b/ribavirin (PEG/RBV) to prevent recurrent hepatitis C virus (HCV) infection after liver transplantation (LT) in the adult-to-adult liver transplantation (A2ALL) Study. Hepatology 2009;50(4 Suppl):302a.
30. Everson GT, Terrault NA, Lok AS, Rodrigo del R, Brown RS Jr, Saab S, et al. A randomized controlled trial of pretransplant antiviral therapy to prevent recurrence of hepatitis C after liver transplantation. Hepatology 2013;57(5):1752-62.
31. Garcia-Retortillo M, Forns X. Prevention and treatment of hepatitis C virus recurrence after liver transplantation. Journal of Hepatology 2004;41(1):2-10.
32. Mazzaferro V, Regalia E, Pulvirenti A, Tagger A, Andreola S, Pasquali M, et al.Prophylaxis against HCV recurrence after liver transplantation: effect of interferon and ribavirin combination. Transplantation Proceedings 1997;29(1-2):519-21.
33. Roche B, Samuel D. Is early antiviral therapy for recurrent hepatitis C after liver transplantation superior to later treatment? The answer is no. Liver Transplantation 2011;17(5):488-91.
34. Samuel D. Hepatitis C, interferon, and risk of rejection after liver transplantation. Liver Transplantation 2004;10(7):868-71.
35. Samuel D, Bizollon T, Trepo C. Chronic hepatitis C after liver transplantation: a randomized study - reply. Gastroenterology 2004; Vol. 126, issue 1:373-4.
36. Taltavull TC, Alvarez LAC. Chronic hepatitis C after liver transplantation: a randomized study. Gastroenterology 2004;126(1):373.
37. Afdhal NH, Dieterich DT, Pockros PJ, Schiff ER, Shiffman ML, Sulkowski MS, et al.Epoetin alfa maintains ribavirin dose in HCV-infected patients: a prospective, double-blind, randomized controlled study. Gastroenterology 2004;126(5):1302-11.
38. 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(1):34-41.
39. Bombuy E, Fondevila C, Rodriguez-Laiz G, Ferrer J, Amador A, Valentini M, et al.Ischemic preconditioning in adult living donor liver transplantation, a pilot study [EASL abstract]. Journal of Hepatology 2004;40(Suppl 1):39.
40. Brok J, Thorlund K, Gluud C, Wetterslev J. Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses. Journal of Clinical Epidemiology 2008;61:763-9.
41. Brok J, Thorlund K, Wetterslev J, Gluud C. Apparently conclusive meta-analyses may be inconclusive - Trial sequential analysis adjustment of random error risk due to repetitive testing of accumulating data in apparently conclusive neonatal meta-analyses. International Journal of Epidemiology 2009;38(1):287-98.
42. Brok J, Gluud LL, Gluud C. Ribavirin plus interferon versus interferon for chronic hepatitis C. Cochrane Database of Systematic Reviews 2010, Issue 1. [DOI: 10.1002/14651858.CD005445.pub2]
43. Cameron AM, Ghobrial RM, Hiatt JR, Carmody IC, Gordon SA, Farmer DG, et al.Effect of nonviral factors on hepatitis C recurrence after liver transplantation. Annals of Surgery 2006;244(4):563-71.
44. Cescon M, Grazi GL, Grassi A, Ravaioli M, Vetrone G, Ercolani G, et al.Effect of ischemic preconditioning in whole liver transplantation from deceased donors. A pilot study. Liver Transplantation 2006;12(4):628-35.
45. Corno V, Colledan M, Dezza MC, Guizzetti M, Lucianetti A, Maldini G, et al.Extended right split liver graft for primary transplantation in children and adults. Transplantation International 2006;19(6):492-9.
46. Copenhagen Trial Unit. TSA - Trial Sequential Analysis, 2011. ctu.dk/tsa/ (accessed 25 November 2013).
47. DeMets DL. Methods for combining randomized clinical trials: strengths and limitations. Statistics in Medicine 1987;6(3):341-50.
48. DerSimonian R, Laird N. Meta-analysis in clinical trials. Controlled Clinical Trials 1986;7(3):177-88.
49. Dieterich DT, Wasserman R, Brau N, Hassanein TI, Bini EJ, Bowers PJ, et al.Once-weekly epoetin alfa improves anemia and facilitates maintenance of ribavirin dosing in hepatitis C virus-infected patients receiving ribavirin plus interferon alfa. American Journal of Gastroenterology 2003;98(11):2491-9.
50. Eason JD, Loss GE, Blazek J, Nair S, Mason AL. Steroid-free liver transplantation using rabbit antithymocyte globulin induction: results of a prospective randomized trial. Liver Transplantation 2001;7(8):693-7.
51. Egger M, Davey SG, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ (Clinical Research Ed.) 1997;315(7109):629-34.
52. 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(4):889-96.
53. Ghobrial RM, Farmer DG, Baquerizo A, Colquhoun S, Rosen HR, Yersiz H, et al.Orthotopic liver transplantation for hepatitis C: outcome, effect of immunosuppression, and causes of retransplantation during an 8-year single-center experience. Annals of Surgery 1999;229(6):824-31; discussion 831-3.
54. Gluud C, Brok J, Gong Y, Koretz RL. Hepatology may have problems with putative surrogate outcome measures. Journal of Hepatology 2007;46(4):734-42.
55. Gluud C, Nikolova D, Klingenberg SL, Alexakis N, Als-Nielsen B, Colli A, et al.Cochrane Hepato-Biliary Group. About The Cochrane Collaboration (Cochrane Review Groups (CRGs)). 2013, Issue 5. Art. No.: LIVER.
56. Gurusamy KS, Osmani B, Xirouchakis E, Burroughs AK, Davidson BR. Antiviral therapy for recurrent liver graft infection with hepatitis C virus. Cochrane Database of Systematic Reviews 2009, Issue 1. [DOI: 10.1002/14651858.CD006803.pub2]
57. Gurusamy KS, Wilson E, Koretz RL, Allen VB, Davidson BR, Burroughs AK, et al.Is sustained virological response a marker of treatment efficacy in patients with chronic hepatitis C viral infection with no response or relapse to previous antiviral intervention?. PLoS One 2013;in press.
58. Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Statistics in Medicine 2002;21(11):1539-58.
59. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
60. International Conference on Harmonisation Expert Working Group. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonised tripartite guideline. Guideline for good clinical practice CFR & ICH Guidelines. Vol. 1, PA 19063-2043, USA: Barnett International/PAREXEL, 1997.
61. Jain A, Kashyap R, Demetris AJ, Eghstesad B, Pokharna R, Fung JJ. A prospective randomized trial of mycophenolate mofetil in liver transplant recipients with hepatitis C. Liver Transplantation 2002;8(1):40-6.
62. Kamath PS, Wiesner RH, Malinchoc M, Kremers W, Therneau TM, Kosberg CL, et al.A model to predict survival in patients with end-stage liver disease. Hepatology 2001;33(2):464-70.
63. Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. Annals of Internal Medicine 2001;135(11):982-9.
64. Koneru B, Fisher A, He Y, Klein KM, Skurnick J, Wilson DJ, et al.Ischemic preconditioning in deceased donor liver transplantation: a prospective randomized clinical trial of safety and efficacy. Liver Transplantation 2005;11(2):196-202.
65. Lim SG, Wai CT, Da Costa M, Sutedja DS, Lee YM, Lee KH, et al.Referral patterns and waiting times for liver transplantation in Singapore. Singapore Medical Journal 2006;47(7):599-603.
66. Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L. Industry sponsorship and research outcome. Cochrane Database of Systematic Reviews 2012, Issue 12. [DOI: 10.1002/14651858.MR000033.pub2]
67. Macaskill P, Walter SD, Irwig L. A comparison of methods to detect publication bias in meta-analysis. Statistics in Medicine 2001;20(4):641-54.
68. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, et al.Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?. Lancet 1998;352(9128):609-13.
69. Newell DJ. Intention-to-treat analysis: implications for quantitative and qualitative research. International Journal of Epidemiology 1992;21(5):837-41.
70. NHS UK Transplant - activity report 2011-2012. www.organdonation.nhs.uk/statistics/transplant_activity_report/current_activity_reports/ukt/liver_activity.pdf (accessed 25 November 2013).
71. The Organ Procurement and Transplant Network/Scientific Registry of Transplant Recipients 2009 annual report. www.ustransplant.org/annual_reports/current/905_li.pdf (accessed 25 November 2013).
72. Parmar MK, Torri V, Stewart L. Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Statistics in Medicine 1998;17(24):2815-34. [PUBMED: 9921604]
73. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 5.2. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012.
74. Royle P, Milne R. Literature searching for randomized controlled trials used in Cochrane reviews: rapid versus exhaustive searches. International Journal of Technology Assessment in Health Care 2003;19(4):591-603.
75. Savovic J, Jones HE, Altman DG, Harris RJ, Jüni P, Pildal J, et al.Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Health Technology Assessment 2012;16(35):1-82.
76. Savovic J, Jones HE, Altman DG, Harris RJ, Jüni P, Pildal J, et al.Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Annals of Internal Medicine 2012;157(6):429-38.
77. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273(5):408-12.
78. Sharvadze L, Tsertsvadze T, Gochitashvili N, Kakabadze T, Dolmazashvili E. IFN/RBV treatment induced anemia and its correction with epoetin alpha in patients with hepatitis C. Georgian Medical News 2006;137:62-5.
79. Sharvadze L, Gochitashvili N, Tophuria A, Bolokadze N, Tsertsvadze T. IFN/RBV treatment induced neutropenia and its correction with neupogen in patients with hepatitis C. Georgian Medical News 2007;147:52-5.
80. Shiffman ML, Saab S, Feng S, Abecassis MI, Tzakis AG, Goodrich NP, et al.Liver and intestine transplantation in the United States, 1995-2004. American Journal of Transplantation 2006;6(5 Pt 2):1170-87.
81. Sugo H, Balderson GA, Crawford DH, Fawcett J, Lynch SV, Strong RW, et al.The influence of viral genotypes and rejection episodes on the recurrence of hepatitis C after liver transplantation. Surgery Today 2003;33(6):421-5.
82. Thorlund K, Devereaux PJ, Wetterslev J, Guyatt G, Ioannidis JP, Thabane L, et al.Can trial sequential monitoring boundaries reduce spurious inferences from meta-analyses. International Journal of Epidemiology 2009;38(1):276-86.
83. Thorlund K, Anema A, Mills E. Interpreting meta-analysis according to the adequacy of sample size. An example using isoniazid chemoprophylaxis for tuberculosis in purified protein derivative negative HIV-infected individuals. Clinical Epidemiology 2010;2:57-66.
84. Thorlund K, Engstrøm J, Wetterslev J, Brok J, Imberger G, Gluud C. User manual for Trial Sequential Analysis (TSA), 2011. ctu.dk/tsa/files/tsa_manual.pdf (accessed 25 November 2013).
85. Wetterslev J, Thorlund K, Brok J, Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. Journal of Clinical Epidemiology 2008;61(1):64-75.
86. Wetterslev J, Thorlund K, Brok J, Gluud C. Estimating required information size by quantifying diversity in random-effects model meta-analyses. BMC Medical Research Methodology 2009;9:86.
87. Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman GD, et al.Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ (Clinical Research Ed.) 2008;336:601-5.
88. Yilmaz N, Shiffman ML, Stravitz RT, Sterling RK, Luketic VA, Sanyal AJ, et al.A prospective evaluation of fibrosis progression in patients with recurrent hepatitis C virus following liver transplantation. Liver Transplantation 2007;13(7):975-83.
89. Gurusamy KS, Tsochatzis E, Davidson BR, Burroughs AK. Antiviral prophylactic intervention for chronic hepatitis C virus in patients undergoing liver transplantation. Cochrane Database of Systematic Reviews 2010, Issue 12. [DOI: 10.1002/14651858.CD006573.pub2]