Safety and efficacy of treatment for chronic hepatitis C with a focus on pegylated interferons: The backbone of therapy today and in the future

Expert Opinion on Drug Safety

Volumn 10, Issue 4, 2011, Pages 529-544

  Ferenci, Peter ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

Author keywords

HCV; hepatitis C; IFN; peg IFN; safety

Indexed keywords

ALBINTERFERON ALPHA2B; ALISPORIVIR; ALPHA2A INTERFERON; ALPHA2B INTERFERON; ANTIVIRUS AGENT; BOCEPREVIR; CONSENSUS INTERFERON; DANOPREVIR; FILIBUVIR; MERICITABINE; NITAZOXANIDE; PEGINTERFERON; PEGINTERFERON ALPHA2A PLUS RIBAVIRIN; PEGINTERFERON ALPHA2B PLUS RIBAVIRIN; PEGINTERFERON LAMBDA; RIBAVIRIN; SILIBININ; TARIBAVIRIN; TCM 435; TELAPREVIR; UNCLASSIFIED DRUG;

ALOPECIA; ANEMIA; ANOREXIA; ANTIVIRAL THERAPY; ARTHRALGIA; BLEEDING; DEPRESSION; DERMATITIS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEVER; HEADACHE; HEPATITIS C; HUMAN; INJECTION SITE INFLAMMATION; INJECTION SITE REACTION; INSOMNIA; IRRITABILITY; LUNG TOXICITY; MEDLINE; MYALGIA; NAUSEA; NEUTROPENIA; OPTIC NERVE DISEASE; PAPILLEDEMA; PNEUMONIA; RETINA ARTERY OCCLUSION; RETINA HEMORRHAGE; RETINA VEIN OCCLUSION; RETINOPATHY; REVIEW; RIGOR; SEPSIS; SIDE EFFECT; SUICIDAL BEHAVIOR; WEIGHT REDUCTION;

ANIMALS; DRUG THERAPY, COMBINATION; HEPATITIS C, CHRONIC; HUMANS; INTERFERON-ALPHA; POLYETHYLENE GLYCOLS; PREDICTIVE VALUE OF TESTS; RECOMBINANT PROTEINS; TREATMENT OUTCOME;

EID: 79958779978     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2011.555079     Document Type: Review

References (137)

1. Global surveillance and control of hepatitis C. Report of a WHO Consultation organized in collaboration with the Viral Hepatitis Prevention Board, Antwerp, Belgium. J Viral Hepat 1999;6(1):35-47
2. National Institutes of Health. National Institutes of Health Consensus Development Conference Statement: management of hepatitis C: 2002-10 - 12 June 2002. Hepatology 2002;36(5 Suppl 1):S3-20
3. Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49(4):1335-74
4. Choo QL, Kuo G, Weiner AJ, et al. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science 1989;244(4902):359-62 (Pubitemid 19117877)
5. Zeuzem S, Nelson DR, Marcellin P. Dynamic evolution of therapy for chronic hepatitis C: how will novel agents be incorporated into the standard of care? Antivir Ther 2008;13(6):747-60
6. Ge D, Fellay J, Thompson AJ, et al. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance. Nature 2009;461(7262):399-401
7. Hoofnagle JH, Mullen KD, Jones DB, et al. Treatment of chronic non-A,non-B hepatitis with recombinant human alpha interferon. A preliminary report. N Engl J Med 1986;315(25):1575-8 (Pubitemid 17055392)
8. Davis GL, Balart LA, Schiff ER, et al. Treatment of chronic hepatitis C with recombinant interferon alfa. A multicenter randomized, controlled trial. Hepatitis Interventional Therapy Group. N Engl J Med 1989;321(22):1501-6 (Pubitemid 20015540)
9. Di Bisceglie AM, Martin P, Kassianides C, et al. Recombinant interferon alfa therapy for chronic hepatitis C. A randomized, double-blind, placebo-controlled trial. N Engl J Med 1989;321(22):1506-10
10. Marcellin P, Boyer N, Giostra E, et al. Recombinant human alpha-interferon in patients with chronic non-A, non-B hepatitis: a multicenter randomized controlled trial from France. Hepatology 1991;13(3):393-7
11. Blatt LM, Davis JM, Klein SB, et al. The biologic activity and molecular characterization of a novel synthetic interferon-alpha species, consensus interferon. J Interferon Cytokine Res 1996;16(7):489-99 (Pubitemid 26306949)
12. McHutchison JG, Gordon SC, Schiff ER, et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N Engl J Med 1998;339(21):1485-92 (Pubitemid 28543496)
13. Poynard T, Marcellin P, Lee SS, et al. Randomised trial of interferon alpha2b plus ribavirin for 48 weeks or for 24 weeks versus interferon alpha2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. International Hepatitis Interventional Therapy Group (IHIT). Lancet 1998;352(9138):1426-32 (Pubitemid 28510876)
14. EASL consensus panel. EASL International Consensus Conference on Hepatitis C. Paris, 26-28, February 1999, Consensus Statement. European Association for the Study of the Liver. J Hepatol 1999;30(5):956-61
15. Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001;358(9286):958-65 (Pubitemid 32913521)
16. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002;347(13):975-82
17. Hadziyannis SJ, Sette H Jr, Morgan TR, et al. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 2004;140(5):346-55
18. Torriani FJ, Rodriguez-Torres M, Rockstroh JK, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med 2004;351(5):438-50 (Pubitemid 38988593)
19. Carrat F, Bani-Sadr F, Pol S, et al. Pegylated interferon alfa-2b vs standard interferon alfa-2b, plus ribavirin, for chronic hepatitis C in HIV-infected patients: a randomized controlled trial. JAMA 2004;292(23):2839-48 (Pubitemid 39628231)
20. Rockstroh JK, Bhagani S, Benhamou Y, et al. European AIDS Clinical Society (EACS) guidelines for the clinical management and treatment of chronic hepatitis B and C coinfection in HIV-infected adults. HIV Med 2008;9(2):82-8 (Pubitemid 351228130)
21. Muir AJ, Shiffman ML, Zaman A, et al. Phase 1b study of pegylated interferon lambda 1 with or without ribavirin in patients with chronic genotype 1 hepatitis C virus infection. Hepatology 2010;52(3):822-32
22. Sommereyns C, Paul S, Staeheli P, Michiels T. IFN-lambda (IFN-k) is expressed in a tissue-dependent fashion and primarily acts on epithelial cells in vivo. PLoS Pathog 2008;4:e10000017
23. Muir AJ, Lawitz E, Ghalib RH, et al. Pegylated interferon lambda (PEG-IFN-lamda) phase 2 dose-ranging, active-controlled study in combination with ribavirin (RBV) for treatment-naive HCV patients (genotypes 1, 2, 3 or 4): safety, viral response, and impact of IL-28b host genotype through week 12 [abstract 821]. Hepatology 2010;52(Suppl):715A
24. Muir AJ, Shiffman ML, Zaman A, et al. Phase 1b study of pegylated interferon lambda 1 with or without ribavirin in patients with chronic genotype 1 hepatitis C virus infection. Hepatology 2010;52(3):822-32
25. Subramanian GM, Fiscella M, Lamouse-Smith A, et al. Albinterferon alpha-2b: a genetic fusion protein for the treatment of chronic hepatitis C. Nat Biotechnol 2007;25(12):1411-19 (Pubitemid 350233139)
26. Zeuzem S, Sulkowski M, Lawitz E, et al. Efficacy and safety of albinterferon alfa-2b in combination with ribavirin in treatment-naive patients with chronic hepatitis C genotype 1. Oral presentation. Available from: www.hgsi. com/albinterferon-alfa-2b.html. [Accessed January 2010]. J Hepatol 2009;50(Suppl 1):S377
27. Nelson D, Benhamou Y, Chuang WL, et al. Efficacy and safety results of albinterferon alfa-2b in combination with ribavirin in interferon alfa treatment naive patients with genotype 2 or 3 chronic hepatitis C. Oral presentation. Available from: www.hgsi.com/ albinterferon-alfa-2b.html. [Accessed January 2010]. J Hepatol 2009;50(Suppl 1):S378
28. Human Genome Sciences. Human Genome Sciences modifies dosing in ACHIEVE trials of Albuferon; Press release 23 January 2008. Available from: http://www.hgsi.com/latest/humangenome- sciences-modifies-dosing-inachieve- trials-of-albuf-2.html
29. Human GenomeSciences. Human Genome Sciences announces preliminary feedback from FDA on Zalbin- BLA for chronic hepatitis C. Press release 14th June 2010. Press release 2010. Available from: http://www.hgsi.com/ latest/human-genome-sciences-announcespreliminary- feedback-from-fda-on- zalbinbla- for-chronic-hepati-2.html
30. European Medicines Agency. Novartis Europharm Ltd withdraws its marketing authorisation application for Joulferon (albinterferon alfa-2b). 10 A.D.; EMA/249301/2010
31. Novartis. Novartis discontinues development of two investigational compounds reflecting enhanced focus on portfolio prioritization and productivity. Available from: http://www.novartis.com/ newsroom/media-releases/ en/2010/ 1449020.shtml
32. Schuster D, Laggner C, Langer T. Why drugs fail-a study on side effects in new chemical entities. Curr Pharm Des 2005;11(27):3545-59 (Pubitemid 41300759)
33. Hammond TG, Valentin J-P, Smith CG, et al. editors, The process of new drug discovery and development. 2nd edition. Safety pharmacology: past, present, and future; 2006
34. Jensen DM, Morgan TR, Marcellin P, et al. Early identification of HCV genotype 1 patients responding to 24 weeks peginterferon alpha-2a (40 kd)/ribavirin therapy. Hepatology 2006;43(5):954-60 (Pubitemid 43724620)
35. Zeuzem S, Buti M, Ferenci P, et al. Efficacy of 24 weeks treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia. J Hepatol 2006;44(1):97-103 (Pubitemid 41772522)
36. Mangia A, Minerva N, Bacca D, et al. Individualized treatment duration for hepatitis C genotype 1 patients: a randomized controlled trial. Hepatology 2008;47(1):43-50 (Pubitemid 351171040)
37. Dalgard O, Bjoro K, Hellum KB, et al. Treatment with pegylated interferon and ribavarin in HCV infection with genotype 2 or 3 for 14 weeks: a pilot study. Hepatology 2004;40(6):1260-5 (Pubitemid 39656999)
38. Mangia A, Santoro R, Minerva N, et al. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J Med 2005;352(25):2609-17 (Pubitemid 41007847)
39. von Wagner M, Huber M, Berg T, et al. Peginterferon-alpha-2a (40KD) and ribavirin for 16 or 24 weeks in patients with genotype 2 or 3 chronic hepatitis C. Gastroenterology 2005;129(2):522-7 (Pubitemid 41096640)
40. Shiffman ML, Suter F, Bacon BR, et al. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med 2007;357(2):124-34 (Pubitemid 47057730)
41. Yu ML, Dai CY, Huang JF, et al. A randomised study of peginterferon and ribavirin for 16 versus 24 weeks in patients with genotype 2 chronic hepatitis C. Gut 2007;56(4):553-9
42. Dalgard O, Bjoro K, Ring-Larsen H, et al. Pegylated interferon alfa and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3 and rapid virological response. Hepatology 2008;47(1):35-42 (Pubitemid 351171039)
43. Zeuzem S, Rizzetto M, Ferenci P, et al. Management of hepatitis C virus genotype 2 or 3 infection: treatment optimization on the basis of virological response. Antivir Ther 2009;14(2):143-54
44. Stattermayer AF, Stauber R, Hofer H, et al. Impact of IL28B genotype on the early and sustained virologic response in treatment-naive patients with chronic hepatitis C. Clin Gastroenterol Hepatol 2010. [Epub ahead of print]
45. Thompson AJ, Muir AJ, Sulkowski MS, et al. Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in hepatitis C virus-1 patients. Gastroenterology 2010;139(1):120-9
46. Mangia A, Thompson AJ, Santoro R, et al. Interleukin-28B polymorphism determines treatment response of patients with hepatitis c genotypes 2 or 3 who do not achieve a rapid virologic response. Gastroenterology 2010;139(3):821-7
47. Rallon NI, Naggie S, Benito JM, et al. Association of a single nucleotide polymorphism near the interleukin-28B gene with response to hepatitis C therapy in HIV/hepatitis C virus-coinfected patients. AIDS 2010;24(8):F23-9
48. Akuta N, Suzuki F, Hirakawa M, et al. Amino acid substitution in hepatitis C virus core region and genetic variation near the interleukin 28B gene predict viral response to telaprevir with peginterferon and ribavirin. Hepatology 2010;52:421-9
49. Zeuzem S, Nelson DR, Andreone P, et al. Phase IIB study of Balapiravir (RG1626; Nucleoside analogue inhibitor of HCV polymerase) plus peginterferon alfa-2a (40KD) and ribavirin for CHC genotype: final results. [abstract]. J Hepatol 2010;52:(1
50. Jacobson I. Telaprevir in combination with peginterferon and ribavirin in genotype 1 HCV treatment naive patients: final results of phase 3 ADVANCE study [abstract 211]. Hepatology 2010;52(Suppl):427A
51. Poordad F. Boceprevir (BOC) combined with peginterferon alfa-2b/ribavirin (P/R) for treatment-naive patients with hepatitis c virus (HCV) genotype (G) 1: SPRINT-2 final results [abstract LB4]. Hepatology 2010;52(Suppl):402A
52. Gane EJ, Roberts SK, Stedman CA, et al. Oral combination therapy with a nucleoside polymerase inhibitor (RG7128) and danoprevir for chronic hepatitis C genotype 1 infection (INFORM-1): a randomised, double-blind, placebo-controlled, dose-escalation trial. Lancet 2010;376(9731):1467-75
53. Hezode C, Forestier N, Dusheiko G, et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med 2009;360(18):1839-50
54. McHutchison JG, Everson GT, Gordon SC, et al. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. NEJM 2009;360:1827-38
55. Kwo P, Lawitz E, McCone J, et al. HCV SPRINT-1 final results: SVR 24 from a phase 2 study of boceprevir plus Pegintron (peginterferon alfa-2b)/ ribavirin in treatment-naive subjects with genotype-1 chronic hepatitis C. J Hepatol 2009;50:(1:54
56. Fried MW. Side effects of therapy of hepatitis C and their management. Hepatology 2002;36(5 Suppl 1):S237-44 (Pubitemid 35253486)
57. Ferenci P, Brunner H, Nachbaur K, et al. Combination of interferon induction therapy and ribavirin in chronic hepatitis C. Hepatology 2001;34(5):1006-11 (Pubitemid 33032036)
58. Jensen DM, Marcellin P, Freilich B, et al. Re-treatment of patients with chronic hepatitis C who do not respond to peginterferon-alpha2b: a randomized trial. Ann Intern Med 2009;150(8):528-40
59. Cooper CL, Al Bedwawi S, Lee C, Garber G. Rate of infectious complications during interferon-based therapy for hepatitis C is not related to neutropenia. Clin Infect Dis 2006;42(12):1674-8 (Pubitemid 43839429)
60. Roomer R, Hansen BE, Janssen HL, de Knegt RJ. Thrombocytopenia and the risk of bleeding during treatment with peginterferon alfa and ribavirin for chronic hepatitis C. J Hepatol 2010;53(3):455-9
61. Ascione A, De Luca M, Tartaglione MT, et al. Peginterferon alfa-2a plus ribavirin is more effective than peginterferon alfa-2b plus ribavirin for treating chronic hepatitis C virus infection. Gastroenterology 2010;138(1):116-22
62. Rumi MG, Aghemo A, Prati GM, et al. Randomized study of peginterferon-alpha2a plus ribavirin vs peginterferon-alpha2b plus ribavirin in chronic hepatitis C. Gastroenterology 2010;138(1):108-15
63. McHutchison JG, Lawitz EJ, Shiffman ML, et al. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med 2009;361(6):580-93
64. Backus LI, Boothroyd DB, Phillips BR, et al. Predictors of response of US veterans to treatment for the hepatitis C virus. Hepatology 2007;46(1):37-47 (Pubitemid 47171919)
65. Witthoeft T, Hueppe D, John C, et al. Efficacy and tolerability of peginterferon alfa-2a or alfa-2b plus ribavirin in the daily routine treatment of patients with chronic hepatitis C in Germany: the PRACTICE Study. J Viral Hepat 2010;17(7):459-68
66. Di Bisceglie AM, Ghalib RH, Hamzeh FM, et al. Early virologic response after peginterferon alpha-2a plus ribavirin or peginterferon alpha-2b plus ribavirin treatment in patients with chronic hepatitis C. J Viral Hepatitis 2007;14:721-9 (Pubitemid 47414932)
67. Awad T, Thorlund K, Hauser G, et al. Peginterferon alpha-2a is associated with higher sustained virological response than peginterferon alfa-2b in chronic hepatitis C: systematic review of randomized trials. Hepatology 2010;51(4):1176-84
68. Diago M, Crespo J, Olveira A, et al. Clinical trial: pharmacodynamics and pharmacokinetics of re-treatment with fixed-dose induction of peginterferon alpha-2a in hepatitis C virus genotype 1 true non-responder patients. Aliment Pharmacol Ther 2007;26(8):1131-8 (Pubitemid 47480964)
69. Roberts SK, Weltman MD, Crawford DH, et al. Impact of high-dose peginterferon alfa-2A on virological response rates in patients with hepatitis C genotype 1: a randomized controlled trial. Hepatology 2009;50(4):1045-55
70. Marcellin P, Jensen DM, Roberts SK, et al. Peginterferon alfa-2a (40KD) (PEGASYS-) plus ribavirin (COPEGUS-) has a wide safety margin in patients infected with HCV genotype 1. Hepatol Int 2010;4:(1):94-345
71. Ferenci P. Predictors of response to therapy for chronic hepatitis C. Semin Liver Dis 2004;24(Suppl 2):25-31 (Pubitemid 39180703)
72. Schmid M, Kreil A, Jessner W, et al. Suppression of haematopoiesis during therapy of chronic hepatitis C with different interferon alpha mono and combination therapy regimens. Gut 2005;54(7):1014-20 (Pubitemid 40873919)
73. Antonini MG, Babudieri S, Maida I, et al. Incidence of neutropenia and infections during combination treatment of chronic hepatitis C with pegylated interferon alfa-2a or alfa-2b plus ribavirin. Infection 2008;36(3):250-5
74. Roomer R, Hansen BE, Janssen HL, de Knegt RJ. Risk factors for infection during treatment with peginterferon alfa and ribavirin for chronic hepatitis C. Hepatology 2010;52(4):1225-31
75. Puoti M, Babudieri S, Rezza G, et al. Use of pegylated interferons is associated with an increased incidence of infections during combination treatment of chronic hepatitis C: a side effect of pegylation? Antivir Ther 2004;9(4):627-30 (Pubitemid 39150220)
76. Koirala J, Gandotra SD, Rao S, et al. Granulocyte colony-stimulating factor dosing in pegylated interferon alpha-induced neutropenia and its impact on outcome of anti-HCV therapy. J Viral Hepat 2007;14(11):782-7 (Pubitemid 47561582)
77. Ochi H, Maekawa T, Abe H, et al. Inosine triphosphate pyrophosphatase polymorphism affects ribavirin-induced anemia and outcomes of therapy-a genome-wide study of Japanese hepatitis C virus patients. Gastroenterology 2010;139(4):1190-7
78. Fellay J, Thompson AJ, Ge D, et al. ITPA gene variants protect against anaemia in patients treated for chronic hepatitis C. Nature 2010;464(7287):405-8
79. Reddy KR, Nelson DR, Zeuzem S. Ribavirin: current role in the optimal clinical management of chronic hepatitis C. J Hepatol 2009;50(2):402-11
80. McHutchison JG, Manns M, Patel K, et al. Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C. Gastroenterology 2002;123(4):1061-9
81. Bronowicki JP, Ouzan D, Asselah T, et al. Effect of ribavirin in genotype 1 patients with hepatitis C responding to pegylated interferon alfa-2a plus ribavirin. Gastroenterology 2006;131(4):1040-8 (Pubitemid 44515099)
82. Reddy KR, Shiffman ML, Morgan TR, et al. Impact of ribavirin dose reductions in hepatitis C virus genotype 1 patients completing peginterferon alfa-2a/ribavirin treatment. Clin Gastroenterol Hepatol 2007;5(1):124-9 (Pubitemid 46096836)
83. Shiffman ML, Salvatore J, Hubbard S, et al. Treatment of chronic hepatitis C virus genotype 1 with peginterferon, ribavirin, and epoetin alpha. Hepatology 2007;46(2):371-9 (Pubitemid 47344771)
84. Available from: http://web.archive.org/ web/20070528103823/http://www. fda. gov/cder/drug/advisory/RHE2007.htm
85. Sulkowski MS, Shiffman ML, Afdhal NH, et al. Hepatitis C virus treatment-related anemia is associated with higher sustained virologic response rate. Gastroenterology 2010;139:1602-11
86. Jensen DM, Freilich B, Andreone P, et al. Easy to assess on-treatement parameters correlate with degree of virological response after 12 weeks of treatment. J Hepatol 2008;48(Suppl 2):S297-8
87. Lindsay KL, Morishima C, Wright EC, et al. Blunted cytopenias and weight loss: new correlates of virologic null response to re-treatment of chronic hepatitis C. Clin Gastroenterol Hepatol 2008;6(2):234-41 (Pubitemid 351181291)
88. F.Hoffmann-La Roche. PEGASYS Summary of Product Characteristics, revised 2010. 2010
89. Zeuzem S, Yoshida EM, Benhamou Y, et al. Albinterferon alfa-2b dosed every two or four weeks in interferon-naive patients with genotype 1 chronic hepatitis C. Hepatology 2008;48(2):407-17
90. Demirturk N, Aykin N, Demirdal T, Cevik F. Alopecia universalis: a rare side effect seen on chronic hepatitis C treatment with peg-IFN and ribavirin. Eur J Dermatol 2006;16(5):579-80 (Pubitemid 44861836)
91. Shafa S, Borum ML, Igiehon E. A case of irreversible alopecia associated with ribavirin and peg-interferon therapy. Eur J Gastroenterol Hepatol 2010;22(1):122-3
92. Taliani G, Biliotti E, Capanni M, et al. Reversible alopecia universalis during treatment with PEG-interferon and ribavirin for chronic hepatitis C. J Chemother 2005;17(2):212-14 (Pubitemid 40732882)
93. Kartal ED, Alpat SN, Ozgunes I, Usluer G. Reversible alopecia universalis secondary to PEG-interferon alpha-2b and ribavirin combination therapy in a patient with chronic hepatitis C virus infection. Eur J Gastroenterol Hepatol 2007;19(9):817-20 (Pubitemid 47266714)
94. Montaudie H, Passeron T, Cardot-Leccia N, et al. Drug rash with eosinophilia and systemic symptoms due to telaprevir. Dermatology 2010. [Epub ahead of print]
95. Cheng YC, Chen CC, Ho AS, et al. Prolonged psychosis associated with interferon therapy in a patient with hepatitis C: case study and literature review. Psychosomatics 2009;50(5):538-42
96. Fabregas BC, Moura AS, Marciano RC, et al. Clinical management of a patient with drug dependence who attempted suicide while receiving peginterferon therapy for chronic hepatitis C. Braz J Infect Dis 2009;13(5):387-90
97. Ferenci P, Staufer K. Depression in chronic hepatitis: the virus, the drug, or the ethnic background? Liver Int 2008;28(4):429-31 (Pubitemid 351411128)
98. Leutscher PD, Lagging M, Buhl MR, et al. Evaluation of depression as a risk factor for treatment failure in chronic hepatitis C. Hepatology 2010;52(2):430-5
99. Neri S, Bertino G, Petralia A, et al. A multidisciplinary therapeutic approach for reducing the risk of psychiatric side effects in patients with chronic hepatitis C treated with pegylated interferon alpha and ribavirin. J Clin Gastroenterol 2010;44(9):e210-17
100. Schmidt F, Janssen G, Martin G, et al. Factors influencing long-term changes in mental health after interferon-alpha treatment of chronic hepatitis C. Aliment Pharmacol Ther 2009;30(10):1049-59
101. Raison CL, Woolwine BJ, Demetrashvili MF, et al. Paroxetine for prevention of depressive symptoms induced by interferon-alpha and ribavirin for hepatitis C. Aliment Pharmacol Ther 2007;25(10):1163-74 (Pubitemid 46650303)
102. Morasco BJ, Rifai MA, Loftis JM, et al. A randomized trial of paroxetine to prevent interferon-alpha-induced depression in patients with hepatitis C. J Affect Disord 2007;103(1-3):83-90 (Pubitemid 47445756)
103. Kraus MR, Schafer A, Schottker K, et al. Therapy of interferon-induced depression in chronic hepatitis C with citalopram: a randomised, double-blind, placebo-controlled study. Gut 2008;57(4):531-6 (Pubitemid 351442539)
104. Rustgi VK, Esposito S, Hamzeh FM, et al. Peginterferon alfa-2a/ribavirin in hepatitis C virus patients nontolerant or nonresponsive to peginterferon alfa-2b/ribavirin. Aliment Pharmacol Ther 2008;27(5):433-40
105. Tran HA, Attia JR, Jones TL, Batey RG. Pegylated interferon-alpha2beta in combination with ribavirin does not aggravate thyroid dysfunction in comparison to regular interferon-alpha2beta in a hepatitis C population: meta-analysis. J Gastroenterol Hepatol 2007;22(4):472-6 (Pubitemid 46434987)
106. Tran HA, Reeves GE, Ianna EA, Leembruggen N. Thyroid function outcomes following pegylated interferon-alpha and ribavirin therapy for chronic hepatitis C. Endocr Pract 2010;1-16
107. Schering-Plough Ltd. ViraferonPeg (PegIntron) Summary of Product Characteristics, revised 2010. 2010
108. Negro F, Alaei M. Hepatitis C virus and type 2 diabetes. World J Gastroenterol 2009;15(13):1537-47
109. Dove LM, Rosen RC, Ramcharran D, et al. Decline in male sexual desire, function, and satisfaction during and after antiviral therapy for chronic hepatitis C. Gastroenterology 2009;137(3):873-84, 884
110. Hofer H, Donnerer J, Sator K, et al. Seminal fluid ribavirin level and functional semen parameters in patients with chronic hepatitis C on antiviral combination therapy. J Hepatol 2010;52(6):812-16
111. Fernandez-Miranda C, Castellano G, Guijarro C, et al. Lipoprotein changes in patients with chronic hepatitis C treated with interferon-alpha. Am J Gastroenterol 1998;93(10):1901-4 (Pubitemid 29071702)
112. Shinohara E, Yamashita S, Kihara S, et al. Interferon alpha induces disorder of lipid metabolism by lowering postheparin lipases and cholesteryl ester transfer protein activities in patients with chronic hepatitis C. Hepatology 1997;25(6):1502-6 (Pubitemid 27250776)
113. Andrade RJ, Garcia-Escano MD, Valdivielso P, et al. Effects of interferon-beta on plasma lipid and lipoprotein composition and post-heparin lipase activities in patients with chronic hepatitis C. Aliment Pharmacol Ther 2000;14(7):929-35 (Pubitemid 30446905)
114. Mandac JC, Chaudhry S, Sherman KE, et al. Y. The clinical and physiological spectrum of interferon-alpha induced thyroiditis: toward a new classification. Hepatology 2006;43(4):661-72
115. Onishi S, Nagashima T, Kimura H, et al. Systemic lupus erythematosus and Sjogrens syndrome induced in a case by interferon-alpha used for the treatment of hepatitis C. Lupus 2010;19(6):753-5
116. Selmi C, Lleo A, Zuin M, et al. Interferon alpha and its contribution to autoimmunity. Curr Opin Investig Drugs 2006;7(5):451-6 (Pubitemid 43772985)
117. Pellicano R, Smedile A, Peyre S, et al. Autoimmune manifestations during interferon therapy in patients with chronic hepatitis C: the hepatologists view. Minerva Gastroenterol Dietol 2005;51(1):55-61 (Pubitemid 44251919)
118. Bell TM, Bansal AS, Shorthouse C, et al. Low-titre auto-antibodies predict autoimmune disease during interferon-alpha treatment of chronic hepatitis C. J Gastroenterol Hepatol 1999;14(5):419-22 (Pubitemid 29256175)
119. Slavenburg S, Heijdra YF, Drenth JP. Pneumonitis as a consequence of (peg) interferon-ribavirin combination therapy for hepatitis C: a review of the literature. Dig Dis Sci 2010;55(3):579-85
120. Tietz A, Liu J, Peng M, et al. Global review of the rate of interstitial pneumonitis among hepatitis virus-C infected patients treated with pegylated interferon +/- ribavirin. Hepatology 2009;50(4 Suppl):676A
121. Carrillo-Esper R, Gonzalez-Avila D, Uribe-Rios M, Mendez-Sanchez N. Interstitial pneumonitis associated with pegylated interferon alpha-2b therapy for chronic hepatitis C: case report. Ann Hepatol 2008;7(1):87-90 (Pubitemid 351468545)
122. Lim JW, Shin MC. Pegylated-interferon-associated retinopathy in chronic hepatitis patients. Ophthalmologica 2010;224(4):224-9
123. Formann E, Stauber R, Denk DM, et al. Sudden hearing loss in patients with chronic hepatitis C treated with pegylated interferon/ribavirin. Am J Gastroenterol 2004;99(5):873-7 (Pubitemid 39090216)
124. Horoldt B, Haydon G, ODonnell K, et al. Results of combination treatment with pegylated interferon and ribavirin in cirrhotic patients with hepatitis C infection. Liver Int 2006;26(6):650-9 (Pubitemid 43983881)
125. Bruno S, Shiffman ML, Roberts SK, et al. Efficacy and safety of peginterferon alfa-2a (40KD) plus ribavirin in hepatitis C patients with advanced fibrosis and cirrhosis. Hepatology 2010;51(2):388-97
126. Tillmann HL, McHutchison JG. Use of thrombopoietic agents for the thrombocytopenia of liver disease. Semin Hematol 2010;47(3):266-73
127. Fabrizi F, Martin P, Dixit V, et al. Hepatitis C virus antibody status and survival after renal transplantation: meta-analysis of observational studies. Am J Transplant 2005;5(6):1452-61 (Pubitemid 40839438)
128. Berenguer M. Treatment of chronic hepatitis C in hemodialysis patients. Hepatology 2008;48(5):1690-9
129. Peck-Radosavljevic P, Boletis J, Besisik F, et al. Low-dose peginterferon alfa-2a (40KD) (PEGASYS) to treat hepatitis C-infected, end-stage renal disease patients undergoing haemodialysis: final study results. J Hepatol 2009;48(Suppl 2):S374
130. Wang K, Lawal A, Majchrowicz M, et al. Pharmacokinetics of ribavirin in patients with renal impairment or end-stage disease and chronic hepatitis C during treatment with peginterferon alfa-2a (40KD) (PEGASYS-) ribavirin (COPEGUS-). Hepatology 2008;48(S1):1142
131. Vigani AG, Pavan MH, Tozzo R, et al. Extended treatment with interferon and ribavirin in a hemodialysis patient with chronic hepatitis C. Braz J Infect Dis 2010;14(2):193-6
132. Hakim W, Sheikh S, Inayat I, et al. HCV response in patients with end stage renal disease treated with combination pegylated interferon alpha-2a and ribavirin. J Clin Gastroenterol 2009;43(5):477-81
133. Goodman ZD, Makhlouf HR, Liu L, et al. Pathology of chronic hepatitis C in children: liver biopsy findings in the Peds-C Trial. Hepatology 2008;47(3):836-43 (Pubitemid 351449675)
134. Guido M, Bortolotti F, Leandro G, et al. Fibrosis in chronic hepatitis C acquired in infancy: is it only a matter of time? Am J Gastroenterol 2003;98(3):660-3 (Pubitemid 36348541)
135. Hu J, Doucette K, Hartling L, et al. Treatment of hepatitis C in children: a systematic review. PLoS One 2010;5(7):e11542
136. Jara P, Hierro L, de la Vega A, et al. Efficacy and safety of peginterferon-alpha2b and ribavirin combination therapy in children with chronic hepatitis C infection. Pediatr Infect Dis J 2008;27(2):142-8
137. Wirth S, Pieper-Boustani H, Lang T, et al. Peginterferon alfa-2b plus ribavirin treatment in children and adolescents with chronic hepatitis C. Hepatology 2005;41(5):1013-18 (Pubitemid 40593909)