Page 36 - EASL Recommendations on Treatment of Hepatitis C 2015 - Full version
P. 36
least one ‘‘second-generation’’ drug with a higher barrier to resis- JOURNAL OF HEPATOLOGY
tance [137,138]. New pangenotypic agents with greater potency
and a higher barrier to resistance will be required to offset drug [7] Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, et al.
resistance associated with treatment failures as treatment is Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J
expanded. Thus, these recommendations will be updated regu- Med 2011;364:1207–1217.
larly, following approval of new drug regimens by the European
Medicines Agency. [8] Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR,
Bzowej NH, et al. Telaprevir for previously untreated chronic hepatitis C
Conflict of interest virus infection. N Engl J Med 2011;364:2405–2416.
Jean-Michel Pawlotsky: Grant and research support: Gilead. [9] Poordad F, McCone Jr J, Bacon BR, Bruno S, Manns MP, Sulkowski MS, et al.
Advisory Boards: Abbvie, Achillion, Bristol-Myers Squibb, Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med
Gilead, Janssen, Merck. Speaking and teaching: Abbvie, 2011;364:1195–1206.
Bristol-Myers Squibb, Gilead, Janssen, Merck, and Roche.
Alessio Aghemo: Advisory Boards: Abbvie, Gilead, Janssen, [10] Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, et al. Telaprevir
and Merck. Speaking and teaching: Abbvie, Bristol-Myers for retreatment of HCV infection. N Engl J Med 2011;364:2417–2428.
Squibb, Gilead, Janssen, Merck, and Roche.
David Back: Grant and research support: Abbvie, Bristol- [11] Lawitz E, Sulkowski MS, Ghalib R, Rodriguez-Torres M, Younossi ZM,
Myers Squibb, Gilead, Janssen, Merck, and Viiv. Advisory Corregidor A, et al. Simeprevir plus sofosbuvir, with or without ribavirin, to
Boards: Abbvie, Gilead, Janssen, and Merck. Speaking and treat chronic infection with hepatitis C virus genotype 1 in non-responders
teaching: Abbvie, Bristol-Myers Squibb, Gilead, Janssen, and to pegylated interferon and ribavirin and treatment-naive patients: the
Merck. COSMOS randomised study. Lancet 2014;384:1756–1765.
Geoffrey Dusheiko: Grant and research support: Abbvie,
Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen, and [12] Doab A, Treloar C, Dore GJ. Knowledge and attitudes about treatment for
Merck. Advisory Boards: Abbvie, Bristol-Myers Squibb, hepatitis C virus infection and barriers to treatment among current
Gilead, GlaxoSmithKline, Janssen, and Merck. Speaking and injection drug users in Australia. Clin Infect Dis 2005;40:S313–S320.
teaching: Abbvie, Bristol-Myers Squibb, Gilead,
GlaxoSmithKline, Janssen, and Merck. [13] Jensen DM, O’Leary JG, Pockros PJ, Sherman KE, Kwo PY, Mailliard ME, et al.
Xavier Forns: Grant and research support: Janssen. Advisory Safety and efficacy of sofosbuvir-containing regimens for hepatitis C: real-
Boards: Abbvie, Gilead, and Janssen. Speaking and teaching: world experience in a diverse, longitudinal observational cohort.
Gilead, and Janssen. Hepatology 2014;60:219A.
Massimo Puoti: Grant and research support: Gilead. Advisory
Boards: Abbvie, Bristol-Myers Squibb, Gilead, Janssen, and [14] Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T,
Merck. Speaking and teaching: Bristol-Myers Squibb, Gilead, Jacobson I, et al. Daclatasvir plus sofosbuvir for previously treated or
Janssen, and Merck. untreated chronic HCV infection. N Engl J Med 2014;370:211–221.
Christoph Sarrazin: Grant and research support: Abbott
Molecular, Abbvie, Gilead, Janssen, Qiagen, Roche, and [15] Andrews J, Guyatt G, Oxman AD, Alderson P, Dahm P, Falck-Ytter Y, et al.
Siemens. Advisory Boards: Abbott Molecular, Abbvie, GRADE guidelines: 14. Going from evidence to recommendations: the
Achillion, Bristol-Myers Squibb, Gilead, Janssen, and Merck. significance and presentation of recommendations. J Clin Epidemiol
Speaking and teaching: Abbott Molecular, Abbvie, Bristol- 2013;66:719–725.
Myers Squibb, Gilead, Janssen, Merck, Qiagen, and Siemens.
[16] Chevaliez S, Pawlotsky JM. Diagnosis and management of chronic viral
References hepatitis: antigens, antibodies and viral genomes. Best Pract Res Clin
Gastroenterol 2008;22:1031–1048.
[1] Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol
Infect 2011;17:107–115. [17] Kamili S, Drobeniuc J, Araujo AC, Hayden TM. Laboratory diagnostics for
hepatitis C virus infection. Clin Infect Dis 2012;55:S43–S48.
[2] Arase Y, Kobayashi M, Suzuki F, Suzuki Y, Kawamura Y, Akuta N, et al. Effect
of type 2 diabetes on risk for malignancies includes hepatocellular [18] Martinot-Peignoux M, Stern C, Maylin S, Ripault MP, Boyer N, Leclere L,
carcinoma in chronic hepatitis C. Hepatology 2013;57:964–973. et al. Twelve weeks posttreatment follow-up is as relevant as 24 weeks to
determine the sustained virologic response in patients with hepatitis C
[3] van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F, et al. virus receiving pegylated interferon and ribavirin. Hepatology
Association between sustained virological response and all-cause mortality 2010;51:1122–1126.
among patients with chronic hepatitis C and advanced hepatic fibrosis.
JAMA 2012;308:2584–2593. [19] Swain MG, Lai MY, Shiffman ML, Cooksley WG, Zeuzem S, Dieterich DT,
et al. A sustained virologic response is durable in patients with chronic
[4] Alsop D, Younossi Z, Stepanova M, Afdhal NH. Cerebral MR spectroscopy hepatitis C treated with peginterferon alfa-2a and ribavirin.
and patient-reported mental health outcomes in hepatitis C genotype 1 Gastroenterology 2010;139:1593–1601.
naive patients treated with ledipasvir and sofosbuvir. Hepatology
2014;60:221A. [20] Castera L, Sebastiani G, Le Bail B, de Ledinghen V, Couzigou P, Alberti A.
Prospective comparison of two algorithms combining non-invasive meth-
[5] European Association for the Study of the Liver. EASL Clinical Practice ods for staging liver fibrosis in chronic hepatitis C. J Hepatol
Guidelines: management of hepatitis C virus infection. J Hepatol 2010;52:191–198.
2011;55:245–264.
[21] Castera L, Vergniol J, Foucher J, Le Bail B, Chanteloup E, Haaser M, et al.
[6] Antaki N, Craxi A, Kamal S, Moucari R, Van der Merwe S, Haffar S, et al. The Prospective comparison of transient elastography, Fibrotest, APRI, and liver
neglected hepatitis C virus genotypes 4, 5, and 6: an international biopsy for the assessment of fibrosis in chronic hepatitis C.
consensus report. Liver Int 2010;30:342–355. Gastroenterology 2005;128:343–350.
[22] Chevaliez S, Bouvier-Alias M, Brillet R, Pawlotsky JM. Hepatitis C virus
(HCV) genotype 1 subtype identification in new HCV drug development
and future clinical practice. PLoS One 2009;4:e8209.
[23] Huisman MT, Snoeys J, Monbaliu J, Martens MA, Sekar VJ, Raoof A. In vitro
studies investigating the mechanism of interaction between TMC435 and
hepatic transporters. Hepatology 2010;52:461A.
[24] European Association for the Study of the Liver. EASL Clinical Practice
Guidelines: management of hepatitis C virus infection. J Hepatol
2014;60:392–420.
[25] Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC,
et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N
Engl J Med 2013;368:1878–1887.
[26] Mishra P, Florian J, Qi K, Zeng W, Naeger LK, Donaldson E, et al. FDA
perspective on sofosbuvir therapy for patients with chronic hepatitis C
virus genotype 1 infection who did not respond to treatment with
pegylated interferon and ribavirin. Gastroenterology
2014;147:1196–1200.
[27] Pol S, Sulkowski M, Hassanein T, Gane E, Liyun N, Ho H, et al. Successful
retreatment with sofosbuvir of HCV genotype 1-infected patients who
failed prior therapy with peginterferon plus ribavirin plus one or two
additional direct-acting antiviral agents. J Hepatol 2014;60:S23.
[28] Dieterich D, Bacon BR, Flamm SL, Kowdley KV, Milligan S, Tsai N, et al.
Evaluation of sofosbuvir and simeprevir-based regimens in the TRIO
35
tance [137,138]. New pangenotypic agents with greater potency
and a higher barrier to resistance will be required to offset drug [7] Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, et al.
resistance associated with treatment failures as treatment is Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J
expanded. Thus, these recommendations will be updated regu- Med 2011;364:1207–1217.
larly, following approval of new drug regimens by the European
Medicines Agency. [8] Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR,
Bzowej NH, et al. Telaprevir for previously untreated chronic hepatitis C
Conflict of interest virus infection. N Engl J Med 2011;364:2405–2416.
Jean-Michel Pawlotsky: Grant and research support: Gilead. [9] Poordad F, McCone Jr J, Bacon BR, Bruno S, Manns MP, Sulkowski MS, et al.
Advisory Boards: Abbvie, Achillion, Bristol-Myers Squibb, Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med
Gilead, Janssen, Merck. Speaking and teaching: Abbvie, 2011;364:1195–1206.
Bristol-Myers Squibb, Gilead, Janssen, Merck, and Roche.
Alessio Aghemo: Advisory Boards: Abbvie, Gilead, Janssen, [10] Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, et al. Telaprevir
and Merck. Speaking and teaching: Abbvie, Bristol-Myers for retreatment of HCV infection. N Engl J Med 2011;364:2417–2428.
Squibb, Gilead, Janssen, Merck, and Roche.
David Back: Grant and research support: Abbvie, Bristol- [11] Lawitz E, Sulkowski MS, Ghalib R, Rodriguez-Torres M, Younossi ZM,
Myers Squibb, Gilead, Janssen, Merck, and Viiv. Advisory Corregidor A, et al. Simeprevir plus sofosbuvir, with or without ribavirin, to
Boards: Abbvie, Gilead, Janssen, and Merck. Speaking and treat chronic infection with hepatitis C virus genotype 1 in non-responders
teaching: Abbvie, Bristol-Myers Squibb, Gilead, Janssen, and to pegylated interferon and ribavirin and treatment-naive patients: the
Merck. COSMOS randomised study. Lancet 2014;384:1756–1765.
Geoffrey Dusheiko: Grant and research support: Abbvie,
Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen, and [12] Doab A, Treloar C, Dore GJ. Knowledge and attitudes about treatment for
Merck. Advisory Boards: Abbvie, Bristol-Myers Squibb, hepatitis C virus infection and barriers to treatment among current
Gilead, GlaxoSmithKline, Janssen, and Merck. Speaking and injection drug users in Australia. Clin Infect Dis 2005;40:S313–S320.
teaching: Abbvie, Bristol-Myers Squibb, Gilead,
GlaxoSmithKline, Janssen, and Merck. [13] Jensen DM, O’Leary JG, Pockros PJ, Sherman KE, Kwo PY, Mailliard ME, et al.
Xavier Forns: Grant and research support: Janssen. Advisory Safety and efficacy of sofosbuvir-containing regimens for hepatitis C: real-
Boards: Abbvie, Gilead, and Janssen. Speaking and teaching: world experience in a diverse, longitudinal observational cohort.
Gilead, and Janssen. Hepatology 2014;60:219A.
Massimo Puoti: Grant and research support: Gilead. Advisory
Boards: Abbvie, Bristol-Myers Squibb, Gilead, Janssen, and [14] Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T,
Merck. Speaking and teaching: Bristol-Myers Squibb, Gilead, Jacobson I, et al. Daclatasvir plus sofosbuvir for previously treated or
Janssen, and Merck. untreated chronic HCV infection. N Engl J Med 2014;370:211–221.
Christoph Sarrazin: Grant and research support: Abbott
Molecular, Abbvie, Gilead, Janssen, Qiagen, Roche, and [15] Andrews J, Guyatt G, Oxman AD, Alderson P, Dahm P, Falck-Ytter Y, et al.
Siemens. Advisory Boards: Abbott Molecular, Abbvie, GRADE guidelines: 14. Going from evidence to recommendations: the
Achillion, Bristol-Myers Squibb, Gilead, Janssen, and Merck. significance and presentation of recommendations. J Clin Epidemiol
Speaking and teaching: Abbott Molecular, Abbvie, Bristol- 2013;66:719–725.
Myers Squibb, Gilead, Janssen, Merck, Qiagen, and Siemens.
[16] Chevaliez S, Pawlotsky JM. Diagnosis and management of chronic viral
References hepatitis: antigens, antibodies and viral genomes. Best Pract Res Clin
Gastroenterol 2008;22:1031–1048.
[1] Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol
Infect 2011;17:107–115. [17] Kamili S, Drobeniuc J, Araujo AC, Hayden TM. Laboratory diagnostics for
hepatitis C virus infection. Clin Infect Dis 2012;55:S43–S48.
[2] Arase Y, Kobayashi M, Suzuki F, Suzuki Y, Kawamura Y, Akuta N, et al. Effect
of type 2 diabetes on risk for malignancies includes hepatocellular [18] Martinot-Peignoux M, Stern C, Maylin S, Ripault MP, Boyer N, Leclere L,
carcinoma in chronic hepatitis C. Hepatology 2013;57:964–973. et al. Twelve weeks posttreatment follow-up is as relevant as 24 weeks to
determine the sustained virologic response in patients with hepatitis C
[3] van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F, et al. virus receiving pegylated interferon and ribavirin. Hepatology
Association between sustained virological response and all-cause mortality 2010;51:1122–1126.
among patients with chronic hepatitis C and advanced hepatic fibrosis.
JAMA 2012;308:2584–2593. [19] Swain MG, Lai MY, Shiffman ML, Cooksley WG, Zeuzem S, Dieterich DT,
et al. A sustained virologic response is durable in patients with chronic
[4] Alsop D, Younossi Z, Stepanova M, Afdhal NH. Cerebral MR spectroscopy hepatitis C treated with peginterferon alfa-2a and ribavirin.
and patient-reported mental health outcomes in hepatitis C genotype 1 Gastroenterology 2010;139:1593–1601.
naive patients treated with ledipasvir and sofosbuvir. Hepatology
2014;60:221A. [20] Castera L, Sebastiani G, Le Bail B, de Ledinghen V, Couzigou P, Alberti A.
Prospective comparison of two algorithms combining non-invasive meth-
[5] European Association for the Study of the Liver. EASL Clinical Practice ods for staging liver fibrosis in chronic hepatitis C. J Hepatol
Guidelines: management of hepatitis C virus infection. J Hepatol 2010;52:191–198.
2011;55:245–264.
[21] Castera L, Vergniol J, Foucher J, Le Bail B, Chanteloup E, Haaser M, et al.
[6] Antaki N, Craxi A, Kamal S, Moucari R, Van der Merwe S, Haffar S, et al. The Prospective comparison of transient elastography, Fibrotest, APRI, and liver
neglected hepatitis C virus genotypes 4, 5, and 6: an international biopsy for the assessment of fibrosis in chronic hepatitis C.
consensus report. Liver Int 2010;30:342–355. Gastroenterology 2005;128:343–350.
[22] Chevaliez S, Bouvier-Alias M, Brillet R, Pawlotsky JM. Hepatitis C virus
(HCV) genotype 1 subtype identification in new HCV drug development
and future clinical practice. PLoS One 2009;4:e8209.
[23] Huisman MT, Snoeys J, Monbaliu J, Martens MA, Sekar VJ, Raoof A. In vitro
studies investigating the mechanism of interaction between TMC435 and
hepatic transporters. Hepatology 2010;52:461A.
[24] European Association for the Study of the Liver. EASL Clinical Practice
Guidelines: management of hepatitis C virus infection. J Hepatol
2014;60:392–420.
[25] Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC,
et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N
Engl J Med 2013;368:1878–1887.
[26] Mishra P, Florian J, Qi K, Zeng W, Naeger LK, Donaldson E, et al. FDA
perspective on sofosbuvir therapy for patients with chronic hepatitis C
virus genotype 1 infection who did not respond to treatment with
pegylated interferon and ribavirin. Gastroenterology
2014;147:1196–1200.
[27] Pol S, Sulkowski M, Hassanein T, Gane E, Liyun N, Ho H, et al. Successful
retreatment with sofosbuvir of HCV genotype 1-infected patients who
failed prior therapy with peginterferon plus ribavirin plus one or two
additional direct-acting antiviral agents. J Hepatol 2014;60:S23.
[28] Dieterich D, Bacon BR, Flamm SL, Kowdley KV, Milligan S, Tsai N, et al.
Evaluation of sofosbuvir and simeprevir-based regimens in the TRIO
35
