Page 37 - EASL Recommendations on Treatment of Hepatitis C 2015 - Full version
P. 37
Clinical Practice Guidelines infected patients who failed prior sofosbuvir plus ribavirin therapy. J
network: academic and community treatment of a real-world, hetero- Hepatol 2014;60:S4.
geneous population. Hepatology 2014;60:220A.
[29] Jacobson IM, Dore GJ, Foster GR, Fried MW, Radu M, Rafalsky VV, et al. [49] Lawitz E, Poordad F, Brainard DM, Hyland RH, An D, Symonds WT, et al.
Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-
naive patients with chronic hepatitis C virus genotype 1 infection (QUEST- Sofosbuvir in combination with PegIFN and ribavirin for 12 weeks provides
1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet
2014;384:403–413. high SVR rates in HCV-infected genotype 2 or 3 treatment-experienced
[30] Manns M, Marcellin P, Poordad F, de Araujo ES, Buti M, Horsmans Y, et al.
Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in patients with and without compensated cirrhosis: results from the
treatment-naive patients with chronic hepatitis C virus genotype 1
infection (QUEST-2): a randomised, double-blind, placebo-controlled phase LONESTAR-2 study. Hepatology 2013;58:1380A.
3 trial. Lancet 2014;384:414–426.
[31] Dieterich D, Rockstroh JK, Orkin C, Gutierrez F, Klein MB, Reynes J, et al. [50] Lawitz E, Lalezari JP, Hassanein T, Kowdley KV, Poordad FF, Sheikh AM, et al.
Simeprevir (TMC435) with pegylated interferon/ribavirin in patients
coinfected with HCV genotype 1 and HIV-1: a phase 3 study. Clin Infect Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-
Dis 2014;59:1579–1587.
[32] Forns X, Lawitz E, Zeuzem S, Gane E, Bronowicki JP, Andreone P, et al. cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C
Simeprevir with peginterferon and ribavirin leads to high rates of SVR in
patients with HCV genotype 1 who relapsed after previous therapy: a phase infection: a randomised, double-blind, phase 2 trial. Lancet Infect Dis
3 trial. Gastroenterology 2014;146:1669–1679.
[33] Reddy KR, Zeuzem S, Zoulim F, Weiland O, Horban A, Stanciu C, et al. 2013;13:401–408.
Simeprevir versus telaprevir with peginterferon and ribavirin in previous
null or partial responders with chronic hepatitis C virus genotype 1 [51] Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, et al.
infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3
trial. Lancet Infect Dis 2015;15:27–35. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. Gastroenterology
[34] Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, et al. Ledipasvir
and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014;370:1993–2001.
2014;370:1889–1898.
[35] Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, et al. [52] Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, et al. All-
Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection.
N Engl J Med 2014;370:1483–1493. oral 12-week treatment with daclatasvir plus sofosbuvir in patients with
[36] Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, et al.
Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without hepatitis C virus genotype 3 infection: ALLY-3 phase 3 study. Hepatology
cirrhosis. N Engl J Med 2014;370:1879–1888.
[37] Townsend KS, Osinusi A, Nelson AK, Kohli A, Gross C, Polis MA, et al. High 2015;61:1127–1135.
efficacy of sofosbuvir/ledipasvir for the treatment of HCV genotype 1 in
patients coinfected with HIV on and off antiretroviral therapy: results from [53] Moreno C, Hezode C, Marcellin P, Bourgeois S, Francque S, Samuel D, et al.
the NIAID ERADICATE trial. Hepatology 2014;60:240A.
[38] Bourlière M, Sulkowski MS, Omata M, Zeuzem S, Feld JJ, Lawitz E, et al. An Efficacy and safety of simeprevir with PegIFN/ribavirin in naive or
integrated safety and efficacy analysis of >500 patients with compensated
cirrhosis treated with ledipasvir/sofosbuvir with or without ribavirin. experienced patients infected with chronic HCV genotype 4. J Hepatol
Hepatology 2014;60:239A.
[39] Bourlière M, Bronowicki JP, de Ledinghen V, Hézode C, Zoulim F, Mathurin 2015, in press.
P, et al. Ledipasvir/sofosbuvir fixed dose combination is safe and efficacious
in cirrhotic patients who have previously failed protease-inhibitor based [54] Kapoor R, Kohli A, Sidharthan S, Sims Z, Petersen TL, Osinusi A, et al. All-oral
triple therapy. Hepatology 2014;60:1271A.
[40] Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, et al. treatment for genotype 4 chronic hepatitis C infection with sofosbuvir and
Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin.
N Engl J Med 2014;370:1594–1603. ledipasvir: interim results from the NIAID SYNERGY trial. Hepatology
[41] Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, et al. ABT-450/r-
ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med 2014;60:321A.
2014;370:1983–1992.
[42] Wyles DL, Sulkowski MS, Eron JJ, Trinh R, Lalezari J, Slim J, et al. [55] Pol S, Reddy KR, Baykal T, Hezode C, Hassanein T, Marcellin P, et al.
TURQUOISE-I: 94% SVR12 in HCV/HIV-1 coinfected patients treated with
ABT-450/r/ombitasvir, dasabuvir and ribavirin. Hepatology Interferon-free regimens of ombitasvir and ABT-450/r with or without
2014;60:1136A.
[43] Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourliere M, et al. ribavirin in patients with HCV genotype 4 infection: PEARL-I study results.
Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with
ribavirin. N Engl J Med 2014;370:1604–1614. Hepatology 2014;60:1129A.
[44] Andreone P, Colombo MG, Enejosa JV, Koksal I, Ferenci P, Maieron A, et al.
ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% [56] Gane EJ, Hyland RH, An D, Svarovskaia ES, Pang PS, Symonds WT, et al. High
sustained virologic response with or without ribavirin in treatment-
experienced patients with HCV genotype 1b infection. Gastroenterology efficacy of LDV/SOF regimens for 12 weeks for patients with HCV genotype
2014;147:359–365.
[45] Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, et al. ABT- 3 or 6 infection. Hepatology 2014;60:1274A.
450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrho-
sis. N Engl J Med 2014;370:1973–1982. [57] Chevaliez S, Bouvier-Alias M, Brillet R, Pawlotsky JM. Overestimation and
[46] Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M,
Sulkowski MS, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients underestimation of hepatitis C virus RNA levels in a widely used real-time
without treatment options. N Engl J Med 2013;368:1867–1877.
[47] Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, et al. polymerase chain reaction-based method. Hepatology 2007;46:22–31.
Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med
2014;370:1993–2001. [58] Sarrazin C, Shiffman ML, Hadziyannis SJ, Lin A, Colucci G, Ishida H, et al.
[48] Esteban R, Nyberg L, Lalezari J, Ni L, Doehle B, Kanwar B, et al. Successful
retreatment with sofosbuvir-containing regimens for HCV genotype 2 or 3 Definition of rapid virologic response with a highly sensitive real-time PCR-
based HCV RNA assay in peginterferon alfa-2a plus ribavirin response-
guided therapy. J Hepatol 2010;52:832–838.
[59] Vermehren J, Kau A, Gartner BC, Gobel R, Zeuzem S, Sarrazin C. Differences
between two real-time PCR-based hepatitis C virus (HCV) assays (RealTime
HCV and Cobas AmpliPrep/Cobas TaqMan) and one signal amplification
assay (Versant HCV RNA 3.0) for RNA detection and quantification. J Clin
Microbiol 2008;46:3880–3891.
[60] Fried MW. Side effects of therapy of hepatitis C and their management.
Hepatology 2002;36:S237–S244.
[61] Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales Jr FL, et al.
Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N
Engl J Med 2002;347:975–982.
[62] Hadziyannis SJ, Sette Jr H, Morgan TR, Balan V, Diago M, Marcellin P, et al.
Peginterferon-alpha2a and ribavirin combination therapy in chronic hep-
atitis C: a randomized study of treatment duration and ribavirin dose. Ann
Intern Med 2004;140:346–355.
[63] Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar
R, 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;358:958–965.
[64] Shiffman ML, Salvatore J, Hubbard S, Price A, Sterling RK, Stravitz RT, et al.
Treatment of chronic hepatitis C virus genotype 1 with peginterferon,
ribavirin, and epoetin alpha. Hepatology 2007;46:371–379.
[65] Soza A, Everhart JE, Ghany MG, Doo E, Heller T, Promrat K, et al.
Neutropenia during combination therapy of interferon alfa and ribavirin
for chronic hepatitis C. Hepatology 2002;36:1273–1279.
[66] 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;126:1302–1311.
[67] Pockros PJ, Shiffman ML, Schiff ER, Sulkowski MS, Younossi Z, Dieterich DT,
et al. Epoetin alfa improves quality of life in anemic HCV-infected patients
receiving combination therapy. Hepatology 2004;40:
1450–1458.
[68] Sulkowski MS, Poordad F, Manns MP, Bronowicki JP, Reddy RK, Harrison SA,
et al. Anemia during treatment with peginterferon alfa-2b/ribavirin and
36 Journal of Hepatology 2015 vol. xxx j xxx–xxx
network: academic and community treatment of a real-world, hetero- Hepatol 2014;60:S4.
geneous population. Hepatology 2014;60:220A.
[29] Jacobson IM, Dore GJ, Foster GR, Fried MW, Radu M, Rafalsky VV, et al. [49] Lawitz E, Poordad F, Brainard DM, Hyland RH, An D, Symonds WT, et al.
Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-
naive patients with chronic hepatitis C virus genotype 1 infection (QUEST- Sofosbuvir in combination with PegIFN and ribavirin for 12 weeks provides
1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet
2014;384:403–413. high SVR rates in HCV-infected genotype 2 or 3 treatment-experienced
[30] Manns M, Marcellin P, Poordad F, de Araujo ES, Buti M, Horsmans Y, et al.
Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in patients with and without compensated cirrhosis: results from the
treatment-naive patients with chronic hepatitis C virus genotype 1
infection (QUEST-2): a randomised, double-blind, placebo-controlled phase LONESTAR-2 study. Hepatology 2013;58:1380A.
3 trial. Lancet 2014;384:414–426.
[31] Dieterich D, Rockstroh JK, Orkin C, Gutierrez F, Klein MB, Reynes J, et al. [50] Lawitz E, Lalezari JP, Hassanein T, Kowdley KV, Poordad FF, Sheikh AM, et al.
Simeprevir (TMC435) with pegylated interferon/ribavirin in patients
coinfected with HCV genotype 1 and HIV-1: a phase 3 study. Clin Infect Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-
Dis 2014;59:1579–1587.
[32] Forns X, Lawitz E, Zeuzem S, Gane E, Bronowicki JP, Andreone P, et al. cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C
Simeprevir with peginterferon and ribavirin leads to high rates of SVR in
patients with HCV genotype 1 who relapsed after previous therapy: a phase infection: a randomised, double-blind, phase 2 trial. Lancet Infect Dis
3 trial. Gastroenterology 2014;146:1669–1679.
[33] Reddy KR, Zeuzem S, Zoulim F, Weiland O, Horban A, Stanciu C, et al. 2013;13:401–408.
Simeprevir versus telaprevir with peginterferon and ribavirin in previous
null or partial responders with chronic hepatitis C virus genotype 1 [51] Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, et al.
infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3
trial. Lancet Infect Dis 2015;15:27–35. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. Gastroenterology
[34] Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, et al. Ledipasvir
and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014;370:1993–2001.
2014;370:1889–1898.
[35] Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, et al. [52] Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, et al. All-
Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection.
N Engl J Med 2014;370:1483–1493. oral 12-week treatment with daclatasvir plus sofosbuvir in patients with
[36] Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, et al.
Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without hepatitis C virus genotype 3 infection: ALLY-3 phase 3 study. Hepatology
cirrhosis. N Engl J Med 2014;370:1879–1888.
[37] Townsend KS, Osinusi A, Nelson AK, Kohli A, Gross C, Polis MA, et al. High 2015;61:1127–1135.
efficacy of sofosbuvir/ledipasvir for the treatment of HCV genotype 1 in
patients coinfected with HIV on and off antiretroviral therapy: results from [53] Moreno C, Hezode C, Marcellin P, Bourgeois S, Francque S, Samuel D, et al.
the NIAID ERADICATE trial. Hepatology 2014;60:240A.
[38] Bourlière M, Sulkowski MS, Omata M, Zeuzem S, Feld JJ, Lawitz E, et al. An Efficacy and safety of simeprevir with PegIFN/ribavirin in naive or
integrated safety and efficacy analysis of >500 patients with compensated
cirrhosis treated with ledipasvir/sofosbuvir with or without ribavirin. experienced patients infected with chronic HCV genotype 4. J Hepatol
Hepatology 2014;60:239A.
[39] Bourlière M, Bronowicki JP, de Ledinghen V, Hézode C, Zoulim F, Mathurin 2015, in press.
P, et al. Ledipasvir/sofosbuvir fixed dose combination is safe and efficacious
in cirrhotic patients who have previously failed protease-inhibitor based [54] Kapoor R, Kohli A, Sidharthan S, Sims Z, Petersen TL, Osinusi A, et al. All-oral
triple therapy. Hepatology 2014;60:1271A.
[40] Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, et al. treatment for genotype 4 chronic hepatitis C infection with sofosbuvir and
Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin.
N Engl J Med 2014;370:1594–1603. ledipasvir: interim results from the NIAID SYNERGY trial. Hepatology
[41] Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, et al. ABT-450/r-
ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med 2014;60:321A.
2014;370:1983–1992.
[42] Wyles DL, Sulkowski MS, Eron JJ, Trinh R, Lalezari J, Slim J, et al. [55] Pol S, Reddy KR, Baykal T, Hezode C, Hassanein T, Marcellin P, et al.
TURQUOISE-I: 94% SVR12 in HCV/HIV-1 coinfected patients treated with
ABT-450/r/ombitasvir, dasabuvir and ribavirin. Hepatology Interferon-free regimens of ombitasvir and ABT-450/r with or without
2014;60:1136A.
[43] Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourliere M, et al. ribavirin in patients with HCV genotype 4 infection: PEARL-I study results.
Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with
ribavirin. N Engl J Med 2014;370:1604–1614. Hepatology 2014;60:1129A.
[44] Andreone P, Colombo MG, Enejosa JV, Koksal I, Ferenci P, Maieron A, et al.
ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% [56] Gane EJ, Hyland RH, An D, Svarovskaia ES, Pang PS, Symonds WT, et al. High
sustained virologic response with or without ribavirin in treatment-
experienced patients with HCV genotype 1b infection. Gastroenterology efficacy of LDV/SOF regimens for 12 weeks for patients with HCV genotype
2014;147:359–365.
[45] Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, et al. ABT- 3 or 6 infection. Hepatology 2014;60:1274A.
450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrho-
sis. N Engl J Med 2014;370:1973–1982. [57] Chevaliez S, Bouvier-Alias M, Brillet R, Pawlotsky JM. Overestimation and
[46] Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M,
Sulkowski MS, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients underestimation of hepatitis C virus RNA levels in a widely used real-time
without treatment options. N Engl J Med 2013;368:1867–1877.
[47] Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, et al. polymerase chain reaction-based method. Hepatology 2007;46:22–31.
Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med
2014;370:1993–2001. [58] Sarrazin C, Shiffman ML, Hadziyannis SJ, Lin A, Colucci G, Ishida H, et al.
[48] Esteban R, Nyberg L, Lalezari J, Ni L, Doehle B, Kanwar B, et al. Successful
retreatment with sofosbuvir-containing regimens for HCV genotype 2 or 3 Definition of rapid virologic response with a highly sensitive real-time PCR-
based HCV RNA assay in peginterferon alfa-2a plus ribavirin response-
guided therapy. J Hepatol 2010;52:832–838.
[59] Vermehren J, Kau A, Gartner BC, Gobel R, Zeuzem S, Sarrazin C. Differences
between two real-time PCR-based hepatitis C virus (HCV) assays (RealTime
HCV and Cobas AmpliPrep/Cobas TaqMan) and one signal amplification
assay (Versant HCV RNA 3.0) for RNA detection and quantification. J Clin
Microbiol 2008;46:3880–3891.
[60] Fried MW. Side effects of therapy of hepatitis C and their management.
Hepatology 2002;36:S237–S244.
[61] Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales Jr FL, et al.
Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N
Engl J Med 2002;347:975–982.
[62] Hadziyannis SJ, Sette Jr H, Morgan TR, Balan V, Diago M, Marcellin P, et al.
Peginterferon-alpha2a and ribavirin combination therapy in chronic hep-
atitis C: a randomized study of treatment duration and ribavirin dose. Ann
Intern Med 2004;140:346–355.
[63] Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar
R, 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;358:958–965.
[64] Shiffman ML, Salvatore J, Hubbard S, Price A, Sterling RK, Stravitz RT, et al.
Treatment of chronic hepatitis C virus genotype 1 with peginterferon,
ribavirin, and epoetin alpha. Hepatology 2007;46:371–379.
[65] Soza A, Everhart JE, Ghany MG, Doo E, Heller T, Promrat K, et al.
Neutropenia during combination therapy of interferon alfa and ribavirin
for chronic hepatitis C. Hepatology 2002;36:1273–1279.
[66] 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;126:1302–1311.
[67] Pockros PJ, Shiffman ML, Schiff ER, Sulkowski MS, Younossi Z, Dieterich DT,
et al. Epoetin alfa improves quality of life in anemic HCV-infected patients
receiving combination therapy. Hepatology 2004;40:
1450–1458.
[68] Sulkowski MS, Poordad F, Manns MP, Bronowicki JP, Reddy RK, Harrison SA,
et al. Anemia during treatment with peginterferon alfa-2b/ribavirin and
36 Journal of Hepatology 2015 vol. xxx j xxx–xxx
