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Volumn 42, Issue 7, 2015, Pages 829-844

Randomised clinical trial: Alisporivir combined with peginterferon and ribavirin in treatment-naïve patients with chronic HCV genotype 1 infection (ESSENTIAL II)

Author keywords

[No Author keywords available]

Indexed keywords

ALISPORIVIR; PEGINTERFERON ALPHA2A PLUS RIBAVIRIN; PLACEBO; ALPHA INTERFERON; ANTIVIRUS AGENT; CYCLOSPORIN; MACROGOL DERIVATIVE; PEGINTERFERON ALPHA2A; RECOMBINANT PROTEIN; RIBAVIRIN;

EID: 84940788102     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.13342     Document Type: Article
Times cited : (35)

References (44)
  • 1
    • 84876149257 scopus 로고    scopus 로고
    • Global epidemiology of hepatitis C virus infection: New estimates of age-specific antibody to HCV seroprevalence
    • Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST,. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology 2013; 57: 1333-42.
    • (2013) Hepatology , vol.57 , pp. 1333-1342
    • Mohd Hanafiah, K.1    Groeger, J.2    Flaxman, A.D.3    Wiersma, S.T.4
  • 2
    • 1642288430 scopus 로고    scopus 로고
    • World Health Organization. April 2014. Available at: (accessed February 2015).
    • World Health Organization. Hepatitis C. Fact sheet N°164. April 2014. Available at: http://www.who.int/mediacentre/factsheets/fs164/en/ (accessed February 2015).
    • Hepatitis C. Fact Sheet N°164
  • 3
    • 84903975871 scopus 로고    scopus 로고
    • Antiviral treatment of hepatitis C
    • Feeney ER, Chung RT,. Antiviral treatment of hepatitis C. BMJ 2014; 349: g3308.
    • (2014) BMJ , vol.349 , pp. g3308
    • Feeney, E.R.1    Chung, R.T.2
  • 4
    • 84905904737 scopus 로고    scopus 로고
    • Treatment of hepatitis C: A systematic review
    • Kohli A, Shaffer A, Sherman A, Kottilil S,. Treatment of hepatitis C: a systematic review. JAMA 2014; 312: 631-40.
    • (2014) JAMA , vol.312 , pp. 631-640
    • Kohli, A.1    Shaffer, A.2    Sherman, A.3    Kottilil, S.4
  • 5
    • 84922787541 scopus 로고    scopus 로고
    • Long-term follow-up of successful hepatitis C virus therapy: Waning immune responses and disappearance of liver disease are consistent with cure
    • Hedenstierna M, Weiland O, Brass A, et al,. Long-term follow-up of successful hepatitis C virus therapy: waning immune responses and disappearance of liver disease are consistent with cure. Aliment Pharmacol Ther 2015; 41: 532-43.
    • (2015) Aliment Pharmacol Ther , vol.41 , pp. 532-543
    • Hedenstierna, M.1    Weiland, O.2    Brass, A.3
  • 6
    • 84922943452 scopus 로고    scopus 로고
    • Successful anti-viral treatment improves survival of patients with advanced liver disease due to chronic hepatitis C
    • Rutter K, Stättermayer AF, Beinhardt S, et al,. Successful anti-viral treatment improves survival of patients with advanced liver disease due to chronic hepatitis C. Aliment Pharmacol Ther 2015; 41: 521-31.
    • (2015) Aliment Pharmacol Ther , vol.41 , pp. 521-531
    • Rutter, K.1    Stättermayer, A.F.2    Beinhardt, S.3
  • 7
    • 84922855628 scopus 로고    scopus 로고
    • Systematic review: Patient-reported outcomes in chronic hepatitis C - The impact of liver disease and new treatment regimens
    • Younossi Z, Henry L,. Systematic review: patient-reported outcomes in chronic hepatitis C-the impact of liver disease and new treatment regimens. Aliment Pharmacol Ther 2015; 41: 497-520.
    • (2015) Aliment Pharmacol Ther , vol.41 , pp. 497-520
    • Younossi, Z.1    Henry, L.2
  • 8
    • 0035934568 scopus 로고    scopus 로고
    • Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: A randomised trial
    • 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: 958-65.
    • (2001) Lancet , vol.358 , pp. 958-965
    • Manns, M.P.1    McHutchison, J.G.2    Gordon, S.C.3
  • 9
    • 0037179698 scopus 로고    scopus 로고
    • Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection
    • 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: 975-82.
    • (2002) N Engl J Med , vol.347 , pp. 975-982
    • Fried, M.W.1    Shiffman, M.L.2    Reddy, K.R.3
  • 10
    • 68249154875 scopus 로고    scopus 로고
    • Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection
    • 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: 580-93.
    • (2009) N Engl J Med , vol.361 , pp. 580-593
    • McHutchison, J.G.1    Lawitz, E.J.2    Shiffman, M.L.3
  • 11
    • 84901492986 scopus 로고    scopus 로고
    • Review article: 2014 UK consensus guidelines - Hepatitis C management and direct-acting anti-viral therapy
    • Miller MH, Agarwal K, Austin A, et al,. Review article: 2014 UK consensus guidelines-hepatitis C management and direct-acting anti-viral therapy. Aliment Pharmacol Ther 2014; 39: 1363-75.
    • (2014) Aliment Pharmacol Ther , vol.39 , pp. 1363-1375
    • Miller, M.H.1    Agarwal, K.2    Austin, A.3
  • 12
    • 84873978406 scopus 로고    scopus 로고
    • Profile of alisporivir and its potential in the treatment of hepatitis C
    • Gallay PA, Lin K,. Profile of alisporivir and its potential in the treatment of hepatitis C. Drug Des Devel Ther 2013; 7: 105-15.
    • (2013) Drug des Devel Ther , vol.7 , pp. 105-115
    • Gallay, P.A.1    Lin, K.2
  • 13
    • 84901278663 scopus 로고    scopus 로고
    • The combination of alisporivir plus an NS5A inhibitor provides additive to synergistic anti-hepatitis C virus activity without detectable cross resistance
    • Chatterji U, Garcia-Rivera JA, Baugh J, et al,. The combination of alisporivir plus an NS5A inhibitor provides additive to synergistic anti-hepatitis C virus activity without detectable cross resistance. Antimicrob Agents Chemother 2014; 58: 3327-34.
    • (2014) Antimicrob Agents Chemother , vol.58 , pp. 3327-3334
    • Chatterji, U.1    Garcia-Rivera, J.A.2    Baugh, J.3
  • 14
    • 84932130844 scopus 로고    scopus 로고
    • Cyclophilin inhibition as potential therapy for liver diseases
    • Naoumov NV,. Cyclophilin inhibition as potential therapy for liver diseases. J Hepatol 2014; 61: 1166-74.
    • (2014) J Hepatol , vol.61 , pp. 1166-1174
    • Naoumov, N.V.1
  • 15
    • 77953111743 scopus 로고    scopus 로고
    • Structural basis for the non-immunosuppressive character of the cyclosporin A analogue Debio 025
    • Landrieu I, Hanoulle X, Bonachera F, et al,. Structural basis for the non-immunosuppressive character of the cyclosporin A analogue Debio 025. Biochemistry 2010; 49: 4679-86.
    • (2010) Biochemistry , vol.49 , pp. 4679-4686
    • Landrieu, I.1    Hanoulle, X.2    Bonachera, F.3
  • 16
    • 66149129922 scopus 로고    scopus 로고
    • The cyclophilin inhibitor Debio 025 combined with PEG IFNalpha2a significantly reduces viral load in treatment-naïve hepatitis C patients
    • Flisiak R, Feinman SV, Jablkowski M, et al,. The cyclophilin inhibitor Debio 025 combined with PEG IFNalpha2a significantly reduces viral load in treatment-naïve hepatitis C patients. Hepatology 2009; 49: 1460-8.
    • (2009) Hepatology , vol.49 , pp. 1460-1468
    • Flisiak, R.1    Feinman, S.V.2    Jablkowski, M.3
  • 17
    • 84930332667 scopus 로고    scopus 로고
    • Alisporivir with peginterferon/ribavirin in patients with chronic hepatitis C genotype-1 infection who failed to respond to or relapsed after prior interferon-based therapy: FUNDAMENTAL, a Phase II trial
    • Buti M, Flisiak R, Kao J-H, et al,. Alisporivir with peginterferon/ribavirin in patients with chronic hepatitis C genotype-1 infection who failed to respond to or relapsed after prior interferon-based therapy: FUNDAMENTAL, a Phase II trial. J Viral Hepat 2015; 22: 596-606.
    • (2015) J Viral Hepat , vol.22 , pp. 596-606
    • Buti, M.1    Flisiak, R.2    Kao, J.-H.3
  • 18
    • 84880304436 scopus 로고    scopus 로고
    • Alisporivir plus ribavirin achieves high rates of sustained HCV clearance (SVR24) as interferon (IFN)-free or IFN-add-on regimen in treatment-naïve patients with HCV GT2 or GT3: Final results from the VITAL-1 study
    • Pawlotsky JM, Sarin SK, Foster GR, et al,. Alisporivir plus ribavirin achieves high rates of sustained HCV clearance (SVR24) as interferon (IFN)-free or IFN-add-on regimen in treatment-naïve patients with HCV GT2 or GT3: final results from the VITAL-1 study. Hepatology 2012; 56 (Suppl. 4): 309A.
    • (2012) Hepatology , vol.56 , pp. 309A
    • Pawlotsky, J.M.1    Sarin, S.K.2    Foster, G.R.3
  • 19
    • 84877782905 scopus 로고    scopus 로고
    • Early sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies
    • Chen J, Florian J, Carter W, et al,. Early sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies. Gastroenterology 2013; 144: 1450-5.
    • (2013) Gastroenterology , vol.144 , pp. 1450-1455
    • Chen, J.1    Florian, J.2    Carter, W.3
  • 21
    • 79951784125 scopus 로고    scopus 로고
    • Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH): Application of this data organization approach to phase III clinical trials of rivaroxaban after total hip or knee replacement surgery
    • Watkins PB, Desai M, Berkowitz SD, et al,. Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH): application of this data organization approach to phase III clinical trials of rivaroxaban after total hip or knee replacement surgery. Drug Saf 2011; 34: 243-52.
    • (2011) Drug Saf , vol.34 , pp. 243-252
    • Watkins, P.B.1    Desai, M.2    Berkowitz, S.D.3
  • 22
    • 84866132802 scopus 로고    scopus 로고
    • Validation of multivariate outlier detection analyses used to identify potential drug-induced liver injury in clinical trial populations
    • Lin X, Parks D, Painter J, et al,. Validation of multivariate outlier detection analyses used to identify potential drug-induced liver injury in clinical trial populations. Drug Saf 2012; 35: 865-75.
    • (2012) Drug Saf , vol.35 , pp. 865-875
    • Lin, X.1    Parks, D.2    Painter, J.3
  • 23
    • 79953173221 scopus 로고    scopus 로고
    • Boceprevir for untreated chronic HCV genotype 1 infection
    • Poordad F, McCone J Jr, Bacon BR, et al,. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011; 364: 1195-206.
    • (2011) N Engl J Med , vol.364 , pp. 1195-1206
    • Poordad, F.1    McCone, J.2    Bacon, B.R.3
  • 24
    • 79959438789 scopus 로고    scopus 로고
    • Telaprevir for previously untreated chronic hepatitis C virus infection
    • Jacobson IM, McHutchison JG, Dusheiko G, et al,. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011; 364: 2405-16.
    • (2011) N Engl J Med , vol.364 , pp. 2405-2416
    • Jacobson, I.M.1    McHutchison, J.G.2    Dusheiko, G.3
  • 25
    • 84906053496 scopus 로고    scopus 로고
    • Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): A phase 3, randomised, double-blind, placebo-controlled trial
    • Jacobson IM, Dore GJ, Foster GR, et al,. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet 2014; 384: 403-13.
    • (2014) Lancet , vol.384 , pp. 403-413
    • Jacobson, I.M.1    Dore, G.J.2    Foster, G.R.3
  • 26
    • 84906059095 scopus 로고    scopus 로고
    • Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): A randomised, double-blind, placebo-controlled phase 3 trial
    • Manns M, Marcellin P, Poordad F, et al,. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2014; 384: 414-26.
    • (2014) Lancet , vol.384 , pp. 414-426
    • Manns, M.1    Marcellin, P.2    Poordad, F.3
  • 27
    • 70349605387 scopus 로고    scopus 로고
    • Identification of cellular and viral factors related to anti-hepatitis C virus activity of cyclophilin inhibitor
    • Goto K, Watashi K, Inoue D, Hijikata M, Shimotohno K,. Identification of cellular and viral factors related to anti-hepatitis C virus activity of cyclophilin inhibitor. Cancer Sci 2009; 100: 1943-50.
    • (2009) Cancer Sci , vol.100 , pp. 1943-1950
    • Goto, K.1    Watashi, K.2    Inoue, D.3    Hijikata, M.4    Shimotohno, K.5
  • 28
    • 78149434641 scopus 로고    scopus 로고
    • DEB025 (Alisporivir) inhibits hepatitis C virus replication by preventing a cyclophilin A induced cis-trans isomerisation in domain II of NS5A
    • Coelmont L, Hanoulle X, Chatterji U, et al,. DEB025 (Alisporivir) inhibits hepatitis C virus replication by preventing a cyclophilin A induced cis-trans isomerisation in domain II of NS5A. PLoS ONE 2010; 5: e13687.
    • (2010) PLoS ONE , vol.5 , pp. e13687
    • Coelmont, L.1    Hanoulle, X.2    Chatterji, U.3
  • 29
    • 77951224110 scopus 로고    scopus 로고
    • Mechanism of resistance of hepatitis C virus replicons to structurally distinct cyclophilin inhibitors
    • Puyang X, Poulin DL, Mathy JE, et al,. Mechanism of resistance of hepatitis C virus replicons to structurally distinct cyclophilin inhibitors. Antimicrob Agents Chemother 2010; 54: 1981-7.
    • (2010) Antimicrob Agents Chemother , vol.54 , pp. 1981-1987
    • Puyang, X.1    Poulin, D.L.2    Mathy, J.E.3
  • 30
    • 84866309587 scopus 로고    scopus 로고
    • Multiple mutations in hepatitis C virus NS5A domain II are required to confer a significant level of resistance to alisporivir
    • Garcia-Rivera JA, Bobardt M, Chatterji U, et al,. Multiple mutations in hepatitis C virus NS5A domain II are required to confer a significant level of resistance to alisporivir. Antimicrob Agents Chemother 2012; 56: 5113-21.
    • (2012) Antimicrob Agents Chemother , vol.56 , pp. 5113-5121
    • Garcia-Rivera, J.A.1    Bobardt, M.2    Chatterji, U.3
  • 31
    • 84888862562 scopus 로고    scopus 로고
    • Interferon (IFN)-free alisporivir (ALV) has a better overall safety profile compared to IFN-containing treatment: A pooled analysis of the ALV development program
    • Griffel L, Bao W, Orsenigo R, et al,. Interferon (IFN)-free alisporivir (ALV) has a better overall safety profile compared to IFN-containing treatment: a pooled analysis of the ALV development program. J Hepatol 2013; 58 (Suppl. 1): S336-7.
    • (2013) J Hepatol , vol.58 , pp. S336-S337
    • Griffel, L.1    Bao, W.2    Orsenigo, R.3
  • 32
    • 3543035786 scopus 로고    scopus 로고
    • Acute pancreatitis associated with interferon and ribavirin therapy in patients with chronic hepatitis C
    • Chaudhari S, Park J, Anand BS, et al,. Acute pancreatitis associated with interferon and ribavirin therapy in patients with chronic hepatitis C. Dig Dis Sci 2004; 49: 1000-6.
    • (2004) Dig Dis Sci , vol.49 , pp. 1000-1006
    • Chaudhari, S.1    Park, J.2    Anand, B.S.3
  • 33
    • 84896258579 scopus 로고    scopus 로고
    • Acute pancreatitis during interferon-alpha and ribavirin treatment for hepatitis C
    • pii: bcr09.2008.0998.
    • da Sila J, Giroldi SB, de Oliveira Basso F, et al,. Acute pancreatitis during interferon-alpha and ribavirin treatment for hepatitis C. BMJ Case Rep 2009; pii: bcr09.2008.0998.
    • (2009) BMJ Case Rep
    • Da, S.J.1    Giroldi, S.B.2    De Oliveira Basso, F.3
  • 34
    • 84875054659 scopus 로고    scopus 로고
    • Acute pancreatitis associated with pegylated interferon and ribavirin treatment of chronic hepatitis C, genotype 1b with high viral load
    • Ando K, Kim SR, Imoto S, et al,. Acute pancreatitis associated with pegylated interferon and ribavirin treatment of chronic hepatitis C, genotype 1b with high viral load. Case Rep Gastroenterol 2009; 3: 372-36.
    • (2009) Case Rep Gastroenterol , vol.3 , pp. 372-336
    • Ando, K.1    Kim, S.R.2    Imoto, S.3
  • 35
    • 84924865589 scopus 로고    scopus 로고
    • Drug-induced pancreatitis. April 2013. (accessed June 2015).
    • Pharmacist's Letter/Prescriber's Letter. Drug-induced pancreatitis. April 2013. http://pharmacistsletter.therapeuticresearch.com/pl/ArticleDD.aspx?nidchk=1&cs=&s=PL&pt=2&fpt=2&dd=290403 (accessed June 2015).
    • Pharmacist's Letter/Prescriber's Letter
  • 36
    • 84983420509 scopus 로고    scopus 로고
    • Does hepatitis C (Hep C) and/or interferon (IFN) increase acute pancreatitis (AP) risk?
    • Whitcomb D, Saul M, Yadav D,. Does hepatitis C (Hep C) and/or interferon (IFN) increase acute pancreatitis (AP) risk? Pancreas 2012; 41: 1413.
    • (2012) Pancreas , vol.41 , pp. 1413
    • Whitcomb, D.1    Saul, M.2    Yadav, D.3
  • 37
    • 84876676302 scopus 로고    scopus 로고
    • First report of telaprevir-induced pancreatitis
    • Ventura C, Urich R, Skinner S, et al,. First report of telaprevir-induced pancreatitis. Dig Dis Sci 2013; 58: 887-8.
    • (2013) Dig Dis Sci , vol.58 , pp. 887-888
    • Ventura, C.1    Urich, R.2    Skinner, S.3
  • 40
    • 84908700865 scopus 로고    scopus 로고
    • A case of chronic hepatitis C with pancreas divisum and acute pancreatitis during combination treatment with telaprevir/peginterferon/ribavirin
    • Morio R, Imamura M, Fukuhara T, et al,. A case of chronic hepatitis C with pancreas divisum and acute pancreatitis during combination treatment with telaprevir/peginterferon/ribavirin. Nihon Shokakibyo Gakkai Zasshi 2014; 111: 1997-2003.
    • (2014) Nihon Shokakibyo Gakkai Zasshi , vol.111 , pp. 1997-2003
    • Morio, R.1    Imamura, M.2    Fukuhara, T.3
  • 41
    • 84883089005 scopus 로고    scopus 로고
    • Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: A randomized clinical trial
    • Osinusi A, Meissner EG, Lee YJ, et al,. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. JAMA 2013; 310: 804-11.
    • (2013) JAMA , vol.310 , pp. 804-811
    • Osinusi, A.1    Meissner, E.G.2    Lee, Y.J.3
  • 42
    • 84940792418 scopus 로고    scopus 로고
    • Clinical Review. April Available at: (accessed June 2015).
    • Fleischer R,. NDA 201-917. Telaprevir. Clinical Review. April 2011. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2011/201917Orig1s000MedR.pdf (accessed June 2015).
    • (2011) NDA 201-917. Telaprevir
    • Fleischer, R.1
  • 43
    • 84859995274 scopus 로고    scopus 로고
    • The cyclophilin inhibitor alisporivir prevents hepatitis C virus-mediated mitochondrial dysfunction
    • Quarato G, D'Aprile A, Gavillet B, et al,. The cyclophilin inhibitor alisporivir prevents hepatitis C virus-mediated mitochondrial dysfunction. Hepatology 2012; 55: 1333-43.
    • (2012) Hepatology , vol.55 , pp. 1333-1343
    • Quarato, G.1    D'Aprile, A.2    Gavillet, B.3
  • 44
    • 84983409770 scopus 로고    scopus 로고
    • Alisporivir treatment does not cause or exacerbate pancreatitis when co-administered with interferon-alpha and/or ribavirin in the cerulein-induced pancreatitis rat model
    • Brees D, Cordier A, Mahl A, et al,. Alisporivir treatment does not cause or exacerbate pancreatitis when co-administered with interferon-alpha and/or ribavirin in the cerulein-induced pancreatitis rat model. Hepatology 2013; 58 (Suppl. 1): 436A.
    • (2013) Hepatology , vol.58 , pp. 436A
    • Brees, D.1    Cordier, A.2    Mahl, A.3


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