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Volumn 50, Issue 3, 2009, Pages 717-726

A phase III study of the safety and efficacy of viramidine versus ribavirin in treatment-naïve patients with chronic hepatitis C: ViSER1 results

Author keywords

[No Author keywords available]

Indexed keywords

PEGINTERFERON ALPHA2B; RIBAVIRIN; TARIBAVIRIN; ALPHA2B INTERFERON; DRUG DERIVATIVE; MACROGOL DERIVATIVE; PEGINTERFERON ALFA-2B;

EID: 70349229380     PISSN: 02709139     EISSN: None     Source Type: Journal    
DOI: 10.1002/hep.23073     Document Type: Article
Times cited : (44)

References (30)
  • 2
    • 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
    • and the International Hepatitis Interventional Therapy Group
    • Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, et al., and the International Hepatitis Interventional Therapy Group. 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.
    • (2001) Lancet , vol.358 , pp. 958-965
    • Manns, M.P.1    McHutchison, J.G.2    Gordon, S.C.3    Rustgi, V.K.4    Shiffman, M.5    Reindollar, R.6
  • 3
    • 0041822106 scopus 로고    scopus 로고
    • Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C
    • Davis GL, Wong JB, McHutchison JG, Manns MP, Harvey J, Albrecht J. Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C.HEPATOLOGY 2003;38:645-652.
    • (2003) Hepatology , vol.38 , pp. 645-652
    • Davis, G.L.1    Wong, J.B.2    McHutchison, J.G.3    Manns, M.P.4    Harvey, J.5    Albrecht, J.6
  • 5
    • 0036788338 scopus 로고    scopus 로고
    • Adherence to combination therapy enhances sustained response in genotype- 1-infected patients with chronic hepatitis C
    • McHutchison JG, Manns M, Patel K, Poynard T, Lindsay KL, Trepo C, et al. Adherence to combination therapy enhances sustained response in genotype- 1-infected patients with chronic hepatitis C. Gastroenterology 2002;123:1061-1069.
    • (2002) Gastroenterology , vol.123 , pp. 1061-1069
    • McHutchison, J.G.1    Manns, M.2    Patel, K.3    Poynard, T.4    Lindsay, K.L.5    Trepo, C.6
  • 6
    • 1842463813 scopus 로고    scopus 로고
    • Changes in haemoglobin during interferon alpha-2b plus ribavirin combination therapy for chronic hepatitis C virus infection
    • DOI 10.1111/j.1365-2893.2004.00490.x
    • Sulkowski MS, Wasserman R, Brooks L, Ball L, Gish R. Changes in haemoglobin during interferon alpha-2b plus ribavirin combination therapy for chronic hepatitis C virus infection. J Viral Hepat 2004;11:243-250. (Pubitemid 38658449)
    • (2004) Journal of Viral Hepatitis , vol.11 , Issue.3 , pp. 243-250
    • Sulkowski, M.S.1    Wasserman, R.2    Brooks, L.3    Ball, L.4    Gish, R.5
  • 7
    • 33645728503 scopus 로고    scopus 로고
    • Definition and management of anemia in patients infected with hepatitis C virus
    • McHutchison JG, Manns MP, Longo DL. Definition and management of anemia in patients infected with hepatitis C virus. Liver Int 2006;26:389-398.
    • (2006) Liver Int , vol.26 , pp. 389-398
    • McHutchison, J.G.1    Manns, M.P.2    Longo, D.L.3
  • 8
    • 26044447260 scopus 로고    scopus 로고
    • Management of the hematologic complications of hepatitis C therapy
    • DOI 10.1016/j.cld.2005.07.007, PII S1089326105000681, Recent Advances in the Treatment of Liver Disorders
    • Sulkowski MS. Management of the hematologic complications of hepatitis C therapy. Clin Liver Dis 2005;9:601-616. (Pubitemid 41406390)
    • (2005) Clinics in Liver Disease , vol.9 , Issue.4 , pp. 601-616
    • Sulkowski, M.S.1
  • 9
    • 33947425672 scopus 로고    scopus 로고
    • The effects of HCV infection and management on health-related quality of life
    • DOI 10.1002/hep.21565
    • Younossi Z, Kallman J, Kincaid J. The effects of HCV infection and management on health-related quality of life. HEPATOLOGY 2007;45:806-816. (Pubitemid 46450632)
    • (2007) Hepatology , vol.45 , Issue.3 , pp. 806-816
    • Younossi, Z.1    Kallman, J.2    Kincaid, J.3
  • 10
    • 34447618973 scopus 로고    scopus 로고
    • Ribavirin up-regulates the activity of double-stranded RNA-activated protein kinase and enhances the action of interferon-alpha against hepatitis C virus
    • Liu WL, Su WC, Cheng CW, Hwang LH, Wang CC, Chen HL, et al. Ribavirin up-regulates the activity of double-stranded RNA-activated protein kinase and enhances the action of interferon-alpha against hepatitis C virus. J Infect Dis 2007;196:425-434.
    • (2007) J Infect Dis , vol.196 , pp. 425-434
    • Liu, W.L.1    Su, W.C.2    Cheng, C.W.3    Hwang, L.H.4    Wang, C.C.5    Chen, H.L.6
  • 12
    • 33750571888 scopus 로고    scopus 로고
    • Ribavirin-induced anemia: Mechanisms, risk factors and related targets for future research
    • DOI 10.2174/092986706778773059
    • Russmann S, Grattagliano I, Portincasa P, Palmieri VO, Palasciano G. Ribavirin-induced anemia: mechanisms, risk factors and related targets for future research. Curr Med Chem 2006;13:3351-3357. (Pubitemid 44669779)
    • (2006) Current Medicinal Chemistry , vol.13 , Issue.27 , pp. 3351-3357
    • Russmann, S.1    Grattagliano, I.2    Portincasa, P.3    Palmieri, V.O.4    Palasciano, G.5
  • 13
    • 11144316875 scopus 로고    scopus 로고
    • Hematologic side effects of interferon and ribavirin therapy
    • Kowdley KV. Hematologic side effects of interferon and ribavirin therapy. J Clin Gastroenterol 2005;39(1 Suppl.):S3-S8. (Pubitemid 40024231)
    • (2005) Journal of Clinical Gastroenterology , vol.39 , Issue.1 SUPPL.
    • Kowdley, K.V.1
  • 14
    • 0141928585 scopus 로고    scopus 로고
    • Ribavirin, viramidine and adenosine-deaminase-catalysed drug activation: Implication for nucleoside prodrug design
    • DOI 10.1093/jac/dkg405
    • Wu JZ, Lin CC, Hong Z. Ribavirin, viramidine and adenosine-deaminase- catalysed drug activation: implication for nucleoside prodrug design. J Antimicrob Chemother 2003;52:543-546. (Pubitemid 37258410)
    • (2003) Journal of Antimicrobial Chemotherapy , vol.52 , Issue.4 , pp. 543-546
    • Wu, J.Z.1    Lin, C.-C.2    Hong, Z.3
  • 15
    • 1242277744 scopus 로고    scopus 로고
    • Pharmacokinetics and Safety of Viramidine, a Prodrug of Ribavirin, in Healthy Volunteers
    • DOI 10.1177/0091270004262974
    • Lin C-C, Philips L, Xu C, Yeh L-T. Pharmacokinetics and safety of viramidine, a prodrug of ribavirin, in healthy volunteers. J Clin Pharmacol 2004;44:265-275. (Pubitemid 38236158)
    • (2004) Journal of Clinical Pharmacology , vol.44 , Issue.3 , pp. 265-275
    • Lin, C.-C.1    Philips, L.2    Xu, C.3    Yeh, L.-T.4
  • 17
    • 34249309613 scopus 로고    scopus 로고
    • Virological response and safety outcomes in therapy-nai{dotless}ve patients treated for chronic hepatitis C with taribavirin or ribavirin in combination with pegylated interferon alfa-2a: A randomized, phase 2 study>
    • DOI 10.1016/j.jhep.2007.02.018, PII S0168827807001353
    • Gish RG, Arora S, Reddy KR, Nelson DR, O'Brien C, Xu Y, et al. Virological response and safety outcomes in therapy-naive patients treated for chronic hepatitis C with taribavirin or ribavirin in combination with pegylated interferon alfa-2a: a randomized, phase 2 study. J Hepatol 2007;47:51-59. (Pubitemid 46817694)
    • (2007) Journal of Hepatology , vol.47 , Issue.1 , pp. 51-59
    • Gish, R.G.1    Arora, S.2    Rajender Reddy, K.3    Nelson, D.R.4    O'Brien, C.5    Xu, Y.6    Murphy, B.7
  • 18
    • 65549156843 scopus 로고    scopus 로고
    • Taribavirin exposure analysis from a previous phase III trial correlates with phase IIb weight-based dosing interim results
    • Abstract
    • Pockros PJ, Jacobson IM, Bacon BR, Afdhal NH, Poordad F, Chun E, et al. Taribavirin exposure analysis from a previous phase III trial correlates with phase IIb weight-based dosing interim results [Abstract].HEPATOLOGY 2008;48:1138A.
    • (2008) Hepatology , vol.48
    • Pockros, P.J.1    Jacobson, I.M.2    Bacon, B.R.3    Afdhal, N.H.4    Poordad, F.5    Chun, E.6
  • 19
    • 33747775068 scopus 로고    scopus 로고
    • The safety and efficacy of viramidine plus pegylated interferon alfa-2b versus ribavirin plus pegylated interferon alfa-2b in therapy-naïve patients infected with HCV: Phase 3 results (VISER1)
    • Abstract
    • Benhamou Y, Pockros P, Rodriguez-Torres M, Gordon S, Shiffman M, Lurie Y, et al. The safety and efficacy of viramidine plus pegylated interferon alfa-2b versus ribavirin plus pegylated interferon alfa-2b in therapy-näve patients infected with HCV: phase 3 results (VISER1) [Abstract]. J Hepatol 2006;44(Suppl 2):S273.
    • (2006) J Hepatol , vol.44 , Issue.SUPPL. 2
    • Benhamou, Y.1    Pockros, P.2    Rodriguez-Torres, M.3    Gordon, S.4    Shiffman, M.5    Lurie, Y.6
  • 20
    • 70450195375 scopus 로고    scopus 로고
    • Viramidine phase III study-did not meet efficacy endpoint. Valeant looking at weight-based dosing of viramidine based on post-hoc analysis
    • NATAP conference report on Benhamou et al., Accessed May 2009
    • Levin J. Viramidine phase III study-did not meet efficacy endpoint. Valeant looking at weight-based dosing of viramidine based on post-hoc analysis [NATAP conference report on Benhamou et al., J Hepatol 2006; 44(Suppl 2):S293.]. http://www.natap.org/2006/EASL/EASL-19.htm. Accessed May 2009.
    • (2006) J Hepatol , vol.44 , Issue.SUPPL. 2
    • Levin, J.1
  • 21
    • 42349106263 scopus 로고    scopus 로고
    • Impact of taribavirin exposure on efficacy, anemia rates, and GI side effects when used with pegylated interferon alfa-2b for the treatment of chronic hepatitis C
    • Abstract
    • Pockros P, Rodriguez-Torres M, Lurie Y, Gordon S, Shiffman M, Li Y, et al. Impact of taribavirin exposure on efficacy, anemia rates, and GI side effects when used with pegylated interferon alfa-2b for the treatment of chronic hepatitis C [Abstract]. J Hepatol 2007;46(Suppl):S239.
    • (2007) J Hepatol , vol.46 , Issue.SUPPL.
    • Pockros, P.1    Rodriguez-Torres, M.2    Lurie, Y.3    Gordon, S.4    Shiffman, M.5    Li, Y.6
  • 22
    • 34848813024 scopus 로고    scopus 로고
    • Impact of taribavirin and ribavirin exposure on efficacy and anemia rates when combined with pegylated interferon alfa-2b in the treatment of chronic HCV
    • Abstract
    • Jacobson I, Pockros P, Benhamou Y, Esteban-Mur R, Lurie Y, Flisiak R, et al. Impact of taribavirin and ribavirin exposure on efficacy and anemia rates when combined with pegylated interferon alfa-2b in the treatment of chronic HCV [Abstract]. HEPATOLOGY 2006;44:610A.
    • (2006) Hepatology , vol.44
    • Jacobson, I.1    Pockros, P.2    Benhamou, Y.3    Esteban-Mur, R.4    Lurie, Y.5    Flisiak, R.6
  • 23
    • 36348981708 scopus 로고    scopus 로고
    • Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: A randomized trial
    • Jacobson IM, Brown RS Jr, Freilich B, Afdhal N, Kwo PY, Santoro J, et al. Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial. HEPATOLOGY 2007;46:971-981.
    • (2007) Hepatology , vol.46 , pp. 971-981
    • Jacobson, I.M.1    Brown Jr., R.S.2    Freilich, B.3    Afdhal, N.4    Kwo, P.Y.5    Santoro, J.6
  • 24
    • 34249313012 scopus 로고    scopus 로고
    • Anemia and clinical outcomes in hepatitis C
    • Benhamou Y. Anemia and clinical outcomes in hepatitis C. J Hepatol 2007;47:7-9.
    • (2007) J Hepatol , vol.47 , pp. 7-9
    • Benhamou, Y.1
  • 25
  • 26
    • 33745788149 scopus 로고    scopus 로고
    • Future therapies for hepatitis C
    • Pawlotsky J-M, Gish RG. Future therapies for hepatitis C. Antivir Ther 2006;11:397-408.
    • (2006) Antivir Ther , vol.11 , pp. 397-408
    • Pawlotsky, J.-M.1    Gish, R.G.2
  • 27
    • 36148961976 scopus 로고    scopus 로고
    • Future treatment of chronic hepatitis C
    • Keeffe EB. Future treatment of chronic hepatitis C. Antivir Ther 2007;12:1015-1025.
    • (2007) Antivir Ther , vol.12 , pp. 1015-1025
    • Keeffe, E.B.1
  • 28
    • 54149103861 scopus 로고    scopus 로고
    • Emerging therapies for chronic hepatitis C virus
    • Pockros PJ. Emerging therapies for chronic hepatitis C virus. Gastroenterol Hepatol 2008;4:729-734.
    • (2008) Gastroenterol Hepatol , vol.4 , pp. 729-734
    • Pockros, P.J.1
  • 29
    • 46249132509 scopus 로고    scopus 로고
    • PROVE1: Results from a phase 2 study of telaprevir with peginterferon alfa-2a and ribavirin in treatment-naive subjects with hepatitis C
    • Abstract
    • McHutchison JG, Everson GT, Gordon SC, Jacobson I, Kauffman R, McNair L, et al. PROVE1: results from a phase 2 study of telaprevir with peginterferon alfa-2a and ribavirin in treatment-naive subjects with hepatitis C [Abstract]. J Hepatol 2008;48(Suppl 2):S4.
    • (2008) J Hepatol , vol.48 , Issue.SUPPL. 2
    • McHutchison, J.G.1    Everson, G.T.2    Gordon, S.C.3    Jacobson, I.4    Kauffman, R.5    McNair, L.6
  • 30
    • 46249097546 scopus 로고    scopus 로고
    • Interim results from HCV SPRINT-1: RVR/EVR from phase 2 study of boceprevir plus PegIntron™ (peginterferon alfa-2b)/ribavirin in treatment-naive subjects with genotype-1 CHC
    • Abstract
    • Kwo P, Lawitz E, McCone J, Schiff EG, Vierling J, Pound D, et al. Interim results from HCV SPRINT-1: RVR/EVR from phase 2 study of boceprevir plus PegIntron™ (peginterferon alfa-2b)/ribavirin in treatment-naive subjects with genotype-1 CHC [Abstract]. J Hepatol 2008;48(Suppl 2):S372.
    • (2008) J Hepatol , vol.48 , Issue.SUPPL. 2
    • Kwo, P.1    Lawitz, E.2    McCone, J.3    Schiff, E.G.4    Vierling, J.5    Pound, D.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.