Investigational drugs for hepatitis C

Bibliography

• Shepard CW, Finelli L, Alter MJ. Global epidemiology of hepatitis C virus infection. Lancet Infect Dis 2005;5(9):558–67
   PubMed Web of Science ®Google Scholar
• Zeuzem S. Interferon-based therapy for chronic hepatitis C: current and future perspectives. Nat Clin Pract Gastroenterol Hepatol 2008;5(11):610-22
   PubMedGoogle Scholar
• Thitinan S, McConville JT. Interferon alpha delivery systems for the treatment of hepatitis C. Int J Pharm 2009;369(1-2):121-35
   PubMed Web of Science ®Google Scholar
• Balan V, Nelson DR, Sulkowski MS, Modulation of interferon-specific gene expression by albumin-interferon-alpha in interferon-alpha-experienced patients with chronic hepatitis C. Antivir Ther 2006;11(7):901-8
   PubMed Web of Science ®Google Scholar
• Zeuzem S, Sulkowski M, Lawitz E. Efficacy and safety of albinterferon alfa-2b in combination with ribavirin in treatment naive, chornic hepatitis C genotype 1 (CHC G1) patients. J Hepatol 2009;50(Suppl.1): S377(Abstract 1041)
   Google Scholar
• Nelson D, Benhamou Y, Chuang W, 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. J Hepatol 2009;50(Suppl.1): S378(Abstract 1042)
   PubMedGoogle Scholar
• Zeuzem S, Yoshida EM, Benhamou Y, 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
   PubMed Web of Science ®Google Scholar
• Neumann AU, Pianko S, Zeuzem S, Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naïve patients with genotype 1, chronic hepatitis C. J Hepatol 2009;1:21-8
   Web of Science ®Google Scholar
• Nelson DR, Rustgi V, Balan V, Safety and antiviral activity of albinterferon alfa-2b in prior interferon nonresponders with chronic hepatitis C. Clin Gastroenterol Hepatol 2009;7(2):212-8
   PubMed Web of Science ®Google Scholar
• Novozhenov V, Zakharova N, Vinogradova E, Phase 2 study of omega interferon alone or in combination with ribavirin in subjects with chronic hepatitis C genotype-1 infection. J Hepatol 2007;46(Suppl.1): S8(Abstract 11)
   Google Scholar
• De Leede LG, Humphries JE, Bechet AC, Novel controlled-release Lemna-derived IFN-alpha2b (Locteron): pharmacokinetics, pharmacodynamics, and tolerability in a phase I clinical trial. J Interferon Cytokine Res 2008;28(2):113-22
   PubMed Web of Science ®Google Scholar
• Dzyublyk I, Yegorova T, Moroz L, Phase 2a study to evaluate the safety and tolerability and antiviral efficacy of 4 doses of a novel, controlled-release interferon alfa-2b (Locteron) given every 2 weeks for 12 weeks in treatment-naive patients with chronic hepatitis C (genotype 1). Hepatology 2006;46(Suppl. 1): 863A-4A(Abstract LB10)
   Google Scholar
• Lawitz E, Younossi ZM, Shiffman M, Randomized trial comparing systemic and local reactions to controlled-release interferon alpha2b and pegylated-interferon alpha2b in hepatitis C patients who failed prior treatment. J Hepatol 2009;50(Suppl.1): S231(Abstract 628)
   Google Scholar
• Trepo C, Guest M, Meyrueix R, Evaluation of antiviral activity and tolerance of a novel sustained release interferon-alpha-2b (IFN-alpha-2bXL) compared to pegylated interferon-alpha-2b (Peg-IFN-alpha-2b): a phase Ib trial in HCV patients. J Hepatol 2008;48(Suppl.2): S28(Abstract 62)
   PubMedGoogle Scholar
• Lawitz E, Zaman A, Muir AJ, Interim results from a phase Ib dose-escalation study of 4 weeks of PEG-interferon lambda (PEG-rIL-29) treatment in subjects with hepatitis C virus (HCV) genotype 1 with prior virologic response and relapse to peginterferon alfa and ribavirin. Hepatology 2008;48(Suppl.1): 385A(Abstract 170)
   Google Scholar
• http://www.clinicaltrials.gov/ct2/show/NCT00695019 Interferon-Alpha Lozenges for Prevention of Relapse in Hepatitis C
   Google Scholar
• Hezode C, Forestier N, Dusheiko G, Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med 2009;360(18):1839-50
   PubMed Web of Science ®Google Scholar
• Manns M, Muir A, Adda N, Telaprevir in hepatitis C genotype-1-infected patients with prior non-response, viral breakthrough or relapse to peginterferon-alfa-2a/b and ribavirin therapy: SVR results of the PROVE 3 study. J Hepatol 2009;50(Supp.1): S379 (Abstract 1044)
   PubMedGoogle Scholar
• Poordad F, Lawitz E, Pozza R, Efficacy and safety of weight-based regimens of taribavirin or ribavirin, given with peginterferon alfa-2b, at 12 weeks after treatment (SVR12) in naive patients with genotype 1 chronic hepatitis C. J Hepatol 2009;50(Suppl.1): S8 (Abstract 14)
   Google Scholar
• Reiser M, Timm J. Serine protease inhibitors as anti-hepatitis C virus agents. Expert Rev Anti Infect Ther 2009;7(5):537-47
   PubMed Web of Science ®Google Scholar
• McHutchison JG, Everson GT, Gordon SC, Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med 2009;360(18):1827-38
   PubMed Web of Science ®Google Scholar
• Foster GR, Hezode C, Bronowicki JP, Activity of telaprevir alone or in combination with peginterferon alfa-2a and ribavirin in treatment-naive genotype 2 and 3 hepatitis-C patients: interim results of study C209. J Hepatol 2009;50(Suppl.1): S22(Abstract 50)
   Google Scholar
• Benhamou Y, Moussalli J, Ratziu V, Results of a proof of concept study (C210) of telaprevir monotherapy and in combination with peginterferon alfa-2a and ribavirin in treatment-naive genotype 4 hcv patients. J Hepatol 2009;50(Suppl.1): S6(Abstract 10)
   PubMedGoogle Scholar
• Kwo P, Lawitz EJ, McCone J, HCV SPRINT-1: Boceprevir plus Peginterferon alfa-2b/Ribavirin for Treatment of Genotype 1 Chronic Hepatitis C in Previously Untreated Patients. Hepatology 2008;48(Suppl.1): 1027A(Abstract LB16)
   Google Scholar
• Kwo P, Lawitz E, McCone J, 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(Suppl.1): S4(Abstract 4)
   Google Scholar
• Sarrazin C, Rouzier R, Wagner F, SCH 503034, a Novel Hepatitis C Virus Protease Inhibitor, Plus Pegylated Interferon alpha-2b for Genotype 1 Nonresponders. Gastroenterology 2007;132(4):1270-8
   Google Scholar
• Kieffer TL, Sarrazin C, Miller JS, Telaprevir and pegylated interferon-alpha-2a inhibit wild-type and resistant genotype 1 hepatitis C virus replication in patients. Hepatology 2007;46(3):631-9
   PubMed Web of Science ®Google Scholar
• Tong X, Chase R, Skelton A, Identification and analysis of fitness of resistance mutations against the HCV protease inhibitor SCH 503034. Antiviral Res 2006;70(2):28-38
   PubMed Web of Science ®Google Scholar
• Bartels DJ, Zhou Y, Zhang EZ, Natural prevalence of hepatitis C virus variants with decreased sensitivity to NS3.4A protease inhibitors in treatment-naive subjects. J Infect Dis 2008;198(6):800-7
   PubMed Web of Science ®Google Scholar
• Qiu P, Sanfiorenzo V, Curry S, Identification of HCV protease inhibitor resistance mutations by selection pressure-based method. Nucleic Acids Res 2009;37(10):e74
   Google Scholar
• Manns M, Reesink H, Moreno C, OPERA-1 trial: interim analysis of safety and antiviral activity of TMC435 in treatment-naive genotype 1 HCV patients. J Hepatol 2009;50(Suppl.1): S7(Abstract 11)
   PubMedGoogle Scholar
• Marcellin P, Reesink H, Berg T, Antiviral activity and safety of TMC435 combined with peginterferon alpha-2a and ribavirin in patients with genotype 1 hepatitis C infection who failed previous IFN-based therapy. J Hepatol 2009;50(Suppl.1): S385(Abstract 1058)
   PubMedGoogle Scholar
• Manns M, Gane E, Rodriguez-Torres M, MK-7009 significantly improves rapid viral response (RVR) in combination with pegylated interferon alfa-2a and ribavirin in patients with chronic hepatitis C (CHC) genotype 1 infection. J Hepatol 2009;50(Suppl.1): S384(Abstract 1056)
   PubMedGoogle Scholar
• Forestier N, Larrey D, Marcellin P, Antiviral activity and safety of ITMN-191 in combination with peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C virus (HCV). J Hepatol 2009;50(Suppl.1): S35(Abstract 85)
   Google Scholar
• Forestier N, Larrey D, Guyader D, Treatment of chronic hepatitis C virus (HCV) genotype 1 patients with the NS3/4A protease inhibitor ITMN-191 leads to rapid reductions in plasma hcv rna: results of a phase 1b multiple ascending dose (MAD) study. Hepatology 2008;4(Suppl.1): 1132A(Abstract 847)
   Google Scholar
• Manns M, Bourliere M, Benhamou Y, Safety and antiviral activity of BI201335, a new HCV NS3 protease inhibitor, in treatment-naive patients with chronic hepatitis C genotype 1 infection given as monotherapy and in combination with peginterferon alfa-2a (P) and ribavirin (R). Hepatology 2008;48(Suppl.1): 1133A (Abstract 849)
   Google Scholar
• Manns M, Bourliere M, Benhamou Y, Safety and antiviral activity of BI201335, a new HCV NS3 protease inhibitor, in combination therapy with peginterferon alfa 2a (P) and ribavirin (R) for 28 days in P+R treatment-experienced patients with chronic hepatitis C genotype-1 infection. Hepatology 2008;48(Suppl.1): 1151A(Abstract 882)
   Google Scholar
• Gane EJ, Roberts SK, Stedman C, First-in-man demonstration of potent antiviral activity with a nucleoside polymerase (R7128) and protease (R7227/ITMN- 191) inhibitor combination in HCV: safety, pharmacokinetics, and virologic results from INFORM-1. J Hepatol 2009;50(Suppl.1): S380(Abstract 1046)
   Google Scholar
• Nettles R, Chien C, Chung E, BMS-790052 is a first-in-class potent hepatitis C virus (HCV) NS5A inhibitor for patients with chronic HCV infection: results from a proof-of-concept study. Hepatology 2008;48(Suppl.1): 1025A(Abstract LB12)
   Google Scholar
• Bavisotto L, Wang CC, Jacobson IM, Antiviral, pharmacokinetic and safety data for GS-9190, a non-nucleoside HCV NS5B polymerase inhibitor, in a phase-1 trial in HCV genotype 1 infected subjects. Hepatology 2007;46(Suppl.1): 255A(Abstract 49)
   Google Scholar
• Larrey D, Benhamou Y, Lohse AW, Safety, pharmacokinetics and antiviral effect of BI 207127, a novel HCV RNA polymerase inhibitor, after 5 days oral treatment in patients with chronic hepatitis C. J Hepatol 2009;50(Suppl.1): S383-S4(Abstract 1054)
   Google Scholar
• Lawitz E, Rodriguez-Torres M, DeMicco M, Antiviral activity of ANA598, a potent non- nucleoside polymerase inhibitor, in chronic hepatitis C patients. J Hepatol 2009;50(Suppl.1): S384(Abstract 1055)
   Google Scholar
• Lawitz E, Cooper C, Rodriguez-Torres M, Safety, tolerability and antiviral activity of VCH-916, a novel non-nucleoside hcv polymerase inhibitor in patients with chronic HCV genotype-1 infection. J Hepatol 2009;50(Suppl.1): S37(Abstract 92)
   Google Scholar
• Nicolas O, Boivin I, Berneche-D'Amours A, Genotypic and phenotypic analysis of HCV NS5B variants selected from patients treated with VCH-916. J Hepatol 2009;50(Suppl. 1): S349 (Abstract 961)
   Google Scholar
• Cooper C, Lawitz EJ, Ghali P, Evaluation of VCH-759 monotherapy in hepatitis C infection. J Hepatol 2009;51(1):39-46
   PubMed Web of Science ®Google Scholar
• Rodriguez-Torres M, Lalezari J, Gane EJ, Potent antiviral response to the HCV nucleoside polymerase inhibitor R7128 for 28 days with peg-IFN and ribavirin: subanalysis by race/ethnicity, weight, and HCV genotype. Hepatology 2008;48(Suppl.1): 1160A(Abstract 899)
   Google Scholar
• Gane EJ, Rodriguez-Torres M, Nelson DR, Antiviral activity of the HCV nucleoside polymerase inhibitor R7128 in HCV genotype 2 and 3 prior non-responders: results of R7128 1500 mg BID with PEG-IFN and ribavirin for 28 days. Hepatology 2008;48(Suppl.1): 1024A(Abstract LB10)
   Google Scholar
• Chatterji U, Bobardt M, Selvarajah S, The isomerase active site of cyclophilin a is critical for hepatitis C virus replication. J Biol Chem 2009;284(25):16998-7005
   PubMed Web of Science ®Google Scholar
• Watashi K, Ishii N, Hijikata M, Cyclophilin B is a functional regulator of hepatitis C virus RNA polymerase. Mol Cell 2005;19(1):111-22
   PubMed Web of Science ®Google Scholar
• Flisiak R, Dumont JM, Crabbe R. Cyclophilin inhibitors in hepatitis C viral infection. Expert Opin Investig Drugs 2007;16(9):1345-54
   PubMed Web of Science ®Google Scholar
• Ishii N, Watashi K, Hishiki T, Diverse effects of cyclosporine on hepatitis C virus strain replication. J Virol 2006;80(9):4510-20
   PubMed Web of Science ®Google Scholar
• Inoue K, Sekiyama K, Yamada M, Combined interferon alpha2b and cyclosporin A in the treatment of chronic hepatitis C: controlled trial. J Gastroenterol 2003;38(6):567-72
   PubMed Web of Science ®Google Scholar
• Berenguer M, Aguilera V, Prieto M, Effect of calcineurin inhibitors on survival and histologic disease severity in HCV-infected liver transplant recipients. Liver Transpl 2006;12(5):762-7
   PubMed Web of Science ®Google Scholar
• Hilgard P, Kahraman A, Lehmann N, Cyclosporine versus tacrolimus in patients with HCV infection after liver transplantation: effects on virus replication and recurrent hepatitis. World J Gastroenterol 2006;12(5):697-702
   PubMed Web of Science ®Google Scholar
• Levy G, Grazi GL, Sanjuan F, 12-month follow-up analysis of a multicenter, randomized, prospective trial in de novo liver transplant recipients (LIS2T) comparing cyclosporine microemulsion (C2 monitoring) and tacrolimus. Liver Transpl 2006;12(10):1464-72
   PubMed Web of Science ®Google Scholar
• Villamil F, Levy G, Grazi GL, Long-term outcomes in liver transplant patients with hepatic C infection receiving tacrolimus or cyclosporine. Transplant Proc 2006;38(9):2964-7
   PubMed Web of Science ®Google Scholar
• Flisiak R, Horban A, Gallay P, The cyclophilin inhibitor Debio-025 shows potent anti-hepatitis C effect in patients coinfected with hepatitis C and human immunodeficiency virus. Hepatology 2008;47(3):817-26
   PubMed Web of Science ®Google Scholar
• Paeshuyse J, Kaul A, De Clercq E, The non-immunosuppressive cyclosporin DEBIO-025 is a potent inhibitor of hepatitis C virus replication in vitro. Hepatology 2006;43(4):761-70
   PubMed Web of Science ®Google Scholar
• Flisiak R, Feinman SV, Jablkowski M, The cyclophilin inhibitor Debio 025 combined with PEG IFNalpha2a significantly reduces viral load in treatment-naive hepatitis C patients. Hepatology 2009;49(5):1460-8
   PubMed Web of Science ®Google Scholar
• Crabbe R, Vuagniaux G, Dumont JM, An evaluation of the cyclophilin inhibitor Debio 025 and its potential as a treatment for chronic hepatitis C. Expert Opin Investig Drugs 2009;18(2):211-20
   PubMed Web of Science ®Google Scholar
• Coelmont L, Kaptein S, Paeshuyse J, Debio 025, a cyclophilin binding molecule, is highly efficient in clearing hepatitis C virus (HCV) replicon-containing cells when used alone or in combination with specifically targeted antiviral therapy for HCV (STAT-C) inhibitors. Antimicrob Agents Chemother 2009;53(3):967-76
   PubMed Web of Science ®Google Scholar
• Mathy JE, Ma S, Compton T, Combinations of cyclophilin inhibitor NIM811 with hepatitis C Virus NS3-4A Protease or NS5B polymerase inhibitors enhance antiviral activity and suppress the emergence of resistance. Antimicrob Agents Chemother 2008;52(9):3267-75
   PubMed Web of Science ®Google Scholar
• Ma S, Boerner JE, TiongYip C, NIM811, a cyclophilin inhibitor, exhibits potent in vitro activity against hepatitis C virus alone or in combination with alpha interferon. Antimicrob Agents Chemother 2006;50(9):2976-82
   PubMed Web of Science ®Google Scholar
• Houck DR. Preclinical evaluation of SCY-635, a cyclophilin inhibitor with potent anti-HCV activity. Hepatology 2006;44(Abstract 934):534A
   Google Scholar
• Hopkins S, Heuman D, Gavis E, Safety, plasma pharmacokinetics, and anti-viral activity of SCY-635 in adult patients with chronic hepatitis C virus infection. J Hepatol 2009;50(Suppl.1): S36(Abstract 89)
   Google Scholar
• Lawitz E, Rouzier R, Nguyen TT, Safety and antiviral efficacy of 14 days of the cyclophilin inhibitor NIM811 in combination with pegylated interferon alpha2a in relapsed genotype 1 hcv infected patients. J Hepatol 2009;50(Suppl.1): S379(Abstract 1045)
   Google Scholar
• Rossignol JF, Elfert A, El-Gohary Y, Improved virologic response in chronic hepatitis C genotype 4 treated with nitazoxanide, peginterferon, and ribavirin. Gastroenterology 2009;136(3):856-62
   PubMed Web of Science ®Google Scholar
• Bacon B, Shiffman ML, Lim J, Phase 2 randomized, double-blinded, placebo-controlled study of nitazoxanide plus peginterferon and ribavirin in HCV genotype 1 patients: interim analysis shows increase in EVR. J Hepatol 2009;50(Suppl.1): S381(Abstract 1049)
   Google Scholar