New Therapies: Oral Inhibitors and Immune Modulators

Clinics in Liver Disease

Volumn 10, Issue 4, 2006, Pages 867-880

  Davis, Gary L ^a,b  

^a BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^b BAYLOR HEALTH CARE SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

3 [2 [(2 TERT BUTYLPHENYLAMINOOXALYL)AMINO]PROPIONYLAMINO] 4 OXO 5 (2,3,5,6 TETRAFLUOROPHENOXY)PENTANOIC ACID; ALPHA GLUCOSIDASE INHIBITOR; ALPHA INTERFERON; ANA 795; ANA 975; CASTANOSPERMINE 6 BUTYRATE; CILUPREVIR; CPG 10101; CYCLOSPORIN A; HCV 796; HEPATITIS C VACCINE; IMMUNOMODULATING AGENT; ISATORIBINE; NEUTRALIZING ANTIBODY; NIM 811; OLIGONUCLEOTIDE; PEGINTERFERON; PROTEINASE INHIBITOR; R 1626; RIBAVIRIN; SCH 503034; VALOPICITABINE; VIRUS PROTEIN; VIRUS RNA; VX 950;

ABSENCE OF SIDE EFFECTS; ACTIVE IMMUNIZATION; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DRUG INDUCED HEADACHE; ENDOPLASMIC RETICULUM; GASTROINTESTINAL SYMPTOM; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; IMMUNE RESPONSE; IMMUNOMODULATION; LIVER CELL; LIVER CELL DAMAGE; MONOTHERAPY; NONHUMAN; PASSIVE IMMUNIZATION; PROTEIN PROCESSING; PROTEINASE INHIBITION; REVIEW; RNA TRANSCRIPTION; SIDE EFFECT; VIRUS ASSEMBLY; VIRUS REPLICATION;

ANTIBODIES, VIRAL; ANTIVIRAL AGENTS; ENZYME INHIBITORS; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; IMMUNOLOGIC FACTORS; OLIGOPEPTIDES; PENTANOIC ACIDS; PYRIMIDINE NUCLEOSIDES;

EID: 33845430132     PISSN: 10893261     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cld.2006.08.013     Document Type: Review

References (69)

1. Pileri P., Uematsu Y., Campagnoli S., et al. Binding of hepatitis C virus to CD81. Science 282 (1998) 938-941
2. Bartenschlager R., Frese M., and Pietschmann T. Novel insights into hepatitis C virus replication and persistence. Adv Virus Res 63 (2004) 71-80
3. Neumann A.U., Lam N.P., Dahari H., et al. Hepatitis C viral dynamics in vivo and the antiviral efficacy of interferon alfa therapy. Science 282 (1998) 103-107
4. Peters M., Davis G.L., Dooley J.S., et al. The interferon system in acute and chronic viral hepatitis. In: Popper H., and Schaffner F. (Eds). Progress in liver diseases, vol. 8 (1986), Grune and Stratton, New York 453-467
5. Gale M., and Foy E. Evasion of intracellular host defense by hepatitis C virus. Nat Med 436 (2005) 939-945
6. Patterson J.L., and Fernandez-Larson R. Molecular action of ribavirin. Rev Infect Dis 12 (1990) 1132-1146
7. Crumpacker C.S. Overview of ribavirin treatment of infection caused by RNA viruses. In: Smith R.A., Knight V., and Smith J.A.D. (Eds). Clinical applications of ribavirin (1984), Academic Press, Orlando 33-38
8. Vo N.V., Young K.C., and Lai M.M. Mutagenic and inhibitory effects of ribavirin on hepatitis C virus RNA polymerase. Biochemistry 42 (2003) 10462-10471
9. Manns M.P., McHutchison J.G., Gordon S., et al. Peginterferon alfa-2b plus ribavirin compared to interferon alfa-2b plus ribavirin for the treatment of chronic hepatitis C: a randomized trial. Lancet 358 (2001) 958-965
10. Fried M.W., Shiffman M.L., Reddy R., et al. Peg-interferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 347 (2002) 975-982
11. Goffard A., Callens N., Bartosch B., et al. Role of N-linked glycans in the functions of hepatitis C virus envelope glycoproteins. J Virol 79 (2005) 8400-8409
12. Heo T.H., Chang J.H., Lee J.W., et al. Incomplete humoral immunity against hepatitis C virus is linked with distinct recognition of putative multiple receptors by E2 envelope glycoprotein. J Immunol 173 (2004) 446-455
13. Bartosch B., Bukh J., Meunier J.C., et al. In vitro assay for neutralizing antibody to hepatitis C virus: evidence for broadly conserved neutralization epitopes. Proc Natl Acad Sci U S A 100 (2003) 14199-14204
14. Netski D.M., Mosbruger T., Depla E., et al. Humoral immune response in acute hepatitis C virus infection. Clin Infect Dis 41 (2005) 667-675
15. Eren R., Landstein D., Terkieltaub D., et al. Preclinical evaluation of two neutralizing human monoclonal antibodies against hepatitis C virus (HCV): a potential treatment to prevent HCV reinfection in liver transplant patients. J Virol 80 (2006) 2654-2664
16. Tarr A.W., Owsianka A.M., Timms J.M., et al. Characterization of the hepatitis C virus E2 epitope defined by the broadly neutralizing monoclonal antibody AP33. Hepatology 43 (2006) 592-601
17. Schofield D.J., Bartosch B., Shimizu Y.K., et al. Human monoclonal antibodies that react with the E2 glycoprotein of hepatitis C virus and possess neutralizing activity. Hepatology 42 (2005) 1055-1062
18. Owsianka A., Tarr A.W., Juttla V.S., et al. Monoclonal antibody AP33 defines a broadly neutralizing epitope on the hepatitis C virus E2 envelope glycoprotein. J Virol 79 (2005) 11095-11104
19. Keck Z.Y., Op De Beeck A., Hadlock K.G., et al. Hepatitis C virus E2 has three immunogenic domains containing conformational epitopes with distinct properties and biological functions. J Virol 78 (2004) 9224-9232
20. Feray C., Gigou M., Samuel D., et al. Incidence of hepatitis C in patients receiving different preparations of hepatitis B immunoglobulins after liver transplantation. Ann Intern Med 128 (1998) 810-816
21. Davis G.L., Nelson D.R., Terrault N., et al. A randomized, open-label study to evaluate the safety and pharmacokinetics of human hepatitis C immune globulin (Civacir) in liver transplant recipients. Liver Transpl 11 (2005) 941-949
22. Yu M.W., Bartosch B., Zhang P., et al. Neutralizing antibodies to hepatitis C virus (HCV) in immune globulins derived from anti-HCV-positive plasma. Proc Natl Acad Sci U S A 101 (2004) 7705-7710
23. Krawczynski K., Alter M.J., Tankersley D.L., et al. Effect of immune globulin on the prevention of experimental hepatitis C virus infection. J Infect Dis 173 (1996) 822-828
24. Willems B., Ede M., Marotta P., et al. Anti-HCV human immunoglobulins for the prevention of graft infection in HCV-related liver transplantation: a pilot study. J Hepatol 36 Suppl 1 (2002) 32
25. Schiano T., Charlton M., Younassi Z., et al. A phase I/II study of monoclonal antibody HCV-ABXTL-68 in patients requiring liver transplant for HCV disease. Hepatology 42 (2005) 701A
26. Petracca R., Falugi F., Galli G., et al. Structure-function analysis of hepatitis C virus envelope-CD81 binding. J Virol 74 (2000) 4824-4830
27. Di Bisceglie A.M., Frey S., Gorse G.J., et al. A phase I safety and immunogenicity trial of a novel E1E2/MF59C.1 hepatitis C vaccine candidate in healthy HCV-negative adults. Hepatology 42 (2005) 750A
28. Leroux-Roels G., Depla E., Hulstaert F., et al. A candidate vaccine based on the hepatitis C E1 protein: tolerability and immunogenicity in healthy volunteers. Vaccine 13 (2004) 3080-3086
29. Seiler P., Senn B.M., Klenerman P., et al. Additive effect of neutralizing antibody and antiviral drug treatment in preventing virus escape and persistence. J Virol 74 (2000) 5896-5901
30. Bartosch B., Verney G., Dreux M., et al. An interplay between hypervariable region 1 of the hepatitis C virus E2 glycoprotein, the scavenger receptor BI, and high-density lipoprotein promotes both enhancement of infection and protection against neutralizing antibodies. J Virol 79 (2005) 8217-8229
31. McConnell J. Enteroviruses succumb to new drug. Lancet 345 (1999) 1185
32. Fukushi S., Kurihara C., Ishiyama N., et al. The sequence element of the internal ribosome entry site and a 25-kilodalton cellular protein contribute to efficient internal initiation of translation of hepatitis C virus RNA. J Virol 71 (1997) 1662-1666
33. Branch A.D., and Antisense R.N.A. In: Schaechter M. (Ed). The desk encyclopedia of microbiology (2004), Elsevier, San Diego 68-83
34. Tong M., Schiff E., Jensen D.M., et al. Preliminary analysis of a phase II study of HEPTAZYME, a nuclease resistant ribozyme targeting HCV RNA. Hepatology 36 (2002) 788A
35. Gordon S.C., Bacon B.R., Jacobson I.M., et al. A phase II, 12-week study of ISIS 14803, an antisense inhibitor of HCV for the treatment of chronic hepatitis C. Hepatology 36 (2002) 362A
36. Stevenson M. Therapeutic potential of RNA interference. N Engl J Med 351 (2004) 1772-1777
37. Welbourn S., Green R., Gamache I., et al. Hepatitis C virus NS2/3 processing is required for NS3 stability and viral RNA replication. J Biol Chem 280 (2005) 29604-29611
38. Grakoui A., McCourt D.W., Wychowski C., et al. Characterization of the hepatitis C virus-encoded serine proteinase: determination of proteinase-dependent polyprotein cleavage sites. J Virol 67 (1993) 2832-2843
39. Lamarre D., Anderson P.C., Bailey M., et al. An NS3 protease inhibitor with antiviral effects in humans infected with hepatitis C virus. Nature 426 (2003) 186-189
40. Reesink H.W., Zeuzem S., Weegink C.J., et al. Final results of a phase 1b, multiple-dose study of VX-950, a hepatitis C virus protease inhibitor. Hepatology 42 (2005) 234A
41. Zeuzem S., Sarrazin C., Wagner F., et al. Combination therapy with the HCV protease inhibitor, SCH 503034, plus PEG-Intron in hepatitis C genotype-1 PEG-Intron non-responders: phase Ib results. Hepatology 42 (2005) 276A
42. Reesink HW, Zeuzem S, Weegink CJ, et al. Initial results of a 14-day study of the hepatitis C virus inhibitor VX-950, in combination with peginterferon-alfa 2a [abstract 737]. J Hepatol 2006;44(Suppl 2):S272.
43. Zeuzem S, Sarrazin C, Wagoner F, et al. The HCV NS3 protease inhibitor SCH 503034 in combination with PEG-IFN-2b in the treatment of HCV-1 PEG IFN-2b nonresponders: antiviral activity and HCV variant analysis [abstract 78]. J Hepatol 2006;44(Suppl 2):S35.
44. Zeuzem S., Sarrazin C., Rouzier R., et al. Anti-viral activity of SCH 503034, a HCV protease inhibitor, administered as monotherapy in hepatitis C genotype-1 (HCV-1) patients refractory to pegylated interferon (peg-IFN-α). Hepatology 42 (2005) 233A
45. Kieffer T, Sarrazin C, Bartels D, et al. Wild-type HCV NS3 protease re-emerges during follow-up after 14 days of dosing with VX-950 in patients with genotype 1 HCV [abstract 12]. J Hepatol 2006;44(Suppl 2):S7.
46. Watashi K., Ishii N., Hijikata M., et al. Cyclophilin B is a functional regulator of hepatitis C virus RNA polymerase. Mol Cell 19 (2005) 111-112
47. Egger D., Wolk B., Gosert R., et al. Expression of hepatitis C virus proteins induces distinct membrane alterations including a candidate viral replication complex. J Virol 76 (2002) 5974-5984
48. Behrens S.-E., Tomei L., and De Francesco R. Identification and properties of the RNA-dependent RNA polymerase of hepatitis C virus. EMBO J 15 (1996) 12-22
49. O'Brien C., Godofsky E., Roriguez-Torres M., et al. Randomized trial of Valopicitabine (NM283) alone or with PEG-Interferon vs. retreatment with PEG-Interferon plus ribavirin (PEGIFN/RBV) in hepatitis C patients with previous non-response to PEGIFN.RBV: first interim results. Hepatology 42 (2005) 232A
50. Dieterich D, Lawitz E, Nguyen T, et al. Early clearance of HCV RNA with valopicitabine (NM283) plus peg-interferon in treatment-naïve patients with HCV-1 infection: first results from a phase IIb trial [abstract 736]. J Hepatol 2006;44(Suppl 2):S271-272.
51. Roberts S, Cooksley G, Shaw D, et al. Interim results of a multiple ascending dose study of R1626, a novel nucleoside analog targeting HCV polymerase in chronic HCV patients [abstract 731]. J Hepatol 2006;44(Suppl 2):S269.
52. Chandra P., Raible D., Harper D., et al. Antiviral activity of the non-nucleoside polymerase inhibitor HCV-796 in patients with chronic hepatitis C virus: preliminary results from a randomized, double-blind, placebo-controlled, ascending multiple dose study. Gastroenterology 130 Suppl 2 (2006) A748
53. Ishii N., Watashi K., Hishiki T., et al. Diverse effects of cyclosporine on hepatitis C virus strain replication. J Virol 80 (2006) 4510-4520
54. Goto K., Watashi K., Murata T., et al. Evaluation of the anti-hepatitis C virus effects of cyclophilin inhibitors, cyclosporin A, and NIM811. Biochem Biophys Res Commun 343 (2006) 879-884
55. Davis G.L. The challenge of progressive hepatitis C following liver transplantation. Liver Transpl 12 (2006) 19-21
56. Zitzmann N., Mehta A.S., Carrouee S., et al. Imino sugars inhibit the formation and secretion of bovine viral diarrhea virus, a pestivirus model of hepatitis C virus: implications for the development of broad spectrum anti-hepatitis virus agents. Proc Natl Acad Sci U S A 96 (1999) 11878-11882
57. Mehta A., Zitzmann N., Rudd P.M., et al. Alpha-glucosidase inhibitors as potential broad based anti-viral agents. FEBS Lett 430 (1998) 17-22
58. Goffard A., Callens N., Bartosch B., et al. Role of N-linked glycans in the functions of hepatitis C virus envelope glycoproteins. J Virol 79 (2005) 8400-8409
59. Yoshida E., Kunimoto D., Lee S.S., et al. Results of a phase IIa dose ranging study of orally administered Celgosivir as monotherapy in chronic hepatitis C genotype-1 patients. Gastroenterology 130 Suppl 2 (2006) A784
60. Yoneyama M., Kikuchi M., Natsukawa T., et al. The RNA helicase RIG-I has an essential function in double-stranded RNA-induced innate antiviral responses. Nat Immunol 5 (2004) 730-737
61. Iwasaki A., and Medzhitov R. Toll-like receptor control of the adaptive immune responses. Nat Immunol 5 (2004) 987-995
62. Malmgaard L. Induction and regulation of IFNs during viral infections. J Interferon Cytokine Res 24 (2004) 439-454
63. Li K., Chen Z., Kato N., et al. Distinct poly-I: C and virus-activated signaling pathways leading to interferon-β production in hepatocytes. J Biol Chem 280 (2005) 16739-16747
64. Platanias L.C. Mechanisms of type-I- and type-II-interferon-mediated signaling. Nat Rev Immunol 5 (2005) 375-386
65. Smee D.F., Alaghamandan H.A., Cottam H.B., et al. Broad-spectrum in vivo antiviral activity of 7-thia-8-oxoguanosine, a novel immunopotentiating agent. Antimicrob Agents Chemother 33 (1989) 1487-1492
66. Horsman Y., Berg T., Virchow-Klinikum C., et al. Isatoribine, a toll-like receptor 7 agonist, significantly reduced plasma viral load in a clinical proof-of-concept study in patients with chronic hepatitis C virus infection. Hepatology 40 Suppl 1 (2004) A282
67. McHutchison JG, Bacon BR, Gordon SC, et al. Final results of a multicenter phase 1b randomized, placebo-controlled, dose escalation trial of CPG 10101 in patients with chronic hepatitis C virus [abstract 111]. J Hepatol 2006;44(Suppl 2):S49.
68. McHutchison JG, Ghalib R, Lawitz E, et al. Early response to CPG 10101 in combination with pegylated interferon and/or ribavirin in chronic HCV genotype 1 infected patients with prior relapse response [abstract 730]. J Hepatol 2006;44(Suppl 2):S269.
69. Schiff E.R., Pockros P., Shiffman M.L., et al. Oral IDN-6556, an anti-apoptotic caspase inhibitor, lowers aminotransferases in HCV patients. Gastroenterology 126 Suppl 2 (2004) A668