24
Views
5
CrossRef citations to date
0
Altmetric
Review

New drugs for hepatitis C virus

Pages 145-154 | Published online: 10 Jan 2014

References

  • National Institutes of Health. Consensus Development Conference Statement: management of hepatitis C. Hepatology36(5 Suppl. 1), S3–S20 (2002).
  • Manns MP, McHutchison JG, Gordon SC et al. Peginterferon α-2b plus ribavirin compared with interferon α-2b plus ribavirin for the treatment of chronic hepatitis C: a randomised trial. Lancet358, 958–965 (2001).
  • Zeuzem S. Feinman SV, Rasenack J et al. Peginterferon-α2a in patients with chronic hepatitis C. N. Engl. J. Med.343(23), 1666–1672 (2000).
  • Heathcote EJ, Shiffman ML, Cooksley WG et al. Peginterferon-α2a in patients with chronic hepatitis C and cirrhosis. N. Engl. J. Med.343(23), 1673–1680 (2000).
  • Reddy KR, Wright TL, Pockros PJ et al. Efficacy and safety of pegylated (40-kd) interferon-α2a compared with interferon-α2a in noncirrhotic patients with chronic hepatitis C. Hepatology33(2), 433–438 (2001).
  • Pockros PJ, Carithers R, Desmond P et al. Efficacy and safety of two-dose regimens of peginterferon-α2a compared with interferon-α2a in chronic hepatitis C: a multicenter, randomized controlled trial. Am. J. Gastroenterol.99(7), 1298–1305 (2004).
  • Fried MW, Shiffman ML, Reddy KR et al. Peginterferon α-2a plus ribavirin for chronic hepatitis C virus infection. N. Engl. J. Med.347, 975–982 (2002).
  • Hadziyannis SJ, Sette H Jr, Morgan TR et al. Peginterferon-α2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann. Intern. Med.140(5), 346–355 (2004).
  • Shiffman ML, Di Bisceglie AM, Lindsay KL et al. Peginterferon-α2a and ribavirin in patients with chronic hepatitis C who have failed prior treatment. Gastroenterology126(4), 1015–1023 (2004).
  • Nelson D, Rustgi V, Balan V et al. A Phase 2 study of Albuferon in combination with ribavirin in non-responders to prior interferon therapy for chronic hepatitis C. Hepatology42(Suppl. 1), 278A (2005).
  • Zeuzem S, Benhamou Y, Bain V et al. Antiviral response at week 12 following completion of treatment with albinterferon α 2b plus ribavirin in genotype 1, IFN-naive, chronic hepatitis C patients. Presented at: The 42nd Annual Meeting of the European Association for the Study of Liver. Barcelona, Spain, April 11–15, 2007.
  • Novozhenov V, Zakharova N, Vinogradova E et al. Phase 2 study of omega interferon alone or in combination with ribavirin in subjects with chronic hepatitis C genotype-1 infection. Presented at: The 42nd Annual Meeting of the European Association for the Study of Liver. Barcelona, Spain, April 11–15, 2007.
  • Marcellin P, Lurie Y, Rodriguez-Torres M et al. The safety and efficacy of taribavirin plus pegylated interferon α-2a versus ribavirin plus pegylated interferon α-2a in therapy-naïve patients infected with HCV: Phase 3 results. Presented at: The 42nd Annual Meeting of the European Association for the Study of Liver. Barcelona, Spain, April 11–15, 2007.
  • Pockros PJ, Jeffers L, Afdhal N, et al. Final results of a double-blind, placebo-controlled trial of the anti-fibrotic efficacy of interferon-γ 1b in chronic hepatitis c with advanced fibrosis or cirrhosis. Hepatology45, 569–578 (2007).
  • Pockros PJ. Current status of immunomodulatory therapies in HCV infection. Curr. Hepatitis Rep.3, 16–22 (2004).
  • Ferenci P, Fried MW, Shiffman ML et al. Predicting sustained virologic response in chronic hepatitis C patients treated with peginterferon α 2a (40 kD)/ribavirin. J. Hepatol.43, 425–433 (2005).
  • Lamarre D, Anderson PC, Bailey M et al. An NS3 protease inhibitor with antiviral effects in humans infected with hepatitis C virus. Nature426, 186–189 (2003).
  • 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). Hepatology42, 233A (2005).
  • 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 1b results. Hepatology.42, 276A (2005).
  • Zeuzem S, Sarrazin C, Wagner F et al. The HCV NS3 protease inhibitor SCH 503034 in combination with PEG-IFNα-2b in the treatment of HCV-1 PED-IFNα-2b nonresponders: antiviral and HCV variant analysis. Gastroenterology32, 1270–1278 (2007).
  • Preston RA, Alonso AB, Feely W et al. SCH 503034, an oral HCV protease inhibitor, is well-tolerated in patients with varying degrees of hepatic impairment. Presented at: The 42nd Annual Meeting of the European Association for the Study of the Liver. Barcelona, Spain, April 11–15, 2007.
  • Reesink HW, Zeuzem S, Weegink CJ et al. Final results of a Phase 1b, multiple-dose study of VX-950, a hepatitis C virus protease inhibitor. Hepatology42, 234A (2005).
  • Reesink HW, Forestier N, Weegink CJ et al. Rapid decline of viral RNA in hepatitis C patients treated with VX-950: a Phase 1b, placebo-controlled, randomized study. Gastroenterology131, 997–1002 (2006).
  • Lawitz EJ, Rodriguez-Torres M, Muir A et al. 28 days of the hepatitis C protease inhibitor VX-950, in combination with peg-interferon-α 2a and ribavirin, is well-tolerated and demonstrates robust antiviral effects. Program and Abstracts of Digestive Disease Week. Los Angeles, CA, USA, May 20–25, 2006.
  • McHutchison JG, Everson GT, Gordon S et al. Results of an interim analysis of a Phase 2 study of telaprevir (VX-950) with peginterferon α-2a and ribavirin in previously untreated subjects with hepatitis C. Presented at: The 42nd Annual Meeting of the European Association for the Study of the Liver. Barcelona, Spain, April 11–15, 2007.
  • Sarrazin C, Keiffer TL, Bartels D et al. Dynamic hepatitis C virus genotypic and phenotypic changes in patients treated with the protease inhibitor telaprevir. Gastroenterology.132, 1767–1777 (2007).
  • Kempf DJ, Chen H-J, Yeung CM et al. Pharmacokinetic boosting of VX-950, an inhibitor of HCV protease, by co-dosing with ritonavir. Program and Abstracts of the 41st Annual Meeting of the European Association for the Study of Liver. Vienna, Austria, April 26–30, 2006.
  • O’Brien C, Godofsky E, Rodriguez-Torres M et al. Randomized trial of valopicitabine (NM283) alone or with PEG-interferon vs retreatment with PEG-interferon plus ribavirin (PEG-IFN/RBV) in hepatitis C patients with previous non-response to PEG-IFN/RBV: first interim results. Hepatology42, 232A (2005).
  • Pockros P, O’Brien C, Godofsky E et al. Valopicitabine (NM283), alone or with PEG-interferon, compared to PEG interferon/ribavirin retreatment in hepatitis C patients with prior non-response to PEG-IFN/RBV: week 24 results. Gastroenterology130(4), 4 (2006).
  • Dieterich D, Lawitz E, Nguyen T et al. Valopicitabine (NM 283) plus Peg-interferon in treatment-naïve hepatitis C patients with genotype-1 infection: HCV clearance during 24 weeks of treatment. Hepatology44(Suppl. 1), 23A (2006).
  • Afdhal N, O’Brien C, Godofsky E et al. Valopicirabine (NM283), alone or with peginterferon, compared to peginterferon/ribavirin treatment in patients with HCV-1 infection and prior non-response to peginterferon/ribavirin: final results [Abstract]. J. Hepatol.46(Suppl. 1) S5A (2007).
  • 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. Program and Abstracts of the 41st Annual Meeting of the European Association for the Study of the Liver. Vienna, Austria, April 26–30, 2006.
  • Chandra P, Raible D, Harper D. 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. Program and Abstracts of Digestive Disease Week. Los Angeles, CA, USA, May 20–25, 2006.
  • Villano SA, Raible D, Harper D et al. Antiviral activity of the non-nucleoside polymerase inhibitor, HCV-796, in combination with pegylated interferon α-2b in treatment-naïve patients with chronic HCV. Presented at: The 42nd Annual Meeting of the European Association for the Study of Liver. Barcelona, Spain, April 11–15, 2007.
  • Ralston R, Howe AY, Chase R et al. Favorable cross-resistance profile of HCV-796 and SCH-503034 and enhanced anti-replicon activity mediated by combination treatment. Presented at: Digestive Disease Week. Washington, DC, USA, May 19–24, 2007.
  • Herrmann E, Flisiak R, Horban A et al. Viral kinetics during 14-day treatment with DEBIO-025 demonstrate efficient blocking of viral replication in different HCV genotypes without signs of emerging viral resistance. Presented at: The 42nd Annual Meeting of the European Association for the Study of the Liver. Barcelona, Spain April 11–15, 2007.
  • McHutchison JG, Patel K, Pockros PJ et al. A Phase I trial of an antisense inhibitor of hepatitis C virus (ISIS 14803), administered to patients with chronic hepatitis C. J. Hepatol.44(1), 88–96 (2006).
  • Tong M, Schiff E, Jensen DM et al. Preliminary analysis of a Phase II study of Heptazyme, a nuclease resistant ribozyme targeting HCV RNA. Hepatology36, 788A (2002).
  • Stevenson M. Therapeutic potential of RNA interference. N. Engl. J. Med.351, 1772–1777 (2004).
  • Yu MW, 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. USA101, 7705–7710 (2004).
  • Drawczynski K, Alter MJ, Tankersley DL et al. Effect of immune globulin on the prevention of experimental hepatitis C virus infection. J. Infect. Dis.173, 822–828 (1996).
  • 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), 32 (2002).
  • Schiano T, Charlton M, Younossi Z et al. A Phase I/II study of monoclonal antibody HCV-ABXTL-68 in patients requiring liver transplant for HCV disease. Hepatology42, 701A (2005).
  • Di Bisceglie AM, Frey S, Gorse GJ et al. A Phase I safety and immunogenicity trial of a novel E1E2/MF59C.1 hepatitis C vaccine candidate in healthy HCV-negative adults. Hepatology42, 750A (2005).
  • 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. Vaccine22, 3080–3086 (2004).
  • Whitby K, Taylor D, Patel D, Ahmed P, Tyms AS. Action of celgosivir (6 O-butanoyl castanospermine) against the pestivirus BVDV: implications for the treatment of hepatitis C. Antivir. Chem. Chemother.15, 141–151 (2004).
  • Dugourd D et al. Investigation of the synergistic interactions of the α-glucosidase I inhibitor celgosivir with various interferons. Presented at: The 13th International Meeting on Hepatitis C Virus and Related Viruses. Cairns, Australia, August 27–31, 2006.
  • Yoshida E, Kunimoto D, Lee SS et al. Results of a Phase II dose ranging study of orally administered celgosivir as monotherapy in chronic hepatitis C genotype-1 patients. Program and Abstracts of Digestive Disease Week. Los Angeles, CA, USA, May 20–25, 2006.
  • Pockros PJ, Schiff ER, Shiffman ML et al. Oral IDN-6556, an anti-apoptotic caspace inhibitor, lowers aminotransferases in patients with chronic hepatitis C. Hepatology46, 324–329 (2007).
  • McHutchison JG, Afdhal NH, Dusheiko G et al. Elthrombopag, an oral platelet growth factor, facilitates initiation of interferon therapy in subjects with HCV associated thrombocytopenia: results from a Phase II placebo controlled, double-blind, dose-ranging study. Hepatology44(Suppl. 1), 75A (2006).
  • Aspinall RJ, Pockros PJ. SCV-07 SciClone Pharmaceuticals /Verta. Curr. Opin. Investig. Drugs7, 180–185 (2006)
  • Pockros PJ, Patton H, Tong M et al. The results of 2 placebo-controlled, double-blind trials to determine the safety, tolerability and efficacy of an oral interferon inducer, Resiquimod, in chronic HCV. J. Hepatol.47, 174–182 (2007).

Websites

  • US FDA Antiviral Drugs Committee briefing document. Pegylated interferon-α2a (Pegasys®) www.fda.gov/ohrms/dockets/ac/02/briefing/3909b1.htm
  • Hepatitis C new drug pipeline www.hcvdrugs.com

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.