Histamine dihydrochloride: actions and efficacy in the treatment of chronic hepatitis C infection

References

• Wasley A, Alter MJ. Epidemiology of hepatitis C: geographic differences and temporal trends. Semin. Liver Dis.20(1), 1–16 (2000).
   PubMed Web of Science ®Google Scholar
• Alberti A, Chemello L, Benvegnu L. Natural history of hepatitis C. J. Hepatol.31(Suppl. 1), 17–24 (1999).
   PubMed Web of Science ®Google Scholar
• Rehermann B, Chisari FV. Cell mediated immune response to the hepatitis C virus. Curr. Top. Microbiol. Immunol.242, 299–325 (2000).
   PubMed Web of Science ®Google Scholar
• Cerny A, Chisari FV. Pathogenesis of chronic hepatitis C: immunological features of hepatic injury and viral persistence. Hepatology30(3), 595–601 (1999).
   PubMed Web of Science ®Google Scholar
• Nelson DR, Lau JY. Pathogenesis of chronic hepatitis C virus infection. Antivir. Ther.3(Suppl. 3), 25–35 (1998).
   PubMedGoogle Scholar
• Gruner NH, Gerlach TJ, Jung MC et al. Association of hepatitis C virus-specific CD8+ T cells with viral clearance in acute hepatitis C. J. Infect. Dis.181(5), 1528–1536 (2000).
   PubMed Web of Science ®Google Scholar
• Eckels DD, Wang H, Bian TH, Tabatabai N, Gill JC. Immunobiology of hepatitis C virus (HCV) infection: the role of CD4 T cells in HCV infection. Immunol. Rev.174, 90–97 (2000).
   PubMed Web of Science ®Google Scholar
• Lechner F, Wong DK, Dunbar PR et al. Analysis of successful immune responses in persons infected with hepatitis C virus. J. Exp. Med.191(9), 1499–512 (2000).
   PubMed Web of Science ®Google Scholar
• Pape GR, Gerlach TJ, Diepolder HM, Gruner N, Jung M, Santantonio T. Role of the specific T-cell response for clearance and control of hepatitis C virus. J. Viral Hepat.6(Suppl. 1), 36–14 (1999).
   PubMed Web of Science ®Google Scholar
• Naoumov NV. Hepatitis C virus-specific CD4(+) T cells: do they help or damage? Gastroenterology117(4), 1012–1014 (1999).
   PubMed Web of Science ®Google Scholar
• Thimme R, Oldach KM, Chang C, Steiger S, Ray SC, Chisari FV. Determinants of viral clearance and persistence during acute HCV infection. J. Exp. Med.194, 1395–1406 (2001).
   PubMed Web of Science ®Google Scholar
• Feld JJ, Hoofnagle JH. Mechanism of action of interferon and ribavirin in treatment of hepatitis C. Nature436(7053), 967–972 (2005).
   PubMed Web of Science ®Google Scholar
• Kim AI, Saab S. Treatment of hepatitis C. Am. J. Med.118(8), 808–815 (2005).
   PubMed Web of Science ®Google Scholar
• Hadziyannis SJ, Sette H Jr, Morgan TR et al. Peginterferon-α2 and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann. Intern. Med.140, 346–355 (2004).
   PubMed Web of Science ®Google Scholar
• Heathcote J, Main J. Treatment of hepatitis C. J. Viral Hepat.12(3), 223–235 (2005).
   PubMed Web of Science ®Google Scholar
• Manns MP, McHutchison JG, Gordon SC et al. Peginterferon α-2b plus ribavirin compared with interferon α-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet358, 958–965 (2001).
   PubMed Web of Science ®Google Scholar
• 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).
   PubMed Web of Science ®Google Scholar
• Shiffman ML, Di Bisceglie AM, Lindsay KL et al. Peginterferon α-2a and ribavirin in patients with chronic hepatitis C who have failed prior treatment. Gastroenterology126, 1015–1023 (2004).
   PubMed Web of Science ®Google Scholar
• Sethi A, Shiffman ML. Approach to the management of patients with chronic hepatitis C who failed to achieve sustained virologic response. Clin. Liver Dis.9(3), 453–471 (2005).
   PubMedGoogle Scholar
• Brok J, Gluud LL, Gluud C. Effects of adding ribavirin to interferon to treat chronic hepatitis C infection: a systematic review and meta-analysis of randomized trials. Arch. Intern. Med.165(19), 2206–2212 (2005).
   PubMedGoogle Scholar
• Pockros P. Developments in treatment of chronic hepatitis C. Expert Opin. Investig. Drugs11, 1–14 (2002).
   PubMed Web of Science ®Google Scholar
• Lin C, Luu K, Lourenco D, Corritori S, Hong Z, Lau J. Viramidine, a prodrug of ribavirin, demonstrated superior liver-targeted properties and much improved toxicity profile in cynomolgus studies. Hepatology34(Suppl.), 453A (2001).
   Web of Science ®Google Scholar
• Gish RG, Nelson D, Arora S et al., and Study Group. Virological response and safety outcomes in therapy-naive patients treated for chronic hepatitis C with viramidine in combination with pegylated interferon α-2a. J. Hepatol.42, 39 (2005).
   Google Scholar
• Yeh L, Fang J, Nguyen M, Lau J, Lin C. Determination of viramidine/ribavirin in human RBC following single oral dosing of viramidine in a phase I study. Hepatology36, 729A (2002).
   PubMed Web of Science ®Google Scholar
• Aora S, Lau D, Gish R et al. Phase I clinical studies of viramidine – a liver-targeting prodrug of ribavirin. Hepatology36, 773A (2002).
   Google Scholar
• Hinrichsen H, Benhamou Y, Reiser M et al. First report on the antiviral efficacy of BILN 2061, a novel oral HCV serine protease inhibitor, in patients with chronic hepatitis C, genotype 1. Hepatology36, 866A (2002).
   Google Scholar
• Benhamou Y, Hinrichsen H, Sentjens R et al. Safety, tolerability and antiviral effect of BILN 2061, a novel HCV serine protease inhibitor, afer oral treatment over 2 days in patients with chronic hepatitis C, genotype 1 with advanced liver fibrosis. Hepatology36, 563A (2002).
   Google Scholar
• 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–235A (2005).
   Google Scholar
• 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–234A (2005).
   Google Scholar
• 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. Hepatology42, 276A–277A (2005).
   Web of Science ®Google Scholar
• Afdhal N, Rodrriguez-Torres M, Lawitz E et al. Enhanced antiviral efficacy for valopicitabine (NM283) plus PEG-interferon in hepatitis C patients with HCV genotype-1 infection: results of a phase IIa multicenter trial. J. Hepatol.42, 39–40 (2005).
   Web of Science ®Google Scholar
• Tong M, Schiff E, Jensen D, Jacobson I, Eversen G, McHutchison J. Preliminary analysis of a phase II study of HEPATOZYME, a nuclease resistant ribozyme targeting hepatitis C virus (HCV) RNA. Hepatology36, 788A (2002).
   Google Scholar
• McHutchison JG, Patel K, Pockros P et al. A phase I trial of an antisense inhibitor of hepatitis C virus (ISIS 14803), administered to chronic hepatitis C patients. J. Hepatol.44(1), 88–96 (2006).
   PubMed Web of Science ®Google Scholar
• Eren R, Ilan E, Nussbaum O et al. Development and clinical evaluation of human monoclonal antibodies for treating HCV infection. Hepatology36, 498A (2002).
   Google Scholar
• Poo JL, Sanchez-Avila F, Kershenobich D, Garcia-Samper X, Gongora J, Uribe M. Triple combination of thymalfasin, peginterferon α-2a and ribavirin in patients with chronic hepatitis C who have failed prior interferon and ribavirin treatment: 24-week interim results of a pilot study. J. Gastroenterol. Hepatol.19(12), S79–S81 (2004).
   Google Scholar
• Zhou S, Liu R, Baroudy BM, Malcolm BA, Reyes GR. The effect of ribavirin and IMPDH inhibitors on hepatitis C virus subgenomic replicon RNA. Virology310(2), 333–342 (2003).
   PubMed Web of Science ®Google Scholar
• Cornberg M, Hinrichsen H, Teuber G et al. Mycophenolate mofetil in combination with recombinant interferon α-2a in interferon-non-responder patients with chronic hepatitis C.J. Hepatol.37(6), 843–847 (2002).
   PubMed Web of Science ®Google Scholar
• Lim JK, Wooten D, Siegel R, Cheung RC. Amantadine in treatment of chronic hepatitis C virus infection? J. Viral Hepat.12(5), 445–455 (2005).
   PubMed Web of Science ®Google Scholar
• Maertens G, Priem S, Ducatteeuw A et al. Improvement of chronic active hepatitis C in chronically infected chimpanzees after therapeutic vaccination with the HCV E1 protein. Acta. Gastroenterol. Belg.63, 203 (2000).
   PubMed Web of Science ®Google Scholar
• Bedossa P, Paradis V. Approaches for treatment of liver fibrosis in chronic hepatitis C. Clin. Liver Dis.7(1), 195–210 (2003).
   PubMedGoogle Scholar
• Lai MM. Hepatitis C virus proteins: direct link to hepatic oxidative stress, steatosis, carcinogenesis and more. Gastroenterology122(2), 568–571 (2002).
   PubMed Web of Science ®Google Scholar
• Thoren F, Romero A, Lindh M, Dahlgren C, Hellstrand K. A hepatitis C virus-encoded, nonstructural protein (NS3), triggers dysfunction and apoptosis in lymphocytes: role of NADPH oxidase-derived oxygen radicals. J. Leukoc. Biol.76, 1180–1186 (2004).
   PubMed Web of Science ®Google Scholar
• Hellstrand K, Asea A, Dahlgren C, Hermodsson S. Histaminergic regulation of NK cells, role of monocyte-derived reactive oxygen metabolites. J. Immunol.153, 4940–4947 (2004).
   Google Scholar
• Galmarini CM. Histamine dihydrochloride (subcutaneous) Maxim. Curr. Opin. Investig. Drugs5(12), 1298–310 (2004).
   PubMedGoogle Scholar
• Hornyak SC, Gehlsen KR, Haaparanta T. Histamine dihydrochloride protects against early alcohol-induced liver injury in a rat model. Inflammation27(5), 317–327 (2003).
   PubMed Web of Science ®Google Scholar
• Umeki S. Activation factors of neutrophil NADPH oxidase complex. Life Sci.55, 1–13 (1994).
   PubMed Web of Science ®Google Scholar
• Nauseef WM, Volpp BD, McCormick S, Leidal KG, Clack RA. Assembly of the neutrophil respiratory burst oxidase. Protein kinase C promotes cytoskeletal and membrane association of cytosolic oxidase components. J. Biol. Chem.266, 5911–5917 (1991).
   PubMed Web of Science ®Google Scholar
• Hansson M, Asea A, Errson U, Hermodsson S, Helstrand K. Induction of apoptosis in NK cells by monocyte-derived reactive oxygen metabolites. J. Immunol.156, 42–47 (1996).
   PubMed Web of Science ®Google Scholar
• Rizzel M, Naredi P, Lindner P, Hellstrand K, Sarno M, Jansson PA. Histamine pharmacokinetics in tumor and host tissues after bolus-dose administration in the rat. Life Sci.70(8), 969–976 (2002).
   PubMed Web of Science ®Google Scholar
• Naredi PLJ, Rizzel M, Lindner P, Hellstrand K. Histmaine dihydrochloride injections inhibit growth rate of rat liver tumors. Proc. Am. Assoc. Cancer Res.42(506) 2722a (2001).
   Google Scholar
• Middleton M, Sarno M, Agarwala SS et al. Pharmacokinetics of histamine dihydrochloride in healthy volunteers and cancer patients: implication s for combined immunotherapy with inerleukin-2. J. Clin. Phamacol.42(7), 774–781 (2002).
   Google Scholar
• Lurie Y, Malnick S, Pakula R, Beer-Gabel M, Cehlsen KR, Neumann AU. Triple combination therapy with histamine dihydrochloride, interferon α-2b and ribavirin for chronic hepatitis C treatment failures: 48 week results. Hepatology34(4 Pt 2), Abstract 332 (2001).
   Google Scholar
• Hugle T, Cerny A. Current therapy and new molecular approaches to antiviral treatment and prevention of hepatitis C. Rev. Med. Virol.13(6), 361–371 (2003).
   PubMed Web of Science ®Google Scholar
• Maxim Pharmaceuticals Inc. Maxim Pharmaceuticals announces preliminary results from phase I study in hepatitis C patients. Press release (1998).
   Google Scholar
• Maxim Pharmaceuticals Inc. Maxim Pharmaceuticals provides update regarding hepatitis C, progress toward first FDA filing, financing and other company matters. Press Release (1999).
   Google Scholar
• Lurie Y, Nevens F, Aprosina ZG et al. A multicentre, randomized study to evaluate the safety and efficacy of histamine dihydrochloride and interferon-α-2b for the treatment of chronic hepatitis C. J. Viral Hepat.9(5), 346–353 (2002).
   PubMed Web of Science ®Google Scholar
• Zeuzem S, Pawlotsky JM, Lukasiewicz E et al; DITTO-HCV Study Group. International, multicenter, randomized, controlled study comparing dynamically individualized versus standard treatment in patients with chronic hepatitis C. J. Hepatol.43(2), 250–257 (2005).
   PubMed Web of Science ®Google Scholar
• Karavodin L, Jensen R, Santo M, Gehisen K. Toxicology and toxicokinetics of acute and subchronic administration of histamine dihydrochloride in rats. Drug Chem. Toxicol.26, 35–49 (2003).
   PubMed Web of Science ®Google Scholar
• Safadi R, Israeli E, Papo O et al. Treatment of chronic HBV infection via oral immune regulation towards hepatitis B virus proteins. Am. J. Gastroenterol.98, 2505–2515 (2003).
   PubMed Web of Science ®Google Scholar
• Israeli E, Safadi R, Melhem A et al. Induction of oral immune regulation towards liver extracted proteins for treatment of chronic HBV and HCV hepatitis: results of a phase I clinical trial. Liver Int.24, 295–307 (2004).
   PubMed Web of Science ®Google Scholar