A randomised, open label, controlled trial on the effect of interferon plus amantadine compared with interferon alone for treatment of chronic hepatitis C

Hepatology Research

Volumn 26, Issue 3, 2003, Pages 167-173

  Baisini, Ornella ^a   Pigozzi, Marie Gracielle ^a   Benini, Federica ^a   Stellini, Roberto ^a   Reggiani, Alessandro ^b   Quattrocchi, Daniela ^b   Salmi, Andrea ^c   Andri, Giovanni ^d   Cominotti, Anna ^a   Favret, Maurizio ^a   Gargiulo, Franco ^a   Lanzini, Alberto ^a  

^a SPEDALI CIVILI   (Italy)

^b CREMONA HOSPITAL   (Italy)

^c S Orsola Hospital   (Italy)

^d Spedali Civili/Medical School ^*

Author keywords

Antiviral therapy; Hepatitis C virus; Therapy of chronic hepatitis

Indexed keywords

ALANINE AMINOTRANSFERASE; ALPHA INTERFERON; AMANTADINE; HUMOFERON; INTERFERON;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG HYPERSENSITIVITY; FEMALE; HEPATITIS C; HISTOPATHOLOGY; HUMAN; KIDNEY COLIC; LIVER BIOPSY; LIVER FIBROSIS; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; TREATMENT OUTCOME;

EID: 17344391029     PISSN: 13866346     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1386-6346(03)00111-6     Document Type: Article

References (31)

1. Global surveillance and control of hepatitis C. Report of a WHO Consultation organized in collaboration with the Viral Hepatitis Prevention Board, Antwerp, Belgium. J. Viral. Hepat. 1999;61:35-47.
2. Tong MJ, el Farra NS, Reikes AR, Co RL. Clinical outcomes after transfusion-associated hepatitis C. N Engl J Med 1995;332(22):1463-6.
3. Alter HJ, Seeff LB. Recovery, persistence, and sequelae in hepatitis C virus infection: a perspective on long-term outcome. Semin Liver Dis 2000;20(1):17-35.
4. Tine F, Magrin S, Craxi A, Pagliaro L. Interferon for non-A, non-B chronic hepatitis. A meta-analysis of randomised clinical trials. J Hepatol 1991;13(2):192-9.
5. Hoofnagle JH, di Bisceglie AM. The treatment of chronic viral hepatitis. N Engl J Med 1997;336(5):347-56.
6. Poynard T, Marcellin P, Lee SS, Niederau C, Minuk GS, Ideo G, et al. Randomised trial of interferon alpha2b plus ribavirin for 48 weeks or for 24 weeks versus interferon alpha2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. International Hepatitis Interventional Therapy Group (IHIT). Lancet 1998;352(9138):1426-32.
7. McHutchison JG, Gordon SC, Schiff ER, Shiffman ML, Lee WM, Rustgi VK, et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N Engl J Med 1998;339(21):1485-92.
8. Schalm SW, Hansen BE, Chemello L, Bellobuono A, Brouwer JT, Weiland O, et al. Ribavirin enhances the efficacy but not the adverse effects of interferon in chronic hepatitis C. Meta-analysis of individual patient data from European centers. J Hepatol 1997;26(5):961-6.
9. Koff WC, Elm JL, Jr., Halstead SB. Inhibition of dengue virus replication by amantadine hydrochloride. Antimicrob Agents Chemother 1980;18(1):125-9.
10. Smith JP. Treatment of chronic hepatitis C with amantadine. Dig Dis Sci 1997;42(8):1681-7.
11. Tabone M, Ercole E, Zaffino C, Sallio BF, Pera A, Bonino F. Amantadine hydrochloride decreases serum ALT activity without effects on serum HCV-RNA in chronic hepatitis C patients. Ital J Gastroenterol Hepatol 1998;30(6):611-3.
12. Senturk H, Mert A, Akdogan M, Tabak F, Basaran G, Turkoglu S, et al. Amantadine monotherapy of chronic hepatitis C patients infected with genotype 1b. Scand J Infect Dis 2000;32(5):575-6.
13. Reichard O, Yun ZB, Sonnerborg A, Weiland O. Hepatitis C viral RNA titers in serum prior to, during, and after oral treatment with ribavirin for chronic hepatitis C. J Med Virol 1993;41(2):99-102.
14. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, et al. 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(9286):958-65.
15. Mangia A, Minerva N, Annese M, Leandro G, Villani MR, Santoro R, et al. A randomized trial of amantadine and interferon versus interferon alone as initial treatment for chronic hepatitis C. Hepatology 2001;33(4):989-93.
16. Zeuzem S, Teuber G, Naumann U, Berg T, Raedle J, Hartmann S, et al. Randomized, double-blind, placebo-controlled trial of interferon alfa2a with and without amantadine as initial treatment for chronic hepatitis C. Hepatology 2000;32(4 Part 1):835-41.
17. Tabone M, Laudi C, Delmastro B, Biglino A, Andreoni M, Chieppa F, et al. Interferon and amantadine in combination as initial treatment for chronic hepatitis C patients. J Hepatol 2001;35(4):517-21.
18. Caronia S, Bassendine MF, Barry R, Mills P, Naoumov NV, Fox R, et al. Interferon plus amantadine versus interferon alone in the treatment of naive patients with chronic hepatitis C: a UK multicentre study. J Hepatol 2001;35(4):512-6.
19. Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology 1981;1(5):431-5.
20. Hubert IF, Lune F, Cadranel JF, Oberti F, Cales P. Treatment of chronic hepatitis C with amantadine. Am J Gastroenterol 1999;94(8):2316-7.
21. Parolin MB, Lacerda MA, Lopes RW. Amantadine-HCl in the treatment of chronic hepatitis C in non-responders to alpha-interferon. Effect on ALT serum levels and viral load. Arq Gastroenterol 1999;36(2):63-7.
22. Andant C, Lamoril J, Deybach JC, Jouet P, Soule JC. Amantadine for chronic hepatitis C: pilot study in 14 patients. Eur J Gastroenterol Hepatol 2000;12(12):1319-22.
23. Goff JS, Reveille RM, Johnson J. Treatment of chronic hepatitis C with amantadine. Dig Dis Sci 2000;45(7):1389-91.
24. Rosenberg S. Recent advances in the molecular biology of hepatitis C virus. J Mol Biol 2001;313(3):451-64.
25. Helbling B, Stamenic I, Viani F, Gonvers JJ, Dufour JF, Reichen J, et al. Interferon and amantadine in naive chronic hepatitis C: a double-blind, randomized, placebo-controlled trial. Hepatology 2002;35(2):447-54.
26. Poynard T, Ratziu V, Charlotte F, Goodman Z, McHutchison J, Albrecht J. Rates and risk factors of liver fibrosis progression in patients with chronic hepatitis C. J Hepatol 2001;34(5):730-9.
27. Poynard T, McHutchison J, Manns M, Trepo C, Lindsay K, Goodman Z, et al. Impact of pegylated interferon alfa-2b and ribavirin on liver fibrosis in patients with chronic hepatitis C. Gastroenterology 2002;122(5):1303-13.
28. Poynard T, Bedossa P, Chevallier M, Mathurin P, Lemonnier C, Trepo C, et al. A comparison of three interferon alfa-2b regimens for the long-term treatment of chronic non-A, non-B hepatitis. Multicenter Study Group. N Engl J Med 1995;332(22):1457-62.
29. David E, Pucci A, Palladin D, Saracco G, Garello E, Pintus C, et al. Histologic changes in liver biopsy specimens produced by recombinant interferon alpha-2b therapy for chronic non-A, non-B viral hepatitis. A randomized controlled trial. Am J Clin Pathol 1992;98(4):397-401.
30. Castillo I, Bartolome J, Navas S, Gonzalez S, Herrero M, Carreno V. Virological and biochemical long-term follow-up of patients with chronic hepatitis C treated with interferon. Hepatology 1994;19(6):1342-6.
31. Shiffman ML, Hofmann CM, Contos MJ, Luketic VA, Sanyal AJ, Sterling RK, et al. A randomized, controlled trial of maintenance interferon therapy for patients with chronic hepatitis C virus and persistent viremia. Gastroenterology 1999;117(5):1164-72.