A prospective, randomized trial comparing lymphoblastoid to recombinant interferon alfa 2a as therapy for chronic hepatitis C

Hepatology

Volumn 24, Issue 6, 1996, Pages 1366-1370

  Rumi, Mariagrazia ^a   Del Ninno, Ersilio ^a   Parravicini, Maria Luisa ^a   Romeo, Raffaella ^a   Soffredini, Roberta ^a   Donato, Maria Francesca ^a   Wilber, Judith ^b   Russo, Antonio ^c   Colombo, Massimo ^a  

^a UNIVERSITY OF MILAN   (Italy)

^b NOVARTIS PHARMA AG   (Switzerland)

^c CENTRO DI RIFERIMENTO ONCOLOGICO   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHAN1 INTERFERON; AMINOTRANSFERASE; LYMPHOBLAST INTERFERON; RECOMBINANT ALPHA2A INTERFERON;

ADULT; ANGINA PECTORIS; ARTICLE; CHRONIC HEPATITIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DOSE RESPONSE; DRUG COST; DRUG EFFICACY; FEMALE; HAIR LOSS; HEADACHE; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; HYPERTHYROIDISM; HYPOTHYROIDISM; INTRAMUSCULAR DRUG ADMINISTRATION; LICHEN PLANUS; MAJOR CLINICAL STUDY; MALE; MYALGIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SEXUAL DYSFUNCTION; THROMBOCYTOPENIA; TREATMENT OUTCOME;

EID: 0029912074     PISSN: 02709139     EISSN: None     Source Type: Journal    
DOI: 10.1053/jhep.1996.v24.pm0008938163     Document Type: Article

References (40)

1. Davis GL, Balart LA, Schiff ER, Lindsay K, Bodenheimer HC, Perrillo RP, Carey W, et al. Treatment of chronic hepatitis C with recombinant interferon alfa. A multicenter randomized, controlled trial. N Engl J Med 1989;321:1501-1506.
2. Causse X, Godinot H, Chevalier M, Chossegros P, Zoulim F, Ouzan D, Heyraud JP, et al. Comparison of 1 or 3 MU of interferon alfa-2b and placebo in patients with chronic non-A, non-B hepatitis. Gastroenterology 1991;101:497-502.
3. Marcellin P, Boyer N, Giostra E, Degott C, Courouce AM, Degos F, Coppere H, et al. Recombinant human alfa-interferon in patients with chronic non-A, non-B hepatitis: a multicenter randomized controlled trial from France. HEPATOLOGY 1991;13:393-397.
4. Saracco G, Rosina F, Abate ML, Chiandussi L, Gallo V, Cerutti E, Di Napoli A, et al. Long-term follow-up of patients with chronic hepatitis C treated with different doses of Interferon-alfa 2b. HEPATOLOGY 1993; 18: 1300-1305.
5. Chemello L, Bonetti P, Cavalletto L, Talato F, Donadon V, Casarin P, Belussi S, et al. Randomized trial comparing three different regimens of alpha-2a-interferon in chronic hepatitis C. HEPATOLOGY 1995;22:700-706.
6. Negro F, Baldi M, Mondardini A, Leandro G, Chaneac M, Manzini P, Abate ML, et al. Continuous versus intermittent therapy for chronic hepatitis C with recombinant interferon alfa-2a. Gastroenterology 1994;107:479-485.
7. Gomez-Rubio M, Porres JC, Castillo I, Quiroga JA, Moreno A, Carreno V. Prolonged treatment (18 months) of chronic hepatitis C with recombinant α-interferon in comparison with a control group. J Hepatol 1990;11(Suppl): 63S-67S.
8. Kasahara A, Hayashi N, Hiramatsu N, Oshita M, Hagiwara H, Katayama K, Kato M, et al. Ability of prolonged interferon treatment to suppress relapse after cessation of therapy in patients with chronic hepatitis C: a multicenter randomized controlled trial. HEPATOLOGY 1995;21:291-297.
9. Reichard O, Foberg U, Fryden A, Mattsson L, Norkrans G, Sonnerborg A, Wejstal R, et al. High sustained response rate and clearance of viremia in chronic hepatitis C after treatment with interferon alfa-2b for 60 weeks. HEPATOLOGY 1994;19:280-285.
10. Larder BA, Darby G, Richman DD. HIV with reduced sensitivity to zidovudine (AZT) isolated during prolonged therapy. Science 1989;243:1731-1734.
11. Enomoto N, Sato C, Kurosaki M, Marumo F. Hepatitis C virus after interferon treatment has the variation in the hypervariable region of envelope 2 gene. J Hepatol 1994;20:252-261.
12. Bonetti P, Diodati G, Drago C, Casarin C, Scaccabarozzi S, Realdi G, Ruol A, et al. Interferon antibodies in patients with chronic hepatitis C virus infection treated with recombinant interferon alpha-2a. J Hepatol 1994;20:416-420.
13. Giannelli G, Antonelli G, Fera G, Del Vecchio S, Riva E, Broccia C, Schiraldi O, et al. Biological and clinical significance of neutralizing and binding antibodies to interferon-alpha (IFN-α) during therapy for chronic hepatitis C. Clin Exp Immunol 1994;97:4-9.
14. Roffi L, Colloredo Mels G, Antonelli G, Bellati G, Panizzuti F, Piperno A, Pozzi M, et al. Breakthrough during recombinant alfa-interferon therapy in patients with chronic hepatitis C virus infection: prevalence, etiology and management. HEPATOLOGY 1995;21:645-649.
15. Rubinstein M. Multiple interferon subtypes: The phenomenon and its relevance. J Interferon Res 1987;7:545-551.
16. Cimino L, Citarella C, Nardone G, Budillon G. Lymphoblastoid interferon in chronic hepatitis C patients "non-responders" to recombinant interferon-α (rIFN-α). [Letter] J Hepatol 1992;14:419-420.
17. Budillon G, Cimino L, D'Ascoli B, Napolitano PV. Lymphoblastoid interferon in chronic hepatitis C patients who were "non-responders" to recombinant interferon alpha (rIFN alpha). Arch Virol 1993;8:S249-S255.
18. Romeo R, Thiers V, Driss F, Berthelot P, Nalpas B, Brèchot C. Hepatitis C virus RNA in serum of blood donors with or without elevated transaminase levels. Transfusion 1993;33:629-633.
19. Detmer J, Lagier R, Flynn J, Zayati C, Kolberg J, Collins M, Urdea M, et al. Accurate quantification of HCV-RNA from all HCV genotypes using branched-DNA (bDNA) technology. J Clin Microbiol 1996;34:901-907.
20. Stuyver L, Rossau R, Wyseur A, Duhamel M, Vanderborght B, Van Heuverswyn H, Maertens G. Typing of hepatitis C virus isolates and characterization of new subtypes using a line probe assay. J Gen Virol 1993; 74: 1093-1102.
21. Simmonds P, Alberti A, Alter HJ, Bonino F, Bradley DW, Brechot C, Brouwer JT, et al. A proposed system for the nomenclature of hepatitis C viral genotypes. HEPATOLOGY 1994;19:1321-1324.
22. Hennes U, Jucker W, Fischer WA, Krummenaker T, Palleroni AV, Trown PW, Linder-Ciccolunghi S, et al. The detection of antibodies to recombinant interferon alpha-2a in human serum. J Biol Standard 1987;15:231-244.
23. Scheuer PJ. Classification of chronic viral hepatitis: a need for reassessment. J Hepatol 1991;13:372-374.
24. Bruzzi P, Green SB, Byar DP, Brinton LA, Schairer C. Estimating the population attributable risk for multiple risk factors using case control data. Am J Epidemiol 1985;122:904-914.
25. Greenway AL, Overall ML, Sattayasai M, Rowley MJ, Hertzog PJ, McMullen BF, Cheetham BF, et al. Selective production of interferon-alpha subtypes by cultured peripheral blood mononuclear cells and lymphoblastoid cell lines. Immunology 1992;75:182-189.
26. Kanai K, Kako M, Okamoto H. HCV genotypes in chronic hepatitis C and response to interferon. [Letter] Lancet 1992;339:1543.
27. Yoshioka K, Kakumu S, Wakita T, Ishikawa T, Itoh Y, Takayanagi M, Higashi Y, et al. Detection of hepatitis C virus by polymerase chain reaction and response to Interferon-alfa therapy: relationship to genotypes of hepatitis C virus. HEPATOLOGY 1992;16:293-299.
28. Hagiwara H, Hayashi N, Mita E, Takehara T, Kasahara A, Fusamoto H, Kamada T. Quantitative analysis of hepatitis C virus RNA in serum during Interferon Alfa therapy. Gastroenterology 1993;104:877-878.
29. Tsubota A, Chayama K, Arase Y, Koida I, Saitoh S, Ikeda K, Iwasaki S, et al. Factors useful in predicting the response to interferon therapy in chronic hepatitis C. J Gastroenterol Hepatol 1993;8:535-539.
30. Nousbaum JB, Pol S, Nalpas B, Landais P, Berthelot P, Brechot C, and the Collaborative Study Group. Hepatitis C virus type 1b (II) infection in France and Italy. Ann Intern Med 1995;122:161-168.
31. Marcellin P, Pouteau M, Martinot-Peignoux M, Degos F, Duchatelle V, Boyer N, Lemonnier C, et al. Lack of benefit of escaleting dosage of interferon alfa in patients with chronic hepatitis C. Gastroenterology 1995;109:156-165.
32. Matsumoto A, Tanaka E, Suzuki T, Ogata H, Kiyosawa K. Viral and host factors that contribute to efficacy of interferon-α2a therapy in patients with chronic hepatitis C. Dig Dis Sci 1994;39:1273-1280.
33. Yamada G, Takatani M, Kishi F, Takahashi M, Doi T, Tsuji T, Shin S, et al. Efficacy of interferon alfa therapy in chronic hepatitis C patients depends primarily on hepatitis C virus RNA level. HEPATOLOGY 1995;22:1351-1354.
34. Pagliaro L, Craxì A, Cammaa C, Tinè F, Di Marco V, Lo Iacono O, Almasio P. Interferon-α for chronic hepatitis C: An analysis of pretreatment clinical predictors of response. HEPATOLOGY 1994;19:820-828.
35. Jouet P, Roudot-Thoraval F, Dhumeaux D, Métreau JM, and le group français pour l'etude du traitement des hépatites chroniques nAnB/C. Comparative efficacy of interferon alfa in cirrhotic and noncirrhotic patients with non-A, non-B, C hepatitis. Gastroenterology 1994;106:686-690.
36. Sieck JO, Ellis ME, Alfurayh O, Asharaf Ali M, Abdalla Ali H, Ayub A, Al-Fadda M, et al. Histologically advanced chronic hepatitis C treated with recombinant alpha-interferon: a randomized placebo-controlled double-blind cross-over study. J Hepatol 1993;19:418-423.
37. Silini E, Bono F, Cividini A, Cerino A, Bruno S, Rossi S, Belloni G, et al. Differential distribution of hepatitis C virus genotypes in patients with and without liver function abnormalities. HEPATOLOGY 1995;21:285-290.
38. Kato N, Yokosuka O, Hosoda K, Ito Y, Ohto M, Omata M. Quantification of hepatitis C virus by competitive reverse transcription-polymerase chain reaction: increase of the virus in advanced liver disease. HEPATOLOGY 1993;18:16-20.
39. Gordon SC, Kodali VP, Silverman AL, Dmuchowski CF, Urdea MS, Chan CS, Wilber JC. Level of hepatitis C virus RNA and liver histology in chronic type C hepatitis. Am J Gastroenterol 1994;89:1458-1461.
40. Pistello M, Maggi F, Vatteroni L, Cecconi N, Panicucci F, Bresci GP, Gambardella L, et al. Prevalence of hepatitis C virus genotypes in Italy. J Clin Microbiol 1994;32:232-234.