Prolonged treatment (2 years) with different doses (3 versus 6 MU) of interferon α-2b for chronic hepatitis type C. Results of a multicenter randomized trial

Journal of Hepatology

Volumn 27, Issue 1, 1997, Pages 56-62

  Saracco, Giorgio ^a   Borghesio, Elisabetta ^a   Mesina, Pietro ^b   Solinas, Antonello ^e   Spezia, Claudia ^c   Macor, Franco ^c   Gallo, Vittorio ^e   Chiandussi, Livio ^e   Donada, Carlo ^e   Donadon, Valter ^e   Spirito, Fulvio ^d   Mangia, Alessandra ^d   Andriulli, Angelo ^d   Verme, Giorgio ^a   Rizzetto, Mario ^a  

^a MOLINETTE HOSPITAL   (Italy)

^b SAN FRANCESCO HOSPITAL   (Italy)

^c AMEDEO DI SAVOIA HOSPITAL   (Italy)

^d CASA SOLLIEVO DELLA SOFFERENZA HOSPITAL   (Italy)

^e NONE

Author keywords

Chronic hepatitis C; Genotype; HCV RNA; Interferon

Indexed keywords

ALANINE AMINOTRANSFERASE; DNA; HEPATITIS C ANTIBODY; MICROSOME ANTIBODY; RECOMBINANT ALPHA2B INTERFERON; VIRUS RNA;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; ENZYME IMMUNOASSAY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FOLLOW UP; GENOTYPE; HEPATITIS C; HUMAN; LIVER BIOPSY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYALGIA; NEUTROPENIA; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RELAPSE; SUBCUTANEOUS DRUG ADMINISTRATION; VIREMIA;

EID: 0030744369     PISSN: 01688278     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0168-8278(97)80280-2     Document Type: Article

References (35)

1. Davis GL, Balart LA, Schiff ER, Lindsay K, Bodenheimer HC Jr, et al. Treatment of chronic hepatitis C with recombinant interferon alpha: a multicenter randomized, controlled trial. N Engl J Med. 321:1989;1501-1506.
2. Di Bisceglie AM, Martin P, Kassianides C, Lisker-Melman M, Murray L, Waggoner J, et al. Recombinant interferon alpha theraphy for chronic hepatitis C: a randomized double-blind, placebo-controlled trial. N Engl J Med. 321:1989;1506-1510.
3. Saracco G, Rosina F, Torrani Cerenzia MR, Lattore V, Chiandussi L, et al. A randomized controlled trial of interferon alpha-2b as therapy for chronic non A, non B hepatitis. J Hepatol. 11:1990;S43-S49.
4. Weiland O, Schvarcz R, Wejstal R, Norkrans G, Fryden A. Therapy of chronic post-transfusion non-A, non-B hepatitis with interferon alpha-2b: Swedish experience. J Hepatol. 11:1990;S57-S62. (suppl. 1).
5. Marcellin P, Boyer N, Giostra E, Degott C, Courouce AM, Degos F, et al. Recombinant human alpha-interferon in patients with chronic non-A, non-B hepatitis: a multicenter randomized controlled trial from France. Hepatology. 13:1991;393-397.
6. Causse X, Godinot H, Chevalier M, Chossegros P, Zoulim F, Ouzan D, et al. Comparison of 1 or 3 MU of interferon-alpha-2b and placebo in patients with chronic nonA, nonB hepatitis. Gastroenterology. 101:1991;497-502.
7. Diodatti G, Bonetti P, Noventa F, Casarin C, Rugge M, Scaccabarozzi S, et al. Treatment of chronic hepatitis C with recombinant human interferon alpha-2a: results of a randomized controlled clinical trial. Hepatology. 19:1994;1-5.
8. Saracco G, Rosina F, Abate ML, Chiandussi L, Gallo V, Cerutti E, et al. Long-term follow-up of patients with chronic hepatitis C treated with different doses of interferon alpha-2b. Hepatology. 18:1993;1300-1305.
9. Reichard O, Foberg U, Fryden A, Mattsson L, Norkrans G, Sonnerborg A, et al. High sustained response rate and clearance of viremia in chronic hepatitis C after treatment with interferon alpha-2b for 60 weeks. Hepatology. 19:1994;280-285.
10. Poynard T, Bedossa P, Chevallier M, Mathurin P, Lemonnier C, et al. A comparison of three interferon alpha-2b regimens for the long-term treatment of chronic non-A, non-B hepatitis. N Engl J Med. 332:1995;1457-1462.
11. Yokosuka O, Kato N, Ito Y, Imazeki F, Ohto M, Omata M. Efficacy of long-term interferon treatment in chronic liver disease evaluated by sensitive polymerase chain reaction assay for hepatitis C virus RNA. Gut. 37:1995;721-726.
12. Kasahara A, Hayashi N, Hiramatsu N, Oshita M, Hagiwara H, Katayama K, 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. 21:1995;291-297.
13. Lin R, Roach E, Zimmerman M, Strasser S, Farrell GC. Interferon alpha-2b for chronic hepatitis C: effects of dose increment and duration of treatment on response rates. Results of the first multicentre Australian trial. J Hepatol. 23:1995;487-496.
14. 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. J Hepatol. 1:1981;431-433.
15. Shindo M, Di Bisceglie AM, Cheung L, Shih JWK, Cristiano K, Feinstone FM, et al. Decrease in serum hepatitis C viral RNA during alpha-interferon therapy for chronic hepatitis C. Ann Intern Med. 115:1991;700-704.
16. Iino S. High dose interferon treatment in chronic hepatitis C. Gut. 34:1993;S114-S118. (suppl. 1).
17. Chemello L, Bonetti P, Cavalleto L, Talato F, Donadon V, Casarin P, et al. Randomized trial comparing three different regimens of alpha-2a interferon in chronic hepatitis C. Hepatology. 22:1995;700-706.
18. Fried MW, Hoofnagle JH. Therapy of hepatitis C. Semin Liver Dis. 15:1995;82-91.
19. Lindsay KL, Davis GL, Schiff E. Long-term response to higher doses of interferon (IFN) alpha-2b treatment of patients with chronic hepatitis C: a randomized multicenter trial (Abstract). Hepatology. 18:1993;106.
20. Benelux multicentre trial of alpha interferon treatment for chronic hepatitis C: standard versus high dose treatment monitored by biochemical and virological markers (interim analysis). Gut. 34:1993;S119-S120. (suppl. 1).
21. Poynard T, Leroy V, Cohard M, Thevenot T, Mathurin P, Opolon P, et al. Meta-analysis of interferon randomized trials in the treatment of viral hepatitis C: effects of dose and duration. Hepatology. 24:1996;778-789.
22. Craxi A, Di Marco V, Iacono OL, Almasio P, Bruno R, Cammaá C, et al. Transfusion-associated chronic hepatitis C: alpha-n1 interferon for 6 vs. 12 months. J Hepatol. 24:1996;539-546.
23. Shiffman ML, Hofmann CM, Luketic VAC, Sanyal AJ, Contos MJ, et al. Improved sustained response following treatment of chronic hepatitis C by gradual reduction in the interferon dose. Hepatology. 24:1996;21-26.
24. Reichen J, Bianchi L, Buhler H, Dolivo N, Gonvers JJ, Lavanchy D, et al. Fixed versus titrated interferon alpha-2b in chronic hepatitis C. A randomized controlled multicenter trial. J Hepatol. 25:1996;275-282.
25. Von Wussow P, Freund M, Block B, Dietrich H, Poliwoda H, Deicher H. Clinical significance of anti-IFN alpha antibodies titres during interferon therapy. Lancet. ii:1987;635-636.
26. Okada SI, Akahane Y, Suzuki H, Okamoto H, Mishiro S. The degree of variability in the amino terminal region of the E2/NS1 protein of hepatitis C virus correlates with responsiveness to interferon therapy in viremic patients. Hepatology. 16:1992;619-624.
27. Finkelstein SD, Sayegh R, Uchman S, Christensen S, Swalsky P. HCV undergoes extensive mutational change in NS5 region in association with relapse/breakthrough following alpha-interferon therapy (Abstract). Hepatology. 16:1992;132.
28. Nakajima S, Kuroki T, Shiomi S, Seki S, Kobayashi K. Changes in interferon receptors on peripheral blood mononuclear cell from patients with chronic hepatitis B being treated with interferon. Hepatology. 12:1990;1261-1265.
29. Tsubota A, Chayama K, Ikeda K, Yasuji A, Koida I, Saitoh S, et al. Factors predictive of response to interferon-alpha therapy in hepatitis C virus infection. Hepatology. 19:1994;1088-1094.
30. Hino K, Sainokami S, Shimoda K, Iiono S, Wang Y, Okamoto H, et al. Genotypes and titers of hepatitis C virus for predicting response to interferon in patients with chronic hepatitis C. J Med Virol. 42:1994;299-305.
31. Martinot-Peignoux M, Marcellin P, Pouteau M, Castelnau C, Boyer N, Poliquin M, et al. Pretreatment serum hepatitis C virus RNA levels and hepatitis C virus genotype are the main and independent prognostic factors of sustained response to interferon alpha therapy in chronic hepatitis C. Hepatology. 22:1995;1050-1056.
32. Mita E, Hayashi N, Hagiwara H, Ueda K, Kanazawa Y, Kasahara A, et al. Predicting interferon therapy efficacy from hepatitis C virus genotype and RNA titer. Dig Dis Sci. 39:1994;977-982.
33. Garson JA, Brillanti S, Whitby K, Foli M, Deaville R, Masci C, et al. Analysis of clinical and virological factors associated with response to alpha interferon therapy in chronic hepatitis C. J Med Virol. 45:1995;348-353.
34. Yuki N, Hayashi A, Hagiwara H, Takehara T, Oshita M, Katayama K, et al. Pretreatment viral load and response to prolonged interferon-alpha course for chronic hepatitis C. J Hepatol. 22:1995;457-463.
35. Marcellin P, Pouteau M, Martinot-Peignoux M, Degos F, Duchatelle V, Boyer N, et al. Lack of benefit of escalating dosage of interferon alpha in patients with chronic hepatitis C. Gastroenterology. 109:1995;156-165.