Prediction of successful outcome in a randomised controlled trial of the long-term efficacy of interferon alpha treatment for chronic hepatitis C

Journal of Medical Virology

Volumn 58, Issue 1, 1999, Pages 26-34

  Vandelli, Carmen ^a,f   Renzo, Francesco ^a   Braun, Hans Bertram ^b   Tisminetzky, Sergio ^c   Albrecht, Marie ^b   De Palma, Marisa ^d   Ranzi, Andrea ^a   Di Marco, Giuseppe ^a   Stroffolini, Tommaso ^e   Baralle, Francesco ^c   Ventura, Ezio ^a   Michel, Gerd ^b  

^a UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^b ABBOTT GMBH AND CO KG   (Germany)

^c INTERNATIONAL CENTRE FOR GENETIC ENGINEERING AND BIOTECHNOLOGY   (Italy)

^d Universitaria di Modena   (Italy)

^e ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^f UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

Author keywords

Anti HCV core IgM; Hepatitis C virus; Interferon alpha

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CORE PROTEIN; HEPATITIS C ANTIBODY; IMMUNOGLOBULIN M; RECOMBINANT ALPHA2B INTERFERON; VIRUS RNA;

ADULT; AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; CHRONIC ACTIVE HEPATITIS; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; FEMALE; HEPATITIS C; HUMAN; HUMAN TISSUE; INTRAMUSCULAR DRUG ADMINISTRATION; LIVER BIOPSY; LIVER HISTOLOGY; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MULTIVARIATE ANALYSIS; PREDICTION; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ALANINE TRANSAMINASE; ASPARTATE AMINOTRANSFERASES; FEMALE; HEPACIVIRUS; HEPATITIS C ANTIBODIES; HEPATITIS C, CHRONIC; HUMANS; INTERFERON ALFA-2B; LIVER; MALE; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; RNA, VIRAL; TIME FACTORS; TREATMENT OUTCOME;

HEPATITIS C VIRUS; RNA VIRUSES;

EID: 20244383945     PISSN: 01466615     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1096-9071(199905)58:1<26::AID-JMV4>3.0.CO;2-W     Document Type: Article

References (37)

1. Brillanti S, Masci C, Ricci P, Miglioli M, Barbara L. 1992. Significance of IgM antibody to hepatitis C virus in patients with chronic hepatitis C. Hepatology 15:998-1001.
2. Camps J, Crisóatomo S, García-Granero M, Riezu-Boj JI, Civeira MP, Prieto J. 1993. Prediction of the response of chronic hepatitis C to interferon alpha: a statistical analysis of pretreatment variables. Gut 34:1714-1717.
3. Castillo I, Bartolome J, Navas S, Gonzalez S, Herrero M, Carreno V. 1994. Virological and biochemical long-term follow-up of patients with chronic hepatitis C treated with interferon. Hepatology 19: 1342-1346.
4. Chemello L, Bonetti P, Cavalletto L, Tolato F, Donadon V, Casarin P, Belussi F, Frezza M, Noventa F, Pontisso P, Benvegnù L, Casarin C, Alberti A, The Triveneto viral hepatitis group. 1995. Randomized trial comparing three different regimens of alpha-2a-interferon in chronic hepatitis C. Hepatology 22:700-706.
5. Conjeevaram HS, Everhart JE, Hoofnagle JH. 1995. Predictors of sustained beneficial response to interferon alpha therapy in chronic hepatitis C. Hepatology 22:1326-1329.
6. Davis GL, Balart LA, Schiff ER, Lindsay K, Bodenheimer HC, Perillo RP, Carey W, Jacobson IM, Payene J, Dienstang JL, Van Thiel DH, Tamburro C, Lefkowicth J, Albrecht J, Meschievitz C, Ortego TJ, Gibas A, the Hepatitis Interventional Therapy Group. 1989. Treatment of chronic hepatitis C with recombinant interferon alpha. A multicenter randomized, controlled trial. N Engl J Med 321:1501-1506.
7. Di Bisceglie AM, Martin P, Kassianides C, Lisker-Melman M, Murray L, Waggoner J, Goodman Z, Banks SM, Hoofnagle JH. 1989. Recombinant interferon alpha therapy for chronic hepatitis C. A randomized, double-blind, placebo-controlled trial. N Engl J Med 321: 1506-1510.
8. Dienstag JL, Alter HJ. 1986. Non-A, non-B hepatitis: evolving epidemiologic and clinical perspective. Semin Liver Dis 6:67-81.
9. Enomoto N, Kurosaki M, Tanaka Y, Marumo P, Sato C. 1994. Fluctuation of hepatitis C virus quasispecies in persistent infection and interferon treatment revealed by single-strand conformation polymorphism analysis. J Gen Virol 75:1361-1369.
10. Enomoto N, Sakuma I, Asahina Y, Kurosaki M, Murakami T, Yamamoto C, Izumi N, Marumo F, Sato C. 1995. Comparison of full-length sequences of interferon-sensitive and resistant hepatitis C virus Ib. J Clin Invest 96:224-230.
11. Hoofnagle JH, Mullen KD, Jones DB, Rustgi V, Di Bisceglie A, Peters M, Waggoner JG, Park Y, Jones A. 1986. Treatment of chronic non-A, non-B hepatitis with recombinant human alpha Interferon: a preliminary report. N Engl J Med 315:1575-1578.
12. Iino S, Hino K, Kuroki T, Suzuki H, Yamamoto S. 1993. Treatment of chronic hepatitis C with high-dose interferon α-2b. A multicenter study. Dig Dis Sci 38:612-618.
13. Ishak K, Baptista A, Bianchi L, Callea F, De Groote J, Gudat F, Denk H, Desmet V, Korb G, MacSween RNM, Phillips MJ, Portman BG, Poulsen H, Scheuer PJ, Schmid M, Thaler H. 1995. Histological grading and staging of chronic hepatitis. J Hepatol 22:629-699.
14. Kanai K, Kako M, Aikawa T, Kumada T, Kawasaki T, Hatahara T, Oka Y, Mizokami M, Sakai T, Iwata K. 1995. Clearance of serum hepatitis C virus RNA after interferon therapy in relation to virus genotype. Liver 15:185-188.
15. Kanazawa Y, Hayashi N, Mita E, Li T, Hagiwara H, Kasahara A, Fusamoto H, Kamada T. 1994. Influence of viral quasispecies on effectiveness of interferon therapy in chronic hepatitis C patients. Hepatology 20:1121-1130.
16. Koretz RL, Stone O, Mousa M, Gitnick GL. 1985. Non-A, non-B post transfusion hepatitis. A decade later. Gastroenterology 88:1251-1254.
17. Mahaney K, Tedeschi V, Maertens G, Di Bisceglie AM, Vergalla J, Hoofnagle JH, Sallie R. 1994. Genotypic analysis of hepatitis C virus in American patients. Hepatology 20:1405-1411.
18. Marcellin P, Boyer N, Giostra E, Degott C, Courouce AM, Degos F, Coppere H, Cales P, Couzigou P, Benhamou JP. 1991. Recombinant human alpha-interferon in patients with chronic non-A, non-B hepatitis: a multicenter randomized controlled trial from France. Hepatology 13:393-397.
19. Mazzella G, Salzetta A, Casanova S, Morelli MC, Villanova N, Miniero R, Sottili S, Novelli A, Cipolla A, Festi D, Roda E. 1994. Treatment of chronic sporadic-type non-A, non-B hepatitis with lymphoblastoid interferon: gamma GT levels predictive for response. Dig Dis Sci 39:866-870.
20. Negro F, Baldi M, Mondarini A, Leandro G, Chaneac M, Manzini P, Abate ML, Zahm F, Dastoli G, Ballarè M, Riff JC, Verme G, Bonino F. 1994. Continuous versus intermittent therapy for chronic hepatitis C with recombinant interferon alpha 2a. Gastroenterology 107:479-485.
21. Okada S, Akahane Y, Suzuki H, Okamoto H, Mishiro S. 1992. 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 16:619-624.
22. Papatheodoridis GV, Delladetsima JK, Katsoulidou A, Sypsa V, Albrecht M, Michel G, Hatzakis A, Tassopoulos NC. 1997. Significance of IgM anti-HCV core level in chronic hepatitis C. J Hepatol 27:36-41.
23. Pawlotsky JM, Roudot-Thoraval F, Duvoux C, Dhumeaux D, Babany G. 1994. Virological and biochemical responses to interferon-α in chronic hepatitis C. Lancet 343:54 (Correction: Lancet 1994; 343: 304).
24. Pawlotsky JM, Darthuy F, Rémiré J, Pellet C, Udin L, Stuyver L, Roudot-Thoraval F, Duvoux C, Dovuin C, Mallat A, Mavier JP, Métreau JM, Duval J, Dhumeaux D. 1995. Significance of anti-hepatitis C virus core IgM antibodies in patients with chronic hepatitis C. J Med Viral 47:285-291.
25. Poynard T, Bedossa P, Chevallier M, Mathurin P, Lemonnier C, Trepo C, Couzigou P, Payen JL, Sajus M, Costa JM, Vidaud M, Chaput JC, the Multieenter Study Group. 1995. A comparison of three interferon alfa-2b regimens for the long-term treatment of chronic non-A, non-B hepatitis. N Engl J Med 332:1457-1462.
26. Poynard T, Leroy V, Cohard M, Thevenot T, Mathurin P, Opolon P, Zarski JP. 1996. Meta-analysis of interferon randomized trials in the treatment of viral hepatitis C: effects of dose and duration. Hepatology 24:778-789.
27. Quiroga JA, Binsbergen JV, Wang CY, Pardo M, Navas S, Trines C, Herrero M, Carreño V. 1995. Immunoglobulin M antibody to hepatitis C virus core antigen: correlation with viral replication, histological activity, and liver disease outcome. Hepatology 22:1635-1640.
28. Reichard O, Foberg U, Fryden A, Mattsson L, Norkrans G, Sönneborg A, Wejstål R, Yun ZB, Weiland O. 1994. High sustained response rate and clearance of viremia in chronic hepatitis C after treatment with interferon-α2b for 60 weeks. Hepatology 19:280-285.
29. Saracco G, Rosina F, Abate ML, Chiandussi L, Gallo V, Cerutti E, Di Napoli A. 1993. Long-term follow-up of patients with chronic hepatitis C treated with different doses of interferon α-2b. Hepatology 18:1300-1305.
30. Simmonds P, Holmes EC, Cha TA, Chan SW, McOmish F, Irvine B, Beall E, Yap PL, Kolberg J, Urdea MS. 1993. Classification of hepatitis C virus into six major genotypes and a series of subtypes by phylogenetic analysis of the NS-5 region. J Gen Virol 74:2391-2399.
31. Tabone M, Secrete P, Marini C, Bonardi R, Boero M, Taraglio S, Ercole E, Sallio-Bruno F, Pera A. 1997. Pre-treatment levels of anti-HCV-core-IgM antibodies are closely associated with response to alpha interferon therapy in chronic hepatitis C patients. Eur J Gastroenterol Hepatol 9:287-291.
32. Tassopoulos NC, Hatzackis AE, Papatheodoridis GV, Karvountzis G, Troonen H, Lennartz L. 1994. Early prediction of successful alpha-interferon therapy of chronic hepatitis C by core IgM antibodies to hepatitis C virus. J Hepatol 20:305-306.
33. Tisminetzky SG, Gerotto M, Pontisso P, Chemello L, Ruvoletto MG, Baralle FE, Alberti A. 1994. Genotypes of hepatitis C virus in Italian patients with chronic hepatitis C. Int Hepatol Commun 2:105-112.
34. Tsubota A, Chayama K, Ikeda K, Yasuji A, Koida I, Saitoh S, Hashimoto M, Iwasaki S, Kobayashi M, Hiromitsu K. 1994. Factors predictive of response to interferon-alpha therapy in hepatitis C virus infection. Hepatology 19:1088-1094.
35. Vandelli C, Renzo F, Braun HB, Albrecht M, Piaggi V, Haibel H, Ventura E, Michel G. 1994. Prediction of outcome of α-interferon therapy: significance of anti-HCV core IgM, ALT and liver histology. J Hepatol 21(S1):S67.
36. Yamada G, Takatani M, Kishi F, Takahashi M, Doi T, Tsuji T, Shin S Tanno M, Urdea MS, Kolberg JA. 1995. Efficacy of interferon alpha therapy in chronic hepatitis C patients depends primarily on hepatitis C virus RNA level. Hepatology 22:1351-1354.
37. Yuki N, Hayashi N, Ohkawa K, Hagiwara H, Oshita M, Katayama K, Sasaki J, Kasahara A, Fusamoto H, Kamada T. 1995. The significance of immunoglobulin M antibody response to hepatitis C virus core protein in patients with chronic hepatitis C. Hepatology 22: 402-406.