Treatment of patients with chronic hepatitis C not responding to interferon with high-dose interferon alpha with or without ribavirin:: final results of a prospective randomized trial

被引:20
作者
Ferenci, P [1 ]
Stauber, R [1 ]
Steindl-Munda, P [1 ]
Gschwantler, M [1 ]
Fickert, P [1 ]
Datz, C [1 ]
Müller, C [1 ]
Hackl, F [1 ]
Rainer, W [1 ]
Watkins-Riedel, T [1 ]
Lin, W [1 ]
Krejs, GJ [1 ]
Gangl, A [1 ]
机构
[1] Univ Vienna, Dept Internal Med 4, A-1090 Vienna, Austria
关键词
chronic hepatitis C; interferon; randomized trial; ribavirin;
D O I
10.1097/00042737-200106000-00014
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Objective To investigate the efficacy of high-dose interferon alpha (IFN-a) with or without ribavirin in interferon (IFN) non-responders. Study design 304 chronic hepatitis C patients received 5 MU IFN-alpha 2b (IntronA(R), Schering-Plough, Kenilworth, NJ, USA) three times a week for 3 months. Non-responders were randomized either to continue with IFN (IFN 5 MU/TIW followed by 10 MU/TIW, each for 3 months) alone (group A: n = 76, m:f = 54:22, age 45.7 +/- 12 years, 16% cirrhosis, alanine aminotransferase [ALT] 66 +/- 35 U/I) or in combination with ribavirin (similar to 14 mg/kg/day) (group B: n = 81, m:f = 57 :24, age 48.2 +/- 12 years, 17% cirrhosis, ALT 71 +/- 40 U/I), At the end of treatment, patients were followed for 6 months. Main outcome measures Virological response at end of treatment and 6 months thereafter. Setting University hospitals and tertiary referral centres. Results At the end of treatment, eight (10.8%) and 25 (31.3%, P= 0.0066) patients were HCV-RNA negative, and 51 and 39 were HCV-RNA positive, in groups A and B, respectively. There were 17 drop-outs in each group. Six months after treatment, only one patient in group A (1.3%) and seven patients (8.6%, P= 0.06) in group B had normal ALT and undetectable serum HCV-RNA. Conclusions A combination of high-dose IFN with ribavirin induces a short-lasting complete response in about one-third of IFN-non-responders. Eur J Gastroenterol Hepatol 13:699-705 (C) 2001 Lippincott Williams & Wilkins.
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页码:699 / 705
页数:7
相关论文
共 41 条
[1]  
[Anonymous], 1999, J Hepatol, V30, P956
[2]   Interferon-α-2B and ribavirin in combination for chronic hepatitis C patients not responding to interferon-α alone:: An Italian multicenter, randomized, controlled, clinical study [J].
Barbaro, G ;
Di Lorenzo, G ;
Soldini, M ;
Giancaspro, G ;
Bellomo, G ;
Belloni, G ;
Grisorio, B ;
Annese, M ;
Bacca, D ;
Francavilla, R ;
Rizzo, G ;
Barbarini, G .
AMERICAN JOURNAL OF GASTROENTEROLOGY, 1998, 93 (12) :2445-2451
[3]  
Bell H, 1999, SCAND J GASTROENTERO, V34, P194, DOI 10.1080/00365529950173087
[4]  
BELLARY S, 1995, AM J GASTROENTEROL, V90, P259
[5]   Ribavirin and interferon-A combination therapy vs interferon-A alone in the retreatment of chronic hepatitis C: A randomized clinical trial [J].
Bellobuono, A ;
Mondazzi, L ;
Tempini, S ;
Silini, E ;
Vicari, F ;
Ideo, G .
JOURNAL OF VIRAL HEPATITIS, 1997, 4 (03) :185-191
[6]   The direct interplay between HCVNS5A protein and interferon transduction signal: from clinical to basic science [J].
Brechot, C .
JOURNAL OF HEPATOLOGY, 1999, 30 (06) :1152-1154
[7]   PILOT-STUDY OF COMBINATION THERAPY WITH RIBAVIRIN PLUS INTERFERON-ALFA FOR INTERFERON ALFA-RESISTANT CHRONIC HEPATITIS-C [J].
BRILLANTI, S ;
GARSON, J ;
FOLI, M ;
WHITBY, K ;
DEAVILLE, R ;
MASCI, C ;
MIGLIOLI, M ;
BARBARA, L .
GASTROENTEROLOGY, 1994, 107 (03) :812-817
[8]  
Chang TT, 1996, HEPATOLOGY, V23, P977
[9]  
CHEMELLO L, 1995, HEPATOLOGY, V22, P700, DOI 10.1016/0270-9139(95)90286-4
[10]   TREATMENT OF CHRONIC HEPATITIS-C WITH RECOMBINANT INTERFERON-ALFA - A MULTICENTER RANDOMIZED, CONTROLLED TRIAL [J].
DAVIS, GL ;
BALART, LA ;
SCHIFF, ER ;
LINDSAY, K ;
BODENHEIMER, HC ;
PERRILLO, RP ;
CAREY, W ;
JACOBSON, IM ;
PAYNE, J ;
DIENSTAG, JL ;
VANTHIEL, DH ;
TAMBURRO, C ;
LEFKOWITCH, J ;
ALBRECHT, J ;
MESCHIEVITZ, C ;
ORTEGO, TJ ;
GIBAS, A .
NEW ENGLAND JOURNAL OF MEDICINE, 1989, 321 (22) :1501-1506