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A randomized controlled trial of high‐dose maintenance interferon therapy in chronic hepatitis C
Author(s) -
Di Marco Vito,
Lo Iacono Oreste,
Cammà Calogero,
Almasio Piero L.,
Vaccaro Alessandra,
Fuschi Patrizia,
Giunta Marco,
Fabiano Carmelo,
Pagliaro Luigi,
Craxì Antonio
Publication year - 1997
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/(sici)1096-9071(199701)51:1<17::aid-jmv3>3.0.co;2-v
Subject(s) - medicine , gastroenterology , cirrhosis , interferon , hepatitis c virus , population , adverse effect , hepatitis c , interferon alfa , randomized controlled trial , alpha interferon , immunology , virus , environmental health
In chronic hepatitis C virus (HCV) infection, the rate of sustained response to interferon is low. We evaluated, in patients responding to a 26‐week course of interferon, the effect of high‐dose maintenance therapy in preventing relapse. Three hundred and ten patients with chronic HCV infection (38.3% with cirrhosis, 80.6% with HCV type 1) received interferon alfa‐2b for 26 weeks (10 MU tiw for 8 weeks, then 5 MU tiw for 18 weeks). One hundred and twenty‐four subjects (40%) normalized aminotransferases, and were allocated randomly either to continue on 5 MU tiw for a further 26 weeks (prolonged therapy group: 60 patients) or to stop interferon (brief therapy group: 64 patients). Fifty‐two weeks after stopping interferon the overall sustained biochemical response rate was 13.2% (41/310). The number of patients with normal aminotransferases was comparable between the prolonged and brief therapy groups (30% vs. 35.9%, P = n.s.), and the rate of HCV‐RNA clearance was similar (48.8% vs. 42.4%, P = n.s.). The timing of posttreatment relapse was not influenced by the duration of therapy. Fifty‐nine patients (19%) did not complete therapy due to adverse effects. Multivariate analysis identified four features predicting sustained biochemical response in subjects normalizing aminotransferases under therapy: negative HCV‐RNA at end of therapy, normal aminotransferases at 4 weeks of therapy, high baseline aminotransferases, and high baseline platelets. Infection with HCV type 1 was not a significant predictor of response, due to its high prevalence in our population (80.6%). It is concluded that in patients with chronic hepatitis C mostly infected by HCV type 1, a prolonged high‐dose interferon course (900 MU over 52 weeks) did not increase the rate of sustained biochemical response and of HCV‐RNA clearance in comparison to a brief course (510 MU over 26 weeks). J Med Virol 51:17–24, 1997. © 1997 Wiley‐Liss, Inc.