Article (Scientific journals)
Reduction of relapse rates by 18-month treatment in chronic hepatitis C. A Benelux randomized trial in 300 patients.
Brouwer, Johannes T; Nevens, Frederik; Bekkering, Frank C et al.
2004In Journal of Hepatology, 40 (4), p. 689-695
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Keywords :
Adult; Antiviral Agents/administration & dosage/adverse effects; Double-Blind Method; Female; Hepatitis C, Chronic/drug therapy/virology; Humans; Interferon Alfa-2b/administration & dosage/adverse effects; Male; Middle Aged; RNA, Viral/blood; Recurrence; Ribavirin/administration & dosage/adverse effects; Time Factors
Abstract :
[en] BACKGROUND/AIMS: Treatment of chronic hepatitis C with interferon can be ineffective due to relapse. We aimed to reduce the 40% relapse rate of 6 months interferon-ribavirin combination therapy by prolonging treatment to 18 months. METHODS: Three hundred patients with treatment-naive hepatitis C, were randomized to 18 months combination therapy with interferon (3MU tiw) and ribavirin (1000-1200 mg/day), 18 months interferon combined with placebo, or 6 months combination therapy with interferon and ribavirin, in a double blinded manner. All 295 patients who received at least one dose of treatment were included in the intention to treat analysis. RESULTS: At the end of treatment, HCV RNA was undetectable in 55 and 49% of those on 6 and 18 months combination therapy, respectively, versus 26% of those on monotherapy (P<0.001). The relapse rate was 38% for 6 months combination therapy, 38% for 18 months monotherapy, and only 13% for 18 months combination treatment (P=0.002). The sustained response rates were 34% for 6 months combination therapy, 16% for 18 months monotherapy and 43% for 18 months combination therapy (P<0.05). CONCLUSIONS: Reduction of relapse rates to 15% or less is feasible by prolongation of interferon-ribavirin treatment to 18 months.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Brouwer, Johannes T;  Erasmus Medical Center > Hepatogastroenterology
Nevens, Frederik;  University Hospital, Leuven > Hepatogastroenterology
Bekkering, Frank C;  Erasmus Medical Center > Hepatogastroenterology
Bourgeois, Nadine;  Erasme University Hospital > Hepatogastroenterology
Van Vlierberghe, Hans;  University Hospital, Gent > Hepatogastroenterology
Weegink, Christine J;  Academic Medical Center, Amsterdam > Hepatogastroenterology
Lefebvre, Veronique;  Centre Hôpital Régionale St. Camille Namen > Hepatogastroenterology
Van Hattum, Jan;  University Hospital, Utrecht > Hepatogastroenterology
Henrion, Jean;  Jolimont Hospital Haine, St. Paul > Hepatogastroenterology
Delwaide, Jean ;  Centre Hospitalier Universitaire de Liège - CHU > Gastro-Entérologie-Hépatologie
Hansen, Bettina E;  Erasmus University > Biostatistics
Schalm, Solko W;  Erasmus Medical Center > Hepatogastroenterology
Language :
English
Title :
Reduction of relapse rates by 18-month treatment in chronic hepatitis C. A Benelux randomized trial in 300 patients.
Publication date :
2004
Journal title :
Journal of Hepatology
ISSN :
0168-8278
eISSN :
1600-0641
Publisher :
Elsevier, Oxford, United Kingdom
Volume :
40
Issue :
4
Pages :
689-695
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 22 July 2010

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