Daily or three times a week interferon alfa-2b in combination with ribavirin or interferon alone for the treatment of patients with chronic hepatitis C

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Journal of Hepatology, Vol. 36 (5) (2002) pp. 672-680

© 2002 European Association for the Study of the Liver. Published by Elsevier

Science B.V. All rights reserved.

PII: S0168-8278(02)00026-0

Daily or three times a week interferon alfa-2b in combination with ribavirin or

interferon alone for the treatment of patients with chronic hepatitis C ¤

Victor de Lédinghen 1, Pascale Trimoulet 2, Winnock 3, tte Foucher

1,4, Marc Bourlière 5, Hervé Desmorat 6, Valérie Canva 7, Dominique Capron 8,

Stéphane Lévy 9, François Mion 10, -Régis Mannant 11, Geneviève Chêne 3,

Hervé Fleury 2, Patrice Couzigou 1, Pierre-Henri Bernard 4 *

pierre-henri.bernard@... and French Multicenter Study Group

1 Service d'Hépato-Gastroentérologie, Centre Hospitalier Universitaire, Pessac,

France

2 Laboratoire de Virologie, Centre Hospitalier Universitaire, Bordeaux, France

3 INSERM U330 et Groupe de Recherches pour l'Etude du Foie, Université Victor

Segalen Bordeaux 2, Bordeaux, France

4 Service d'Hépato-Gastroentérologie, Hôpital Saint-André, Centre Hospitalier

Universitaire, 33075 Bordeaux, France

5 Service d'Hépato-Gastroentérologie, Hôpital Saint ph, Marseille, France

6 Service d'Hépato-Gastroenterologie, Clinique du Parc, Toulouse, France

7 Service d'Hépato-Gastroentérologie, Centre Hospitalier Universitaire, Lille,

France

8 Service d'Hépato-Gastroentérologie, Centre Hospitalier Universitaire, Amiens,

France

9 Service d'Hépato-Gastroentérologie, Centre Hospitalier Universitaire, Reims,

France

10 Service d'Hépato-Gastroentérologie, Centre Hospitalier Universitaire, Lyon,

France

11 Service d'Hépato-Gastroentérologie, Clinique Bordeaux Nord, Bordeaux, France

Received 17 May 2001; received in revised form 4 December 2001; accepted 2

January 2002

Abstract

Background/Aims: Data on hepatitis C virus (HCV) viral dynamics and on the

effect of interferon in blocking virion production have suggested a rationale

for daily administration of interferon in patients with chronic hepatitis C

infection. We compared the efficacy and safety of daily interferon alfa-2b in

combination with ribavirin with those of interferon alfa-2b three times a week

alone or in combination with ribavirin.

Methods: We randomly assigned 321 patients with chronic hepatitis C to receive

standard-dose interferon alfa-2b alone or in combination with ribavirin for 48

weeks or daily interferon alfa-2b (3 million units per day for 12 weeks then 3

million units three times per week for 24 weeks) and ribavirin (36 week

treatment).

Results: The rate of sustained virologic response (defined as an undetectable

serum HCV-RNA level 72 weeks after initiation of treatment) was higher in

patients who received combination therapy with three times weekly interferon

(51.7%) or daily interferon (46.1%) than in patients who received interferon

alone (25%) (P=0.0001 and P=0.002, respectively). Independent predictive factors

for sustained virologic response were combination therapy, weight, genotype and

viral load. In conclusion, in patients with chronic hepatitis C, combination

therapy with induction treatment (daily interferon for 12 weeks) and shorter

duration of treatment was not different from combination therapy for 48 weeks

without induction treatment.

Conclusions: Induction treatment with interferon for 12 weeks and combination

therapy for a total duration of 36 weeks could therefore be cost effective.

Keywords: Ribavirin; Hepatitis C; Chronic hepatitis; Interferon; Cirrhosis;

Anti-viral therapy; Daily interferon; Induction dose

*Corresponding author. Tel.: +33-556-795-806; fax: +33-556-794-781

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¤The authors of this study state that they have no relationship past or present

with the pharmaceutical company involved with the drugs mentioned in the study.

The authors state that they received funding from the maufacturers to carry out

their research.

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