title: Peginterferon alpha-2b plus ribavirin for treatment of chronic hepatitis C with severe fibrosis: a multicentre randomized controlled trial comparing two doses of peginterferon alpha-2b.
abstract: We compared sustained virological response (SVR) in chronic hepatitis C patients with severe fibrosis treated with pegylated interferon (Peg-IFN) alpha-2b 1.5 microg/kg/week or 0.75 microg/kg/week in combination with ribavirin 800 mg/day for 48 weeks. This was a multicentre randomized controlled study. SVR was observed in 44.5% (45/101) of patients treated with the standard dose of Peg-IFN and 37.2% (38/102) of patients treated with the low dose (NS). In patients with genotypes 1, 4 and 5, SVR was observed in 25.0% of patients who received the standard dose and 16.9% of patients who received the low dose of Peg-IFN (P = NS). In patients with genotypes 1, 4 and 5 and low viraemia, SVR was obtained in 27.3% of patients treated with the standard dose and 25.8% of patients treated with the low dose (P = NS). In the high-viraemia subgroup, SVR was obtained in 24.0% and 9.1% of patients, respectively. In patients with genotypes 2 and 3, SVR was similar in both groups (73.2%vs 73.0%). Thus, (1) patients with genotypes 2 and 3 and severe fibrosis can be treated with low dose of Peg-IFN and ribavirin, (2) this study suggests that patients with genotypes 1, 4 and 5 and high viraemia could receive a standard dose of Peg-IFN associated with ribavirin for 48 weeks, (3) side effects limit the efficacy of the treatment with standard dose of Peg-IFN in patients with genotypes 1, 4 and 5 and low viraemia, (4) more studies are needed for patients with genotype 2 or 3 to define the optimal duration (24 or 48 weeks) in patients with severe fibrosis.
authors.affiliation: Service d'Hépato-Gastroentérologie, Hôtel-Dieu, Clermont-Ferrand, France. aabergel@chu-clermontferrand.fr
authors.forename: A
authors.initials: A
authors.lastname: Abergel
authors.forename: C
authors.initials: C
authors.lastname: Hezode
authors.forename: V
authors.initials: V
authors.lastname: Leroy
authors.forename: K
authors.initials: K
authors.lastname: Barange
authors.forename: J P
authors.initials: JP
authors.lastname: Bronowicki
authors.forename: A
authors.initials: A
authors.lastname: Tran
authors.forename: L
authors.initials: L
authors.lastname: Alric
authors.forename: L
authors.initials: L
authors.lastname: Castera
authors.forename: P-H
authors.initials: PH
authors.lastname: Bernard
authors.forename: C
authors.initials: C
authors.lastname: Henquell
authors.forename: H
authors.initials: H
authors.lastname: Lafeuille
authors.forename: S
authors.initials: S
authors.lastname: Ughetto
authors.forename: C
authors.initials: C
authors.lastname: Darcha
authors.forename: M
authors.initials: M
authors.lastname: Chevallier
authors.forename: N
authors.initials: N
authors.lastname: Martineau
authors.forename: S
authors.initials: S
authors.lastname: Dubost
authors.forename: K
authors.initials: K
authors.lastname: Randl
authors.forename: D
authors.initials: D
authors.lastname: Dhumeaux
authors.forename: G
authors.initials: G
authors.lastname: Bommelaer
authors.forename: C
authors.initials: C
authors.lastname: Bonny
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000473:pathology / Q000821:virology; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b