title: Efficacy of prolonged 5 million units of interferon in combination with ribavirin for relapser patients with chronic hepatitis C.
abstract: summary. Retreatment of relapser patients with chronic hepatitis C with the standard dose of interferon (IFN) of 3 million units (MU) thrice weekly (tiw) plus ribavirin for 24 weeks achieves a sustained response in 30 and 73% of patients with genotype 1 and 2 or 3, respectively. The aim of this study was to evaluate the efficacy and safety of IFN alpha-2b induction therapy, followed by prolonged treatment with a high dose of IFN alpha-2b plus ribavirin in relapser patients. A total of 119 patients were randomized to receive IFN alpha-2b 5 MU daily (Group A: 59 patients) or IFN alpha-2b 5 MU tiw (Group B: 60 patients) for 4 weeks followed by IFN (5 MU tiw) and ribavirin (1000-1200 mg/day) for 48 weeks in both groups. The primary end point was hepatitis C virus (HCV)-RNA clearance at week 24 after the end of treatment. A sustained virological response (SVR) was achieved in 68 and 60% of Group A and B patients, respectively (P = 0.37). Logistic regression analysis identified genotype 2 or 3 as the only independent factor associated with response, whereas induction regimen and baseline viraemia levels did not affect the response. The overall SVR was 53 and 72% in patients with genotype 1 or 4 and 2 or 3, respectively. In conclusion, induction IFN therapy does not enhance the SVR to a 48-week combination therapy. Our study suggests that relapsed patients with genotype 1 or 4 may achieve significant response rates of approximately 50%, if retreated with 5 MU tiw IFN plus ribavirin for 48 weeks.
authors.affiliation: Servizio Autonomo Clinicizzato di Gastroenterologia, Università di Verona, Verona, Italy. giovanna_fattovich@tin.it
authors.forename: G
authors.initials: G
authors.lastname: Fattovich
authors.forename: I
authors.initials: I
authors.lastname: Zagni
authors.forename: G
authors.initials: G
authors.lastname: Fornaciari
authors.forename: E
authors.initials: E
authors.lastname: Minola
authors.forename: P
authors.initials: P
authors.lastname: Fabris
authors.forename: S
authors.initials: S
authors.lastname: Boccia
authors.forename: M
authors.initials: M
authors.lastname: Giusti
authors.forename: G
authors.initials: G
authors.lastname: Abbati
authors.forename: M
authors.initials: M
authors.lastname: Felder
authors.forename: P
authors.initials: P
authors.lastname: Rovere
authors.forename: A
authors.initials: A
authors.lastname: Redaelli
authors.forename: A
authors.initials: A
authors.lastname: Tonon
authors.forename: R
authors.initials: R
authors.lastname: Montanari
authors.forename: C
authors.initials: C
authors.lastname: Paternoster
authors.forename: M
authors.initials: M
authors.lastname: Distasi
authors.forename: E
authors.initials: E
authors.lastname: Castagnetti
authors.forename: G
authors.initials: G
authors.lastname: Tositti
authors.forename: C
authors.initials: C
authors.lastname: Rizzo
authors.forename: S
authors.initials: S
authors.lastname: Suppressa
authors.forename: M
authors.initials: M
authors.lastname: Pantalena
authors.forename: L
authors.initials: L
authors.lastname: Lomonaco
authors.forename: C
authors.initials: C
authors.lastname: Scattolini
authors.forename: A
authors.initials: A
authors.lastname: Tagger
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000254:growth & development*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D016015:Logistic Models; D008297:Male; D012367:RNA, Viral / Q000097:blood / Q000235:genetics; D011994:Recombinant Proteins; D012008:Recurrence; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012254:Ribavirin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D012254:Ribavirin