title: A short induction regimen of interferon-alpha is not effective for treatment of relapse in chronic hepatitis C: a randomized trial. For the multicentre GER-CYT-01 group.
abstract: The aim of this work was to assess the effect of a high-dose (10 million units, MU) short-duration (14 weeks) interferon-alpha2b (IFN-alpha2b) regimen in relapsers compared with the standard IFN regimen of 3 MU three times weekly (t.i.w.) for 6 months. Fifty-eight non-cirrhotic patients (who had relapsed after previous treatment with IFN) with chronic hepatitis were randomized: 29 to the high-dose, short-duration regimen and 29 to the standard regimen. By the end of IFN therapy, in the high-dose, short-duration group alanine aminotransferase (ALT) normalization was observed in 23 (79%) of 29 patients, and undetectable hepatitis C virus (HCV) RNA in eight (28%) vs 25 (86%) and 11 (38%) of the 29 patients in the standard group, respectively (P = NS). At the end of the 72-week follow-up, in the high-dose, short-duration group a sustained ALT normalization was observed in two (7%) patients, and undetectable HCV RNA in 0 (0%) vs five (17%) and four (14%) patients in the standard group (P = NS). There was less fibrosis improvement in the high-dose, short-duration group (two of 26 patients, 8%) than in the standard group (eight of 25 patients, 32%) (P = 0.04). Tolerance to IFN was good and similar in the two groups. In conclusion, in IFN relapsers, high-dose, short-duration treatment with IFN-alpha has no advantage when compared to a 6-month treatment with 3 MU IFN t.i.w.
authors.affiliation: Service d'Hépato Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, Paris, France.
authors.forename: T
authors.initials: T
authors.lastname: Poynard
authors.forename: V
authors.initials: V
authors.lastname: Daurat
authors.forename: S
authors.initials: S
authors.lastname: Chevret
authors.forename: J
authors.initials: J
authors.lastname: Moussalli
authors.forename: F
authors.initials: F
authors.lastname: Degos
authors.forename: F
authors.initials: F
authors.lastname: Bailly
authors.forename: E
authors.initials: E
authors.lastname: Borotto
authors.forename: C
authors.initials: C
authors.lastname: Buffet
authors.forename: I
authors.initials: I
authors.lastname: Bartolomei-Portal
authors.forename: J P
authors.initials: JP
authors.lastname: Richardet
authors.forename: G
authors.initials: G
authors.lastname: Riachi
authors.forename: Y
authors.initials: Y
authors.lastname: Calmus
authors.forename: C
authors.initials: C
authors.lastname: Bréchot
authors.forename: M
authors.initials: M
authors.lastname: Vidaud
authors.forename: M
authors.initials: M
authors.lastname: Olivi
authors.forename: P
authors.initials: P
authors.lastname: Bedossa
authors.forename: P C
authors.initials: PC
authors.lastname: Riffaud
authors.forename: C
authors.initials: C
authors.lastname: Chastang
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D016174:Hepacivirus / Q000302:isolation & purification / Q000502:physiology; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012008:Recurrence; D017211:Treatment Failure
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D000410:Alanine Transaminase