title: From trials to a real hospital setting: effectiveness of pegylated interferon-alpha-2b/ribavirin combination therapy for naïve chronic hepatitis C patients.
abstract: Registration trials regarding pegylated interferon treatment of hepatitis C have created great expectations for improved results, but there is little information on actual outcomes in everyday hospital practice. We aimed to define the effectiveness of this treatment in a hospital setting. Seventy-four naïve patients with hepatitis C treated with 12 kD-pegylated-interferon-alpha-2-b/ribavirin (PEG-IFN) were retrospectively analyzed in comparison with 54 patients treated with IFN-alpha-2-b/ribavirin (STANDARD IFN) and with results of three main registration trials. Overall sustained viral response rates were 46% in the STANDARD IFN group and 54% in PEG-IFN group, ranging from 48-61% in similar arms of the registration trials considered, although more of our patients presented comorbidity and high-grade fibrosis, and our dosages at outset of PEG-IFN were lower than optimal (mean 1.18 microg/kg BW). In our hospital setting, the effectiveness of PEG-IFN/ribavirin therapy appeared similar to that reported in large registration trials.
authors.affiliation: UOS Malattie Epatiche Croniche, UOC Gastroenterologia ed Endoscopia Digestiva, AORN San Sebastiano, via Palasciano, 81100 Caserta, Italy. guidopiai@tin.it
authors.forename: Guido
authors.initials: G
authors.lastname: Piai
authors.forename: Elisa
authors.initials: E
authors.lastname: Scalice
authors.forename: Rosaria
authors.initials: R
authors.lastname: Focareta
authors.forename: Fulvia
authors.initials: F
authors.lastname: Terracciano
authors.forename: Francesca Romana
authors.initials: FR
authors.lastname: de Filippo
authors.forename: Giovambattista
authors.initials: G
authors.lastname: Forte
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011092:Polyethylene Glycols; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b