title: [Pegylated interferon-alfa 2a with ribavirin in chronic viral hepatitis C (final report)].
abstract: We evaluated the efficacy and safety of peginterferon alfa-2a [40KD] (Peg-IFNalpha-2a) plus ribavirin in patients with chronic hepatitis C in an open-label programme in a routine clinical setting in Poland. Patients received Peg-IFNalpha-2a 180mg/week plus ribavirin 800-1200 mg/d for 48 weeks. Sustained virological response (SVR) was defined as undetectable HCV RNA (<50IU/mL) at the end of follow-up (week 72). 466 adults were enrolled. Most patients (87.3%) had genotype 1 infection. 440 subjects (94,4%) completed treatment. The overall SVR rate was 55.7%. A higher SVR rate was obtained in treatment-naïve patients (58.7%) than in relapsers (47.8%; p=0,048). SVR rates in genotype 1 and non-1 patients were 51.1% and 88.5%, respectively (p<0.001). There were significant higher SVR rates in patients with lower baseline fibrosis (p=0,01). There were no differences in SVRs by gender or viral load. Hemoglobin, leukocyte and neutrophil levels decreased significantly during treatment, but returned to baseline after the end of treatment. ALT levels decreased significantly during treatment in patients with and without an SVR. 38.4% of patients experienced adverse events like neutropenia, anemia, thrombocytopenia, and other. There was one death (severe thrombocytopenia).
  
  
  CONCLUSIONS
  The overall SVR achieved in this predominantly genotype 1 population was 55.7%. SVR rates were significantly higher in treatment-naïve patients, those with non-1 genotypes, and in patients with lower baseline fibrosis scores.
authors.affiliation: Katedra i Oddział Kliniczny Chorób Zakaźnych, SLAM, Katowice. juszczyk@post.pl
authors.forename: Jacek
authors.initials: J
authors.lastname: Juszczyk
authors.forename: Barbara
authors.initials: B
authors.lastname: Baka-Cwierz
authors.forename: Marek
authors.initials: M
authors.lastname: Beniowski
authors.forename: Hanna
authors.initials: H
authors.lastname: Berak
authors.forename: Beata
authors.initials: B
authors.lastname: Bolewska
authors.forename: Anna
authors.initials: A
authors.lastname: Boroń-Kaczmarska
authors.forename: Janusz
authors.initials: J
authors.lastname: Cianciara
authors.forename: Andrzej
authors.initials: A
authors.lastname: Cieśla
authors.forename: Andrzej
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authors.lastname: Dziambor
authors.forename: Jacek
authors.initials: J
authors.lastname: Gasiorowski
authors.forename: Andrzej
authors.initials: A
authors.lastname: Gietka
authors.forename: Ewa
authors.initials: E
authors.lastname: Gliwińska
authors.forename: Andrzej
authors.initials: A
authors.lastname: Gładysz
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Gonciarz
authors.forename: Waldemar
authors.initials: W
authors.lastname: Halota
authors.forename: Andrzej
authors.initials: A
authors.lastname: Horban
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Inglot
authors.forename: Urszula
authors.initials: U
authors.lastname: Janas-Skulina
authors.forename: Ewa
authors.initials: E
authors.lastname: Janczewska-Kazek
authors.forename: Jolanta
authors.initials: J
authors.lastname: Jaskowska
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Jurczyk
authors.forename: Brygida
authors.initials: B
authors.lastname: Knysz
authors.forename: Wiesław
authors.initials: W
authors.lastname: Kryczka
authors.forename: Jan
authors.initials: J
authors.lastname: Kuydowicz
authors.forename: Elzbieta A
authors.initials: EA
authors.lastname: Lakomy
authors.forename: Beata
authors.initials: B
authors.lastname: Logiewa-Bazger
authors.forename: Anna
authors.initials: A
authors.lastname: Lyczak
authors.forename: Tomasz
authors.initials: T
authors.lastname: Mach
authors.forename: Włodzimierz
authors.initials: W
authors.lastname: Mazur
authors.forename: Zofia
authors.initials: Z
authors.lastname: Michalska
authors.forename: Roma
authors.initials: R
authors.lastname: Modrzewska
authors.forename: Khalil
authors.initials: K
authors.lastname: Nazzal
authors.forename: Paweł
authors.initials: P
authors.lastname: Pabjan
authors.forename: Anna
authors.initials: A
authors.lastname: Piekarska
authors.forename: Paweł
authors.initials: P
authors.lastname: Piszko
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Sikorska
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Szamotulska
authors.forename: Magdalena
authors.initials: M
authors.lastname: Sliwińska
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Swietek
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Tomasiewicz
authors.forename: Ewa
authors.initials: E
authors.lastname: Topczewska-Staubach
authors.forename: Hanna
authors.initials: H
authors.lastname: Trocha
authors.forename: Marek
authors.initials: M
authors.lastname: Wasilewski
authors.forename: Marta
authors.initials: M
authors.lastname: Wawrzynowicz-Syczewska
authors.forename: Witold
authors.initials: W
authors.lastname: Wrodycki
authors.forename: Dorota
authors.initials: D
authors.lastname: Zarebska-Michaluk
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Zejc-Bajsarowicz
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004337:Drug Carriers / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004337:Drug Carriers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b