title: Peginterferon alfa-2a and peginterferon alfa-2b combined with ribavirin in patients with genotype 1 chronic hepatitis C: results of a prospective single-centre study.
abstract: OBJECTIVE
  This prospective, randomized, single-centre study compared peginterferons alfa-2a and alfa-2b, combined with ribavirin, in treating patients infected with hepatitis C virus (HCV) genotype 1.
  
  
  METHODS
  Hundred-and-one patients received 48 weeks of open-label treatment with peginterferon alfa-2a (180 μg/week) and 111 patients received peginterferon alfa-2b (1.5 μg/kg/week). All patients received the same dose of ribavirin 1000/1200 mg/day, depending on weight. The primary efficacy endpoint was sustained virologic response (SVR), defined as undetectable HCV RNA (<50 IU/mL) 24 weeks after the end of treatment.
  
  
  RESULTS
  Early virologic response (EVR), defined as at least 2 log₁₀ IU/mL reduction of viral load at 12 weeks, was more common in patients treated with peginterferon alfa-2a (88% vs. 74.8%; p=0.04). However, the difference in SVR was not statistically significant (49.5% vs. 44.1%; p=0.43).
  
  
  CONCLUSIONS
  Peginterferon alfa-2a treated patients were also more likely to be HCV RNA negative at the end of treatment (67.3% vs. 57.7%), but this difference did not reach statistical significance. Multivariate logistic regression analysis found that SVR was associated with low fibrosis stage (F1-2 by Scheuer; p=0.001) and low serum HCV RNA level (<400,000 IU/L; p=0.023). While both forms of peginterferon showed similar efficacy as measured by SVR, use of peginterferon alfa-2b could lower the number of patients receiving unnecessary treatment beyond 12 weeks.
authors.affiliation: Daily Department, Hospital of Infectious Diseases, Warsaw, Poland.
authors.forename: Hanna
authors.initials: H
authors.lastname: Berak
authors.affiliation: Department of Immunopathology of Infectious and Parasitic Diseases, Warsaw Medical University, Warsaw, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Laskus
authors.affiliation: Daily Department, Hospital of Infectious Diseases, Warsaw, Poland.
authors.forename: Anna
authors.initials: A
authors.lastname: Kołakowska-Rządzka
authors.affiliation: Daily Department, Hospital of Infectious Diseases, Warsaw, Poland.
authors.forename: Marek
authors.initials: M
authors.lastname: Wasilewski
authors.affiliation: Department of Molecular Diagnostics, Hospital of Infectious Diseases, Warsaw, Poland.
authors.forename: Janusz J
authors.initials: JJ
authors.lastname: Stańczak
authors.affiliation: Department of Pathomorphology, Medical Center for Postgraduate Education, Warsaw, Poland.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Bardadin
authors.affiliation: Department of Pathomorphology, National Institute of Hygiene, Warsaw, Poland.
authors.forename: Bożena
authors.initials: B
authors.lastname: Walewska-Zielecka
authors.affiliation: Daily Department, Hospital of Infectious Diseases, Warsaw, Poland; Department of Infectious Diseases for Adults, Warsaw Medical University, Warsaw, Poland. Electronic address: ahorban@zakazny.pl.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Horban
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics / Q000378:metabolism; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011044:Poland; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood / Q000378:metabolism; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use; D019562:Viral Load / Q000187:drug effects; D055815:Young Adult
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; C100416:peginterferon alfa-2a
keywords: HCV; Interferon; Pegylated interferon; Ribavirin; Treatment