title: Association of immune response parameters with virological response in hepatitis C virus patients treated with pegylated consensus interferon.
abstract: BACKGROUND
  A new, potent, long lasting recombinant interferon variant (pegylated consensus interferon, PEGCIFN) was expressed by Escherichia coli. The aim of this study was to test safety and antiviral activity of the new type of interferon in adults with hepatitis C virus (HCV) infection and to determine the relationship between immune response markers and virological response.
  
  
  METHODS
  40 naive HCV patients (1 : 1 : 1 : 1) were injected subcutaneously with PEG-CIFN 1.0, 1.5, 2.0 μg/kg and peginterferon-α 180 μg once per week for 12 weeks. Serum HCV RNA, cytokines, chemokines levels were tested, and clinical data were collected at this course.
  
  
  RESULTS
  PEG-CIFN is safety/tolerability. The serum HCV RNA levels were markedly decreased after therapy. 20% (2/10), 70% (7/10), 70% (7/10), and 60% (6/10) exhibited early virologic responses (EVR (+)) during PEGCIFN 1.0, 1.5, and 2.0 μg/kg treatment and peginterferon-α 180 μg treatment, respectively. Interleukin-4, interferon induced protein 10 (IP-10), and macrophage inflammatory protein 1β (MIP-1β) levels were lower, and granulocyte colony-stimulating factor levels were higher in EVR (+) than in the group not having an EVR (EVR (-)) (p < 0.05) after PEG-CIFN treatment. IP-10 and MIP-1β levels were associated with HCV RNA values, alanine aminotransferase, and aspartate aminotransferase levels after PEG-CIFN treatment.
  
  
  CONCLUSIONS
  PEGCIFN was well tolerated and effective at inhibiting HCV RNA, which is associated with changes in markers of immune response. PEG-CIFN 1.5 μg/kg has been selected for further hepatitis C clinical development.
authors.forename: Yanhua
authors.initials: Y
authors.lastname: Ding
authors.forename: Hong
authors.initials: H
authors.lastname: Zhang
authors.forename: Hong
authors.initials: H
authors.lastname: Chen
authors.forename: Xiaojiao
authors.initials: X
authors.lastname: Li
authors.forename: Chengjiao
authors.initials: C
authors.lastname: Liu
authors.forename: Qingmei
authors.initials: Q
authors.lastname: Li
authors.forename: Junqi
authors.initials: J
authors.lastname: Niu
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D018925:Chemokines / Q000097:blood; D016207:Cytokines / Q000097:blood; D005260:Female; D006526:Hepatitis C / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D018925:Chemokines; D016207:Cytokines; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; C050739:interferon alfacon-1