title: Early and sustained virological response in non-responders with chronic hepatitis C: a randomized open-label study of pegylated interferon-alpha-2a versus pegylated interferon-alpha-2b.
abstract: OBJECTIVE
  The purpose of this randomized open-label study was to assess the efficacy of treatment with pegylated interferon-alpha-2a versus pegylated interferon-alpha-2b, both plus ribavirin, in inducing early and sustained virological response (EVR and SVR) in chronic hepatitis C non-responders.
  
  
  METHODS
  A total of 108 patients with chronic hepatitis C who were non-responders to previous combined therapy (standard interferon-alpha plus ribavirin for > or = 3 months) were enrolled and equally randomized into two groups in this intention-to-treat analysis. The patients exhibited similar baseline features. One group received subcutaneous pegylated interferon-alpha-2a 180 microg once weekly, while the other was treated with subcutaneous pegylated interferon-alpha-2b 1.5 microg/kg once weekly. Ribavirin 15 mg/kg/day was included in both protocols. Treatment duration for EVR was 12 weeks. Patients who demonstrated non-detectable hepatitis C virus (HCV) RNA or a > or = 2 log(10) reduction in viral load at week 12 continued therapy up to 48 weeks, with assessments every 3 months during a follow-up of 24 weeks.
  
  
  RESULTS
  All patients in both groups completed the EVR study, then seven patients receiving pegylated interferon-alpha-2a and seven patients receiving pegylated interferon-alpha2b discontinued treatment as a result of severe adverse effects. After 12 weeks of treatment, viral load reduction was >2 log(10) with both pegylated interferon-alpha-2a (-2.53) and pegylated interferon-alpha-2b (-2.48) with no significant difference. At the end of week 48, HCV RNA was undetectable in 14 of 54 patients (25.9%) receiving pegylated interferon-alpha-2a and in 15 of 54 patients (27.7%) receiving pegylated interferon-alpha-2b. When terminating follow-up, an SVR was observed in 11 of 54 patients (20.4%) who received pegylated interferon-alpha-2a and 10 of 54 patients (18.4%) receiving pegylated interferon-alpha-2b. The incidence and severity of adverse events was similar in both groups.
  
  
  CONCLUSIONS
  Our results seem to show that in chronic hepatitis C patients who are non-responsive to previous therapy, EVR to the two pegylated interferons did not significantly differ with a similar therapeutic efficacy defined as SVR.
authors.affiliation: Clinic of Infectious Diseases, University of Foggia, Foggia, Italy. gaescot@tin.it
authors.forename: Gaetano
authors.initials: G
authors.lastname: Scotto
authors.forename: Vincenzina
authors.initials: V
authors.lastname: Fazio
authors.forename: Chiara
authors.initials: C
authors.lastname: Fornabaio
authors.forename: Alessandra
authors.initials: A
authors.lastname: Tartaglia
authors.forename: Rocco
authors.initials: R
authors.lastname: Di Tullio
authors.forename: Annalisa
authors.initials: A
authors.lastname: Saracino
authors.forename: Gioacchino
authors.initials: G
authors.lastname: Angarano
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D006526:Hepatitis C / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007700:Kinetics; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*; D017211:Treatment Failure; 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; C100416:peginterferon alfa-2a