title: Extended duration therapy with pegylated interferon and ribavirin for patients with genotype 3 hepatitis C and advanced fibrosis: final results from the STEPS trial.
abstract: OBJECTIVE
  Patients with genotype 3 hepatitis C virus (HCV) infection and cirrhosis have poor response rates after 24 weeks treatment with pegylated interferon and ribavirin. Treatment for 48 weeks is therefore recommended, although the benefits of this are untested. We examined extended therapy in patients with genotype 3 HCV and advanced fibrosis.
  
  
  METHODS
  Multicentre, open labelled randomized trial comparing therapy with 24 weeks pegylated interferon and ribavirin to 48 weeks of the same therapy.
  
  
  RESULTS
  136 patients completed the study. 67 received 24 weeks therapy and the SVR rate (48%) did not differ from that seen in the 69 patients who received 48 weeks therapy (42%). The response rates in patients with biopsy proven cirrhosis (13 patients treated for 24 weeks, 18 patients treated for 48 weeks) or cirrhosis proven on imaging (28 patients treated for 24 weeks and 25 patients treated for 48 weeks) were 46% in those treated for 24 weeks and 40% in those treated for 48 weeks. The differences were not significantly different. Treatment failure was due to relapse in the majority of patients.
  
  
  CONCLUSIONS
  Patients with genotype 3 HCV and advanced fibrosis do not benefit from extended therapy with pegylated interferon and ribavirin.
authors.affiliation: Queen Marys University of London, The Liver Unit, Blizard Institute, United Kingdom.
authors.forename: D
authors.initials: D
authors.lastname: Shoeb
authors.affiliation: Queen Marys University of London, The Liver Unit, Blizard Institute, United Kingdom.
authors.forename: J
authors.initials: J
authors.lastname: Dearden
authors.affiliation: Queen Marys University of London, The Liver Unit, Blizard Institute, United Kingdom.
authors.forename: A
authors.initials: A
authors.lastname: Weatherall
authors.affiliation: Queen Marys University of London, The Liver Unit, Blizard Institute, United Kingdom.
authors.forename: C
authors.initials: C
authors.lastname: Bargery
authors.affiliation: Bradford Teaching Hospitals Foundation Trust, Bradford, United Kingdom.
authors.forename: S
authors.initials: S
authors.lastname: Moreea
authors.affiliation: Bradford Teaching Hospitals Foundation Trust, Bradford, United Kingdom.
authors.forename: S
authors.initials: S
authors.lastname: Alam
authors.affiliation: Barts Health, Clinical Transplantation Laboratory, London, United Kingdom.
authors.forename: E
authors.initials: E
authors.lastname: White
authors.affiliation: North Manchester General Hospital, Manchester, United Kingdom.
authors.forename: X
authors.initials: X
authors.lastname: Vila
authors.affiliation: University Hospitals, Birmingham NHS Foundation Trust, Birmingham, United Kingdom.
authors.forename: D
authors.initials: D
authors.lastname: Freshwater
authors.affiliation: Queens Medical Centre, Nottingham, United Kingdom.
authors.forename: S
authors.initials: S
authors.lastname: Ryder
authors.affiliation: Gartnavel General Hospital, Glasgow, United Kingdom.
authors.forename: P R
authors.initials: PR
authors.lastname: Mills
authors.affiliation: Addenbrooke's Hospital, Cambridge, United Kingdom.
authors.forename: G J
authors.initials: GJ
authors.lastname: Alexander
authors.affiliation: St George's University of London, London, United Kingdom.
authors.forename: D
authors.initials: D
authors.lastname: Forton
authors.affiliation: Queen Marys University of London, The Liver Unit, Blizard Institute, United Kingdom. Electronic address: g.r.foster@qmul.ac.uk.
authors.forename: G R
authors.initials: GR
authors.lastname: Foster
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000473:pathology / Q000821:virology*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000473:pathology / Q000821:virology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a
keywords: Cirrhosis; Extended therapy; Genotype 3; HCV; PegIFN/RBV; Sustained virologic response