title: Therapy of chronic hepatitis C with PEG-IFN α-2b plus ribavirin in patients with genotype 2 or 3: 16 versus 24 weeks, clinical outcome and direct cost analyses.
abstract: BACKGROUND
  Short antiviral therapy has been proposed for patients with chronic hepatitis C, easy genotypes, low fibrosis score, low viral load at baseline, and rapid virological response (RVR). However, this approach is not completely accepted.
  
  
  OBJECTIVE
  The aims of this study were (a) to evaluate the sustained virological response (SVR) in noncirrhotic patients with genotype 2 or 3, achieving an RVR, randomized to receive pegylated-interferon (IFN) α-2b plus ribavirin for either 16 or 24 weeks and (b) to carry out direct cost analysis comparing patients treated for 16 versus 24 weeks.
  
  
  RESULTS
  Of the 142 initially evaluated patients, 130 were enrolled according to the selection criteria, but independent of the viral load. According to the intention-to-treat analysis, SVR was achieved in 104 patients (80%). Logistic regression analysis showed that RVR (P<0.001) and genotype 2 (P<0.03) were the most important factors independently associated with SVR. Among patients with RVR, SVR was comparable between patients treated for 16 weeks and those treated for 24 weeks (86.2 vs. 89.7%, P=NS). The mean direct costs were €4003.7 for patients treated for 16 weeks and €5676.7 for those treated for 24 weeks, with a 30% difference between the two arms.
  
  
  CONCLUSIONS
  In patients achieving an RVR, a 16-week treatment with pegylated-interferon plus ribavirin was comparable to a 24-week treatment. Short treatment in patients with RVR allows us to save 30% of the direct costs, independent of the viral load at baseline.
authors.affiliation: aDepartment of Infectious Diseases and Tropical Medicine, S. Bortolo Hospital bDepartment of Infectious Diseases, Schio, Vicenza cGastroenterology Unit, Gorizia Hospital, Gorizia dDepartment of Gastroenterology, AASL2, San Paolo Hospital, Savona eInstitute of Hygiene fDepartment of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Fabris
authors.forename: Antonio
authors.initials: A
authors.lastname: Carlotto
authors.forename: Tiziana
authors.initials: T
authors.lastname: Del Bianco
authors.forename: Federica
authors.initials: F
authors.lastname: Malfatti
authors.forename: Andrea
authors.initials: A
authors.lastname: Tramarin
authors.forename: Marco A
authors.initials: MA
authors.lastname: Miotti
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Baldo
authors.forename: Annarosa
authors.initials: A
authors.lastname: Floreani
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Giordani
authors.forename: Alessandro
authors.initials: A
authors.lastname: Grasso
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D004334:Drug Administration Schedule; D016527:Drug Costs / Q000706:statistics & numerical data; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D017048:Health Care Costs / Q000706:statistics & numerical data; D016174:Hepacivirus / Q000145:classification / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D007558:Italy; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D012008:Recurrence; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b