title: Prospective, observational real-life study on eligibility for and outcomes of antiviral treatment with peginterferon α plus ribavirin in chronic hepatitis C.
abstract: BACKGROUND
  We aimed to investigate eligibility, reasons for treatment discontinuation and characteristics of chronic hepatitis C patients with treatment failure to peginterferon/ribavirin in clinical practice.
  
  
  METHODS
  1128 chronic hepatitis C patients, from 45 Italian Hepatology centres, were enrolled in this phase-4, prospective, observational study from January 2009 to February 2010.
  
  
  RESULTS
  687/1118 patients (61.4%) were eligible for antiviral treatment, of which 598 (87.0%) agreed with the physician's decision. Outcome information was available in 500/598 patients, among whom 348 (69.6%) completed treatment. Treatment was discontinued in 152 patients due to: lack of response (28.9%), personal reasons (29.6%), adverse events (38.2%), and decompensation (1.3%). Sustained virological response was obtained in 263/500 (52.6%), 71 (14.2%) relapsed and 61 (12.2%) were non-responders. Treatment outcome was not available in 105 (21%): lost while receiving treatment (33.3%), lost during follow-up (25.7%), withdrawn for adverse events (19.1%) or for administrative reasons (21.9%).
  
  
  CONCLUSIONS
  In clinical practice, only 61% of chronic hepatitis C patients are considered eligible for peginterferon/ribavirin. Of these, 13% refuse treatment. Approximately 30% do not complete the scheduled treatment and, despite this, the sustained virological response rate is similar to that of randomized-controlled trials. In the era of new antiviral combinations, these findings have important implications for assessing eligibility and estimating drop-out rates.
authors.affiliation: Department of Medical and Surgical Sciences, Bologna University, Bologna, Italy.
authors.forename: Ranka
authors.initials: R
authors.lastname: Vukotic
authors.affiliation: Department of Medical and Surgical Sciences, Bologna University, Bologna, Italy.
authors.forename: Nesrine
authors.initials: N
authors.lastname: Gamal
authors.affiliation: Department of Medical and Surgical Sciences, Bologna University, Bologna, Italy. Electronic address: pietro.andreone@unibo.it.
authors.forename: Pietro
authors.initials: P
authors.lastname: Andreone
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000453:epidemiology; D015897:Comorbidity; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D001523:Mental Disorders / Q000453:epidemiology; D008875:Middle Aged; D018579:Patient Selection; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D012254:Ribavirin / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011092:Polyethylene Glycols; D012254:Ribavirin
keywords: Antiviral therapy; Eligibility; Hepatitis C; Real clinical practice