title: Real-world outcomes in patients with chronic hepatitis C: primary results of the PROBE study.
abstract: BACKGROUND
  This large prospective multicentre cohort study aimed to improve knowledge of therapy for chronic hepatitis C (CHC) in real clinical practice.
  
  
  METHODS
  A diverse population of adults with CHC including patients with comorbid conditions, laboratory abnormalities and demographic features [comorbidities or special populations (CSP)] who were under-represented or excluded from peginterferon registration studies was treated with peginterferon α-2a (40 kDa) or α-2b (12 kDa) plus ribavirin at the investigator's discretion.
  
  
  RESULTS
  During the study, 5399 treatment-naive patients [2527 (46.8%) with CSP] received peginterferon α-2a (n=3513, 65.1%) or peginterferon α-2b (n=1886, 34.9%). The sustained virological response rate was 56.6% (3057/5399) overall, 59.7% (1716/2872) in patients without CSP and 53.1% (1341/2527) in patients with CSP. Significant predictors of sustained virological response included hepatitis C virus genotype 2 or 3 infection, absence of cirrhosis, hepatitis C virus RNA≤500 000 IU/ml, alanine transaminase quotient >3× the upper limit of normal, age ≤65 years, BMI<25 kg/m, at least 80% of the planned exposure to peginterferon and ribavirin and prescription of peginterferon α-2a.
  
  
  CONCLUSIONS
  The results provide detailed information on the outcome of therapy for CHC in a diverse Italian population that included a large number of patients with CSP and provides an insight into the generalizability of the results obtained in the more restricted setting of randomized registration trials.
authors.affiliation: aDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, University of Palermo, Palermo bDepartment of Public Medicine, Section of Infectious Diseases, Second University of Naples, Naples cDepartment of Gastroenterology and Hepatology, University of Torino, Torino dSPARC Consulting, Milan eRoche SpA, Monza fDepartment of Medicine, Centre for Liver Disease, Fatebenefratelli Hospital, Napoli, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Craxì
authors.forename: Felice
authors.initials: F
authors.lastname: Piccinino
authors.forename: Alessia
authors.initials: A
authors.lastname: Ciancio
authors.forename: Claudio
authors.initials: C
authors.lastname: Iannacone
authors.forename: Barbara
authors.initials: B
authors.lastname: Deodato
authors.forename: Caterina
authors.initials: C
authors.lastname: Golotta
authors.forename: Antonio
authors.initials: A
authors.lastname: Ascione
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012008:Recurrence; D012074:Remission Induction; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
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