title: Safety and efficacy of combination therapy with peginterferon alfa-2a (40kD) and ribavirin in the outpatient setting: prospective analysis of 197 patients with chronic hepatitis C viral infection.
abstract: OBJECTIVE
  Combination therapy using peginterferon alfa-2a (40 kD) plus ribavirin achieves viral eradication in nearly 60% of patients with chronic hepatitis C viral infection. However, because of the numerous side effects, use of the combination regimen might be restricted for patients consulting private practitioners specialized in hepatogastroenterology.
  
  
  METHODS
  Conducted in this specific context, this prospective clinical trial investigated the safety and efficacy of combination therapy in 197 patients. Therapy was given in compliance with the recommendations of the French consensus conference on hepatitis C treatment.
  
  
  RESULTS
  Commonly reported adverse effects were noted in 90% of patients, most occurring during the first three months, with a stable prevalence thereafter and resolution after treatment end. The most frequent adverse events were asthenia (35 to 37.5% according to the treatment group pruritus (25 to 26.3%) and flu-like syndrome (19 to 21.7%). A depressive syndrome was reported in 20 to 21% of patients. Grade 4 neutropenia was exceptional and never led to severe infections. At intent-to-treat analysis, the rate of sustained virological response was 54.8% for the entire population. It was 71.1% for patients with genotypes 2 or 3 (mainly treated for 24 weeks) and 44.6% for patients with genotype 1 (all treated 48 weeks).
  
  
  CONCLUSIONS
  The characteristic features of combination therapy observed in the context of private hepatogastroenterology consultations are similar to those observed in randomized clinical trials.
authors.affiliation: 93, rue de la Libération, 38300 Bourgoin-Jallieu. fontanges@aol.com
authors.forename: Thierry
authors.initials: T
authors.lastname: Fontanges
authors.forename: Sylvain
authors.initials: S
authors.lastname: Beorchia
authors.forename: Catherine
authors.initials: C
authors.lastname: Douvin
authors.forename: Patrick
authors.initials: P
authors.lastname: Delassalle
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Combis
authors.forename: Bertrand
authors.initials: B
authors.lastname: Hanslik
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Jacques
authors.forename: Bernard
authors.initials: B
authors.lastname: Filoche
authors.forename: Hervé
authors.initials: H
authors.lastname: Desmorat
authors.forename: Catherine
authors.initials: C
authors.lastname: Chandelier
authors.forename: Denis
authors.initials: D
authors.lastname: Ouzan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*; D012449:Safety
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a