title: Long-term effects of treatment and response in patients with chronic hepatitis C on quality of life. An international, multicenter, randomized, controlled study.
abstract: BACKGROUND
  Hepatitis C decreases health related quality of life (HRQL) which is further diminished by antiviral therapy. HRQL improves after successful treatment. This trial explores the course of and factors associated with HRQL in patients given individualized or standard treatment based on early treatment response (Ditto-study).
  
  
  METHODS
  The Short Form (SF)-36 Health Survey was administered at baseline (n = 192) and 24 weeks after the end of therapy (n = 128).
  
  
  RESULTS
  At baseline HRQL was influenced by age, participating center, severity of liver disease and income. Exploring the course of HRQL (scores at follow up minus baseline), only the dimension general health increased. In this dimension patients with a relapse or sustained response differed from non-responders. Men and women differed in the dimension bodily pain. Treatment schedule did not influence the course of HRQL.
  
  
  CONCLUSIONS
  Main determinants of HRQL were severity of liver disease, age, gender, participating center and response to treatment. Our results do not exclude a more profound negative impact of individualized treatment compared to standard, possibly caused by higher doses and extended treatment duration in the individualized group. Antiviral therapy might have a more intense and more prolonged negative impact on females.
authors.affiliation: Dpt, Gastroenterology & Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Geert
authors.initials: G
authors.lastname: Bezemer
authors.forename: Arthur R
authors.initials: AR
authors.lastname: Van Gool
authors.forename: Elke
authors.initials: E
authors.lastname: Verheij-Hart
authors.forename: Bettina E
authors.initials: BE
authors.lastname: Hansen
authors.forename: Yoav
authors.initials: Y
authors.lastname: Lurie
authors.forename: Juan I
authors.initials: JI
authors.lastname: Esteban
authors.forename: Martin
authors.initials: M
authors.lastname: Lagging
authors.forename: Francesco
authors.initials: F
authors.lastname: Negro
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
authors.forename: Carlo
authors.initials: C
authors.lastname: Ferrari
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Pawlotsky
authors.forename: Avidan U
authors.initials: AU
authors.lastname: Neumann
authors.forename: Solko W
authors.initials: SW
authors.lastname: Schalm
authors.forename: Robert J
authors.initials: RJ
authors.lastname: de Knegt
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D006306:Health Surveys; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011788:Quality of Life; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use*; D012720:Severity of Illness Index; D012727:Sex Characteristics; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a