title: Treatment of chronic hepatitis C patients with persistently normal alanine aminotransferase levels with the combination of peginterferon alpha-2a (40 kDa) plus ribavirin: impact on health-related quality of life.
abstract: BACKGROUND
  Peginterferon alpha-2a (40 kDa) plus ribavirin is equally effective in chronic hepatitis C patients with normal or elevated alanine aminotransferase (ALT) values. This analysis, in patients with normal ALT levels, compared health-related quality of life (HRQoL) measurements between untreated control patients and treated patients grouped by virological response. HRQoL in the present population was also compared with HRQoL in patients with elevated ALT levels, observed in a previous study.
  
  
  METHODS
  A total of 491 patients with persistently normal ALT levels were randomized to peginterferon alpha-2a (40 kDa)/ribavirin for 24 (group A) or 48 weeks (group B) or no treatment for 72 weeks (group C). Quality of life was assessed with valid instruments (self-administered Short Form (SF)-36 Health Survey and Fatigue Severity Scale).
  
  
  RESULTS
  In groups A and B, patients with sustained virological responses after combination therapy had significantly better quality of life and less fatigue than patients without sustained responses. Differences were significant for five SF-36 domains, the SF-36 Physical Component score and both Fatigue Severity Scale scores. Viral clearance was not observed in any untreated patients (group C). Comparison with data from elevated ALT patients revealed little difference in baseline quality of life, although normal ALT patients had significantly higher scores related to mental health than elevated ALT patients.
  
  
  CONCLUSIONS
  Eradication of HCV with peginterferon alpha-2a (40 kDa) plus ribavirin is associated with better quality of life and less fatigue in normal ALT patients. These patient benefits, coupled with the high probability of eradicating HCV, should be considered in making decisions about treating this population.
authors.affiliation: Department of Internal Medicine, University of New Mexico School of Medicine, Albuquerque, New Mexico 87131-0001, USA. sarora@salud.unm.edu
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Arora
authors.forename: Christopher
authors.initials: C
authors.lastname: O'Brien
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
authors.forename: Mitchell L
authors.initials: ML
authors.lastname: Shiffman
authors.forename: Moises
authors.initials: M
authors.lastname: Diago
authors.forename: Albert
authors.initials: A
authors.lastname: Tran
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Pockros
authors.forename: Robert W
authors.initials: RW
authors.lastname: Reindollar
authors.forename: Edward
authors.initials: E
authors.lastname: Gane
authors.forename: Kavita
authors.initials: K
authors.lastname: Patel
authors.forename: Neil
authors.initials: N
authors.lastname: Wintfeld
authors.forename: Jesse
authors.initials: J
authors.lastname: Green
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood*; D000998:Antiviral Agents / Q000627:therapeutic use*; D004337:Drug Carriers; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000201:enzymology / Q000523:psychology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004337:Drug Carriers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D000410:Alanine Transaminase; C100416:peginterferon alfa-2a