title: Prognostic factors and early predictability of sustained viral response with peginterferon alfa-2a (40KD).
abstract: OBJECTIVE
  Baseline factors and early decline in serum hepatitis C virus RNA are predictive of sustained virological response to interferon therapy in patients with chronic hepatitis C. We evaluated the prognostic value of baseline factors and early viral RNA among patients treated with peginterferon alfa-2a (40KD).
  
  
  METHODS
  Data were pooled from three randomized trials involving 814 patients treated with peginterferon alfa-2a (40KD) (90, 135, or 180 mirog). Stepwise and multiple logistic regression identified independent baseline factors associated with response. Receiver operating characteristic curves for both absolute values and log(10) decline in viral RNA at 4, 8, 12 and 24 weeks of therapy were created.
  
  
  RESULTS
  Independent prognostic factors for sustained virological response included viral genotype non-1, low pretreatment viral load, age (<40 years), no cirrhosis and body weight (<85 kg). In addition, alanine aminotransferase quotient (>3) and histological activity index score (>10) were also independently prognostic. Receiver operating characteristic curves showed that detectable or less than 2-log(10) decline in viral RNA at week 12 predicted sustained virological non-response (negative predictive value is 98%) .
  
  
  CONCLUSIONS
  In patients with chronic hepatitis C treated with peginterferon alfa-2a (40KD), the decision to continue or stop treatment can be made as early as week 12.
authors.affiliation: Faculty of Medicine, University of Calgary, 3330 Hospital Drive NW, Calgary, Alberta, Canada T2N 4N1. samlee@ucalgary.ca
authors.forename: Samuel S
authors.initials: SS
authors.lastname: Lee
authors.forename: E Jenny
authors.initials: EJ
authors.lastname: Heathcote
authors.forename: K Rajender
authors.initials: KR
authors.lastname: Reddy
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
authors.forename: Michael W
authors.initials: MW
authors.lastname: Fried
authors.forename: Teresa L
authors.initials: TL
authors.lastname: Wright
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Pockros
authors.forename: Dieter
authors.initials: D
authors.lastname: Häussinger
authors.forename: Coleman I
authors.initials: CI
authors.lastname: Smith
authors.forename: Amy
authors.initials: A
authors.lastname: Lin
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Pappas
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics* / Q000254:growth & development; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011237:Predictive Value of Tests; D011379:Prognosis; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins; D014779:Virus Replication / Q000187:drug effects
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a