title: In routine clinical practice, few physicians use early viral kinetics to guide HCV dual therapy treatment decisions.
abstract: OBJECTIVE
  PROPHESYS is a large, multinational, non-interventional prospective cohort study of chronic hepatitis C patients treated with peginterferon alfa/ribavirin. This subanalysis assesses rates of premature treatment discontinuation stratified by on-treatment virological response (VR).
  
  
  METHODS
  This PROPHESYS subanalysis is restricted to treatment-naive, hepatitis C virus (HCV) genotype (G)1/2/3 mono-infected patients who received peginterferon alfa-2a (40KD)/ribavirin with intended treatment duration of 48 (G1) or 24 weeks (G2/3). Early virological responses were classified into four mutually exclusive categories [rapid VR (RVR), complete early VR (cEVR), partial EVR (pEVR), no RVR/EVR], using standard criteria.
  
  
  RESULTS
  The likelihood for shortening treatment owing to good efficacy was highest among patients with an RVR and HCV RNA≤400 000 IU/ml (G1 10.0%; G2/3 5.8%) whereas for poor efficacy, it was highest in G1 non-RVR/EVR patients with HCV RNA>400 000 IU/ml (56.6%). Factors significantly associated with early treatment discontinuation as a result of good efficacy in G1 patients included RVR vs. no RVR/EVR and, at baseline, lower HCV RNA, lower FIB-4 score, HCV infection via injection drug use. For G2/3 patients, factors included lower baseline HCV RNA and G2 vs. G3 infection. Most patients started with the recommended peginterferon alfa-2a dose, but a high proportion received a higher-than-recommended ribavirin dose.
  
  
  CONCLUSIONS
  Despite international guidelines, few physicians used early viral kinetics to abbreviate treatment. Therefore, relatively few patients with an RVR and low baseline HCV RNA abbreviated treatment. In addition, there were deviations in ribavirin starting doses, suggesting that physicians tailor treatment according to local guidelines or previous experience.
authors.affiliation: Liver Unit, IRCCS Hospital 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Mangia
authors.forename: Tivadar
authors.initials: T
authors.lastname: Bányai
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Bartolomeo
authors.forename: Judit
authors.initials: J
authors.lastname: Gervain
authors.forename: François
authors.initials: F
authors.lastname: Habersetzer
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Mulkay
authors.forename: Denis
authors.initials: D
authors.lastname: Ouzan
authors.forename: Giustino
authors.initials: G
authors.lastname: Parruti
authors.forename: Nicola
authors.initials: N
authors.lastname: Passariello
authors.forename: Andre-Jean
authors.initials: AJ
authors.lastname: Remy
authors.forename: Mario
authors.initials: M
authors.lastname: Rizzetto
authors.forename: Mitchell L
authors.initials: ML
authors.lastname: Shiffman
authors.forename: Alan D
authors.initials: AD
authors.lastname: Tice
authors.forename: Manuela
authors.initials: M
authors.lastname: Schmitz
authors.forename: Fernando
authors.initials: F
authors.lastname: Tatsch
authors.forename: Maribel
authors.initials: M
authors.lastname: Rodriguez-Torres
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D015331:Cohort Studies; D004359:Drug Therapy, Combination / Q000706:statistics & numerical data; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000502:physiology; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha; D007700:Kinetics; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D011446:Prospective Studies; D012367:RNA, Viral / Q000235:genetics; D011994:Recombinant Proteins; D012254:Ribavirin; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a
keywords: PROPHESYS; abbreviated therapy; clinical practice; hepatitis C; peginterferon alfa/ribavirin; physician behaviour; ribavirin dose; treatment decisions; viral kinetics