title: Economic and clinical effects of evaluating rapid viral response to peginterferon alfa-2b plus ribavirin for the initial treatment of chronic hepatitis C.
abstract: OBJECTIVE
  Evaluation of 12-wk viral response to initial antiviral therapy for chronic hepatitis C has been recommended to minimize antiviral-associated morbidity and costs. The aim of this study was to examine the economic and clinical effects of evaluating rapid viral response during antiviral therapy for treatment naive chronic hepatitis C patients.
  
  
  METHODS
  We applied viral response and drug dosage from an international randomized clinical trial of ribavirin plus peginterferon alfa-2b or ribavirin plus interferon alfa-2b to a previously published computer cohort simulation to project lifelong clinical and economic outcomes. Natural history and economic estimates were based on published literature, expert panel estimates, and actual variable and reimbursement cost data.
  
  
  RESULTS
  The assessment of 12-wk rapid viral response reduced antiviral treatment duration by 40-44% and antiviral costs by 44-45% (savings of $15,116-16,268 for peginterferon plus ribavirin and $8300 for interferon plus ribavirin) compared to full 48-wk dosing. With the 12-wk evaluation, the marginal cost-effectiveness of peginterferon plus ribavirin versus interferon plus ribavirin was $13,600-22,800 compared with $14,600-25,000 per discounted quality adjusted life-year gained with the 24-wk evaluation. For genotype 1, hepatitis C infected patients, 12-wk testing for peginterferon plus ribavirin remaining preferred and cost-effective compared with interferon plus ribavirin. For genotype 2 or 3, hepatitis C infected patients, 12-wk testing yielded similar results to those of 24-wk treatment.
  
  
  CONCLUSIONS
  Assessment of 12-wk viral response in genotype 1, hepatitis C infected patients should reduce peginterferon plus ribavirin morbidity and costs and improve its cost-effectiveness; however, for genotype 2 and 3, hepatitis C infected patients, 12-wk testing and 24-wk treatment have similar outcomes. Decisions regarding continuation of antiviral treatment should also consider the variability in the accuracy of quantitative viral assays as well as patient preferences and other potential benefits of the same treatments.
authors.affiliation: Division of Clinical Decision Making, Department of Medicine, Tupper Research Institute, Tufts-New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts 02111, USA.
authors.forename: John B
authors.initials: JB
authors.lastname: Wong
authors.forename: Gary L
authors.initials: GL
authors.lastname: Davis
authors.forename: John G
authors.initials: JG
authors.lastname: McHutchison
authors.forename: Michael P
authors.initials: MP
authors.lastname: Manns
authors.forename: Janice K
authors.initials: JK
authors.lastname: Albrecht
mesh_terms: D003362:Cost-Benefit Analysis; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005069:Evaluation Studies as Topic; D005260:Female; D016174:Hepacivirus / Q000187:drug effects* / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics* / Q000401:mortality; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000191:economics / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols; D016133:Polymerase Chain Reaction; D019057:Quality-Adjusted Life Years; D011994:Recombinant Proteins; D012254:Ribavirin / Q000191:economics / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a