title: Economic evaluation of early monotherapy versus delayed monotherapy or combination therapy in patients with acute hepatitis C in Germany.
abstract: BACKGROUND
  Antiviral treatment of acute hepatitis C virus (HCV) almost doubles the chance of sustained virological response (SVR) compared with that achievable by treating chronic HCV.
  
  
  OBJECTIVE
  To conduct a health economic evaluation comparing early and delayed therapies for acute HCV in Germany.
  
  
  METHODS
  One hundred and thirty-three patients with acute HCV were evaluated in two early monotherapy (EMT) studies and 60 in a delayed therapy study. Efficacy was determined by SVR. In the EMT studies, patients were treated with either standard or pegylated interferon for 24 weeks. In the delayed therapy study, patients with persisting infection were treated with interferon monotherapy or combination therapy with ribavirin for a median of 36 weeks. We conducted a cost-effectiveness analysis based on the study results and a linear simulation model based on current treatment recommendations.
  
  
  RESULTS
  The SVR rate for the sex-adjusted on-treatment analysis between early and delayed therapies was not significantly different (92.7 vs. 90.9%; P = 0.7). Medication costs accounted for more than 90% in both treatment options. Direct medical costs of early therapy (euro7064/patient) were euro321 lower than those of delayed therapy (P = 0.8). The incremental cost-effectiveness ratio was -178 euro/SVR(%) (confidence interval: -224 to 360 euro/SVR(%)). Average modeled direct medical costs of delayed combination therapy were from euro6745 to euro8299 per patient (from approximately 7% less up to 15% higher than EMT). Spontaneous viral clearance and therapy duration were the most sensitive variables.
  
  
  CONCLUSIONS
  There was no significant efficacy and cost difference between therapy alternatives in base cases. However, in the majority of scenarios in the sensitivity analyses, EMT was a more cost-effective option in acute HCV therapy.
authors: Department of Epidemiology, Social Medicine and Health System Research, Hanover Medical School, Hanover, Germany. Charalabos-Markos.Dintsios@iqwig.de
authors: Charalabos-Markos
authors: CM
authors: Dintsios
authors: Alexander
authors: A
authors: Haverkamp
authors: Johannes
authors: J
authors: Wiegand
authors: Tilman
authors: T
authors: Gerlach
authors: Heiner
authors: H
authors: Wedemeyer
authors: Gerd
authors: G
authors: Pape
authors: Michael Peter
authors: MP
authors: Manns
authors: Christian
authors: C
authors: Krauth
mesh_terms: D000208:Acute Disease; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000191:economics*; D002986:Clinical Trials as Topic; D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D004334:Drug Administration Schedule; D016527:Drug Costs; D004359:Drug Therapy, Combination; D005260:Female; D005858:Germany; D016174:Hepacivirus / Q000235:genetics / Q000276:immunology; D006526:Hepatitis C / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics*; D018937:Hepatitis C Antibodies / Q000097:blood; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000191:economics; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000191:economics; D017410:Practice Guidelines as Topic; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D018937:Hepatitis C Antibodies; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a