Economic evaluation of early monotherapy versus delayed monotherapy or combination therapy in patients with acute hepatitis C in Germany.
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.
Dintsios
Charalabos-Markos
CM
Department of Epidemiology, Social Medicine and Health System Research, Hanover Medical School, Hanover, Germany. Charalabos-Markos.Dintsios@iqwig.de
Haverkamp
Alexander
A
Wiegand
Johannes
J
Gerlach
Tilman
T
Wedemeyer
Heiner
H
Pape
Gerd
G
Manns
Michael Peter
MP
Krauth
Christian
C
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
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