title: Predicting the impact of adverse events and treatment duration on medical resource utilization-related costs in hepatitis C genotype 1 treatment-naïve patients receiving antiviral therapy.
abstract: OBJECTIVE
  Studies on medical resource utilization (MRU) and related costs are important for evaluating the potential patient management and cost-effectiveness implications of antiviral treatments for hepatitis C virus (HCV) infection. The objectives of this study were (i) to compare the MRU and related costs for two treatment approaches; (ii) to identify the main drivers of resource use and costs; and (iii) to assess the effects of various treatment regimen attributes on MRU-related costs in a UK clinical setting.
  
  
  METHODS
  The analysis used data collected alongside the simeprevir (SMV) phase III trials for treatment-naïve genotype 1 HCV-infected patients; these data covered outpatient consultations with specialists, emergency room visits and hospital admissions. Logistic regressions were constructed to estimate the predictors of resource utilization, and a two-part multivariable analysis model was used to determine the total costs of treatment in the UK.
  
  
  RESULTS
  Data on 731 patients receiving SMV plus pegylated interferon and ribavirin (SMV/PegIFN/R) or PegIFN/R were included in the analysis. While MRU was similar between the SMV and PegIFN/R groups, MRU-related costs were significantly lower in the SMV group than in the PegIFN/R group (P < 0.05). High body mass index (P < 0.05), severe fibrosis (P < 0.05), shortened treatment duration to 24 weeks (P < 0.05), and anaemia and rash during treatment (P < 0.001) were identified as predictors of hospitalization and outpatient visits and as drivers of total costs. Univariate sensitivity analyses suggested that shortened treatment duration and lower occurrence of rash lead to large cost savings.
  
  
  CONCLUSIONS
  This study identified both baseline and on-treatment antiviral therapy characteristics as drivers of MRU-related costs for HCV patients following antiviral therapy. The shortened treatment duration and reduction in rash due to treatment with SMV triple therapy lead to substantial non-drug cost savings, compared with PegIFN/R treatment. This suggests that there are potential patient management and cost-effectiveness implications associated with the choice of specific antiviral treatments.
authors.affiliation: Deloitte, Diegem, Belgium, eakpo@deloitte.com.
authors.forename: Essè Ifèbi Hervé
authors.initials: EI
authors.lastname: Akpo
authors.forename: Karin
authors.initials: K
authors.lastname: Cerri
authors.forename: Joris
authors.initials: J
authors.lastname: Kleintjens
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic; D003362:Cost-Benefit Analysis; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000191:economics* / Q000628:therapy; D005838:Genotype; D017048:Health Care Costs; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics; D006801:Humans; D016015:Logistic Models; D015999:Multivariate Analysis; D016032:Randomized Controlled Trials as Topic; D040841:Resource Allocation; D013997:Time Factors
chemical_list: D000998:Antiviral Agents