title: Effectiveness and cost-effectiveness of initial combination therapy with interferon/peginterferon plus ribavirin in patients with chronic hepatitis C in Germany: a health technology assessment commissioned by the German Federal Ministry of Health and Social Security.
abstract: OBJECTIVE
  The purpose of this health technology assessment (HTA), commissioned by the German Federal Ministry of Health and Social Security, was to systematically review the evidence for the effectiveness and cost-effectiveness of antiviral treatment (AVT) with interferon (INF) or peginterferon (PegIFN) in combination with ribavirin (RBV) in treatment-naïve patients with chronic hepatitis C (CHC) and to apply these data in the context of the German health-care system.
  
  
  METHODS
  We performed a systematic literature search on effectiveness and cost-effectiveness of AVT and summarized results using meta-analysis and evidence tables. We applied the German Hepatitis C Model (GEHMO), a decision-analytic Markov model, to determine long-term clinical effectiveness, costs, and incremental cost-effectiveness ratios (ICER) of the examined treatment strategies. Model parameters were derived from German databases, published international randomized clinical trials (RCT), and a Cochrane Review.
  
  
  RESULTS
  Overall, nine RCTs, two HTA reports, one Cochrane review, two meta-analyses, and seven economic evaluations met the inclusion criteria. These studies indicate that PegIFN + RBV achieved the highest sustained virological response rates (SVR) (54-61 percent), followed by IFN + RBV (38-54 percent) and IFN monotherapy (11-21 percent). Based on our meta-analysis, PegIFN + RBV reduced cases without SVR by 17 percent compared with INF + RBV. International cost-effectiveness studies indicate that INF+ RBV is cost-effective when compared with INF monotherapy. For PegIFN + RBV, our decision analysis yielded an ICER of 9,800 Euros per quality-adjusted life-year gained.
  
  
  CONCLUSIONS
  This HTA suggests that initial combination therapy prolongs life, improves quality of life, and is cost-effective in patients with CHC. Peginterferon plus ribavirin is the most effective and efficient treatment among the examined options. However, because not all chronic hepatitis C patients will develop progressive liver disease, a thorough assessment of the eligibility and appropriateness of treatment with combination therapy must be performed in each individual patient.
authors.affiliation: Institute of Medical Informatics, Biometry, and Epidemiology, Ludwig-Maximilians-University, Munich, Germany. usiebert@hsph.harvard.edu
authors.forename: Uwe
authors.initials: U
authors.lastname: Siebert
authors.forename: Gaby
authors.initials: G
authors.lastname: Sroczynski
mesh_terms: D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination; D005858:Germany; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000191:economics / Q000627:therapeutic use*; D008390:Markov Chains; D011092:Polyethylene Glycols / Q000191:economics / Q000627:therapeutic use*; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins; D012254:Ribavirin / Q000191:economics / Q000627:therapeutic use*; D013673:Technology Assessment, Biomedical
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin