The Cost-Effectiveness Of Sofosbuvir And Ribavirin Treatment In Hcv-Infected Patients Listed For Liver Transplantation

Objectives: Sofosbuvir in combination with ribavirin (SOF/RBV) is a novel treatment able to suppress HCV viremia when applied to HCV patients listed for transplant, preventing HCV recurrence. Aim of this study was to assess the costeffectiveness of this regimen in HCV patients listed for transplant for cirrhosis (HCVcirrhosis) or for hepatocellular carcinoma (HCV-HCC). Methods: a semi-Markov model was developed. The model simulates the progression of HCV-cirrhosis or HCV-HCC patients from the time of listing until death considering the risk of HCV recurrence post-transplant. The model compared 2 different strategies: 1) SOF/RBV up to a maximum of 24 weeks or until OLT if performed before the 24th week, 2) No antiviral treatment. The model estimated the costs related to the treatment with SOF/RBV, the costs associated to each health state, the life-years (LYSs), the quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER) expressed as € per QALY gained. The analysis was performed from the Italian National Health System perspective with a lifetime time horizon and one-month Markov cycles. Future costs and clinical benefits, expressed as QALYs, were discounted at 3% per year. Results: in the base-case analysis the ICER for 24 weeks of SOF/RBVR was € 30,518 per QALY gained in HCV-cirrhosis patients and € 41,610 in HCV-HCC patients. The reliability of our results was confirmed by the one way sensitivity-analysis and by the cost-effectiveness acceptability curve. Further, SOF/RBV cost-effectiveness was clearly sensitive to the duration of treatment; assuming 12 weeks SOF/RBV treatment duration, the ICER decreased to € 19,317 in HCVCirrhosis and € 29,540 in HCV-HCC. Conclusions: our study shows that treating patients with HCV-cirrhosis or HCV-HCC listed for transplant with SOF/RBV is costeffective and may become the new standard of care for these patients. However a well-defined prospective study is needed to confirm the value of the parameters assumed in the model and the results