title: Cost-effectiveness of pretransplant sofosbuvir for preventing recurrent hepatitis C virus infection after liver transplantation.
abstract: There are reports of pretransplant sofosbuvir (SOF) plus ribavirin being effective in preventing recurrent hepatitis C virus (HCV) infection after liver transplantation (LT). The aim of this study was to assess the cost-effectiveness of this strategy in the area served by the North Italy Transplant program. We retrospectively assessed the impact of HCV infection on post-LT survival in 2376 consecutive adult patients (MELD ≤ 25, unknown genotype, period 2004-2009) and the prevalence costs of conventional standard of care (SOC) antiviral therapy (pegylated interferon plus ribavirin) after LT. A Markov model was developed to compare two strategies: 12-24 weeks of SOF+ ribavirin for pre-LT anti-HCV treatment versus on-demand post-LT SOC antiviral therapy. Among the 1794 patients undergoing LT, 860 (48%) were HCV+ and 50% of them were given SOC therapy after LT (mean cost of drugs and adverse effect management = 14,421€ per patient). HCV etiology had a strong impact on post-LT survival (hazard ratio = 1.59, 95% CI = 1.22-2.09, P = 0.0007). After Monte Carlo simulation, pre-LT SOF therapy showed a median survival benefit of 1.5 quality-adjusted life years and an Incremental cost-effectiveness ratio (ICER) of 30,663€/QALY, proving cost-effective in our particular Italian scenario. The costs of SOF therapy, sustained viral response rate 12 weeks after LT, and recipient's age were the main ICER predictors at multivariate analysis. This study proposes a dynamic model based on real-life data from northern Italy for adjusting the costs of pre-LT direct-acting antiviral therapies to the actual sustained virological response reached after LT.
authors: University Hospital of Padua, Padua, Italy.
authors: Alessandro
authors: A
authors: Vitale
authors: University Hospital of Padua, Padua, Italy.
authors: Gaya
authors: G
authors: Spolverato
authors: University Hospital of Padua, Padua, Italy.
authors: Patrizia
authors: P
authors: Burra
authors: North Italy Transplant program, Fond. IRCCS Ca' Granda OMP, Milan, Italy.
authors: Tullia Maria
authors: TM
authors: De Feo
authors: Hepatology and Gastroenterology, Ospedale Niguarda Ca' Granda, Milan, Italy.
authors: Luca
authors: L
authors: Belli
authors: Gastroenterology Unit, Ospedale Maggiore Policlinico, Milan, Italy.
authors: Francesca
authors: F
authors: Donato
authors: Liver Transplantation Unit, Ancona Hospital, Ancona, Italy.
authors: Gianluca Svegliati
authors: GS
authors: Baroni
authors: Liver Unit, Tor Vergata University, Rome, Italy.
authors: Tania
authors: T
authors: Marianelli
authors: IRCCS San Martino, IST Genova, Genova, Italy.
authors: Antonio
authors: A
authors: Picciotto
authors: Medical Liver Transplant Unit, University of Udine, Udine, Italy.
authors: Pierluigi
authors: P
authors: Toniutto
authors: Liver Transplantation, IRCCS INT, Milan, Italy.
authors: Sherrie
authors: S
authors: Bhoori
authors: Liver Transplantation Unit, Verona Hospital, Verona, Italy.
authors: Nicola
authors: N
authors: Passigato
authors: Gastroenterology and Transplant Hepatology, Ospedale Papa Giovanni XXIII, Bergamo, Italy.
authors: Maria Grazia
authors: MG
authors: Lucà
authors: University Hospital of Padua, Padua, Italy.
authors: Francesco Paolo
authors: FP
authors: Russo
authors: University Hospital of Padua, Padua, Italy.
authors: Umberto
authors: U
authors: Cillo
authors: Gastroenterology and Transplant Hepatology, Ospedale Papa Giovanni XXIII, Bergamo, Italy.
authors: Stefano
authors: S
authors: Fagiuoli
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage* / Q000191:economics; D002908:Chronic Disease; D003362:Cost-Benefit Analysis; D058625:End Stage Liver Disease / Q000601:surgery; D005260:Female; D016174:Hepacivirus; D019698:Hepatitis C, Chronic / Q000150:complications / Q000517:prevention & control*; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D017093:Liver Failure / Q000150:complications / Q000601:surgery*; D016031:Liver Transplantation / Q000009:adverse effects / Q000191:economics*; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D057234:Preoperative Period; D011336:Probability; D012008:Recurrence; D012107:Research Design; D012189:Retrospective Studies; D000069474:Sofosbuvir / Q000008:administration & dosage* / Q000191:economics; D016896:Treatment Outcome; D014850:Waiting Lists
chemical_list: D000998:Antiviral Agents; D000069474:Sofosbuvir
keywords: cost-effectiveness analysis; hepatitis C virus infection; liver transplantation; recurrent HCV; sofosbuvir