title: Cost-effectiveness of sofosbuvir-based triple therapy for untreated patients with genotype 1 chronic hepatitis C.
abstract: We assessed the cost-effectiveness of sofosbuvir (SOF)-based triple therapy (TT) compared with boceprevir (BOC)- and telaprevir (TVR)-based TT in untreated genotype 1 (G1) chronic hepatitis C (CHC) patients discriminated according to IL28B genotype, severity of liver fibrosis, and G1 subtype. The available published literature provided the data source. The target population was made up of untreated Caucasian patients, aged 50 years, with G1CHC and these were evaluated over a lifetime horizon by Markov model. The study was carried out from the perspective of the Italian National Health Service. Outcomes included discounted costs (in euros at 2013 value), life-years gained (LYG), quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Cost of SOF was assumed to be € 3,500 per week, i.e., the price generating a willingness-to-pay threshold of € 25,000 per LYG compared with TVR in the entire population of untreated G1 patients. The robustness of the results was evaluated by one-way deterministic and multivariate probabilistic sensitivity analyses. SOF was cost-effective compared with BOC in all strategies with the exception of cirrhosis and IL28B CC patients. In comparison with TVR-based strategies, SOF was cost-effective in IL28B CT/TT (ICER per LYG € 22,229) and G1a (€ 19,359) patients, not cost-effective in IL28B CC (€45,330), fibrosis F0-F3 (€ 26,444), and in cirrhosis (€ 34,906) patients, and dominated in G1b patients. The models were sensitive to SOF prices and to likelihood of sustained virological response.
  
  
  CONCLUSIONS
  In untreated G1 CHC patients, SOF-based TT may be a cost-effective alternative to first-generation protease inhibitors depending on pricing. The cost-effectiveness of SOF improved in IL28B CT/TT and G1a patients. SOF was dominated by TVR in G1b patients even if, in clinical practice, this issue could be counterbalanced by the good tolerability profile of SOF and by the shorter treatment duration.
authors.affiliation: Sezione di Gastroenterologia, Di.Bi.M.I.S., University of Palermo, Palermo, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Petta
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cabibbo
authors.forename: Marco
authors.initials: M
authors.lastname: Enea
authors.forename: Fabio Salvatore
authors.initials: FS
authors.lastname: Macaluso
authors.forename: Antonella
authors.initials: A
authors.lastname: Plaia
authors.forename: Raffaele
authors.initials: R
authors.lastname: Bruno
authors.forename: Antonio
authors.initials: A
authors.lastname: Gasbarrini
authors.forename: Antonio
authors.initials: A
authors.lastname: Craxì
authors.forename: Calogero
authors.initials: C
authors.lastname: Cammà
mesh_terms: D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D009842:Oligopeptides / Q000627:therapeutic use; D011392:Proline / Q000031:analogs & derivatives / Q000627:therapeutic use; D019057:Quality-Adjusted Life Years; D000069474:Sofosbuvir; D014542:Uridine Monophosphate / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D009842:Oligopeptides; C486464:telaprevir; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D011392:Proline; D014542:Uridine Monophosphate; D000069474:Sofosbuvir