January 15, 2014

Hepatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

Viral Hepatitis

Salvatore Petta1, Giuseppe Cabibbo1,  Marco Enea2, Fabio Salvatore Macaluso1,  Antonella Plaia2, Raffaele Bruno3, Antonio Gasbarrini4, Antonio Craxì1, Calogero CammĂ 1, on behalf of the WEF study group

DOI: 10.1002/hep.27010

Copyright © 2014 American Association for the Study of Liver Diseases

Publication History
Accepted manuscript online: 13 JAN 2014 01:48PM EST
Manuscript Accepted: 4 DEC 2013
Manuscript Revised: 19 NOV 2013
Manuscript Received: 9 AUG 2013

Abstract

Background and aims: We assess the cost-effectiveness of sofosbuvir (SOF)-based triple therapy(TT) compared with boceprevir(BOC)- and telaprevir(TVR)-based TT in untreated G1CHC patients discriminated according to IL28B genotype, severity of liver fibrosis and genotype1(G1) subtype.

Methods: 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 euro 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 for 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 multivariable probabilistic sensitivity analyses.

Results: SOF was cost-effective compared with BOC in all strategies with the exception of cirrhotic 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 cirrhotic(€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. (Hepatology 2014;)

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