Cost-effectiveness of tenofovir in the treatment of patients with chronic hepatitis B: data from literature

Massimo Fasano, Giorgio L. Colombo, Sergio Di Matteo, Claudia Randazzo, Gioacchino Angarano, Teresa Antonia Santantonio



Chronic hepatitis B (CHB) is a complex disease with significant social impact both on the patients’ quality of life of and the economic resources involved. Its chronicity affects considerably not only the clinical management of the disease (for the need for drugs with proven long-term safety and low rate of resistance), but also the economic impact (for the high costs of treatment, the management of complications, and the constant monitoring of therapy).
Since, as is well known, the main problem of modern health care systems is the general scarcity of available resources in the face of growing demand for health, the issue of economic evaluation of therapies for the treatment of chronic hepatitis B has been addressed in numerous national and international studies. In fact, clinicians find a strong support for the choice of the most suitable therapeutic pathway in the major scientific societies’ guidelines (European Association for the Study of The Liver – EASL, American Association for the Study of Liver Diseases – AASLD, Associazione Italiana per lo Studio del Fegato – AISF), while the analysis of the economic implications is rather more difficult, even for the methodological differences and peculiarities of the different countries.
The aim of this paper is to present a brief summary of some of the recently conducted cost-effectiveness analyses and extrapolate some data to support the economic evidence related to the treatment of CHB with nucleos(t)ide analogs. In particular, the article focuses on the comparison between entecavir (ETV) and tenofovir (TDF), the two oral antiviral therapies recommended for first-line treatment. In the selected studies, the comparison between the different treatment options was conducted in order to assess the incremental cost-effectiveness ratio (ICER) and the results were expressed in terms of QALYs (Quality Adjusted Life Years) gained.
Despite the methodological differences among the selected studies, tenofovir is found to be, in the context of first-line oral antiviral therapies, the most cost-effective treatment for patients with chronic hepatitis B.


Chronic hepatitis B (CHB); First-line oral antiviral therapies; Tenofovir; Cost-effectiveness analysis

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  • McMahon BJ. The natural history of chronic hepatitis B virus infection. Semin Liver Dis 2004; 24: S17-21;
  • Fattovich G, et al. Natural history of chronic hepatitis B: special emphasis on disease progression and prognostic factors. J Hepatol 2008; 48: 335-52;
  • Hadziyannys SJ. Natural history of chronic hepatitis B in Euro-Mediterranean and African countries. J Hepatol 2011; 55: 183-91;
  • Legge 27 Maggio 1991, n. 165. Gazzetta Ufficiale n. 127 del 01/06/1991
  • Stroffolini T, Mele A, Tosti ME, et al. The impact of the hepatitis B mass immunization campaign on the incidence and risk factors of acute hepatitis B in Italy. J Hepatol 2000; 33: 980-85;
  • Stroffolini T. The changing pattern of hepatitis B virus infection over the past three decades in Italy. Dig Liver Dis 2005; 37: 622-27;
  • Sistema Epidemiologico Integrato dell’Epatite Virale Acuta. Disponibile online su: (ultimo accesso febbraio 2014)
  • Zuccaro O, Tosti ME, Mele A, et al; SEIEVA Collaborative Group. Epidemiology of acute viral hepatitis in Italy: results of the surveillance through SEIEVA (Sistema Epidemiologico Integrato dell’Epatite Virale Acuta). Roma: Istituto Superiore di Sanità; 2012 (Rapporti ISTISAN 12/4). Disponibile online su (ultimo accesso febbraio 2014)
  • European Association For The Study Of The Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol 2012; 57: 167-85;
  • Lok AS, McMahon BJ. AASLD Practice Guideline Update. Chronic hepatitis B: update 2009. Hepatology 2009; 50: 661-62;
  • Chang TT, Gish RG, de Man R, et al; BEHoLD AI463022 Study Group. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006; 354: 1001-10;
  • Marcellin P, Heathcote EJ, Buti M, et al. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med 2008; 359: 2442-55;
  • Woo G, Tomlinson G, Nishikawa Y, et al. Tenofovir and entecavir are the most effective antiviral agents for chronic hepatitis B: a systematic review and Bayesian meta-analyses. Gastroenterology 2010; 139: 1218-29;
  • Carosi G, Rizzetto M, Alberti A, et al. Treatment of chronic hepatitis B: update of the recommendations from the 2007 Italian Workshop. Dig Liver Dis 2011; 43: 259-65;
  • Buti M, Oyagüez I, Lozano V, et al. Cost effectiveness of first-line oral antiviral therapies for chronic hepatitis B: a systematic review. Pharmacoeconomics 2013; 31: 63-75;
  • Colombo GL, Gaeta GB, Vigano M, et al. A cost-effectiveness analysis of different therapies in patients with chronic hepatitis B in Italy. Clin Outcomes Res 2011; 3: 37-46;
  • Iannazzo S, Coco B, Brunetto MR, et al. Valutazioni economiche sulle strategie di trattamento dell’epatite B cronica in Italia. Farmeconomia. Health Economics and Therapeutics Pathways 2013; 14: 111-18;
  • Fasano M, Colombo GL, Di Matteo S, et al. Analisi di costo-efficacia del trattamento dell’epatite cronica B con analoghi nucleos(t)idici nella pratica clinica. Comunicazione orale. XII Congresso Nazionale della Società Italiana di Malattie Infettive e Tropicali (SIMIT). Milano, 27-30 ottobre 2013
  • Drummond MF, Sculpher MJ, Torrance GW, et al. Methods for the economic evaluation of health care programmes. 3rd ed. New York: Oxford University Press, 2005
  • Arnold E, Yuan Y, Iloeje U, et al. Cost-effectiveness analysis of entecavir versus lamivudine in the first-line treatment of Australian patients with chronic hepatitis B. Appl Health Econ Health Policy 2008; 6: 231-46;
  • Buti M, Brosa M, Casado MA, et al. Modeling the cost-effectiveness of different oral antiviral therapies in patients with chronic hepatitis B. J Hepatol 2009; 51: 640-4;
  • Costa AM, L’Italien G, Nita ME, et al. Cost-effectiveness of entecavir versus lamivudine for the suppression of viral replication in chronic hepatitis B patients in Brazil. Braz J Infect Dis 2008; 12: 368-73
  • Dakin H, Bentley A, Dusheiko G. Cost-utility analysis of tenofovir disoproxil fumarate in the treatment of chronic hepatitis B. Value Health 2010; 13: 922-33;
  • Dakin H, Sherman M, Fung S, et al. Cost effectiveness of tenofovir disoproxil fumarate for the treatment of chronic hepatitis B from a Canadian public payer perspective. Pharmacoeconomics 2011; 29: 1075-91;
  • Kanwal F, Farid M, Martin P, et al. Treatment alternatives for hepatitis B cirrhosis: a cost-effectiveness analysis. Am J Gastroenterol 2006; 101: 2076-89;
  • Lui YY, Tsoi KK, Wong VW, et al. Cost-effectiveness analysis of roadmap models in chronic hepatitis B using tenofovir as the rescue therapy. Antivir Ther 2010; 15: 145-55;
  • Orlewska E, Zammit D, Yuan Y, et al. The cost-effectiveness analysis of entecavir in the treatment of chronic hepatitis B (CHB) patients in Poland. Exp Clin Hepatol 2008; 4: 20-8
  • Schwierz C, Thiry N, Van de Sande S, et al. Economic evaluation of antiviral treatment of chronic hepatitis B in Belgium: part 2 [KCE reports 157B]. Brussels: Belgian Health Care Knowledge Centre (KCE); 2011
  • Spackman DE, Veenstra DL. A cost-effectiveness analysis of currently approved treatments for HBeAg-positive chronic hepatitis B. Pharmacoeconomics 2008; 26: 937-49;
  • Veenstra DL, Sullivan SD, Clarke L, et al. Cost effectiveness of entecavir versus lamivudine with adefovir salvage in HBeAg-positive chronic hepatitis B. Pharmacoeconomics 2007; 25: 963-77;
  • Veenstra DL, Spackman DE, Di Bisceglie A, et al. Evaluating anti-viral drug selection and treatment duration in HBeAg-. Review of the Efficiency of Oral Antivirals in Hepatitis B 73 negative chronic hepatitis B: a cost-effectiveness analysis. Aliment Pharmacol Ther 2008; 27: 1240-52;
  • Wu B, Li T, Chen H, et al. Cost-effectiveness of nucleoside analog therapy for hepatitis B in China: a Markov analysis. Value Health 2010; 13: 592-600;
  • Yuan Y, Iloeje U, Li H, et al. Economic implications of entecavir treatment in suppressing viral replication in chronic hepatitis B (CHB) patients in China from a perspective of the Chinese Social Security program. Value Health 2008;11(Suppl 1): S11-22;
  • Yuan Y, Iloeje UH, Hay J, et al. Evaluation of the cost-effectiveness of entecavir versus lamivudine in hepatitis BeAg-positive chronic hepatitis B patients. J Manag Care Pharm 2008; 14: 21-33
  • Levy AR, Kowdley KV, Iloeje U, et al. The impact of chronic hepatitis B on quality of life: a multinational study of utilities from infected and uninfected persons. Value Health 2008; 11: 527-38;
  • Briggs A. Transportability of comparative effectiveness and cost effectiveness between countries. Value Health 2010; 13(Suppl1): S22-5;
  • Vemer P, Rutten-van Moelken MP. Largely ignored: the impact of the threshold value for a QALY on the importance of a transferability factor. Eur J Health Econ 2011; 12: 397-404;
  • Gaeta GB, Stornaiuolo G, Precone DF, et al. Epidemiological and clinical burden of chronic hepatitis B virus/hepatitis C virus infection. A multicenter Italian study. J Hepatol 2003; 39: 1036-41;
  • Chapman RH, Stone PW, Sandberg EA, et al. A comprehensive league table of cost-utility ratios and a sub-table of “panel-worthy” studies. Med Decis Making 2000; 20: 451-67;
  • Iannazzo S, Coco B, Brunetto RM, et al. Individualized treatment of HBeAg-negative CHB using peg-interferon alfa-2a as first-line and week 12 HBV-DNAHBsAg stopping rule. A cost-effectiveness analysis. Antivir Ther 2013; 18: 623-33;
  • The National Institute for Health and Clinical Excellence. Social value judgements: principles for the development of NICE guidance. Second ed. 2008. (ultimo accesso novembre 2013)
  • Associazione Italiana di Economia Sanitaria (AIES). Proposta di linee guida per la valutazione economica degli interventi sanitari. PharmacoEconomics. Italian Research Articles 2009; 11: 83-93


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