Cost-effectiveness of sofosbuvir in the treatment of patients with hepatitis C

Journal of Viral Hepatitis

Volumn 22, Issue 4, 2015, Pages 376-383

  Leleu, Henri ^a   Blachier, M ^a   Rosa, I ^b  

^a Public Health Expertise   (France)

^b CENTRE HOSPITALIER INTERCOMMUNAL DE CRÉTEIL   (France)

Author keywords

cost benefit analysis; France; healthcare costs; hepatitis C; sofosbuvir

Indexed keywords

PEGINTERFERON; RIBAVIRIN; SOFOSBUVIR; TELAPREVIR; ANTIVIRUS AGENT;

ARTICLE; CLINICAL TRIAL (TOPIC); COST EFFECTIVENESS ANALYSIS; DRUG COST; DRUG EFFICACY; HEPATITIS C; HUMAN; LIVER CIRRHOSIS; LIVER FIBROSIS; PRIORITY JOURNAL; QUALITY OF LIFE; SENSITIVITY ANALYSIS; SUSTAINED VIRAL RESPONSE; TREATMENT PLANNING; TREATMENT RESPONSE; ADOLESCENT; ADULT; AGED; CLINICAL TRIAL; CONTROLLED STUDY; COST BENEFIT ANALYSIS; ECONOMICS; FEMALE; FRANCE; HEPATITIS C, CHRONIC; MALE; MIDDLE AGED; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIVIRAL AGENTS; COST-BENEFIT ANALYSIS; FEMALE; FRANCE; HEPATITIS C, CHRONIC; HUMANS; MALE; MIDDLE AGED; SOFOSBUVIR; YOUNG ADULT;

EID: 84925615383     PISSN: 13520504     EISSN: 13652893     Source Type: Journal    
DOI: 10.1111/jvh.12311     Document Type: Article

References (41)

1. Alter MJ,. Epidemiology of hepatitis C. Hepatol Baltim Md. 1997; 26 (3 Suppl 1): 62S-65S.
2. INVS. [National reference lab data for hepatitis C, 2001-2007] Surveillance nationale de l'hépatite C à partir des pôles de référence, données épidémiologiques 2001-2007. Saint-Maurice Cedex, France: Institut de Veille Sanitaire, 2009.
3. Meffre C, Le Strat Y, Delarocque-Astagneau E, et al,. Prevalence of hepatitis B and hepatitis C virus infections in France in 2004: social factors are important predictors after adjusting for known risk factors. J Med Virol 2010; 82 (4): 546-555.
4. Deuffic-Burban S, Mathurin P, Pol S, et al,. Impact of hepatitis C triple therapy availability upon the number of patients to be treated and associated costs in France: a model-based analysis. Gut 2012; 61 (2): 290-296.
5. Henri L, Homie R, Chris E, Christophe H, Martin B, Francoise R-T,. Modeling the epidemiological impact of upcoming direct antiviral agents in hepatitis C treatment. Hepatology 2013; 58: 208A-1309A.
6. Lee LY, Tong CYW, Wong T, Wilkinson M,. New therapies for chronic hepatitis C infection: a systematic review of evidence from clinical trials. Int J Clin Pract 2012; 66 (4): 342-355.
7. van der Meer AJ, Veldt BJ, Feld JJ, et al,. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA, J Am Med Assoc 2012; 308 (24): 2584-2593.
8. Poynard T, Bedossa P, Opolon P,. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet 1997; 349 (9055): 825-832.
9. Association Francaise pour l'Etude du Foie (AFEF). Prise de position de l'Association Française pour l'Etude du Foie (AFEF) sur les trithérapies (Peg-IFN + ribavirine + inhibiteur de protéase) dans la prise en charge des malades atteints d'hépatite chronique C [Internet]. 2011. Available from: http://www.afef.asso.fr/rc/org/afef/htm/Article/2011/htm-20110414-094626-465/src/htm-fullText/fr/reco%20afef%20V2%2030%2011%2011.pdf
10. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol 2011; 55 (2): 245-264.
11. Arvieux C, Bourlière M, Cacoub P, et al,. L'utilisation des inhibiteurs de protéase du VHC de première génération chez les patients co-infectés par le VIH et le VHC, de génotype 1. 2013 [cited 2014 Feb 19]; Available from: http://www.vih.org/sites/default/files/RecomandationsIPantiVHC%20coinfection%20VIHVHC220313.pdf
12. Jacobson IM, McHutchison JG, Dusheiko G, et al,. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011; 364 (25): 2405-2416.
13. Hézode C, Fontaine H, Dorival C, et al,. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC)-NCT01514890. J Hepatol 2013; 59: 434-441.
14. Bota S, Sporea I, Sirli R, et al,. Severe adverse events during antiviral therapy in hepatitis C virus cirrhotic patients: a systematic review. World J Hepatol 2013; 5 (3): 120-126.
15. Pariente A, Lahmek P, Duprat C, et al,. Treatment of chronic hepatitis C with pegylated interferon and ribavirin in treatment-naive patients in "true life": a plea in favor of independent postmarketing evaluations. Eur J Gastroenterol Hepatol 2010; 22 (11): 1297-1302.
16. Falck-Ytter Y, Kale H, Mullen KD, Sarbah SA, Sorescu L, McCullough AJ,. Surprisingly small effect of antiviral treatment in patients with hepatitis C. Ann Intern Med 2002; 136 (4): 288-292.
17. Jacobson IM, Gordon SC, Kowdley KV, et al,. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013; 368 (20): 1867-1877.
18. Gane EJ, Stedman CA, Hyland RH, et al,. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med 2013; 368 (1): 34-44.
19. Kowdley KV, Lawitz E, Crespo I, et al,. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. Lancet 2013; 381 (9883): 2100-2107.
20. Lawitz E, Mangia A, Wyles D, et al,. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368 (20): 1878-1887.
21. Lawitz E, Lalezari JP, Hassanein T, et al,. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial. Lancet Infect Dis 2013; 13 (5): 401-408.
22. Bourlière M, Ouzan D, Rosenheim M, et al,. Pegylated interferon-α2a plus ribavirin for chronic hepatitis C in a real-life setting: the Hepatys French cohort (2003-2007). Antivir Ther 2012; 17 (1): 101-110.
23. Marcellin P, Chousterman M, Fontanges T, et al,. Adherence to treatment and quality of life during hepatitis C therapy: a prospective, real-life, observational study. Liver Int 2011; 31 (4): 516-524.
24. Bennett WG, Inoue Y, Beck JR, Wong JB, Pauker SG, Davis GL,. Estimates of the cost-effectiveness of a single course of interferon-α2b in patients with histologically mild chronic hepatitis C. Ann Intern Med 1997; 127 (10): 855-865.
25. Deuffic-Burban S, Deltenre P, Buti M, et al,. HCV burden in Europe: impact of national treatment practices on future HCV-related morbidity and mortality through a modeling approach. J Hepatol 2011; 54: S54.
26. Fattovich G, Giustina G, Degos F, et al,. Morbidity and mortality in compensated cirrhosis type C: a retrospective follow-up study of 384 patients. Gastroenterology 1997; 112 (2): 463-472.
27. Shepperd S, Richards S,. Continuity of care-a chameleon concept. J Health Serv Res Policy 2002; 7 (3): 130-132.
28. Janssen pharmaceutical companies of Johnson&Johnson. Telaprevir for the Treatment of Genotype 1 Chronic Hepatitis C. London: NICE, 2011.
29. Wright TL,. Treatment of patients with hepatitis C and cirrhosis. Hepatology 2002; 36 (S1): S185-S194.
30. Gao X, Stephens JM, Carter JA, Haider S, Rustgi VK,. Impact of adverse events on costs and quality of life in protease inhibitor-based combination therapy for hepatitis C. Expert Rev Pharmacoecon Outcomes Res 2012; 12 (3): 335-343.
31. Schwarzinger M, Deuffic-Burban S, Mallet V, et al,. Lifetime costs attributable to chronic hepatitis C from the French healthcare perspective. J Hepatol 2013; 58 (Supplement 1): S21-S22.
32. HAS. Hépatite Chronique C [Internet]. Saint-Denis: HAS; 2006 Mai. Available at: www.has-sante.fr/portail/upload/docs/application/pdf/06-072-hepat-c-internet-sans-liste.pdf
33. Lalezari JP, Nelson DR, Hyland RH, et al,. Once daily sofosbuvir plus ribavirin for 12 and 24 weeks in treatment-naïve patients with HCV infection: the quantum study. J Hepatol 2013; 58: S346.
34. Vutien P, Kim Y, Brooks L, Livornese R, Nguyen MH,. Low Treatment Rates and Suboptimal Treatment Completion Rates to Hepatitis C Virus (HCV) Therapy: A Real-World Analysis of a Large US Cohort. Gastroenterology 2014 May 1; 146 (5): S-920.
35. Beste LA, Ioannou GN, Larson MS, Chapko M, Dominitz JA,. Predictors of early treatment discontinuation among patients with genotype 1 hepatitis C and implications for viral eradication. Clin Gastroenterol Hepatol 2010; 8 (11): 972-978.
36. Sulkowski MS, Rodriguez-Torres M, Lalezari JP, Fessel W, Mounzer K, Shuhart M,. All-oral therapy with sofosbuvir plus ribavirin for the treatment of HCV genotype 1, 2, and 3 infection in patients co-infected with HIV (PHOTON-1). Hepatology 2013; 58 (S1): 313-4A.
37. Lagging M, Rembeck K, Rauning BM, et al,. Retreatment with peg-interferon and ribavirin in patients with chronic hepatitis C virus genotype 2 or 3 infection with prior relapse. Scand J Gastroenterol 2013; 48 (7): 839-847.
38. Zeuzem S, Dusheiko GM, Salupere R,. Sofosbuvir+ ribavirin for 12 or 24 weeks for patients with HCV genotype 2 or 3: the VALENCE Trial. 64th Annu Meet Am Assoc Study Liver Dis, 2013: 1-5.
39. Labarga P, Barreiro P, da Silva A, et al,. Comparison of high ribavirin induction versus standard ribavirin dosing, plus peginterferon-α for the treatment of chronic hepatitis C in HIV-infected patients: the PERICO trial. J Infect Dis 2012; 206 (6): 961-968.
40. Lawitz E, Poordad F, Brainard DM, Hyland RH, An D, Symonds WT, et al. Sofosbuvir in Combination With PegIFN and Ribavirin for 12 Weeks Provides High SVR Rates in HCV-Infected Genotype 2 or 3 Treatment Experienced Patients with and without Compensated Cirrhosis: Results from the LONESTAR-2 Study. Hepatology. Hoboken, NJ, USA: Wiley-Blackwell, 2013: 1380A-1380A.
41. Hsu PC, Federico CA, Krajden M, et al,. Health utilities and psychometric quality of life in patients with early-and late-stage hepatitis C virus infection. J Gastroenterol Hepatol 2012; 27: 149-157.