Personalized cost-effectiveness of boceprevir-based triple therapy for untreated patients with genotype 1 chronic hepatitis C

Digestive and Liver Disease

Volumn 46, Issue 10, 2014, Pages 936-942

  Petta, Salvatore ^a   Cabibbo, Giuseppe ^a   Enea, Marco ^a   Macaluso, Fabio Salvatore ^a   Plaia, Antonella ^a   Bruno, Raffaele ^b   Gasbarrini, Antonio ^c   Bruno, Savino ^d   Craxì, Antonio ^a   Cammà, Calogero ^a  

^a UNIVERSITY OF PALERMO   (Italy)

^b UNIVERSITY OF PAVIA   (Italy)

^c CATHOLIC UNIVERSITY   (Italy)

^d FATEBENEFRATELLI HOSPITAL   (Italy)

Author keywords

Boceprevir; Cost effectiveness; Peg interferon

Indexed keywords

BOCEPREVIR; PEGINTERFERON ALPHA; RIBAVIRIN; VIRUS RNA; ALPHA INTERFERON; ANTIVIRUS AGENT; MACROGOL DERIVATIVE; 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; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; PROLINE; RECOMBINANT PROTEIN;

ADULT; ANTIVIRAL THERAPY; ARTICLE; BODY MASS; COST EFFECTIVENESS ANALYSIS; DRUG COST; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 1; HUMAN; LIVER FIBROSIS; MALE; PERSONALIZED MEDICINE; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; SENSITIVITY ANALYSIS; TREATMENT RESPONSE; VIRUS LOAD; ANALOGS AND DERIVATIVES; COMPARATIVE STUDY; COST BENEFIT ANALYSIS; DRUG COMBINATION; ECONOMICS; EVALUATION STUDY; FEMALE; GENETICS; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; ITALY; MIDDLE AGED; MULTIVARIATE ANALYSIS; PROBABILITY; PUBLIC HEALTH; QUALITY OF LIFE; STATISTICAL MODEL; TREATMENT OUTCOME; VIROLOGY;

ANTIVIRAL AGENTS; COST-BENEFIT ANALYSIS; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; INTERFERON-ALPHA; ITALY; MALE; MARKOV CHAINS; MIDDLE AGED; MODELS, ECONOMIC; MULTIVARIATE ANALYSIS; NATIONAL HEALTH PROGRAMS; POLYETHYLENE GLYCOLS; PROLINE; QUALITY OF LIFE; QUALITY-ADJUSTED LIFE YEARS; RECOMBINANT PROTEINS; RIBAVIRIN; TREATMENT OUTCOME;

EID: 84922245019     PISSN: 15908658     EISSN: 18783562     Source Type: Journal    
DOI: 10.1016/j.dld.2014.06.009     Document Type: Article

References (46)

1. Global burden of disease (GBD) for hepatitis C. Journal of Clinical Pharmacology 2004, 44:20-29. Global Burden of Hepatitis C Working Group.
2. Hepatitis B and C in the EU neighbourhood: prevalence, burden of disease and screening policies September 2010, European Centre for Disease Prevention and Control.
3. Cammà C., Di Bona D., Schepis F., et al. Effect of peginterferon alpha-2a on liver histology in chronic hepatitis C: a meta-analysis of individual patient data. Hepatology 2004, 39:333-342.
4. Bruno S., Crosignani A., Facciotto C., et al. Sustained virologic response prevents the development of esophageal varices in compensated. Child-Pugh class A hepatitis C virus-induced cirrhosis. A 12-year prospective follow-up study. Hepatology 2010, 51:2069-2076.
5. Cammà C., Giunta M., Andreone P., et al. Interferon and prevention of hepatocellular carcinoma in viral cirrhosis: an evidence-based approach. Journal of Hepatology 2001, 34:593-602.
6. Singal A.G., Volk M.L., Jensen D., et al. A sustained viral response is associated with reduced liver-related morbidity and mortality in patients with hepatitis C virus. Clinical Gastroenterology and Hepatology 2010, 8:280-288.
7. Ghany M., Nelson D., Strader D., et al. An update on treatment of genotype 1 chronic hepatitis c virus infection: 2011 practice guidelines by the American Association for the Study of Liver Diseases. Hepatology 2011, 54:1433-1444.
8. Poordad F., McCone J., Bacon B.R., et al. Boceprevir for untreated chronic HCV genotype 1 infection. New England Journal of Medicine 2011, 364:1195-1206.
9. Jacobson I.M., McHutchison J.G., Dusheiko G., et al. Telaprevir for previously untreated chronic hepatitis C virus infection. New England Journal of Medicine 2011, 364:2405-2416.
10. Cammà C., Petta S., Enea M., et al. Cost-effectiveness of boceprevir or telaprevir for untreated patients with genotype 1 chronic hepatitis C. Hepatology 2012, 56:850-860.
11. 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. Journal of Hepatology 2013, 59:534-541.
12. Poordad F., Bronowicki J.P., Gordon S.C., et al. Factors that predict response of patients with hepatitis C virus infection to boceprevir. Gastroenterology 2012, 143. 608-18.e1-5.
13. McHutchison J.G., Lawitz E.J., Shiffman M.L., et al. Peginterferon alpha-2b or alpha-2a with ribavirin for treatment of hepatitis C infection. New England Journal of Medicine 2009, 361:580-593.
14. Bruno S., Crosignani A., Facciotto C., et al. Sustained virologic response prevents the development of esophageal varices in compensated, Child-Pugh class A hepatitis C virus-induced cirrhosis. A 12-year prospective follow-up study. Hepatology 2010, 51:2069-2076.
15. Cardoso A.C., Moucari R., Figueiredo-Mendes C., et al. Impact of peginterferon and ribavirin therapy on hepatocellular carcinoma: incidence and survival in hepatitis C patients with advanced fibrosis. Journal of Hepatology 2010, 52:652-657.
16. Drummond A.J., Ho S.Y., Phillips M.J., et al. Relaxed phylogenetics and dating with confidence. PLoS Biology 2006, 4:e88.
17. Tavole di mortalità della popolazione italiana 2010, ISTAT. http://dati.istat.it/%3Flang=it.
18. Cammà C., Di Marco V., Cabibbo G., et al. Survival of patients with hepatocellular carcinoma in cirrhosis: a comparison of BCLC, CLIP and GRETCH staging systems. Alimentary Pharmacology and Therapeutics 2008, 28:62-75.
19. Angelico M., Cillo U., Fagiuoli S., et al. Liver Match, a prospective observational cohort study on liver transplantation in Italy: study design and current practice of donor-recipient matching. Digestive and Liver Disease 2011, 43:155-164.
20. Guido M., Fagiuoli S., Tessari G., et al. Histology predicts cirrhotic evolution of post transplant hepatitis C. Gut 2002, 50:697-700.
21. Benvegnù L., Noventa F., Bernardinello E., et al. Evidence for an association between the aetiology of cirrhosis and pattern of hepatocellular carcinoma development. Gut 2001, 48:110-115.
22. D'Amico G., Garcia-Tsao G., Pagliaro L. Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies. Journal of Hepatology 2006, 44:217-231.
23. Freeman A.J., Dore G.J., Law M.G., et al. Estimating progression to cirrhosis in chronic hepatitis C virus infection. Hepatology 2001, 34:809-816.
24. Salomon J.A., Weinstein M.C., Hammitt J.K., et al. Cost-effectiveness of treatment for chronic hepatitis C infection in an evolving patient population. Journal of the American Medical Association 2003, 290:228-237.
25. Liu S., Schwarzinger M., Carrat F., et al. Cost effectiveness of fibrosis assessment prior to treatment for chronic hepatitis C patients. PLoS ONE 2011, 6:e26783.
26. Liu S., Cipriano L.E., Holodniy M., et al. New protease inhibitors for the treatment of chronic hepatitis C: a cost-effectiveness analysis. Annals of Internal Medicine 2012, 156:279-290.
27. Rein D.B., Smith B.D., Wittenborn J.S., et al. The cost-effectiveness of birth-cohort screening for hepatitis C antibody in U.S. primary care settings. Annals of Internal Medicine 2012, 156:263-270.
28. R Development Core Team R: a language and environment for statistical computing 2011, R Foundation for Statistical Computing, Vienna, Austria. http://www.r-project.org/.
29. Wasson J.H., Sox H.C., Neff R.K., et al. Clinical prediction rules: applications and methodological standards. New England Journal of Medicine 1985, 313:793-799.
30. FDA Antiviral Drugs Advisory Committee Meeting. Boceprevir. Available at: . http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM254079.pdf.
31. Victrelis [boceprevir]. European Medicines Agency. Available at: . http://www.ema.europa.eu/ema/index.jsp%3Fcurl=pages/medicines/human/medicines/002332/human_med_001464.jsp.
32. Siebert U., Sroczynski G., Rossol S., et al. Cost effectiveness of peginterferon alpha-2b plus ribavirin versus interferon alpha-2b plus ribavirin for initial treatment of chronic hepatitis C. Gut 2003, 52:425-432.
33. Sassi F. Calculating QALYs, comparing QALY and DALY calculations. Health Policy and Planning 2006, 21:402-408.
34. Sullivan S.D., Craxì A., Alberti A., et al. Cost effectiveness of peginterferon alpha-2a plus ribavirin versus interferon alpha-2b plus ribavirin as initial therapy for treatment-naïve chronic hepatitis C. Pharmacoeconomics 2004, 22:257-265.
35. Alberti A. Impact of a sustained virological response on the long-term outcome of hepatitis C. Liver International 2011, 1:18-22.
36. Munari L., Picciotto A. Recombinant interferon alpha-2b therapy for chronic hepatitis C in Italy: an economic analysis. FORUM Trends Experimental and Clinical Medicine 1996, 6:347-353.
37. Conferenza delle Regioni e Provincie Autonome. Tariffa Unica Convenzionale per le prestazioni di assistenza ospedaliera. Regole e tariffe valide per il 2006. Roma, 15 dicembre 2005.
38. Libro Bianco AISF 2011. Available at: . http://www.webaisf.org/media/13891/libro-bianco-aisf-2011.pdf.
39. Shiroiwa T., Sung Y.K., Fukuda T., et al. International survey on willingness-to-pay (WTP) for one additional QALY gained: what is the threshold of cost effectiveness?. Health Economics 2010, 19:422-437.
40. NICE. Available at: . http://www.nice.org.uk/page.aspx%3Fo=201974.
41. Lawitz E., Mangia A., Wyles D., et al. Sofosbuvir for previously untreated chronic hepatitis C infection. New England Journal of Medicine 2013, 368:1878-1887.
42. Lok A.S., Gardiner D.F., Lawitz E., et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. New England Journal of Medicine 2012, 366:216-224.
43. Aronsohn A., Jensen D. Informed deferral: a moral requirement for entry into the hepatitis C virus treatment warehouse. Hepatology 2012, 56:1591-1592.
44. Callahan D. Health technology assessment implementation: the politics of ethics. Medical Decision Making 2012, 32:E13-E19.
45. Scalone L., Ciampichini R., Fagiuoli S., et al. Comparing the performance of the standard EQ-5D 3L with the new version EQ-5D 5L in patients with chronic hepatic diseases. Quality of Life Research 2013, 22:1707-1716.
46. Salomon J.A., Weinstein M.C., Hammitt J.K., et al. Empirically calibrated model of hepatitis C virus infection in the United States. American Journal of Epidemiology 2002, 156:761-773.