The value of cure associated with treating treatment-naïve chronic hepatitis C genotype 1: Are the new all-oral regimens good value to society?

Liver International

Volumn 37, Issue 5, 2017, Pages 662-668

  Younossi, Zobair M ^a,b   Park, Haesuk ^c   Dieterich, Douglas ^d   Saab, Sammy ^e   Ahmed, Aijaz ^f   Gordon, Stuart C ^g  

^a INOVA FAIRFAX HOSPITAL   (United States)

^b BETTY AND GUY BEATTY CENTER FOR INTEGRATED RESEARCH   (United States)

^c UNIVERSITY OF FLORIDA   (United States)

^d MOUNT SINAI MEDICAL CENTER   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f STANFORD UNIVERSITY   (United States)

^g HENRY FORD HOSPITAL   (United States)

Author keywords

all oral regimens; economic analysis; HCV treatment; hepatitis C; hepatitis C virus; Markov model; value of cure

Indexed keywords

DASABUVIR; LEDIPASVIR; OMBITASVIR; PARITAPREVIR; PEGINTERFERON; RIBAVIRIN; RITONAVIR; SIMEPREVIR; SOFOSBUVIR; ANTIVIRUS AGENT; BENZIMIDAZOLE DERIVATIVE; FLUORENE DERIVATIVE; LEDIPASVIR, SOFOSBUVIR DRUG COMBINATION; URIDINE PHOSPHATE;

ADULT; ANTIVIRAL THERAPY; ARTICLE; CHRONIC HEPATITIS C; CONTROLLED STUDY; DRUG COST; HEPATITIS C VIRUS GENOTYPE 1; HUMAN; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; PHASE 3 CLINICAL TRIAL; QUALITY ADJUSTED LIFE YEAR; RANDOMIZED CONTROLLED TRIAL; SOCIETY; SUSTAINED VIROLOGIC RESPONSE; UNITED STATES; ANALOGS AND DERIVATIVES; COMBINATION DRUG THERAPY; DECISION MAKING; DRUG ADMINISTRATION; ECONOMICS; GENETICS; HEPACIVIRUS; MARKOV CHAIN; ORAL DRUG ADMINISTRATION; STATISTICS AND NUMERICAL DATA; VIROLOGY;

ADMINISTRATION, ORAL; ANTIVIRAL AGENTS; BENZIMIDAZOLES; DECISION MAKING; DRUG ADMINISTRATION SCHEDULE; DRUG COSTS; DRUG THERAPY, COMBINATION; FLUORENES; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; LIVER CIRRHOSIS; MARKOV CHAINS; QUALITY-ADJUSTED LIFE YEARS; RIBAVIRIN; SIMEPREVIR; SOFOSBUVIR; SUSTAINED VIROLOGIC RESPONSE; UNITED STATES; URIDINE MONOPHOSPHATE;

EID: 85041062535     PISSN: 14783223     EISSN: 14783231     Source Type: Journal    
DOI: 10.1111/liv.13298     Document Type: Article

References (42)

1. Denniston MM, Klevens RM, McQuillan GM, Jiles RB. Awareness of infection, knowledge of hepatitis C, and medical follow-up among individuals testing positive for hepatitis C: National Health and Nutrition Examination Survey 2001-2008. Hepatology. 2012;55:1652–1661.
2. Denniston MM, Jiles RB, Drobeniuc J, et al. Chronic hepatitis C virus infection in the United States, National Health and Nutrition Examination Survey 2003 to 2010. Ann Intern Med. 2014;160:293–300.
3. Cacoub P, Gragnani L, Comarmond C, Zignego AL. Extrahepatic manifestations of chronic hepatitis C virus infection. Dig Liver Dis. 2014;46(Suppl 5):S165–S173.
4. Ly KN, Xing J, Klevens RM, Jiles RB, Ward JW, Holmberg SD. The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007. Ann Intern Med. 2012;156:271–278.
5. Chhatwal J, Kanwal F, Roberts MS, Dunn MA. Cost-effectiveness and budget impact of hepatitis C virus treatment with sofosbuvir and ledipasvir in the United States. Ann Intern Med. 2015a;162:397–406.
6. Younossi Z, Henry L. Systematic review: patient-reported outcomes in chronic hepatitis C–the impact of liver disease and new treatment regimens. Aliment Pharmacol Ther. 2015;41:497–520.
7. Menzin J, White LA, Nichols C, Deniz B. The economic burden of advanced liver disease among patients with hepatitis C virus: a large state Medicaid perspective. BMC Health Serv Res. 2012;12:459.
8. Manne V, Sassi K, Allen R, Saab S. Hepatitis C and work impairment: a review of current literature. J Clin Gastroenterol. 2014;48:595–599.
9. Razavi H, Elkhoury AC, Elbasha E, et al. Chronic hepatitis C virus (HCV) disease burden and cost in the United States. Hepatology. 2013;57:2164–2170.
10. Messina JP, Humphreys I, Flaxman A, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 2015;61:77–87.
11. Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879–1888.
12. Feld JJ, Kowdley KV, Coakley E, et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014;370:1594–1603.
13. Assoumou SA, Huang W, Horsburgh CR Jr, Drainoni ML, Linas BP. Relationship between hepatitis C clinical testing site and linkage to care. Open Forum Infect Dis. 2014;1:ofu009.
14. Reau N. HCV testing and linkage to care: expanding access. Clin Liver Dis. 2014;4:31–34.
15. 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;136:288–292.
16. Stepanova M, Younossi ZM. Interferon-free regimens for chronic hepatitis C: barriers due to treatment candidacy and insurance coverage. Dig Dis Sci. 2015;60:3248–3251.
17. Linas BP, Barter DM, Morgan JR, et al. The cost-effectiveness of sofosbuvir-based regimens for treatment of hepatitis C virus genotype 2 or 3 infection. Ann Intern Med. 2015;162:619–629.
18. Younossi ZM, Stepanova M, Nader F, et al. Patient-reported outcomes in chronic hepatitis C patients with cirrhosis treated with sofosbuvir-containing regimens. Hepatology. 2014a;59:2161–2169.
19. Younossi Z, Henry L. The impact of the new antiviral regimens on patient reported outcomes and health economics of patients with chronic hepatitis C. Dig Liver Dis. 2014;46(Suppl 5):S186–S196.
20. Younossi ZM, Park H, Saab S, Ahmed A, Dieterich D, Gordon SC. Cost-effectiveness of all-oral ledipasvir/sofosbuvir regimens in patients with chronic hepatitis C virus genotype 1 infection. Aliment Pharmacol Ther. 2015a;41:544–563.
21. Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-Effectiveness in Health and Medicine. New York, NY: Oxford University Press; 1996.
22. Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness–the curious resilience of the $50,000-per-QALY threshold. N Engl J Med. 2014;371:796–797.
23. Nainan OV, Alter MJ, Kruszon-Moran D, et al. Hepatitis C virus genotypes and viral concentrations in participants of a general population survey in the United States. Gastroenterology. 2006;131:478–484.
24. Red Book Online [Internet]. Micromedex 2.0. http://www.micromedexsolutions.com/home/dispatch. Accessed October 15, 2015.
25. Manos MM, Shvachko VA, Murphy RC, Arduino JM, Shire NJ. Distribution of hepatitis C virus genotypes in a diverse US integrated health care population. J Med Virol. 2012;84:1744–1750.
26. Zein NN, Rakela J, Krawitt EL, Reddy KR, Tominaga T, Persing DH. Hepatitis C virus genotypes in the United States: epidemiology, pathogenicity, and response to interferon therapy. Collaborative Study Group. Ann Intern Med. 1996;125:634–639.
27. Ipsos Healthcare. US HCV Monitor; 2012.
28. Hajkowicz H, Buggisch P, Petersen J, et al. Ledipasvir/sofosbuvir for 8 weeks—a comparative analysis of clinical trial efficacy versus real world effectiveness. https://www.eiseverywhere.com/file_uploads/c8b381436c7c4414d4838ce778d38098_KrispinHajkowicz-10.pdf. Accessed October 15, 2016.
29. Gilead Sciences Inc. Data on file; 2015.
30. Vernaz N, Girardin F, Goossens N, et al. Drug pricing evolution in hepatitis C. PLoS ONE. 2016;11:e0157098–12. doi:10.1371/journal.pone.0157098.
31. Chhatwal J, Chen Q, Kanwal F. Why we should be willing to pay for hepatitis C treatment. Clin Gastroenterol Hepatol. 2015b;13:1711–1713.
32. Hagan LM, Yang Z, Ehteshami M, Schinazi RF. All-oral, interferon-free treatment for chronic hepatitis C: cost-effectiveness analyses. J Viral Hepatitis. 2013;20:847–857.
33. Zhang S, Bastian ND, Griffin PM. Cost-effectiveness of sofosbuvir-based treatments for chronic hepatitis C in the US. BMC Gastroenterol. 2015;15:98–107.
34. Chhatwal J, He T, Hur C, Lopez-Olivo MA. Direct-acting antiviral agents for patients with hepatitis C virus genotype 1 infection are cost saving. Clin Gastroenterol Hepatol. 2016; doi:10.1016/j.cgh.2016.09.015.
35. Roy V, King L. Betting on hepatitis C: how financial speculation in drug development influences access to medicines. BMJ. 2016; 354–359. doi:10.1136/bmj.i3718.
36. Younossi ZM, Jiang Y, Smith NJ, Stepanova M, Beckerman R. Ledipasvir/sofosbuvir regimens for chronic hepatitis C infection: insights from a work productivity economic model from the United States. Hepatology. 2015b;61:1471–1478.
37. Henry J. Kaiser Family Foundation. Summary of the Affordable Care Act. http://files.kff.org/attachment/fact-sheet-summary-of-the-affordable-care-act. Accessed February 29, 2016.
38. Ferro C, Blumen HE, Johnson RL. The burden of hepatitis C virus disease in commercial and managed Medicaid populations. http://us.milliman.com/insight/2015/The-burden-of-hepatitis-C-virus-disease-in-commercial-and-managed-Medicaid-populations/. Accessed January 15, 2016.
39. McLernon DJ, Dillon J, Donnan PT. Health-state utilities in liver disease: a systematic review. Med Decis Mak. 2008;28:582–592.
40. Wright NM, Tompkins CN. A review of the evidence for the effectiveness of primary prevention interventions for hepatitis C among injecting drug users. Harm Reduct J. 2006;3:27–36.
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.
42. Younossi ZM, Singer ME, Mir HM, Henry L, Hunt S. Impact of interferon free regimens on clinical and cost outcomes for chronic hepatitis C genotype 1 patients. J Hepatol. 2014b;60:530–537.