What is the ethical responsibility of a provider when prescribing the new direct-acting antiviral agents to patients with hepatitis C infection?

Clinical Liver Disease

Volumn 6, Issue 5, 2015, Pages 117-119

  Younossi, Zobair M ^a,b  

^a INOVA FAIRFAX HOSPITAL   (United States)

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

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVIRUS AGENT;

CLINICAL DECISION MAKING; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG RESEARCH; DRUG TOLERABILITY; FATIGUE; HEALTH CARE COST; HEPATITIS C; HUMAN; LIVER FIBROSIS; MEDICAL ETHICS; PATIENT ATTITUDE; PATIENT GUIDANCE; PRESCRIPTION; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW;

EID: 84949668014     PISSN: None     EISSN: 20462484     Source Type: Journal    
DOI: 10.1002/cld.509     Document Type: Review

References (24)

1. Muir AJ, Naggie S. HCV treatment: is it possible to cure all HCV patients? Clin Gastroenterol Hepatol 2015;13:2166-2172.
2. Younossi ZM, Stepanova M, Afdhal N, Kowdley KV, Zeuzem S, Henry L, et al. Improvement of health-related quality of life and work productivity in chronic hepatitis C patients with early and advanced fibrosis treated with ledipasvir and sofosbuvir. J Hepatol 2015;63:337-345.
3. Younossi ZM, Stepanova M, Marcellin P, Afdhal N, Kowdley KV, Zeuzem S, et al. Treatment with ledipasvir and sofosbuvir improves patient-reported outcomes: Results from the ION-1, -2, and -3 clinical trials. Hepatology 2015;61:1798-1808.
4. Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, et al. Sofosbuvir and ribavirin for treatment of chronic hepatitis C in patients coinfected with hepatitis C virus and HIV: The impact on patient-reported outcomes. J Infect Dis 2015;212:367-377.
5. Younossi ZM, Stepanova M, Zeuzem S, Dusheiko G, Esteban R, Hezode C, et al. Patient-reported outcomes assessment in chronic hepatitis C treated with sofosbuvir and ribavirin: the VALENCE study. J Hepatol. 2014;61:228-234.
6. Younossi ZM, Stepanova M, Nader F, Jacobson IM, Gane E, Nelson D, et al. Patient-reported outcomes in chronic hepatitis C patients with cirrhosis treated with sofosbuvir-containing regimens. Hepatology 2014;59:2161-2169.
7. Younossi ZM, Stepanova M, Henry L, Gane E, Jacobson IM, Lawitz E, et al. Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C. Clin Gastroenterol Hepatol 2014;12:1349-1359.
8. 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.
9. 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.
10. 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 2014;60:530-537.
11. Najafzadeh M, Andersson K, Shrank WH, Krumme AA, Matlin OS, Brennan T, et al. Cost-effectiveness of novel regimens for the treatment of hepatitis C virus. Ann Intern Med 2015;162:407-419.
12. Leidner AJ, Chesson HW, Xu F, Ward JW, Spradling PR, Holmberg SD. Cost-effectiveness of hepatitis C treatment for patients in early stages of liver disease. Hepatology 2015;61:1860-1869.
13. 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 2015;41:544-563.
14. 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 2015;61:1471-1478.
15. Younossi ZM, Park H, Dieterich D, Saab S, Ahmed A, Gordon S. Quality-adjusted cost of care for treatment naive (TN) patients with genotype 1 (GT1) chronic hepatitis C (CH-C): an assessment of innovation cost of drug regimens versus the value of health gains to the society. In: Proceedings of the Annual Meeting of the American Association for the Study of Liver Diseases, San Francisco, CA; November 13-17, 2015. Abstract 2317281.
16. Beauchamp T, Childress J. Principles of Biomedical Ethics, 7th edition. New York: Oxford University Press; 2013.
17. Glassman PA, Schneider PL, Good CB. An ethical framework for pharmacy management: balancing autonomy and other principles. J Manag Care Spec Pharm 2014;20:334-338.
18. Daniels N, Teagarden JR, Sabin JE. An ethical template for pharmacy benefits. Health Aff (Millwood) 2003;22:125-137.
19. Povar GJ, Blumen H, Daniel J, Daub S, Evans L, Holm RP, et al; Medicine as a Profession Managed Care Ethics Working Group. Ethics in practice: managed care and the changing health care environment: medicine as a profession managed care ethics working group statement. Ann Intern Med 2004;141:131-136.
20. Synder L; American College of Physicians Ethics, Professionalism, and Human Rights Committee. American College of Physicians Ethics Manual: sixth edition. Ann Intern Med 2012;156(1 pt 2):73-104.
21. Rein DB, Wittenborn JS, Smith BD, Liffmann DK, Ward JW. The cost-effectiveness, health benefits, and financial costs of new antiviral treatments for hepatitis C virus. Clin Infect Dis 2015;61:157-168.
22. Younossi ZM, Kanwal F, Saab S, Brown KA, El-Serag HB, Kim WR, et al. The impact of hepatitis C burden: an evidence-based approach. Aliment Pharmacol Ther 2014;39:518-531.
23. McCombs J, Matsuda T, Tonnu-Mihara I, Saab S, Hines P, L'italien G, et al. The risk of long-term morbidity and mortality in patients with chronic hepatitis C: results from an analysis of data from a Department of Veterans Affairs Clinical Registry. JAMA Intern Med 2014;174:204-212.
24. 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 2015;162:397-406.