Acta Scientific Medical Sciences (ISSN: 2582-0931)

Research Article Volume 4 Issue 9

The Cost-Effectiveness of Treatments in Non-Cirrhotic Saudi Arabian Patients with Genotype 1 and Genotype 4 Chronic Hepatitis C

Mohammad Alowairdhi1,2, Varun Vaidya3,4*, Eric Sahloff4 and Cindy Puffer5

1Department of Health Outcomes and Socioeconomic Sciences, University of Toledo, Toledo, OH, USA
2Senior Pharmacist, Pricing and Pharmacoeconomics Department, Drug Sector, Saudi Food and Drug Authority, USA
3Division Head, Center for Pharmaceutical Care and Outcomes Research, College of Pharmacy and Pharmaceutical Sciences, University of Toledo, Toledo, OH, USA
4Associate Professor, Department of Health Outcomes and Socioeconomic Sciences, University of Toledo, Toledo, OH, USA
5Managed Care Pharmacy Operations Manager, Department of Health Outcomes and Socioeconomic Sciences, University of Toledo, Toledo, OH, USA

*Corresponding Author: Varun Vaidya, Division Head, Center for Pharmaceutical Care and Outcomes Research, College of Pharmacy and Pharmaceutical Sciences and Associate Professor, Department of Health Outcomes and Socioeconomic Sciences, University of Toledo, Toledo, OH, USA.

Received: May 28, 2020; Published: August 26, 2020

Reprints View PDF Related Articles

×

Abstract

Objectives: (1) To estimate the total costs of hepatitis C treatment choices recommended by the Saudi Association for the Study of Liver Diseases and Transplantation (SASLT) based on data from the Saudi Food and Drug Authority (SFDA), (2) To develop and operationalize the decision tree model and calculate the base case incremental cost-effectiveness ratio (ICER), (3) To perform one-way and probabilistic sensitivity analyses testing the underlying assumptions in the decision tree model.

Method: A cost-effectiveness analysis was performed on a hypothetical cohort comparing different chronic hepatitis C treatment strategies from the (SFDA)’s perspective over a three-month period using a decision tree model. Data for this study were obtained retrospectively from the (SFDA) and published literature. Costs were measured in United States Dollars (USD). Life-years gained (Ly) were the outcomes measured in this study. Since the SASLT guidelines differ between genotype 1 and genotype 4, There were two separate decision tree models and analyses for each genotype cohort at a willingness to pay (WTP) of $65,000.

Result and Discussion: In genotype 1 base case analysis, the incremental cost-effectiveness comparison between the interventions showed that both Elbasvir/Grazoprevir and Paritaprevir/Ritonavir/Ombitasvir plus Dasabuvir with Ribavirin (3D+RBV) dominated Sofosbuvir with Simeprevir and Ledipasvir/Sofosbuvir. Against 3D+RBV, the ICER was $33,796/Ly for each additional cure. In genotype 4 base case analysis, Paritaprevir/Ritonavir/Ombitasvir with Ribavirin (2D+RBV) dominated Ledipasvir/Sofosbuvir and Sofosbuvir plus Simeprevir. The interventions compared in genotype 1 are competitive and cost effective in exception of Sofosbuvir with Simeprevir while 2D+RBV is highly recommended in genotype 4. Interventions in both genotypes will be dominated by Sofosbuvir low-priced generics.

Keywords: Hepatitis C; Genotype 1; Genotype 4

×

References

  1. “Hepatitis C”. World Health Organization (2016).
  2. Wang LS., et al. “Hepatitis C—A clinical review”. Journal of Medical Virology 88 (2016): 1844-1855.
  3. Surveillance for viral hepatitis - United States, 2013 (2016).
  4. AASLD/IDSA. Recommendations for testing, managing, and treating hepatitis C.
  5. Thomas XV. “Epidemiological, immunological and virological aspects of acute and chronic hepatitis C virus infections” (2015).
  6. Murphy DG., et al. “Use of sequence analysis of the NS5B region for routine genotyping of hepatitis C virus with reference to C/E1 and 5' untranslated region sequences”. Journal of Clinical Microbiology 45 (2007): 1102-1112.
  7. Shire NJ and Sherman KE. “Epidemiology of Hepatitis C Virus: A Battle on New Frontiers”. Gastroenterology clinics of North America4 (2015): 699-716.
  8. Messina JP., et al. “Global distribution and prevalence of hepatitis C virus genotypes”. Hepatology1 (2015): 77-87.
  9. Shepard CW., et al. “Global epidemiology of hepatitis C virus infection”. The Lancet Infectious Diseases9 (2005): 558-567.
  10. Simmonds P. “The origin and evolution of hepatitis viruses in humans”. Journal of General Virology 82 (2001): 693-712.
  11. Mohamed AA., et al. “Hepatitis C virus: A global view”. World Journal of Hepatology26 (2015): 2676.
  12. Alghamdi AS., et al. “SASLT Position Statement on the Direct-Acting Antiviral Agents for the Treatment of Hepatitis C Virus Infection”. Saudi Journal of Gastroenterology: Official Journal of the Saudi Gastroenterology Association2 (2015): 60-63.
  13. Team MP. Kingdom of Saudi Arabia - ministry of health portal (2015).
  14. Alghamdi AS., et al. “SASLT Guidelines: Update in Treatment of Hepatitis C Virus Infection”. Saudi Journal of Gastroenterology: Official Journal of the Saudi Gastroenterology Association 22 (2015): S25-S57.
  15. Abdo AA., et al. “Epidemiology of Viral Hepatitis in Saudi Arabia: Are We Off the Hook?” Saudi Journal of Gastroenterology: Official Journal of the Saudi Gastroenterology Association6 (2012): 349-357.
  16. Drugs@FDA: FDA approved drug products (2016).
  17. Zhang X. “Direct anti-HCV agents”. Acta Pharmaceutica Sinica B 6.1 (2016): 26-31.
  18. Saudi Food and Drug Authority - drug list search (2016).
  19. Saudi Food and Drug Authority Regulations and guidelines (2016).
  20. Noureddin M., et al. “Association of IL28B genotype with fibrosis progression and clinical outcomes in patients with chronic hepatitis C: A longitudinal analysis”. Hepatology 5 (2013): 1548-1557.
  21. Boglione L., et al. “The Role of IL28B Genotype in HCV-RNA Baseline Levels”. Intervirology2 (2016): 67-68.
  22. Arenas‐Guzman R., et al. “Pharmacoeconomics-an aid to better decision‐making”. Journal of the European Academy of Dermatology and Venereology 19 (2005): 34-39.
  23. Trask LS. Pharmacoeconomics: Principles, Methods, and Applications: Pharmacotherapy: A Pathophysiologic approach (2011).
  24. Al-Jazairi AS., et al. “Pharmacoeconomic Analysis in Saudi Arabia: An Overdue Agenda Item for Action”. Annals of Saudi Medicine4 (2011): 335-341.
  25. Marseille E., et al. “Thresholds for the cost-effectiveness of interventions: alternative approaches”. Bulletin of the World Health Organization2 (2015): 118-124.
  26. Saudi Center for Organ Transplantation (2016).
  27. Aljumah AA., et al. “Epidemiology, Disease Burden, and Treatment Strategies of Chronic Hepatitis C Virus Infections in Saudi Arabia in the New Treatment Paradigm Shift”. Saudi Journal of Gastroenterology: Official Journal of the Saudi Gastroenterology Association4 (2016): 269-281.
  28. Davis KL., et al. “Direct economic burden of chronic hepatitis C virus in a United States managed care population”. Journal of Clinical Gastroenterology 45 (2011): e17-e24.
  29. Alkhamis A. “Health care system in Saudi Arabia: an overview”. Eastern Mediterranean Health Journal10 (2012): 1078-1080.
  30. Saudi Arabia: Saudi Food and Drug Authority - SFDA (2017).
  31. SPO Regulations. (KACST) (2017).
  32. Saudi Arabian Monetary Agency Yearly statistics (2016).
  33. Devarajan, Shantayanan Mottaghi Lili. MENA Quarterly Economic Brief, July 2016: Whither Oil Prices?. Washington, DC: World Bank. © World Bank (2016).
  34. Saudi Arabia economy - GDP, inflation, CPI and interest rate (2016).
  35. Ministry of Economy and Planning. Knowledge resources - ministry of economy and planning (2016).
  36. Saab S., et al. “Cost-effectiveness of currently recommended direct-acting antiviral treatments in patients infected with genotypes 1 or 4 hepatitis C virus in the US”. Journal of Medical Economics (2016): 1-11.
  37. Liu S., et al. “New protease inhibitors for the treatment of chronic hepatitis C: a cost-effectiveness analysis”. Annals of Internal Medicine4 (2012): 279-290.
  38. TreeAge Pro. R1.0. TreeAge Software, Williamstown, MA software (2015).
  39. Ryder HF., et al. “Decision Analysis and Cost-effectiveness Analysis”. Seminars in Spine Surgery4 (2009): 216-222.
  40. Liakina V., et al. “Historical epidemiology of hepatitis C virus (HCV) in select countries-volume 3”. Journal of viral hepatitis 22 (2015): 4-20.
  41. Saudi Arabia, World Health Organization (2017).
  42. Lawitz E., et al. “Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial”. The Lancet9916 (2014): 515-523.
  43. Lawitz E., et al. “Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial”. The Lancet9973 (2015): 1075-1086.
  44. Lawitz E., et al. “Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study”. The Lancet9956 (2014): 1756-1765.
  45. Lawitz E., et al. “Efficacy and safety of ombitasvir, paritaprevir, and ritonavir in an open-label study of patients with genotype 1b chronic hepatitis C virus infection with and without cirrhosis”. Gastroenterology 4 (2015): 971-980.
  46. Younossi ZM., et al. “Ledipasvir/sofosbuvir treatment of hepatitis C virus is associated with reduction in serum apolipoprotein levels”. Journal of Viral Hepatitis 12 (2015): 977-982.
  47. Younossi, ZM., et al. “Treatment with ledipasvir and sofosbuvir improves patient‐reported outcomes: Results from the ION‐1,‐2, and‐3 clinical trials”. Hepatology62 (2015): 1798-1808.
  48. Abergel A., et al. “Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection”. Hepatology4 (2016): 1049-1056.
  49. Kumada H., et al. “The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study”. Journal of Gastroenterology (2016): 1-14.
  50. Zeuzem S., et al. “Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 InfectionA Randomized TrialC-EDGE Treatment-Naive Trial of Grazoprevir-Elbasvir”. Annals of Internal Medicine1 (2015): 1-13.
  51. Buti M., et al. “Simeprevir in combination with sofosbuvir in treatment‐naïve and‐experienced patients with hepatitis C virus genotype 4 infection: a Phase III, open‐label, single‐arm study (PLUTO)”. Alimentary Pharmacology and Therapeutics 3 (2017): 468-475.
  52. Ferenci P., et al. “ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV”. New England Journal of Medicine21 (2014): 1983-1992.
  53. Andreone P., et al. “ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection”. Gastroenterology2 (2014): 359-365.
  54. Feld JJ., et al. “Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin”. New England Journal of Medicine17 (2014): 1594-1603.
  55. Saudi Arabia GDP per capita | 1968-2017 | Data | Chart | Calendar.
  56. Zhang S., et al. “Cost-effectiveness of sofosbuvir-based treatments for chronic hepatitis C in the US”. BMC Gastroenterology1 (2015): 98.
×

Citation

Citation: Varun Vaidya., et al. “The Cost-Effectiveness of Treatments in Non-Cirrhotic Saudi Arabian Patients with Genotype 1 and Genotype 4 Chronic Hepatitis C".Acta Scientific Medical Sciences 4.9 (2020): 03-14.




Metrics

Acceptance rate32%
Acceptance to publication20-30 days

Indexed In




News and Events


  • Certification for Review
    Acta Scientific certifies the Editors/reviewers for their review done towards the assigned articles of the respective journals.
  • Submission Timeline for Upcoming Issue
    The last date for submission of articles for regular Issues is December 25, 2024.
  • Publication Certificate
    Authors will be issued a "Publication Certificate" as a mark of appreciation for publishing their work.
  • Best Article of the Issue
    The Editors will elect one Best Article after each issue release. The authors of this article will be provided with a certificate of "Best Article of the Issue"

Contact US





Creative Commons License Open Access by Acta Scientific is licensed under a Creative Commons Attribution 4.0 International License
Based on a work at https://actascientific.com

ff

Acta-Publications

ff

© 2021 Acta Scientific, All rights reserved.