title: Cost-Effectiveness Modelling of Sofosbuvir-Containing Regimens for Chronic Genotype 5 Hepatitis C Virus Infection in South Africa.
abstract: BACKGROUND
  The recently launched nucleotide polymerase inhibitor sofosbuvir represents a significant turn in the treatment paradigm of chronic hepatitis C. While effective, sofosbuvir is also associated with a considerable cost.
  
  
  OBJECTIVE
  The objective of this study was to evaluate the cost effectiveness of sofosbuvir-containing regimens in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 5 (HCV-G5) mono-infection in South Africa (SA).
  
  
  METHODS
  We constructed a lifetime horizon decision-analytic Markov model of the natural history of HCV infection to evaluate the cost effectiveness of sofosbuvir-ledipasvir (SOF/LDV) monotherapy against sofosbuvir triple therapy (SOF-TT) (sofosbuvir + pegylated interferon and ribavirin [peg-INF/RBV]) and the current standard of care (SOC) (peg-INF/RBV) for patients with chronic HCV-G5 in the South African context. The model was populated with data from published literature, expert opinion and South African private sector cost data. The price modelled for sofosbuvir was the predicted South African private sector price of 82,129.32 South African rand (R) (US$7000) for 12 weeks. The analysis was conducted from a third-party payer perspective.
  
  
  METHODS
  The outcome measures were discounted and undiscounted costs (in 2015 South African rand and US dollars) and quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).
  
  
  RESULTS
  Outcomes from the cost-effectiveness model show that SOF/LDV yields the most favourable future health economic outcomes compared with SOF-TT and the current SOC in SA. Findings relating to the lifetime incremental cost per QALY gained for patients infected with HCV-G5 indicate that SOF/LDV dominated both SOF-TT and SOC, i.e. SOF/LDV is less costly and more effective.
  
  
  CONCLUSIONS
  Outcomes from this analysis suggest that at a price of R123,190 ($US10,500) for 12 weeks of SOF/LDV might be cost effective for South African patients infected with HCV-G5.
authors.affiliation: Medicine Usage in South Africa (MUSA), Faculty of Health Sciences, North-West University (Potchefstroom Campus), Potchefstroom, South Africa.
authors.forename: Ilanca
authors.initials: I
authors.lastname: Fraser
authors.affiliation: Medicine Usage in South Africa (MUSA), Faculty of Health Sciences, North-West University (Potchefstroom Campus), Potchefstroom, South Africa. johanita.burger@nwu.ac.za.
authors.forename: Johanita
authors.identifier: http://orcid.org/0000-0002-1740-5675
authors.initials: J
authors.lastname: Burger
authors.affiliation: Medicine Usage in South Africa (MUSA), Faculty of Health Sciences, North-West University (Potchefstroom Campus), Potchefstroom, South Africa.
authors.forename: Martie
authors.initials: M
authors.lastname: Lubbe
authors.affiliation: Augmentium Pharma Consulting Inc., Toronto, ON, Canada.
authors.forename: George
authors.initials: G
authors.lastname: Dranitsaris
authors.affiliation: Department of Medicine and Division of Hepatology, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa.
authors.forename: Mark
authors.initials: M
authors.lastname: Sonderup
authors.affiliation: HEXOR (Pty) Ltd., Midrand, Gauteng, South Africa.
authors.forename: Tienie
authors.initials: T
authors.lastname: Stander
mesh_terms: D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use; D001562:Benzimidazoles / Q000191:economics* / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D004359:Drug Therapy, Combination / Q000191:economics*; D005449:Fluorenes / Q000191:economics* / Q000627:therapeutic use*; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics* / Q000235:genetics; D016898:Interferon-alpha / Q000191:economics / Q000627:therapeutic use; D008390:Markov Chains; D015233:Models, Statistical; D011092:Polyethylene Glycols / Q000191:economics / Q000627:therapeutic use; D019057:Quality-Adjusted Life Years; D011994:Recombinant Proteins / Q000191:economics / Q000627:therapeutic use; D012254:Ribavirin / Q000191:economics / Q000627:therapeutic use; D000069474:Sofosbuvir; D013019:South Africa; D014542:Uridine Monophosphate / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; D016898:Interferon-alpha; D011994:Recombinant Proteins; C000595958:ledipasvir, sofosbuvir drug combination; D011092:Polyethylene Glycols; D012254:Ribavirin; D014542:Uridine Monophosphate; C100416:peginterferon alfa-2a; D000069474:Sofosbuvir