title: Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 hepatitis C virus in interferon-ineligible/intolerant individuals.
abstract: Treatment guidance for chronic hepatitis C (CHC) released by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) offers two options for interferon (IFN)-ineligible/intolerant individuals with genotype 1 infection: sofosbuvir/ribavirin (SOF/RBV) for 24 weeks or sofosbuvir/simeprevir (SOF/SMV) for 12 weeks. A 24-week course of SOF/RBV costs approximately US$169,000, with sustained virologic response (SVR) rates ranging from 52% to 84%; 12 weeks of SOF/SMV costs approximately $150,000, with SVR between 89% and 100%. Because SOF/SMV is currently used off-label, debate exists among physicians and payers about whether it should be prescribed and covered. This article presents a cost-effectiveness analysis of these two treatment regimens accounting for costs of drugs, treatment-related medical care, retreatment for individuals who do not achieve SVR, and natural history of continued HCV infection after failed retreatment. Analysis uses a Markov model with a lifetime horizon and a societal perspective. In the base-case scenario, SOF/SMV dominated SOF/RBV in a modeled 50-year-old cohort of treatment-naïve and -experienced subjects, excluding those who failed earlier therapy with telaprevir or boceprevir. SOF/SMV yielded lower costs and more quality-adjusted life years (QALYs) for the average subject, compared to SOF/RBV ($165,336 and 14.69 QALYs vs. $243,586 and 14.45 QALYs, respectively). In base-case cost analysis, the SOF/SMV treatment strategy saved $91,590 per SVR, compared to SOF/RBV. Under all one-way sensitivity scenarios, SOF/SMV remained dominant and resulted in cost savings.
  
  
  CONCLUSIONS
  These results suggest that a 12-week course of SOF/SMV is a more cost-effective treatment for genotype 1 CHC than 24 weeks of SOF/RBV among IFN-ineligible/intolerant individuals, supporting the AASLD/IDSA guidance and offering implications for both clinical and regulatory decision making as well as pharmaceutical pricing.
authors.affiliation: Center for AIDS Research, Emory University School of Medicine and Veterans Affairs Medical Center, Atlanta, GA.
authors.forename: Liesl M
authors.initials: LM
authors.lastname: Hagan
authors.forename: Mark S
authors.initials: MS
authors.lastname: Sulkowski
authors.forename: Raymond F
authors.initials: RF
authors.lastname: Schinazi
mesh_terms: D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D016527:Drug Costs / Q000706:statistics & numerical data*; D004359:Drug Therapy, Combination; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy / Q000191:economics / Q000401:mortality; D006575:Heterocyclic Compounds, 3-Ring / Q000191:economics* / Q000627:therapeutic use; D006801:Humans; D007372:Interferons / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000191:economics / Q000401:mortality; D008390:Markov Chains; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D019233:Retreatment / Q000191:economics; D012254:Ribavirin / Q000191:economics* / Q000627:therapeutic use; D000069616:Simeprevir; D000069474:Sofosbuvir; D013449:Sulfonamides / Q000191:economics* / Q000627:therapeutic use; D014542:Uridine Monophosphate / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D006575:Heterocyclic Compounds, 3-Ring; D013449:Sulfonamides; D012254:Ribavirin; D007372:Interferons; D000069616:Simeprevir; D014542:Uridine Monophosphate; D000069474:Sofosbuvir