title: Cost-effectiveness of all-oral ledipasvir/sofosbuvir regimens in patients with chronic hepatitis C virus genotype 1 infection.
abstract: BACKGROUND
  An all-oral, pegylated interferon (pegIFN)-free and ribavirin (RBV)-free single-tablet of ledipasvir (LDV) and sofosbuvir (SOF) is now approved for the treatment of patients infected with hepatitis C virus (HCV) genotype 1.
  
  
  OBJECTIVE
  To estimate the health economic outcomes for LDV/SOF compared with current treatments in US patients infected with HCV genotype 1.
  
  
  METHODS
  A hybrid decision-tree and Markov state-transition model was developed. For a cohort of 10,000 patients, the model captured outcomes for several pairings of LDV/SOF with comparators, including long-term health outcomes, number need to treat, life-years gained, quality-adjusted life-years (QALYS) gained, incremental cost-effectiveness ratios and costs per sustained virologic response (SVR). Patients with different levels of treatment experience and different cirrhosis stages were included.
  
  
  RESULTS
  LDV/SOF decreased the number of advanced liver disease cases by 0-93% compared with current regimens or no treatment in treatment-naïve patients. In treatment-experienced [pegIFN plus ribavirin (PR) or protease inhibitor (PI) + PR] patients, treatment with LDV/SOF decreased the incidence of advanced liver disease complications in most of the cases analysed, except SOF + SMV. For all patient sub-cohorts, LDV/SOF was associated with the lowest 1-year costs per SVR and, with regard to lifetime incremental costs per QALY gained, was either dominant or the most cost-effective treatment. Overall, treatment initiation at earlier stages of liver fibrosis resulted in improved health economic outcomes.
  
  
  CONCLUSIONS
  LDV/SOF is associated with more favourable short- and long-term health economic outcomes compared with current therapies for patients across all levels of treatment experience and cirrhosis stages.
authors.affiliation: Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA.
authors.forename: Z M
authors.initials: ZM
authors.lastname: Younossi
authors.forename: H
authors.initials: H
authors.lastname: Park
authors.forename: S
authors.initials: S
authors.lastname: Saab
authors.forename: A
authors.initials: A
authors.lastname: Ahmed
authors.forename: D
authors.initials: D
authors.lastname: Dieterich
authors.forename: S C
authors.initials: SC
authors.lastname: Gordon
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination; D005449:Fluorenes / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D005838:Genotype; D017048:Health Care Costs; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics; D006801:Humans; D007372:Interferons / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000821:virology; D008297:Male; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D012254:Ribavirin / Q000627:therapeutic use; D000069474:Sofosbuvir; D016896:Treatment Outcome; D014542:Uridine Monophosphate / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C000595958:ledipasvir, sofosbuvir drug combination; D012254:Ribavirin; D007372:Interferons; D014542:Uridine Monophosphate; D000069474:Sofosbuvir