Cost-effectiveness of all-oral ledipasvir/sofosbuvir regimens in patients with chronic hepatitis C virus genotype 1 infection

Aliment Pharmacol Ther. 2015 Mar;41(6):544-63. doi: 10.1111/apt.13081. Epub 2015 Jan 26.


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.

Aim: 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.

Conclusion: 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.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / economics
  • Antiviral Agents / therapeutic use*
  • Benzimidazoles / administration & dosage
  • Benzimidazoles / economics
  • Benzimidazoles / therapeutic use*
  • Cost-Benefit Analysis
  • Drug Therapy, Combination
  • Fluorenes / administration & dosage
  • Fluorenes / economics
  • Fluorenes / therapeutic use*
  • Genotype
  • Health Care Costs
  • Hepacivirus / genetics
  • Hepacivirus / isolation & purification
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / economics
  • Humans
  • Interferons / therapeutic use
  • Liver Cirrhosis / drug therapy*
  • Liver Cirrhosis / virology
  • Male
  • Middle Aged
  • Quality-Adjusted Life Years
  • Ribavirin / therapeutic use
  • Sofosbuvir
  • Treatment Outcome
  • Uridine Monophosphate / administration & dosage
  • Uridine Monophosphate / analogs & derivatives*
  • Uridine Monophosphate / economics
  • Uridine Monophosphate / therapeutic use


  • Antiviral Agents
  • Benzimidazoles
  • Fluorenes
  • ledipasvir, sofosbuvir drug combination
  • Ribavirin
  • Interferons
  • Uridine Monophosphate
  • Sofosbuvir