title: Cost-effectiveness analysis of ledipasvir/sofosbuvir in patients with chronic hepatitis C: Treatment of patients with absence or mild fibrosis compared to patients with advanced fibrosis.
abstract: To evaluate the cost-effectiveness of ledipasvir/sofosbuvir (LDV/SOF) in treatment-naïve patients with chronic hepatitis C (CHC) genotype 1 (GT1) in the absence or mild fibrosis (F0-F1) versus advanced fibrosis (F2-F4), from the perspective of the Spanish Health System. A Markov model was developed to simulate disease progression, estimating costs and outcomes [life years gained (LYG) and quality-adjusted life years (QALY)] derived from starting with LDV/SOF in patients with F0-F1 compared with F2-F4. Therapy duration was 8 weeks in noncirrhotic patients with viral load <6 million IU/mL and 12 weeks in the remaining patients. Sustained virologic response rates were obtained from real-world cohort studies. Transition probabilities, utilities and direct costs were obtained from the literature. A 3% annual discount rate was applied to costs and outcomes. Sensitivity analyses were performed. LDV/SOF in F0-F1 patients was a dominant strategy, being more effective (19.85 LYG and 19.80 QALY) than beginning treatment in F2-F4 patients (18.63 LYG and 16.25 QALY), generating savings of €9228 per patient (€3661 due to disease management and monitoring). In a cohort of 1000 patients, LDV/SOF in F0-F1 patients decreased the number of cases of decompensated cirrhosis (93%), hepatocellular carcinoma (97%) and liver-related deaths (95%) and prevented 6 liver transplants compared to initiating LDV/SOF in F2-F4 patients. In CHC treatment-naïve GT1 patients, starting treatment with LDV/SOF in patients with F0-F1 compared to those with F2-F4 increases effectiveness by 1.22 LYG and 3.55 QALY gained and reduces disease burden and it is associated with cost savings.
authors.affiliation: Liver Unit, University Hospital Vall d'Hebron and CIBERehd, Barcelona, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Buti
authors.affiliation: Pharmacoeconomics & Outcomes Research Iberia (PORIB), Madrid, Spain.
authors.forename: R
authors.identifier: 0000-0003-1083-7288
authors.initials: R
authors.lastname: Domínguez-Hernández
authors.affiliation: Pharmacoeconomics & Outcomes Research Iberia (PORIB), Madrid, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Oyagüez
authors.affiliation: Pharmacoeconomics & Outcomes Research Iberia (PORIB), Madrid, Spain.
authors.forename: M A
authors.initials: MA
authors.lastname: Casado
authors.affiliation: Liver Unit, University Hospital Vall d'Hebron and CIBERehd, Barcelona, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Esteban
mesh_terms: D000998:Antiviral Agents / Q000191:economics* / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000191:economics* / Q000627:therapeutic use*; D015331:Cohort Studies; D003362:Cost-Benefit Analysis; D005449:Fluorenes / Q000191:economics* / Q000627:therapeutic use*; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy*; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D000069474:Sofosbuvir; D013030:Spain; D000072230:Sustained Virologic Response; D016896:Treatment Outcome; D014542:Uridine Monophosphate / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C000595958:ledipasvir, sofosbuvir drug combination; D014542:Uridine Monophosphate; D000069474:Sofosbuvir
keywords: cost-effectiveness; genotype 1; hepatitis C; treatment