Evaluation of the clinical and economic value of sofosbuvir/velpatasvir (SOF/VEL) in patients with chronic hepatitis C in Spain during the last 5 years

Gastroenterol Hepatol. 2024 Dec;47(10):502199. doi: 10.1016/j.gastrohep.2024.502199. Epub 2024 May 7.
[Article in English, Spanish]

Abstract

Objective: Direct-acting antivirals for the treatment of hepatitis C virus (HCV) represented a paradigm shift. In 2017, sofosbuvir/velpatasvir (SOF/VEL-Epclusa®) was approved, which showed a high cure rate in all patient, contributing to HCV elimination. The analysis aimed to quantify the clinical and economic value of SOF/VEL in HCV chronic patients since its approval in Spain.

Methods: An economic evaluation was elaborated adapting a Markov model that simulated the lifetime disease progression in of all HCV chronic patients treated with SOF/VEL (30,488 patients) since its launch (5-years), compared to previous therapies. Patients entered the model and were distributed between the fibrosis states (F0-to-F4) in treated and untreated. All patients (100%) were treated with SOF/VEL regardless of their fibrosis, and 49% with previous therapies in ≥F2. The average sustained viral response (SVR) rates 98.9% SOF/VEL versus 61.0% previous therapies. All parameters for the analysis were obtained from real-life data and literature. Only direct healthcare costs associated with disease management were included. The SOF/VEL value was measured as the number of hepatic complications avoided and their associated cost, and hepatic mortality compared to previous therapies. National Health System perspective and a 3% discount rate was applied.

Results: SOF/VEL decreased the number of liver complications, avoiding 92% decompensated cirrhosis, 80% hepatocellular carcinomas, and 87% liver transplants, as well as 85% liver-related mortality. Their cost associated was reduced, amounting to savings of 197M€.

Conclusion: SOF/VEL adds relevant value to the HCV treatment, reducing the clinical and economic disease burden and contributing to HCV elimination in Spain.

Keywords: Antivirales de acción directa; DAAs; Economía de la salud; Health economics; Hepatitis C; Sofosbuvir/velpatasvir; Valor; Value.

MeSH terms

  • Antiviral Agents* / economics
  • Antiviral Agents* / therapeutic use
  • Carbamates* / economics
  • Carbamates* / therapeutic use
  • Cost-Benefit Analysis
  • Disease Progression
  • Drug Combinations*
  • Female
  • Hepatitis C, Chronic* / complications
  • Hepatitis C, Chronic* / drug therapy
  • Hepatitis C, Chronic* / economics
  • Heterocyclic Compounds, 4 or More Rings* / economics
  • Heterocyclic Compounds, 4 or More Rings* / therapeutic use
  • Humans
  • Liver Cirrhosis / economics
  • Liver Neoplasms / drug therapy
  • Liver Neoplasms / economics
  • Male
  • Markov Chains
  • Middle Aged
  • Sofosbuvir* / economics
  • Sofosbuvir* / therapeutic use
  • Spain

Substances

  • Sofosbuvir
  • Carbamates
  • Heterocyclic Compounds, 4 or More Rings
  • Antiviral Agents
  • Drug Combinations
  • sofosbuvir-velpatasvir drug combination