Effectiveness of interferon-free therapy for the treatment of HCV-patients with compensated cirrhosis treated through the Irish early access program

Expert Rev Gastroenterol Hepatol. 2017 Jun;11(6):593-601. doi: 10.1080/17474124.2017.1292850. Epub 2017 Feb 22.

Abstract

Background: We investigated the real-world effectiveness of interferon-free regimens for the treatment of patients with compensated cirrhosis infected with hepatitis C virus (HCV).

Method: Using the Irish national HCV treatment registry, the effectiveness and safety of interferon-free regimens for HCV-infected patients treated between April 2015 and August 2016, was determined.

Results: A SVR12 was achieved in 86% of subjects treated with sofosbuvir/ledipasvir ± ribavirin (SOF/LDV±RBV), 93% treated with paritaprevir, ombitasvir and ritonavir combined with dasabuvir ± ribavirin (3D±RBV) and 89% treated with sofosbuvir/daclatasvir ± ribavirin (SOF/DCV±RBV). The discontinuation rate was 5% and the on-treatment mortality rate was 1%.

Conclusion: The availability of interferon-free regimens represents a significant breakthrough for the treatment of HCV infection. Treatments options, with high SVR12 rates, are now available for patients with compensated cirrhosis who were unsuitable for treatment with interferon-based regimens. Data obtained from studies conducted in real world practice provide robust information fundamental for input into future economic evaluations for agents used for the treatment of HCV infection.

Keywords: Hepatitis C; cirrhosis; direct acting antiviral agents; effectiveness; real world data.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Benzimidazoles / adverse effects
  • Benzimidazoles / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Fluorenes / adverse effects
  • Fluorenes / therapeutic use*
  • Genotype
  • Health Services Accessibility*
  • Hepacivirus / drug effects*
  • Hepacivirus / genetics
  • Hepacivirus / growth & development
  • Hepatitis C / complications
  • Hepatitis C / diagnosis
  • Hepatitis C / drug therapy*
  • Hepatitis C / mortality
  • Humans
  • Ireland
  • Liver Cirrhosis / diagnosis
  • Liver Cirrhosis / drug therapy*
  • Liver Cirrhosis / mortality
  • Liver Cirrhosis / virology
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Program Evaluation
  • Prospective Studies
  • Registries
  • Ribavirin / adverse effects
  • Ribavirin / therapeutic use*
  • Sofosbuvir
  • Sustained Virologic Response
  • Time Factors
  • Treatment Outcome
  • Uridine Monophosphate / adverse effects
  • Uridine Monophosphate / analogs & derivatives*
  • Uridine Monophosphate / therapeutic use

Substances

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