title: Effectiveness of interferon-free therapy for the treatment of HCV-patients with compensated cirrhosis treated through the Irish early access program.
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).
  
  
  METHODS
  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%.
  
  
  CONCLUSIONS
  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.
authors.affiliation: a School of Medicine, Trinity College Dublin , Dublin , Ireland.
authors.forename: E
authors.initials: E
authors.lastname: Gray
authors.affiliation: b National Centre for Pharmacoeconomics, St. James' Hospital , Dublin , Ireland.|c School of Pharmacy, Royal College of Surgeons of Ireland , Dublin , Ireland.
authors.forename: A
authors.initials: A
authors.lastname: O'Leary
authors.affiliation: a School of Medicine, Trinity College Dublin , Dublin , Ireland.|e St James' Hospital , Dublin , Ireland.
authors.forename: C
authors.initials: C
authors.lastname: Bergin
authors.affiliation: f Beaumont Hospital , Dublin , Ireland.
authors.forename: M
authors.initials: M
authors.lastname: Cannon
authors.affiliation: g St. Luke's Hospital , Kilkenny , Ireland.
authors.forename: G
authors.initials: G
authors.lastname: Courtney
authors.affiliation: h Cork University Hospital , Cork , Ireland.
authors.forename: O
authors.initials: O
authors.lastname: Crosbie
authors.affiliation: i National Virus Reference Laboratory , University College Dublin , Dublin , Ireland.
authors.forename: C F
authors.initials: CF
authors.lastname: De Gascun
authors.affiliation: j Molecular Virology Diagnostic & Research Laboratory, Department of Medicine , University College Cork , Cork , Ireland.
authors.forename: L J
authors.initials: LJ
authors.lastname: Fanning
authors.affiliation: k St. Vincent's University Hospital , Dublin , Ireland.
authors.forename: E
authors.initials: E
authors.lastname: Feeney
authors.affiliation: k St. Vincent's University Hospital , Dublin , Ireland.
authors.forename: D D
authors.initials: DD
authors.lastname: Houlihan
authors.affiliation: d Mater Misericordiae University Hospital , Dublin , Ireland.
authors.forename: B
authors.initials: B
authors.lastname: Kelleher
authors.affiliation: d Mater Misericordiae University Hospital , Dublin , Ireland.|n School of Medicine , University College Dublin , Dublin , Ireland.
authors.forename: J S
authors.initials: JS
authors.lastname: Lambert
authors.affiliation: l University College Hospital , Galway , Ireland.
authors.forename: J
authors.initials: J
authors.lastname: Lee
authors.affiliation: d Mater Misericordiae University Hospital , Dublin , Ireland.|n School of Medicine , University College Dublin , Dublin , Ireland.
authors.forename: Pwg
authors.initials: P
authors.lastname: Mallon
authors.affiliation: f Beaumont Hospital , Dublin , Ireland.
authors.forename: S
authors.initials: S
authors.lastname: McConkey
authors.affiliation: k St. Vincent's University Hospital , Dublin , Ireland.
authors.forename: A
authors.initials: A
authors.lastname: McCormick
authors.affiliation: e St James' Hospital , Dublin , Ireland.
authors.forename: S
authors.initials: S
authors.lastname: McKiernan
authors.affiliation: f Beaumont Hospital , Dublin , Ireland.
authors.forename: C
authors.initials: C
authors.lastname: McNally
authors.affiliation: f Beaumont Hospital , Dublin , Ireland.
authors.forename: F
authors.initials: F
authors.lastname: Murray
authors.affiliation: d Mater Misericordiae University Hospital , Dublin , Ireland.
authors.forename: G
authors.initials: G
authors.lastname: Sheehan
authors.affiliation: d Mater Misericordiae University Hospital , Dublin , Ireland.
authors.forename: S
authors.initials: S
authors.lastname: Stewart
authors.affiliation: m University of Limerick , Limerick , Ireland.
authors.forename: C
authors.initials: C
authors.lastname: Walsh
authors.affiliation: a School of Medicine, Trinity College Dublin , Dublin , Ireland.|e St James' Hospital , Dublin , Ireland.
authors.forename: S
authors.initials: S
authors.lastname: Norris
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005449:Fluorenes / Q000009:adverse effects / Q000627:therapeutic use*; D005838:Genotype; D006297:Health Services Accessibility; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics / Q000254:growth & development; D006526:Hepatitis C / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D007494:Ireland; D008103:Liver Cirrhosis / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000821:virology; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D015397:Program Evaluation; D011446:Prospective Studies; D012042:Registries; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D000069474:Sofosbuvir; D000072230:Sustained Virologic Response; D013997:Time Factors; D016896:Treatment Outcome; D014542:Uridine Monophosphate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C000595958:ledipasvir, sofosbuvir drug combination; D012254:Ribavirin; D014542:Uridine Monophosphate; D000069474:Sofosbuvir
keywords: Hepatitis C; cirrhosis; direct acting antiviral agents; effectiveness; real world data