E Gray1, A O'Leary2,3, C Bergin1,4, M Cannon5, G Courtney6, O Crosbie7, C F De Gascun8, L J Fanning9, E Feeney10, D D Houlihan10, B Kelleher11, J S Lambert11,12, J Lee13, Pwg Mallon11,12, S McConkey5, A McCormick10, S McKiernan4, C McNally5, F Murray5, G Sheehan11, S Stewart11, C Walsh14, S Norris1,4. 1. a School of Medicine, Trinity College Dublin , Dublin , Ireland. 2. b National Centre for Pharmacoeconomics, St. James' Hospital , Dublin , Ireland. 3. c School of Pharmacy, Royal College of Surgeons of Ireland , Dublin , Ireland. 4. e St James' Hospital , Dublin , Ireland. 5. f Beaumont Hospital , Dublin , Ireland. 6. g St. Luke's Hospital , Kilkenny , Ireland. 7. h Cork University Hospital , Cork , Ireland. 8. i National Virus Reference Laboratory , University College Dublin , Dublin , Ireland. 9. j Molecular Virology Diagnostic & Research Laboratory, Department of Medicine , University College Cork , Cork , Ireland. 10. k St. Vincent's University Hospital , Dublin , Ireland. 11. d Mater Misericordiae University Hospital , Dublin , Ireland. 12. n School of Medicine , University College Dublin , Dublin , Ireland. 13. l University College Hospital , Galway , Ireland. 14. m University of Limerick , Limerick , Ireland.
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.
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-infectedpatients 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.
Entities:
Keywords:
Hepatitis C; cirrhosis; direct acting antiviral agents; effectiveness; real world data