Michelle C M Cheung1, Alex J Walker2, Benjamin E Hudson3, Suman Verma4, John McLauchlan5, David J Mutimer6, Ashley Brown7, William T H Gelson8, Douglas C MacDonald9, Kosh Agarwal4, Graham R Foster10, William L Irving11. 1. Liver Unit, Blizard Insitute, Queen Mary University of London, United Kingdom. 2. Faculty of Medicine & Health Sciences, University of Nottingham, United Kingdom. 3. University Hospitals Bristol NHS Trust, United Kingdom. 4. Institute of Liver Studies, King's College London, United Kingdom. 5. MRC-University of Glasgow Centre for Virus Research, United Kingdom. 6. Centre for Liver Research and NIHR Biomedical Research Unit, Queen Elizabeth Hospital, Birmingham, United Kingdom. 7. Department of Hepatology, St Mary's Hospital, Imperial College London, United Kingdom. 8. Department of Hepatology, Cambridge University Hospitals NHS Foundation Trust, United Kingdom. 9. UCL Institute for Liver and Digestive Health, University College London, United Kingdom. 10. Queen Mary University of London, United Kingdom. Electronic address: g.r.foster@qmul.ac.uk. 11. NIHR Nottingham Digestive Diseases Biomedical Research Unit, United Kingdom.
Abstract
BACKGROUND & AIMS: Direct-acting antivirals have become widely used for patients with chronic hepatitis C virus infection with decompensated cirrhosis. Virological responses are excellent and early improvements in liver function, at least in a proportion of patients, have been observed but the longer term impact of viral clearance on end-stage liver disease complications is unclear. METHODS: Prospective study of patients with decompensated cirrhosis who received 12weeks of all-oral direct-acting antivirals through the English Expanded Access Programme. Endpoints were deaths, liver transplantation, hepatocellular carcinoma, serious decompensation events, sepsis or hospitalisations, and MELD scores between start of therapy to 15months post-treatment start. An untreated cohort of patients was retrospectively studied over 6months for comparison. RESULTS: Amongst 317/406 patients who achieved sustained virological response at 24weeks post-treatment, there were 9 deaths (3%), 17 new liver cancers (5%), 39 transplantations (12%) and 52 with serious decompensations (16%), over 15months. When compared to the first six months from treatment start and to untreated patients, there was a reduction in incidence of decompensations [30/406 (7%) in months 6-15 and 72/406 (18%) in months 0-6 for treated patients vs. 73/261 (28%) in untreated patients]. There was no significant difference in liver cancer incidence (10/406 (2.5%) in months 6-15 and 17/406 (4%) in months 0-6 for treated patients vs. 11/261 (4%) in untreated patients). CONCLUSIONS: This study suggests that antiviral therapy in patients with decompensated cirrhosis led to prolonged improvement in liver function, with no evidence of paradoxical adverse impact nor increase in liver malignancy. LAY SUMMARY: This is a report of a large group of patients in England who have hepatitis C virus (HCV) infection with advanced liver disease. They have been treated with new anti-HCV drugs, which cured the infection in the majority. This study looks at their outcomes a year following treatment, in terms of deaths, cancers and other complications of advanced liver disease. We conclude that in most patients anti-HCV treatment is beneficial even in advanced liver disease.
BACKGROUND & AIMS: Direct-acting antivirals have become widely used for patients with chronic hepatitis C virus infection with decompensated cirrhosis. Virological responses are excellent and early improvements in liver function, at least in a proportion of patients, have been observed but the longer term impact of viral clearance on end-stage liver disease complications is unclear. METHODS: Prospective study of patients with decompensated cirrhosis who received 12weeks of all-oral direct-acting antivirals through the English Expanded Access Programme. Endpoints were deaths, liver transplantation, hepatocellular carcinoma, serious decompensation events, sepsis or hospitalisations, and MELD scores between start of therapy to 15months post-treatment start. An untreated cohort of patients was retrospectively studied over 6months for comparison. RESULTS: Amongst 317/406 patients who achieved sustained virological response at 24weeks post-treatment, there were 9 deaths (3%), 17 new liver cancers (5%), 39 transplantations (12%) and 52 with serious decompensations (16%), over 15months. When compared to the first six months from treatment start and to untreated patients, there was a reduction in incidence of decompensations [30/406 (7%) in months 6-15 and 72/406 (18%) in months 0-6 for treated patients vs. 73/261 (28%) in untreated patients]. There was no significant difference in liver cancer incidence (10/406 (2.5%) in months 6-15 and 17/406 (4%) in months 0-6 for treated patients vs. 11/261 (4%) in untreated patients). CONCLUSIONS: This study suggests that antiviral therapy in patients with decompensated cirrhosis led to prolonged improvement in liver function, with no evidence of paradoxical adverse impact nor increase in liver malignancy. LAY SUMMARY: This is a report of a large group of patients in England who have hepatitis C virus (HCV) infection with advanced liver disease. They have been treated with new anti-HCV drugs, which cured the infection in the majority. This study looks at their outcomes a year following treatment, in terms of deaths, cancers and other complications of advanced liver disease. We conclude that in most patients anti-HCV treatment is beneficial even in advanced liver disease.
Authors: Marcus-Alexander Wörns; Peter Robert Galle; Stefan Zeuzem; Peter Schirmacher; Michael Manns; Arndt Vogel Journal: Dtsch Arztebl Int Date: 2017-09-04 Impact factor: 5.594