Raoel Maan1, Marjolein van Tilborg2, Katja Deterding3, Alnoor Ramji4, Adriaan J van der Meer2, Florence Wong5, Scott Fung5, Morris Sherman5, Michael P Manns3, Markus Cornberg3, Bettina E Hansen2, Heiner Wedemeyer3, Harry L A Janssen6, Robert J de Knegt2, Jordan J Feld5. 1. Toronto Centre for Liver Disease, Toronto Western and General Hospital, University Health Network, University of Toronto, Toronto, Canada; Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands. Electronic address: r.maan@erasmusmc.nl. 2. Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands. 3. Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. 4. Department of Medicine, Division of Gastroenterology, University of British Columbia, Vancouver, British Columbia, Canada. 5. Toronto Centre for Liver Disease, Toronto Western and General Hospital, University Health Network, University of Toronto, Toronto, Canada. 6. Toronto Centre for Liver Disease, Toronto Western and General Hospital, University Health Network, University of Toronto, Toronto, Canada; Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands.
Abstract
BACKGROUND & AIMS: Direct-acting antivirals (DAAs) have revolutionized treatment for patients with chronic hepatitis C virus (HCV) infection, leading to a high rates of sustained virologic response. This study assessed the real-world safety and effectiveness of DAA-based antiviral therapy for the treatment of cirrhotic patients with chronic HCV infection. METHODS: This international, multicenter cohort study included all consecutive patients with chronic HCV infection and cirrhosis who underwent antiviral therapy with second-generation DAAs. Data on all patients were analyzed to assess treatment response. Predictors of hepatic decompensation during antiviral therapy were assessed using Cox proportional hazards regression analyses. RESULTS: Until June 2015, 433 cirrhotic patients with chronic HCV infection started DAA-based treatment. Their mean age was 57.8 (±8.7) years, 277 (64.0%) patients were male, and 114 (26.3%) had a Child-Pugh (CP) score of B/C cirrhosis. The sustained virologic response rate at 12 weeks was similar among patients with a CP score of A (261 of 304 [85.9%]) and a CP score of B/C (83 of 101 [82.2%]; P = .37). A baseline albumin level less than 35 g/L (hazard ratio [HR], 3.11; 95% confidence interval [CI], 1.23-7.84; P = .005), baseline MELD score of 14 or higher (HR, 1.63; 95% CI, 1.03-2.61; P = .037), and HCV genotype 3 (HR, 2.05; 95% CI, 1.09-3.88; P = .033) were associated independently with hepatic decompensation during antiviral treatment among patients with a CP score of B/C. CONCLUSIONS: This large cohort study showed that therapy is safe and effective in patients with compensated (CP score of A) cirrhosis. For patients with decompensated (CP score of B/C) cirrhosis, albumin level less than 35 g/L, MELD score of 14 or greater, and HCV genotype 3 are important risk factors for hepatic decompensation during DAA-based treatment. Therefore, these patients require close monitoring during antiviral therapy or treatment should be deferred until after transplantation.
BACKGROUND & AIMS: Direct-acting antivirals (DAAs) have revolutionized treatment for patients with chronic hepatitis C virus (HCV) infection, leading to a high rates of sustained virologic response. This study assessed the real-world safety and effectiveness of DAA-based antiviral therapy for the treatment of cirrhoticpatients with chronic HCV infection. METHODS: This international, multicenter cohort study included all consecutive patients with chronic HCV infection and cirrhosis who underwent antiviral therapy with second-generation DAAs. Data on all patients were analyzed to assess treatment response. Predictors of hepatic decompensation during antiviral therapy were assessed using Cox proportional hazards regression analyses. RESULTS: Until June 2015, 433 cirrhoticpatients with chronic HCV infection started DAA-based treatment. Their mean age was 57.8 (±8.7) years, 277 (64.0%) patients were male, and 114 (26.3%) had a Child-Pugh (CP) score of B/C cirrhosis. The sustained virologic response rate at 12 weeks was similar among patients with a CP score of A (261 of 304 [85.9%]) and a CP score of B/C (83 of 101 [82.2%]; P = .37). A baseline albumin level less than 35 g/L (hazard ratio [HR], 3.11; 95% confidence interval [CI], 1.23-7.84; P = .005), baseline MELD score of 14 or higher (HR, 1.63; 95% CI, 1.03-2.61; P = .037), and HCV genotype 3 (HR, 2.05; 95% CI, 1.09-3.88; P = .033) were associated independently with hepatic decompensation during antiviral treatment among patients with a CP score of B/C. CONCLUSIONS: This large cohort study showed that therapy is safe and effective in patients with compensated (CP score of A) cirrhosis. For patients with decompensated (CP score of B/C) cirrhosis, albumin level less than 35 g/L, MELD score of 14 or greater, and HCV genotype 3 are important risk factors for hepatic decompensation during DAA-based treatment. Therefore, these patients require close monitoring during antiviral therapy or treatment should be deferred until after transplantation.
Authors: Victor Dong; Maxime Gosselin; Nishita Jagarlamudi; Beverley Kok; Mark G Swain; Jasmohan S Bajaj; Juan G Abraldes; Vladimir Marquez; R Todd Stravitz; Aldo J Montano-Loza; Manuela Merli; Phil Wong; Amanda Brisebois; Puneeta Tandon; Julia Wendon; Scott L Nyberg; François M Carrier; Michael R Lucey; Florence Wong; Jordan J Feld; Constantine J Karvellas; Christopher F Rose; Julien Bissonnette Journal: Can Liver J Date: 2019-12-10
Authors: Fatih Karbeyaz; Seraphina Kissling; Paul Julius Jaklin; Jaqueline Bachofner; Barbara Brunner; Beat Müllhaupt; Thomas Winder; Joachim C Mertens; Benjamin Misselwitz; Stefanie von Felten; Alexander R Siebenhüner Journal: J Hepatocell Carcinoma Date: 2021-06-11