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Safety and Effectiveness of Direct-Acting Antiviral Agents for Treatment of Patients With Chronic Hepatitis C Virus Infection and Cirrhosis.
- Source :
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Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association [Clin Gastroenterol Hepatol] 2016 Dec; Vol. 14 (12), pp. 1821-1830.e6. Date of Electronic Publication: 2016 Jul 09. - Publication Year :
- 2016
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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.<br />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.<br />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.<br />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.<br /> (Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Cohort Studies
Drug-Related Side Effects and Adverse Reactions epidemiology
Drug-Related Side Effects and Adverse Reactions pathology
Female
Humans
International Cooperation
Male
Middle Aged
Treatment Outcome
Antiviral Agents adverse effects
Antiviral Agents therapeutic use
Hepatic Insufficiency epidemiology
Hepatitis C, Chronic complications
Hepatitis C, Chronic drug therapy
Liver Cirrhosis drug therapy
Sustained Virologic Response
Subjects
Details
- Language :
- English
- ISSN :
- 1542-7714
- Volume :
- 14
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
- Publication Type :
- Academic Journal
- Accession number :
- 27404965
- Full Text :
- https://doi.org/10.1016/j.cgh.2016.07.001