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Hepatology. 2017 Feb 7. doi: 10.1002/hep.29097. [Epub ahead of print]

Treatment of hepatitis C virus infection in patients with cirrhosis and predictive value of MELD: Analysis of data from the Hepa-C registry.

Author information

  • 1Liver Unit, Hospital Universitario Puerta de Hierro, Majadahonda, IDIPHIM, CIBERehd, Majadahonda, Madrid.
  • 2Liver Unit, Hospital Cliníc de Barcelona, IDIBAPS, CIBERehd, Barcelona.
  • 3Department of Gastroenterology, Hospital Universitario Virgen del Rocío, IBIS, CIBERehd, Sevilla.
  • 4Gastroenterology and Hepatology Unit, Hospital Universitario Marqués de Valdecilla, Santander, IDIVAL, Universidad de Cantabria, Santander.
  • 5Department of Gastroenterology, Hospital Universitario Donostia, San Sebastián.
  • 6Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid.
  • 7Digestive Service, Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona.
  • 8Liver Section, Gastroenterology Department, Hospital del Mar, IMIM, Barcelona.
  • 9Hepatology & Liver Transplant Unit, Hospital Universitario Reina Sofía, IMIBIC, CIBERehd, Córdoba.
  • 10Liver Unit, Hospital Universitario Vall d'Hebrón, CIBERehd, Barcelona.
  • 11Gastroenterology and Hepatology Department, Hospital Universitario Ramón y Cajal, University of Alcalá, IRYCIS, CIBERehd, Madrid.
  • 12Digestive Diseases Unit, Hospital Universitario Virgen de Valme, CIBERehd, Sevilla.
  • 13Department of Gastroenterology, Complejo Hospitalario Universitario de Pontevedra and IISGS, Pontevedra.
  • 14Digestive Service, Hospital General Universitario de Castellón, Castellón de la Plana.
  • 15Department of Gastroenterology, Complejo Hospitalario Universitario de Albacete, Albacete.
  • 16Internal Medicine, Hospital General de Segovia, Segovia.
  • 17Department of Gastroenterology, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid.
  • 18Liver Unit, Hospital Universitario La Paz, CIBERehd, IdiPAZ, Madrid.
  • 19Servicio de Medicina Digestiva, Unidad de Hepatología, Hospital Universitari i Politècnic La Fe and CIBERehd, Valencia.
  • 20Digestive Service, Hospital San Pedro de Alcántara, Cáceres.
  • 21Digestive Service, Hospital Universitario San Cecilio, CIBERehd, Granada.
  • 22Digestive Service, Hospital Universitario de Burgos, Burgos.
  • 23Liver Unit, Hospital General Universitario Gregorio Marañón, IiSGM, Madrid.
  • 24Liver Unit, Clínica Universitaria de Navarra, IdiSNA, CIBERehd, Pamplona.
  • 25Internal Medicine Service, H. U. de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria.
  • 26Servidigest Clinic of Barcelona.
  • 27Liver Unit, Hospital Universitario Puerta de Hierro, Universidad Autónoma de Madrid and CIBERehd, Madrid, Spain.

Abstract

Direct-acting antiviral agents (DAAs) are highly effective and well tolerated in patients with chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis. However, fewer data are available in patients with more advanced liver disease. Our retrospective, non-interventional, national, multi-center study in patients from the Spanish Hepa-C registry investigated the effectiveness and safety of interferon-free DAA regimens in patients with advanced liver disease, including those with decompensated cirrhosis, in routine practice (all currently approved regimens were registered). Patients transplanted during treatment or within 12 weeks of completing treatment were excluded. Among 843 cirrhotic patients (Child A, n=564; Child B/C, n=175), 90% achieved sustained virologic response 12 weeks post-treatment (SVR12). Significant differences in SVR12 and relapse rates were observed between Child A and Child B/C patients (94% vs. 78%, and 4% vs. 14%, respectively; both P<0.001). Serious adverse events (SAEs) were more common in Child B/C vs. Child A patients (50% vs. 12%, respectively; P<0.001). Incident decompensation was the most common SAE (7% overall). Death rate during the study period was 16/843 (2%), significantly higher among Child B/C vs. Child A patients (6.4% vs. 0.9%; P<0.001). Baseline Model for End-Stage Liver Disease (MELD) score alone (cut-off 18) was the best predictor of survival. Conclusions Patients with decompensated cirrhosis receiving DAAs present lower response rates and experience more SAEs. In this setting, a MELD score ≥18 may help clinicians to identify those patients with a higher risk of complications and to individualize treatment decisions. This article is protected by copyright. All rights reserved.

KEYWORDS:

Direct-acting antiviral therapy; decompensated cirrhosis; effectiveness; liver transplantation; real-world

PMID:
28170112
DOI:
10.1002/hep.29097
[PubMed - as supplied by publisher]
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