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Hepatology. 2017 Jun;65(6):1810-1822. doi: 10.1002/hep.29097. Epub 2017 Apr 28.

Treatment of hepatitis C virus infection in patients with cirrhosis and predictive value of model for end-stage liver disease: Analysis of data from the Hepa-C registry.

Author information

1
Liver Unit, Hospital Universitario Puerta de Hierro-Majadahonda, IDIPHIM, CIBERehd, Majadahonda, Madrid, Spain.
2
Liver Unit, Hospital Clínic de Barcelona, University of Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
3
Department of Gastroenterology, Hospital Universitario Virgen del Rocío, IBIS, CIBERehd, Sevilla, Spain.
4
Gastroenterology and Hepatology Unit, Hospital Universitario Marqués de Valdecilla, Santander, IDIVAL, Universidad de Cantabria, Santander, Spain.
5
Department of Gastroenterology, Hospital Universitario Donostia, San Sebastián, Spain.
6
Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.
7
Digestive Service, Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.
8
Liver Section, Gastroenterology Department, Hospital del Mar, IMIM, Barcelona, Spain.
9
Hepatology & Liver Transplant Unit, Hospital Universitario Reina Sofía, IMIBIC, CIBERehd, Córdoba, Spain.
10
Liver Unit, Hospital Universitario Vall d'Hebrón, CIBERehd, Barcelona, Spain.
11
Gastroenterology and Hepatology Department, Hospital Universitario Ramón y Cajal, University of Alcalá, IRYCIS, CIBERehd, Madrid, Spain.
12
Digestive Diseases Unit, Hospital Universitario Virgen de Valme, CIBERehd, Sevilla, Spain.
13
Department of Gastroenterology, Complejo Hospitalario Universitario de Pontevedra and IISGS, Pontevedra, Spain.
14
Digestive Service, Hospital General Universitario de Castellón, Castellón de la Plana, Spain.
15
Department of Gastroenterology, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.
16
Internal Medicine, Hospital General de Segovia, Segovia, Spain.
17
Department of Gastroenterology, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain.
18
Liver Unit, Hospital Universitario La Paz, CIBERehd, IdiPAZ, Madrid, Spain.
19
Servicio de Medicina Digestiva, Unidad de Hepatología, Hospital Universitari i Politècnic La Fe and CIBERehd, Valencia, Spain.
20
Digestive Service, Hospital San Pedro de Alcántara, Cáceres, Spain.
21
Digestive Service, Hospital Universitario San Cecilio, CIBERehd, Granada, Spain.
22
Digestive Service, Hospital Universitario de Burgos, Burgos, Spain.
23
Liver Unit, Hospital General Universitario Gregorio Marañón, IiSGM, Madrid, Spain.
24
Liver Unit, Clínica Universitaria de Navarra, IdiSNA, CIBERehd, Pamplona, Spain.
25
Internal Medicine Service, H. U. de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Spain.
26
Servidigest Clinic of Barcelona, Spain.
27
Liver Unit, Hospital Universitario Puerta de Hierro-Majadahonda, 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 infection, including those with compensated cirrhosis. However, fewer data are available in patients with more advanced liver disease. Our retrospective, noninterventional, national, multicenter 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 patients with cirrhosis (Child-Turcotte-Pugh [CTP] class A, n = 564; CTP class B/C, n = 175), 90% achieved sustained virologic response 12 weeks after treatment (SVR12). Significant differences in SVR12 and relapse rates were observed between CTP class A and CTP class B/C patients (94% versus 78%, and 4% versus 14%, respectively; both P < 0.001). Serious adverse events (SAEs) were more common in CTP class B/C versus CTP class A patients (50% versus 12%, respectively; P < 0.001). Incident decompensation was the most common serious adverse event (7% overall). Death rate during the study period was 16/843 (2%), significantly higher among CTP class B/C versus CTP class A patients (6.4% versus 0.9%; P < 0.001). Baseline Model for End-Stage Liver Disease (MELD) score alone (cut-off 18) was the best predictor of survival.

CONCLUSION:

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. (Hepatology 2017;65:1810-1822).

PMID:
28170112
DOI:
10.1002/hep.29097
[Indexed for MEDLINE]

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