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.
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.



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).
Liver Unit, Hospital Universitario Puerta de Hierro-Majadahonda, IDIPHIM, CIBERehd, Majadahonda, Madrid, Spain.
Carlos
C
Fernández Carrillo
Liver Unit, Hospital Clínic de Barcelona, University of Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
Sabela
S
Lens
Liver Unit, Hospital Universitario Puerta de Hierro-Majadahonda, IDIPHIM, CIBERehd, Majadahonda, Madrid, Spain.
Elba
E
Llop
Department of Gastroenterology, Hospital Universitario Virgen del Rocío, IBIS, CIBERehd, Sevilla, Spain.
Juan Manuel
JM
Pascasio
Gastroenterology and Hepatology Unit, Hospital Universitario Marqués de Valdecilla, Santander, IDIVAL, Universidad de Cantabria, Santander, Spain.
Javier
J
Crespo
Department of Gastroenterology, Hospital Universitario Donostia, San Sebastián, Spain.
Juan
J
Arenas
Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.
Inmaculada
I
Fernández
Digestive Service, Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.
Carme
C
Baliellas
Liver Section, Gastroenterology Department, Hospital del Mar, IMIM, Barcelona, Spain.
José Antonio
JA
Carrión
Hepatology & Liver Transplant Unit, Hospital Universitario Reina Sofía, IMIBIC, CIBERehd, Córdoba, Spain.
Manuel
M
de la Mata
Liver Unit, Hospital Universitario Vall d'Hebrón, CIBERehd, Barcelona, Spain.
Maria
M
Buti
Liver Unit, Hospital Universitario Vall d'Hebrón, CIBERehd, Barcelona, Spain.
Lluís
L
Castells
Gastroenterology and Hepatology Department, Hospital Universitario Ramón y Cajal, University of Alcalá, IRYCIS, CIBERehd, Madrid, Spain.
Agustín
A
Albillos
Digestive Diseases Unit, Hospital Universitario Virgen de Valme, CIBERehd, Sevilla, Spain.
Manuel
M
Romero
Department of Gastroenterology, Complejo Hospitalario Universitario de Pontevedra and IISGS, Pontevedra, Spain.
Juan
J
Turnes
Digestive Service, Hospital General Universitario de Castellón, Castellón de la Plana, Spain.
Clara
C
Pons
Department of Gastroenterology, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.
José María
JM
Moreno-Planas
Internal Medicine, Hospital General de Segovia, Segovia, Spain.
José Javier
JJ
Moreno-Palomares
Department of Gastroenterology, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain.
Conrado
C
Fernández-Rodriguez
Liver Unit, Hospital Universitario La Paz, CIBERehd, IdiPAZ, Madrid, Spain.
Javier
J
García-Samaniego
Servicio de Medicina Digestiva, Unidad de Hepatología, Hospital Universitari i Politècnic La Fe and CIBERehd, Valencia, Spain.
Martín
M
Prieto
Digestive Service, Hospital San Pedro de Alcántara, Cáceres, Spain.
Miguel
M
Fernández Bermejo
Digestive Service, Hospital Universitario San Cecilio, CIBERehd, Granada, Spain.
Javier
J
Salmerón
Digestive Service, Hospital Universitario de Burgos, Burgos, Spain.
Ester
E
Badia
Liver Unit, Hospital General Universitario Gregorio Marañón, IiSGM, Madrid, Spain.
Magdalena
M
Salcedo
Liver Unit, Clínica Universitaria de Navarra, IdiSNA, CIBERehd, Pamplona, Spain.
José Ignacio
JI
Herrero
Internal Medicine Service, H. U. de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria, Spain.
Rafael
R
Granados
Servidigest Clinic of Barcelona, Spain.
Michel
M
Blé
Liver Unit, Hospital Clínic de Barcelona, University of Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
Zoe
Z
Mariño
Liver Unit, Hospital Universitario Puerta de Hierro-Majadahonda, Universidad Autónoma de Madrid and CIBERehd, Madrid, Spain.
José Luis
JL
Calleja
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000008:administration & dosage*; D002423:Cause of Death; D015331:Cohort Studies; D018450:Disease Progression; D058625:End Stage Liver Disease / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000821:virology; D005260:Female; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology / Q000821:virology; D008111:Liver Function Tests; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011237:Predictive Value of Tests; D011379:Prognosis; D016016:Proportional Hazards Models; D012042:Registries; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage; D018570:Risk Assessment; D012720:Severity of Illness Index; D000069474:Sofosbuvir / Q000008:administration & dosage; D013030:Spain; D016019:Survival Analysis; D016896:Treatment Outcome
D000998:Antiviral Agents; D012254:Ribavirin; D000069474:Sofosbuvir