PMID- 30265418
OWN - NLM
STAT- MEDLINE
DCOM- 20200626
LR  - 20200626
IS  - 1365-2893 (Electronic)
IS  - 1352-0504 (Linking)
VI  - 26
IP  - 1
DP  - 2019 Jan
TI  - Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic 
      HCV infection: Results from the Spanish HEPA-C real-world cohort.
PG  - 55-64
LID - 10.1111/jvh.13008 [doi]
AB  - In randomized controlled trials of patients with chronic HCV infection, 
      elbasvir/grazoprevir (EBR/GZR) demonstrated high cure rates and a good safety 
      profile. This study assessed the effectiveness and safety of EBR/GZR, with and 
      without ribavirin, in a real-world HCV patient cohort. HEPA-C is a collaborative, 
      monitored national registry of HCV patients directed by the Spanish Association 
      for the Study of the Liver and the Networked Biomedical Research Centre for 
      Hepatic and Digestive Diseases. Patients entered into HEPA-C between December 
      2016 and May 2017, and treated with EBR/GZR with at least end-of-treatment 
      response data, were included. Demographic, clinical and virologic data were 
      analysed, and adverse events (AEs) recorded. A total of 804 patients were 
      included in the study. The majority were male (57.9%), with a mean age of 60 
      (range, 19-92) years. Genotype (GT) distribution was GT 1, 86.8% (1a, 14.3%; 1b, 
      72.5%); GT 4, 13.2% and 176 patients (21.9%) were cirrhotic. Overall, among 588 
      patients with available data, 570 (96.9%) achieved sustained virologic response 
      at 12 weeks post-treatment (SVR12). SVR12 rates by genotype were GT 1a, 97.7%; GT 
      1b, 98.6%; and GT 4, 98.1%. No significant differences in SVR12 according to 
      fibrosis stage were observed. Eighty patients experienced an AE, resulting in 
      treatment discontinuation in three. In this large cohort of patients with chronic 
      HCV managed in a real-world setting in Spain, EBR/GZR achieved high rates of 
      SVR12, comparable to those observed in randomized controlled trials, with a 
      similarly good safety profile.
CI  - (c) 2018 John Wiley & Sons Ltd.
FAU - Hernandez-Conde, Marta
AU  - Hernandez-Conde M
AD  - Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
FAU - Fernandez, Inmaculada
AU  - Fernandez I
AD  - Hospital Universitario 12 de Octubre, Madrid, Spain.
FAU - Perello, Christie
AU  - Perello C
AD  - Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
FAU - Gallego, Adolfo
AU  - Gallego A
AD  - H. Santa Creu i Sant Pau, Madrid, Spain.
FAU - Bonacci, Martin
AU  - Bonacci M
AD  - Hospital Clinic of Barcelona, Barcelona, Spain.
FAU - Pascasio, Juan M
AU  - Pascasio JM
AD  - University Hospital Virgen del Rocio, IBIS, CIBERehd, Sevilla, Spain.
FAU - Romero-Gomez, Manuel
AU  - Romero-Gomez M
AD  - University Hospital Virgen del Rocio, IBIS, CIBERehd, Sevilla, Spain.
FAU - Llerena, Susana
AU  - Llerena S
AD  - Hospital Universitario Marques de Valdecilla, IDIVAL, Cantabria, Spain.
FAU - Fernandez-Rodriguez, Conrado
AU  - Fernandez-Rodriguez C
AD  - Hospital Universitario Fundacion Alcorcon, Alcorcon, Spain.
FAU - Castro Urda, Jose L
AU  - Castro Urda JL
AD  - Hospital Severo Ochoa de Leganes, Leganes, Spain.
FAU - Garcia Buey, Luisa
AU  - Garcia Buey L
AD  - Hospital Universitario la Princesa, IIS-IP, Madrid, Spain.
FAU - Carmona, Isabel
AU  - Carmona I
AD  - Hospital Virgen de la Macarena, Sevilla, Spain.
FAU - Morillas, Rosa M
AU  - Morillas RM
AD  - Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.
FAU - Garcia, Nuria Dominguez
AU  - Garcia ND
AD  - Hospital Infanta Cristina de Parla, Madrid, Spain.
FAU - Gea, Francisco
AU  - Gea F
AD  - Hospital Universitario Ramon y Cajal, Madrid, Spain.
FAU - Carrion, Jose A
AU  - Carrion JA
AUID- ORCID: 0000-0001-7191-6081
AD  - Hospital del Mar, Barcelona, Spain.
FAU - Castellote, Jose
AU  - Castellote J
AD  - Hospital Universitari de Bellvitge, Catalunya, Spain.
FAU - Moreno-Planas, Jose M
AU  - Moreno-Planas JM
AD  - Complejo Hospitalario Universitario de Albacete, Albacete, Spain.
FAU - Piqueras Alcol, Belen
AU  - Piqueras Alcol B
AD  - Hospital de Fuenlabrada, Fuenlabrada, Spain.
FAU - Molina, Esther
AU  - Molina E
AD  - Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain.
FAU - Diago, Moises
AU  - Diago M
AD  - Hospital General Universitario de Valencia, Valencia, Spain.
FAU - Montoliu, Silvia
AU  - Montoliu S
AD  - Hospital Universitario Joan XXIII de Tarragona, Tarragona, Spain.
FAU - de la Vega, Juan
AU  - de la Vega J
AD  - Hospital Universitario San Agustin, Asturias, Spain.
FAU - Menendez, Fernando
AU  - Menendez F
AD  - Hospital Universitario Basurto, Bilbao, UK.
FAU - Sanchez Ruano, Juan J
AU  - Sanchez Ruano JJ
AD  - Hospital de Toledo, Toledo, Spain.
FAU - Garcia-Samaniego, Javier
AU  - Garcia-Samaniego J
AD  - Hospital Universitario La Paz, IdiPAZ, CIBERehd, Madrid, Spain.
FAU - Rosales-Zabal, Jose M
AU  - Rosales-Zabal JM
AD  - Hospital Costa del Sol, Marbella, Spain.
FAU - Anton, Maria D
AU  - Anton MD
AD  - Hospital Universitario Dr Peset, Valencia, Spain.
FAU - Badia, Ester
AU  - Badia E
AD  - Hospital Universitario de Burgos, Burgos, Spain.
FAU - Souto-Rodriguez, Raquel
AU  - Souto-Rodriguez R
AD  - Complejo Hospitalario Universitario de Pontevedra and IISGS, Pontevedra, Spain.
FAU - Salmeron, Francisco J
AU  - Salmeron FJ
AD  - Hospital Universitario San Cecilio, Granada, Spain.
FAU - Fernandez-Bermejo, Miguel
AU  - Fernandez-Bermejo M
AD  - Hospital Universitario San Pedro de Alcantara, Malaga, Spain.
FAU - Figueruela, Blanca
AU  - Figueruela B
AD  - Hospital Virgen de Valme, Sevilla, Spain.
FAU - Moreno-Palomares, Jose J
AU  - Moreno-Palomares JJ
AD  - Hospital General de Segovia, Segovia, Spain.
FAU - Calleja, Jose L
AU  - Calleja JL
AD  - Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20181025
PL  - England
TA  - J Viral Hepat
JT  - Journal of viral hepatitis
JID - 9435672
RN  - 0 (Antiviral Agents)
RN  - 0 (Benzofurans)
RN  - 0 (Drug Combinations)
RN  - 0 (Imidazoles)
RN  - 0 (Quinoxalines)
RN  - 0 (elbasvir-grazoprevir drug combination)
RN  - 49717AWG6K (Ribavirin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antiviral Agents/adverse effects/*therapeutic use
MH  - Benzofurans/adverse effects/*therapeutic use
MH  - Cohort Studies
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Female
MH  - Genotype
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Imidazoles/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Quinoxalines/adverse effects/*therapeutic use
MH  - Registries
MH  - Retrospective Studies
MH  - Ribavirin/adverse effects/therapeutic use
MH  - Spain
MH  - *Sustained Virologic Response
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Spain
OT  - chronic hepatitis C
OT  - elbasvir/grazoprevir
OT  - real-world
EDAT- 2018/09/29 06:00
MHDA- 2020/06/27 06:00
CRDT- 2018/09/29 06:00
PHST- 2018/05/23 00:00 [received]
PHST- 2018/08/21 00:00 [accepted]
PHST- 2018/09/29 06:00 [pubmed]
PHST- 2020/06/27 06:00 [medline]
PHST- 2018/09/29 06:00 [entrez]
AID - 10.1111/jvh.13008 [doi]
PST - ppublish
SO  - J Viral Hepat. 2019 Jan;26(1):55-64. doi: 10.1111/jvh.13008. Epub 2018 Oct 25.