High efficacy of Sofosbuvir plus Simeprevir in a large cohort of Spanish cirrhotic patients infected with genotypes 1 and 4.

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XF: received support in part by Instituto de Salud Carlos III (PI15/00151), Spanish Health Ministry, integrated in Plan Nacional I+D+I, and co-funded by Fondo Europeo de Desarrollo Regional (FEDER-Una manera de Hacer Europa). XF also received a grant from Secretaria d'Universitats i Recerca del Departament d'Economia i Coneixement (grant 2014_SGR_605). ZM and XF also received support by the Spanish Health Ministry (Plan Estrategico Nacional contra la Hepatitis C). CIBERehd is funded by the Instituto de Salud Carlos III

Analysis of institutional authors

Marino ZCorresponding AuthorPrieto MAuthorMoreno JmAuthorFernández IAuthorForns XAuthor

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Article

Publicated to:Liver International. 37 (12): 1823-1832 - 2017-12-01 37(12), DOI: 10.1111/liv.13470

Authors: Marino, Zoe; Pascasio-Acevedo, Juan M; Gallego, Adolfo; Diago, Moises; Baliellas, Carme; Morillas, Rosa; Prieto, Martin; Moreno, Jose M; Sanchez-Antolin, Gloria; Vergara, Mercedes; Forne, Montserrat; Fernandez, Inmaculada; Castro, Maria A; Pascual, Sonia; Gomez, Alexandra; Castells, Lluis; Montero, Jose L; Crespo, Javier; Calleja, Jose L; Garcia-Samaniego, Javier; Carrion, Jose A; Arencibia, Ana C; Blasco, Alejandro; Lopez-Nunez, Carmen; Sanchez-Ruano, Juan J; Gea-Rodriguez, Francisco; Giraldez, Alvaro; Cabezas, Joaquin; Hontangas, Vanessa; Torras, Xavier; Castellote, Jose; Romero-Gomez, Manuel; Turnes, Juan; de Artaza, Tomas; Narvaez, Isidoro; Cuervas-Mons, Valentin; Forns, Xavier

Affiliations

CIBERehd, Hosp Clin, Liver Unit, IDIBAPS, Barcelona, Spain. University of Barcelona CIBEREHD CIBER - Centro de Investigacion Biomedica en Red Hospital Clinic de Barcelona IDIBAPS - Author

Complejo Hosp Univ Albacete, Dept Gastroenterol, Albacete, Spain - Author

Complejo Hosp Univ Pontevedra, Digest Dis, Pontevedra, Spain Complexo Hospitalario Universitario de Pontevedra - Author

Ctr Invest Biomed Red Enfermedades Hepat & Digest, Barcelona, Spain CIBEREHD CIBER - Centro de Investigacion Biomedica en Red - Author

Hosp Badalona Germans Trias & Pujol, Liver Unit, CIBERehd, Badalona, Spain CIBER - Centro de Investigacion Biomedica en Red Hospital Germans Trias i Pujol CIBEREHD - Author

Hosp Gen Univ Alicante, Liver Unit, CIBERehd, Alicante, Spain General University Hospital of Alicante CIBER - Centro de Investigacion Biomedica en Red CIBEREHD - Author

Hosp Infanta Cristina, Liver Unit, Badajoz, Spain - Author

Hosp Ramon & Cajal, Liver Unit, Madrid, Spain Hospital Universitario Ramon y Cajal - Author

Hosp Santa Creu & Sant Pau, Liver Unit, CIBERehd, Barcelona, Spain CIBEREHD CIBER - Centro de Investigacion Biomedica en Red Hospital of Santa Creu i Sant Pau - Author

Hosp St Joan Despi Moises Broggi, Digest Dis, Barcelona, Spain - Author

Hosp Univ 12 Octubre, Liver Unit, Madrid, Spain Hospital Universitario 12 de Octubre - Author

Hosp Univ A Coruna, Internal Med, Grp Virol Clin, Inst Invest Biomed A Coruna INIBIC, La Coruna, Spain Universidade da Coruna Complejo Hospitalario Universitario A Coruna Instituto de Investigacion Biomedica de A Coruna (INIBIC) - Author

Hosp Univ Bellvitge, Liver Unit, Inst Invest Biomed Bellvitge IDIBELL, Hosp Llobregat, Barcelona, Spain Catalan Health Institute Bellvitge University Hospital Institut d'Investigacio Biomedica de Bellvitge (IDIBELL) - Author

Hosp Univ Donostia, Liver Unit, San Sebastian, Spain - Author

Hosp Univ Gen, Digest Dis, Valencia, Spain - Author

Hosp Univ La Fe, Liver Unit, Valencia, Spain Hospital Universitari i Politecnic La Fe - Author

Hosp Univ La Paz, Liver Unit, CIBERehd, IdiPAZ, Madrid, Spain CIBEREHD Hospital Universitario La Paz CIBER - Centro de Investigacion Biomedica en Red - Author

Hosp Univ Mutua Terrassa, Liver Unit, Terrassa, Spain Hospital Universitario Mutua Terrassa - Author

Hosp Univ Nuestra Senora de Candelaria, Liver Unit, Santa Cruz De Tenerife, Spain - Author

Hosp Univ Reina Sofia, Liver Unit, CIBERehd, Cordoba, Spain CIBEREHD Hospital Universitario Reina Sofia CIBER - Centro de Investigacion Biomedica en Red - Author

Hosp Univ Rio Hortega, Dept Gastroenterol, Valladolid, Spain Hospital del Rio Hortega - Author

Hosp Univ Toledo, Digest Dis, Toledo, Spain - Author

Hosp Univ Vail Hebron, Internal Med Dept, Liver Unit, CIBERehd, Barcelona, Spain CIBEREHD CIBER - Centro de Investigacion Biomedica en Red Hospital Universitari Vall d'Hebron - Author

Hosp Univ Virgen del Rocio, Clin Management Unit Digest Dis, CIBERehd, Seville, Spain CIBEREHD CIBER - Centro de Investigacion Biomedica en Red - Author

Hosp Universitari DrJosep Trueta, Digest Dis, Girona, Spain - Author

Hosp Virgen de Valme, Liver Unit, Seville, Spain - Author

IISGS, Pontevedra, Spain - Author

Univ Autonoma Barcelona, IMIM, Hosp del Mar, Liver Sect,Gastroenterol Dept,Med Res Inst, Barcelona, Spain Institut Hospital del Mar d'Investigacions Mediques (IMIM) Autonomous University of Barcelona Hospital del Mar - Author

Univ Autonoma Barcelona, Parc Tauli Sabadell Hosp Univ, Liver Unit, Serv Aparell Digestiu, Sabadell, Spain Autonomous University of Barcelona - Author

Univ Autonoma Madrid, Liver Unit, Hosp Univ Puerta de Hierro, CIBERehd, Madrid, Spain CIBER - Centro de Investigacion Biomedica en Red CIBEREHD Hospital Puerta de Hierro-Majadahonda Autonomous University of Madrid - Author

Univ Barcelona, Liver Unit, Hosp Clin, IDIBAPS, Barcelona, Spain IDIBAPS Hospital Clinic de Barcelona University of Barcelona - Author

Univ Cantabria, Univ Hosp Marques de Valdecilla, iDIVAL, Gastroenterol & Hepatol Dept, Santander, Spain Hospital Universitario Marques de Valdecilla (HUMV) Universidad de Cantabria - Author

Abstract

Hepatitis C (HCV) therapy with Sofosbuvir (SOF)/Simeprevir (SMV) in clinical trials and real-world clinical practice, showed high rates of sustained virological response (SVR) in non-cirrhotic genotype (GT)-1 and GT-4 patients. These results were slightly lower in cirrhotic patients. We investigated real-life effectiveness and safety of SOF/SMV with or without ribavirin (RBV) in a large cohort of cirrhotic patients.This collaborative multicentre study included data from 968 patients with cirrhosis infected with HCV-GT1 or 4, treated with SOF/SMV±RBV in 30 centres across Spain between January-2014 and December-2015. Demographic, clinical, virological and safety data were analysed.Overall SVR was 92.3%; the majority of patients were treated with RBV (62%) for 12 weeks (92.4%). No significant differences in SVR were observed between genotypes (GT1a:94.3%; GT1b:91.7%; GT4:91.1%). Those patients with more advanced liver disease (Child B/C, MELD?10) or portal hypertension (platelet count?100×109 /L, transient elastography?21 Kpa) showed significantly lower SVR rates (84.4%-91.9%) than patients with less advanced liver disease (93.8%-95.9%, P<.01 in all cases). In the multivariate analysis, the use of RBV, female gender, baseline albumin?35 g/L, MELD<10 and lack of exposure to a triple therapy regimen were independent predictors of SVR (P<.05). Serious adverse events (SAEs) and SAE-associated discontinuation events occurred in 5.9% and 2.6%.In this large cohort of cirrhotic patients managed in the real-world setting in Spain, SOF/SMV±RBV yielded to excellent SVR rates, especially in patients with compensated liver cirrhosis. In addition, this combination showed to be safe, with low rates of SAEs and early discontinuations.© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Keywords

peginterferonpegylated interferonphase-3prevalenceratesreal-life cohortribavirinsafetysimeprevirsofosbuvirtherapytreatment-naive patientsAdultAgedAged, 80 and overAntiviral agentsChronic hepatitis-cCirrhosisDrug therapy, combinationFemaleHepacivirusHepatitis cHumansMaleMiddle agedReal-life cohortRegistriesRetrospective studiesSimeprevirSofosbuvirTreatment outcomeYoung adult

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Liver International due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2017, it was in position 16/80, thus managing to position itself as a Q1 (Primer Cuartil), in the category Gastroenterology & Hepatology.

From a relative perspective, and based on the normalized impact indicator calculated from the Field Citation Ratio (FCR) of the Dimensions source, it yields a value of: 2.95, which indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: Dimensions May 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-05-10, the following number of citations:

WoS: 8
Scopus: 12
Europe PMC: 6
Google Scholar: 15
OpenCitations: 11

Impact and social visibility

Leadership analysis of institutional authors

There is a significant leadership presence as some of the institution’s authors appear as the first or last signer, detailed as follows: First Author (Mariño Mendez, Zoe) and Last Author (Forns Bernhardt, Xavier).