Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in spanish clinical practice – Vie-KinD study

HIV and Hepatitis C Coinfection; Chronic Renal Failure; Ribavirin

Detalles Bibliográficos
Autores: Londoño, María-Carlota, Riveiro Barciela, Maria del Mar, Ahumada, Adriana, Muñoz-Gómez, Raquel, Roget, Mercé, Devesa-Medina, María J.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2019
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:11351/5132
Acceso en línea:https://hdl.handle.net/11351/5132
http://hdl.handle.net/11351/5132
Access Level:acceso abierto
Palabra clave:Infeccions per VIH - Tractament
Hepatitis C - Tractament
DISEASES::Infections::Coinfection
/drug therapy
DISEASES::Infections::Virus Diseases::Hepatitis, Viral, Human::Hepatitis C::Hepatitis C, Chronic
DISEASES::Infections::Infections::Virus Diseases::RNA Virus Infections::Retroviridae Infections::Lentivirus Infections::Infections::Virus Diseases::HIV Infections
ENFERMEDADES::enfermedades parasitarias::coinfección
/tratamiento farmacológico
ENFERMEDADES::virosis::hepatitis viral humana::hepatitis C::hepatitis C crónica
ENFERMEDADES::virosis::infecciones por virus ARN::infecciones por Retroviridae::infecciones por Lentivirus::infecciones por VIH
id ES_2a010f11e55c43f4ba8d2cdf6a3c3a8e
oai_identifier_str oai:recercat.cat:11351/5132
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in spanish clinical practice – Vie-KinD study
title Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in spanish clinical practice – Vie-KinD study
spellingShingle Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in spanish clinical practice – Vie-KinD study
Londoño, María-Carlota
Infeccions per VIH - Tractament
Hepatitis C - Tractament
DISEASES::Infections::Coinfection
/drug therapy
DISEASES::Infections::Virus Diseases::Hepatitis, Viral, Human::Hepatitis C::Hepatitis C, Chronic
DISEASES::Infections::Infections::Virus Diseases::RNA Virus Infections::Retroviridae Infections::Lentivirus Infections::Infections::Virus Diseases::HIV Infections
ENFERMEDADES::enfermedades parasitarias::coinfección
/tratamiento farmacológico
ENFERMEDADES::virosis::hepatitis viral humana::hepatitis C::hepatitis C crónica
ENFERMEDADES::virosis::infecciones por virus ARN::infecciones por Retroviridae::infecciones por Lentivirus::infecciones por VIH
title_short Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in spanish clinical practice – Vie-KinD study
title_full Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in spanish clinical practice – Vie-KinD study
title_fullStr Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in spanish clinical practice – Vie-KinD study
title_full_unstemmed Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in spanish clinical practice – Vie-KinD study
title_sort Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in spanish clinical practice – Vie-KinD study
dc.creator.none.fl_str_mv Londoño, María-Carlota
Riveiro Barciela, Maria del Mar
Ahumada, Adriana
Muñoz-Gómez, Raquel
Roget, Mercé
Devesa-Medina, María J.
author Londoño, María-Carlota
author_facet Londoño, María-Carlota
Riveiro Barciela, Maria del Mar
Ahumada, Adriana
Muñoz-Gómez, Raquel
Roget, Mercé
Devesa-Medina, María J.
author_role author
author2 Riveiro Barciela, Maria del Mar
Ahumada, Adriana
Muñoz-Gómez, Raquel
Roget, Mercé
Devesa-Medina, María J.
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv [Londoño MC] Liver Unit, Hospital Clínic/IDIBAPS, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERhed), Instituto de Salud Carlos III, Madrid, Spain. [Riveiro-Barciela M] Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERhed), Instituto de Salud Carlos III, Madrid, Spain. Servei de Medicina Interna, Unitat de Malalties Hepàtiques, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Ahumada A] Department of Gastroenterology, Hospital General Universitario Gregorio Marañón, Madrid, Spain. [Muñoz-Gómez R] Department of Gastroenterology, Hospital General Universitario 12 de Octubre, Madrid, Spain. [Roget M] Liver Unit, Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain. [Devesa-Medina MJ] Department of Gastroenterology, Hospital Universitario Clínico San Carlos, Madrid, Spain
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Infeccions per VIH - Tractament
Hepatitis C - Tractament
DISEASES::Infections::Coinfection
/drug therapy
DISEASES::Infections::Virus Diseases::Hepatitis, Viral, Human::Hepatitis C::Hepatitis C, Chronic
DISEASES::Infections::Infections::Virus Diseases::RNA Virus Infections::Retroviridae Infections::Lentivirus Infections::Infections::Virus Diseases::HIV Infections
ENFERMEDADES::enfermedades parasitarias::coinfección
/tratamiento farmacológico
ENFERMEDADES::virosis::hepatitis viral humana::hepatitis C::hepatitis C crónica
ENFERMEDADES::virosis::infecciones por virus ARN::infecciones por Retroviridae::infecciones por Lentivirus::infecciones por VIH
topic Infeccions per VIH - Tractament
Hepatitis C - Tractament
DISEASES::Infections::Coinfection
/drug therapy
DISEASES::Infections::Virus Diseases::Hepatitis, Viral, Human::Hepatitis C::Hepatitis C, Chronic
DISEASES::Infections::Infections::Virus Diseases::RNA Virus Infections::Retroviridae Infections::Lentivirus Infections::Infections::Virus Diseases::HIV Infections
ENFERMEDADES::enfermedades parasitarias::coinfección
/tratamiento farmacológico
ENFERMEDADES::virosis::hepatitis viral humana::hepatitis C::hepatitis C crónica
ENFERMEDADES::virosis::infecciones por virus ARN::infecciones por Retroviridae::infecciones por Lentivirus::infecciones por VIH
description HIV and Hepatitis C Coinfection; Chronic Renal Failure; Ribavirin
publishDate 2019
dc.date.none.fl_str_mv 2019
2020
2020
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/5132
http://hdl.handle.net/11351/5132
url https://hdl.handle.net/11351/5132
http://hdl.handle.net/11351/5132
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv PLoS One;14(9)
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0221567
dc.rights.none.fl_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Public Library of Science
publisher.none.fl_str_mv Public Library of Science
dc.source.none.fl_str_mv Scientia
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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spelling Effectiveness, safety/tolerability of OBV/PTV/r ± DSV in patients with HCV genotype 1 or 4 with/without HIV-1 co-infection, chronic kidney disease (CKD) stage IIIb-V and dialysis in spanish clinical practice – Vie-KinD studyLondoño, María-CarlotaRiveiro Barciela, Maria del MarAhumada, AdrianaMuñoz-Gómez, RaquelRoget, MercéDevesa-Medina, María J.Infeccions per VIH - TractamentHepatitis C - TractamentDISEASES::Infections::Coinfection/drug therapyDISEASES::Infections::Virus Diseases::Hepatitis, Viral, Human::Hepatitis C::Hepatitis C, ChronicDISEASES::Infections::Infections::Virus Diseases::RNA Virus Infections::Retroviridae Infections::Lentivirus Infections::Infections::Virus Diseases::HIV InfectionsENFERMEDADES::enfermedades parasitarias::coinfección/tratamiento farmacológicoENFERMEDADES::virosis::hepatitis viral humana::hepatitis C::hepatitis C crónicaENFERMEDADES::virosis::infecciones por virus ARN::infecciones por Retroviridae::infecciones por Lentivirus::infecciones por VIHHIV and Hepatitis C Coinfection; Chronic Renal Failure; RibavirinCoinfecció VIH i Hepatitis C; Insuficiència Renal Crònica; RibavirinaCoinfección VIH y Hepatitis C; Insuficiencia Renal Crónica; RibavirinaBackground and aims: Limited data are available on the effectiveness and tolerability of direct-acting antivirals (DAAs) therapies in the real world for HCV-infected patients with comorbidities. This study aimed to describe the effectiveness of OBV/PTV/r ± DSV (3D/2D regimen) with or without ribavirin (RBV) in HCV or HCV/HIV co-infected patients with GT1/GT4 and CKD (IIIb-V stages), including those under hemodialysis and peritoneal dialysis in routine clinical practice in Spain in 2015. Material and methods: Non-interventional, retrospective, multicenter data collection study in 31 Spanish sites. Socio-demographic, clinical variables, study treatment characteristics, effectiveness and tolerability data were collected from medical records. Results: Data from 135 patients with a mean age (SD) of 58.3 (11.4) years were analyzed: 92.6% GT1 (81.6% GT1b and 17.6% GT1a) and 7.4% GT4, 14 (10.4%) HIV/HCV co-infected, 19.0% with fibrosis F3 and 28.1% F4 by FibroScan®, 52.6% were previously treated with pegIFN and RBV. 11.1%, 14.8% and 74.1% of patients had CKD stage IIIb, IV and V respectively. 68.9% of patients were on hemodialysis; 8.9% on peritoneal dialysis and 38.5% had history of renal transplant. A total of 125 (96.2%) of 135 patients were treated with 3D, 10 (7.4%) with 2D and 30.4% received RBV. The overall intention-to-treat (ITT) sustained virologic response at week 12 (SVR12) was 92.6% (125/135) and the overall modified-ITT (mITT) SVR12 was 99.2% (125/126). The SVR12 rates (ITT) per sub-groups were: HCV mono-infected (91.7%), HCV/HIV co-infected (100%), GT1 (92.0%), GT4 (100%), CKD stage IIIb (86.7%), stage IV (95%) and stage V (93%). Among the 10 non-SVR there was only 1 virologic failure (0.7%); 4 patients had missing data due lost to follow up (3.0%) and 5 patients discontinued 3D/2D regimen (3.7%): 4 due to severe adverse events (including 3 deaths) and 1 patient´s decision. Conclusions: These results have shown that 3D/2D regimens are effective and tolerable in patients with advanced CKD including those in dialysis with GT 1 or 4 chronic HCV mono-infection and HIV/HCV coinfection in a real-life cohort. The overall SVR12 rates were 92.6% (ITT) and 99.2% (mITT) without clinically relevant changes in eGFR until 12 weeks post-treatment. These results are consistent with those reported in clinical trials.MCL has served as consultant for AbbVie, MSD, Janssen, BMS and Gilead; MRB has received grant research from Gilead Science, and speaker fees from AbbVie, Gilead and MSD; MR has received speaker fees from AbbVie; MD has received grant support and consultancy fees from AbbVie, Bayer, Bristol-Myers Squibb, Gilead and Merck, Sharp & Dhome; FGR has served as speaker for AbbVie, Gilead and BMS; MLM has served as a speaker for AbbVie, BMS, Gilead, Janssen, MSD and ViiV; as a consultant for AbbVie, BMS and Janssen and has received research funding from FIPSE 36465/03, FIPSE 36680/07.-NEAT IG5 (NEAT is a project funded by the European Union under the 6th Framework programme) contract number LSHP-CT-2006-037570; MAC has served as a consultant for Gilead and and ViiV healthcare, and has received speaker fees from Janssens, Gilead, ViiV Healthcare; MMA reports personal fees from ViiV Healthcare, Gilead Sciences, Merck, Janssen, AbbVie and ABBOTT Laboratories, outside the submitted work; AR has received consultancy and speaker fees from AbbVie, Gilead Sciences and Merck Sharp & Dohme; JM has received honoraria, speaker fees, consultant fees or funds for research from AbbVie, BMS, Boehringer-Ingelheim, Gilead, Janssen, MSD, Roche and ViiV; EGP has received speaker fees from AbbVie and Gilead; LGB has served as consultant for AbbVie and Intercept and has received speaker fees from Gilead and MSD; AA, RMG, CB, TAE, MLG, BPL, IC, SB, LB, JGS, MJP, IMG, LM, IdlS, ML and JEL don't have a financial interest or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this paper; CdA and AM are paid employees of AbbVie and may hold stock or options. The specific roles of these authors are articulated in the 'author contributions' section. The design, study conduct, and financial support for the study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the manuscript.Public Library of Science[Londoño MC] Liver Unit, Hospital Clínic/IDIBAPS, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERhed), Instituto de Salud Carlos III, Madrid, Spain. [Riveiro-Barciela M] Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERhed), Instituto de Salud Carlos III, Madrid, Spain. Servei de Medicina Interna, Unitat de Malalties Hepàtiques, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Ahumada A] Department of Gastroenterology, Hospital General Universitario Gregorio Marañón, Madrid, Spain. [Muñoz-Gómez R] Department of Gastroenterology, Hospital General Universitario 12 de Octubre, Madrid, Spain. [Roget M] Liver Unit, Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain. [Devesa-Medina MJ] Department of Gastroenterology, Hospital Universitario Clínico San Carlos, Madrid, SpainVall d'Hebron Barcelona Hospital Campus202020202019info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11351/5132http://hdl.handle.net/11351/5132Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésPLoS One;14(9)https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0221567Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/51322026-05-29T05:05:01Z
score 15,81155

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