Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C

Background and aim Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety and efficacy of telaprevir (TVR) plus pegylated-interferon-α...

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Detalles Bibliográficos
Autores: Colombo, M., Fernández Vázquez, María Inmaculada, Wedemeyer, H.
Tipo de recurso: artículo
Fecha de publicación:2013
País:España
Institución:Universidad Complutense de Madrid (UCM)
Repositorio:Docta Complutense
Idioma:inglés
OAI Identifier:oai:docta.ucm.es:20.500.14352/114145
Acceso en línea:https://hdl.handle.net/20.500.14352/114145
Access Level:acceso abierto
Palabra clave:616.36-002
Anemia
Hepatitis C
Interferon
Ciencias Biomédicas
Gastroenterología y hepatología
32 Ciencias Médicas
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spelling Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis CColombo, M.Fernández Vázquez, María InmaculadaWedemeyer, H.616.36-002AnemiaHepatitis CInterferonCiencias BiomédicasGastroenterología y hepatología32 Ciencias MédicasBackground and aim Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety and efficacy of telaprevir (TVR) plus pegylated-interferon-α (PEG-IFNα) and ribavirin (RBV) in patients with advanced liver fibrosis caused by HCV genotype 1 (HCV-1). Methods 1782 patients with HCV-1 and bridging fibrosis or compensated cirrhosis were prospectively recruited from 16 countries worldwide, and treated with 12 weeks of TVR plus PEG-IFN/RBV, followed by 12 or 36 weeks of PEG-IFN and RBV (PR) alone dependent on virological response to treatment and previous response type. Results 1587 patients completed 12 weeks of triple therapy and 4 weeks of PR tail (53% cirrhosis, 22% HCV-1a). By week 12, HCV RNA was undetectable in 85% of naives, 88% of relapsers, 80% of partial responders and 72% of null responders. Overall, 931 patients (59%) developed grade 1–4 anaemia (grade 3/4 in 31%), 630 (40%) dose reduced RBV, 332 (21%) received erythropoietin and 157 (10%) were transfused. Age and female gender were the strongest predictors of anaemia. 64 patients (4%) developed a grade 3/4 rash. Discontinuation of TVR due to AEs was necessary in 193 patients (12%). Seven patients died (0.4%, six had cirrhosis). Conclusions In compensated patients with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory rates of safety, tolerability and on-treatment virological response with adequate managements of AEs.BMJUniversidad Complutense de Madrid20132013-11-0720132013-11-07journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.14352/114145reponame:Docta Complutenseinstname:Universidad Complutense de Madrid (UCM)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:docta.ucm.es:20.500.14352/1141452026-06-02T12:44:21Z
dc.title.none.fl_str_mv Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C
title Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C
spellingShingle Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C
Colombo, M.
616.36-002
Anemia
Hepatitis C
Interferon
Ciencias Biomédicas
Gastroenterología y hepatología
32 Ciencias Médicas
title_short Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C
title_full Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C
title_fullStr Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C
title_full_unstemmed Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C
title_sort Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C
dc.creator.none.fl_str_mv Colombo, M.
Fernández Vázquez, María Inmaculada
Wedemeyer, H.
author Colombo, M.
author_facet Colombo, M.
Fernández Vázquez, María Inmaculada
Wedemeyer, H.
author_role author
author2 Fernández Vázquez, María Inmaculada
Wedemeyer, H.
author2_role author
author
dc.contributor.none.fl_str_mv Universidad Complutense de Madrid
dc.subject.none.fl_str_mv 616.36-002
Anemia
Hepatitis C
Interferon
Ciencias Biomédicas
Gastroenterología y hepatología
32 Ciencias Médicas
topic 616.36-002
Anemia
Hepatitis C
Interferon
Ciencias Biomédicas
Gastroenterología y hepatología
32 Ciencias Médicas
description Background and aim Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety and efficacy of telaprevir (TVR) plus pegylated-interferon-α (PEG-IFNα) and ribavirin (RBV) in patients with advanced liver fibrosis caused by HCV genotype 1 (HCV-1). Methods 1782 patients with HCV-1 and bridging fibrosis or compensated cirrhosis were prospectively recruited from 16 countries worldwide, and treated with 12 weeks of TVR plus PEG-IFN/RBV, followed by 12 or 36 weeks of PEG-IFN and RBV (PR) alone dependent on virological response to treatment and previous response type. Results 1587 patients completed 12 weeks of triple therapy and 4 weeks of PR tail (53% cirrhosis, 22% HCV-1a). By week 12, HCV RNA was undetectable in 85% of naives, 88% of relapsers, 80% of partial responders and 72% of null responders. Overall, 931 patients (59%) developed grade 1–4 anaemia (grade 3/4 in 31%), 630 (40%) dose reduced RBV, 332 (21%) received erythropoietin and 157 (10%) were transfused. Age and female gender were the strongest predictors of anaemia. 64 patients (4%) developed a grade 3/4 rash. Discontinuation of TVR due to AEs was necessary in 193 patients (12%). Seven patients died (0.4%, six had cirrhosis). Conclusions In compensated patients with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory rates of safety, tolerability and on-treatment virological response with adequate managements of AEs.
publishDate 2013
dc.date.none.fl_str_mv 2013
2013-11-07
2013
2013-11-07
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.14352/114145
url https://hdl.handle.net/20.500.14352/114145
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv BMJ
publisher.none.fl_str_mv BMJ
dc.source.none.fl_str_mv reponame:Docta Complutense
instname:Universidad Complutense de Madrid (UCM)
instname_str Universidad Complutense de Madrid (UCM)
reponame_str Docta Complutense
collection Docta Complutense
repository.name.fl_str_mv
repository.mail.fl_str_mv
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