Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis

Detalhes bibliográficos
Autor(a) principal: Montes, Marisa
Data de Publicação: 2014
Outros Autores: Mark, Nelson, Girard, Pierre Marie, Sasadeusz, Joe, Horban, Andrzej, Grinsztejn, Beatriz, Zakharova, Natalia, Rivero, Antonio, Lathouwers, Erkki, Janssen, Katrien, Mahadevan, Sivi Ouwerkerk, Witek, James
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/11203
Resumo: Universidad Autónoma de Madrid. Hospital La Paz. HIV Unit. Internal Medicine. Madrid, Spain.
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spelling Montes, MarisaMark, NelsonGirard, Pierre MarieSasadeusz, JoeHorban, AndrzejGrinsztejn, BeatrizZakharova, NataliaRivero, AntonioLathouwers, ErkkiJanssen, KatrienMahadevan, Sivi OuwerkerkWitek, James2015-07-10T12:09:15Z2015-07-10T12:09:15Z2014MONTES, Marisa et al. Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis. Journal of the International AIDS Society, v. 17, suppl. 3, p. 1-2, 2014.1758-2652https://www.arca.fiocruz.br/handle/icict/1120310.7448/IAS.17.4.196261758-2652engBioMed CentralTelaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysisinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleUniversidad Autónoma de Madrid. Hospital La Paz. HIV Unit. Internal Medicine. Madrid, Spain.Chelsea and Westminster Hospital. London, UK.Hôpital St. Antoine. Paris, France.Royal Melbourne Hospital. Melbourne, Australia / Alfred Hospital. Melbourne, Australia.Warsaw Medical University. Hospital of Infectious Diseases. Warsaw, Poland.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e AIDS. Rio de Janeiro, RJ, Brasil.Saint-Petersburg AIDS Center. St Petersburg, Russian Federation.Hospital Universitario Reina Sofía. Instituto Maimónides de Investigación Biomédica de Córdoba. Cordoba, Spain.Janssen Infectious Diseases BVBA. Beerse, Belgium.Janssen Research & Development LLC. Titusville, PA, USA.Janssen Research & Development LLC. Titusville, PA, USA.Janssen Research & Development LLC. Titusville, PA, USA.Abstract Introduction: We report the SVR12 final analysis of a phase 3 study of telaprevir in combination with peginterferon (P)/ribavirin (R) in HCV-genotype 1, treatment-naïve and -experienced patients with HCV/HIV co-infection (INSIGHT). Materials and Methods: Patients receiving stable, suppressive HIV antiretroviral (ARV) therapy, containing atazanavir/ritonavir, efavirenz, darunavir/ritonavir, raltegravir, etravirine or rilpivirine, received telaprevir 750 mg q8h (1125 mg q8h if on efavirenz) plus P (180 µg once-weekly) and R (800 mg/day) for 12 weeks, followed by an additional 12 weeks (non-cirrhotic HCV treatment-naïve and relapse patients with extended rapid viral response [eRVR]) or 36 weeks (all others) of PR alone. Analysis was performed when all patients had completed the follow-up visit of 12 weeks after last planned dose. Results: One hundred sixty-two patients were enrolled and treated (65 efavirenz, 59 atazanavir/ritonavir, 17 darunavir/ritonavir, 17 raltegravir, 4 etravirine). Mean age was 45 years, 78% were male, 92% were Caucasian; mean CD4 count was 687 cells/mm3. Sixty four patients (40%) were HCV treatment-naïve and 98 (60%) were treatment experienced (29 relapsers, 18 partial responders and 51 null responders). 64% were subtype 1a. 30% had bridging fibrosis (17%) or cirrhosis (13%). 19% of patients discontinued telaprevir, including 9% due to an adverse event (AE), 8% reaching a virologic endpoint and 2% for other reasons (non compliance or not defined). Treatment responses are shown in Table 1. There were no HIV RNA breakthroughs. Most frequently reported (≥20% patients) AEs were pruritus 43%; fatigue 27%; rash 34%, anorectal events 30% and influenza-like illness (25%). Anemia was reported in 15% of patients; grade ≥3 haemoglobin decrease occurred in 2.5% of patients. 6% of patients experienced serious AEs. Conclusions: In this phase 3 study of HIV-infected, HCV treatment-naïve and -experienced patients, 49% achieved eRVR and 57% reached SVR12. In patients with an eRVR, SVR12 rates were >80%, irrespective of prior treatment history.HIVHepacivirusStatistical analysisAnti-retroviral agentsHIVHepacivirusAnálise estatísticaAntirretroviraisinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82354https://www.arca.fiocruz.br/bitstream/icict/11203/1/license.txt8b4c200b4e10021c5683c6ccaba07169MD51ORIGINALTelaprevir combination therapy in HCVHIV co-infected patients INSIGHT study sustained virologic response at 12 weeks final analysis.pdfTelaprevir combination therapy in HCVHIV co-infected patients INSIGHT study sustained virologic response at 12 weeks final analysis.pdfapplication/pdf85715https://www.arca.fiocruz.br/bitstream/icict/11203/2/Telaprevir%20combination%20therapy%20in%20HCVHIV%20co-infected%20patients%20INSIGHT%20study%20sustained%20virologic%20response%20at%2012%20weeks%20final%20analysis.pdfdb555767cd3a8f7fa2addd14c8150116MD52TEXTTelaprevir combination therapy in HCVHIV co-infected patients INSIGHT study sustained virologic response at 12 weeks final analysis.pdf.txtTelaprevir combination therapy in HCVHIV co-infected patients INSIGHT study sustained virologic response at 12 weeks final analysis.pdf.txtExtracted texttext/plain4931https://www.arca.fiocruz.br/bitstream/icict/11203/3/Telaprevir%20combination%20therapy%20in%20HCVHIV%20co-infected%20patients%20INSIGHT%20study%20sustained%20virologic%20response%20at%2012%20weeks%20final%20analysis.pdf.txt8a8be11fbc039e0881429296f01b48b2MD53icict/112032023-06-15 16:15:26.682oai:www.arca.fiocruz.br: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Repositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-06-15T19:15:26Repositório Institucional da FIOCRUZ (ARCA) - 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dc.title.pt_BR.fl_str_mv Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis
title Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis
spellingShingle Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis
Montes, Marisa
HIV
Hepacivirus
Statistical analysis
Anti-retroviral agents
HIV
Hepacivirus
Análise estatística
Antirretrovirais
title_short Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis
title_full Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis
title_fullStr Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis
title_full_unstemmed Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis
title_sort Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis
author Montes, Marisa
author_facet Montes, Marisa
Mark, Nelson
Girard, Pierre Marie
Sasadeusz, Joe
Horban, Andrzej
Grinsztejn, Beatriz
Zakharova, Natalia
Rivero, Antonio
Lathouwers, Erkki
Janssen, Katrien
Mahadevan, Sivi Ouwerkerk
Witek, James
author_role author
author2 Mark, Nelson
Girard, Pierre Marie
Sasadeusz, Joe
Horban, Andrzej
Grinsztejn, Beatriz
Zakharova, Natalia
Rivero, Antonio
Lathouwers, Erkki
Janssen, Katrien
Mahadevan, Sivi Ouwerkerk
Witek, James
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Montes, Marisa
Mark, Nelson
Girard, Pierre Marie
Sasadeusz, Joe
Horban, Andrzej
Grinsztejn, Beatriz
Zakharova, Natalia
Rivero, Antonio
Lathouwers, Erkki
Janssen, Katrien
Mahadevan, Sivi Ouwerkerk
Witek, James
dc.subject.en.pt_BR.fl_str_mv HIV
Hepacivirus
Statistical analysis
Anti-retroviral agents
topic HIV
Hepacivirus
Statistical analysis
Anti-retroviral agents
HIV
Hepacivirus
Análise estatística
Antirretrovirais
dc.subject.decs.pt_BR.fl_str_mv HIV
Hepacivirus
Análise estatística
Antirretrovirais
description Universidad Autónoma de Madrid. Hospital La Paz. HIV Unit. Internal Medicine. Madrid, Spain.
publishDate 2014
dc.date.issued.fl_str_mv 2014
dc.date.accessioned.fl_str_mv 2015-07-10T12:09:15Z
dc.date.available.fl_str_mv 2015-07-10T12:09:15Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv MONTES, Marisa et al. Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis. Journal of the International AIDS Society, v. 17, suppl. 3, p. 1-2, 2014.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/11203
dc.identifier.issn.none.fl_str_mv 1758-2652
dc.identifier.doi.none.fl_str_mv 10.7448/IAS.17.4.19626
dc.identifier.eissn.none.fl_str_mv 1758-2652
identifier_str_mv MONTES, Marisa et al. Telaprevir combination therapy in HCV/HIV co-infected patients (insight study): sustained virologic response at 12 weeks final analysis. Journal of the International AIDS Society, v. 17, suppl. 3, p. 1-2, 2014.
1758-2652
10.7448/IAS.17.4.19626
url https://www.arca.fiocruz.br/handle/icict/11203
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
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