Efficacy and safety of glecaprevir/pibrentasvir in treatment-naive adults with chronic hepatitis C virus genotypes 1-6 in Brazil

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Autor(es): dc.contributorHosp Dia-
Autor(es): dc.contributorAbbVie Inc-
Autor(es): dc.contributorInst Infectol Campinas-
Autor(es): dc.contributorUniv Fed Rio Grande do Sul-
Autor(es): dc.contributorUniversidade de São Paulo (USP)-
Autor(es): dc.contributorUniv Fed Maranhao-
Autor(es): dc.contributorHosp Ernesto Dornelles-
Autor(es): dc.contributorUniversidade Estadual Paulista (Unesp)-
Autor(es): dc.contributorOutclin 5-
Autor(es): dc.creatorPeribanez-Gonzaleza, Mario-
Autor(es): dc.creatorCheinquer, Hugo-
Autor(es): dc.creatorRodrigues, Lino-
Autor(es): dc.creatorLima, Maria Patelli-
Autor(es): dc.creatorAlvares-da-Silva, Mario Reis-
Autor(es): dc.creatorMadruga, Jose-
Autor(es): dc.creatorParise, Edison Roberto-
Autor(es): dc.creatorPessoa, Mario Guimaraes-
Autor(es): dc.creatorFurtado, Juvencio-
Autor(es): dc.creatorVillanova, Marcia-
Autor(es): dc.creatorFerreira, Adalgisa-
Autor(es): dc.creatorMazzoleni, Felipe-
Autor(es): dc.creatorNascimento, Ecio-
Autor(es): dc.creatorSilva, Giovanni Faria [UNESP]-
Autor(es): dc.creatorFredrick, Linda-
Autor(es): dc.creatorKrishnan, Preethi-
Autor(es): dc.creatorBurroughs, Margaret-
Autor(es): dc.creatorReuter, Tania-
Data de aceite: dc.date.accessioned2022-02-22T00:59:47Z-
Data de disponibilização: dc.date.available2022-02-22T00:59:47Z-
Data de envio: dc.date.issued2021-06-25-
Data de envio: dc.date.issued2021-06-25-
Data de envio: dc.date.issued2020-12-31-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.1016/j.aohep.2020.09.002-
Fonte completa do material: dc.identifierhttp://hdl.handle.net/11449/210421-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/210421-
Descrição: dc.descriptionIntroduction and objectives: Glecaprevir/pibrentasvir is a highly effective and well tolerated treatment for hepatitis C infection. Brazilian patients were not included in the original development studies for glecaprevir/pibrentasvir. This study aimed to assess safety and efficacy of glecaprevir/pibrentasvir in treatment-naive Brazilian adults without cirrhosis or with compensated cirrhosis. Patients and methods: EXPEDITION-3 was a Phase 3, open-label, multicenter study in treatment-naive Brazilian adults with hepatitis C infection genotype 1-6. Patients without cirrhosis (F2 or F3) or with compensated cirrhosis (F4) received 8 or 12 weeks of glecaprevir/pibrentasvir, respectively. The primary efficacy endpoint was the rate of sustained virologic response at post-treatment Week 12. Secondary endpoints were on-treatment virologic failure and relapse rates. Baseline polymorphisms were assessed in NS3 and NS5A. Adverse events and laboratory abnormalities were monitored. Results: 100 patients were enrolled, 75 received 8 weeks of treatment and 25 received 12 weeks; all patients completed treatment. Overall sustained virologic response at post-treatment Week 12 rate was high (98.0%; 98/100; 95% confidence interval: 93.0-99.4) and remained high regardless of baseline viral or host factors, including demographics, hepatitis C virus RNA levels, polymorphisms in NS3 and/or NS5A, genotype, and relevant comorbidities. 55% of patients reported >= 1 adverse event, the most common being headache (18.0%). Four patients reported serious adverse events; none were considered drug related or led to study drug discontinuation. No hepatic decompensations were observed. Conclusions: Glecaprevir/pibrentasvir was effective and well tolerated in treatment-nave Brazilian patients with hepatitis C infection without cirrhosis and with compensated cirrhosis. (C) 2020 Published by Elsevier Espafia, S.L.U. on behalf of Fundacion Clinica Medica Sur, A.C. This is an open access article under the CC BY-NC-ND license.-
Descrição: dc.descriptionAbbVie-
Descrição: dc.descriptionHosp Dia, Ave Dr Arnaldo,165, Sao Paulo, Brazil-
Descrição: dc.descriptionRamiro Barcelos 2350,CPC Sala,21216, Porto Alegre, RS, Brazil-
Descrição: dc.descriptionAbbVie Inc, N Chicago, IL USA-
Descrição: dc.descriptionInst Infectol Campinas, Rua Dr Quirino,524,Sala 72, Campinas, Brazil-
Descrição: dc.descriptionUniv Fed Rio Grande do Sul, Sch Med, GI Liver Div, Hosp Clin Porto Alegre, Porto Alegre, RS, Brazil-
Descrição: dc.descriptionRua Santa Cruz,81, Sao Paulo, Brazil-
Descrição: dc.descriptionRua Diogo Faria,816 Vila Clementino, Sao Paulo, Brazil-
Descrição: dc.descriptionUniv Sao Paulo, Sch Med, Div Gastroenterol & Hepatol, Ave Eneas Carvalho Aguiar,255 Bloco B 4 Andar, Sao Paulo, Brazil-
Descrição: dc.descriptionRua Conego Xavier,276 Amb Infectol, Sao Paulo, Brazil-
Descrição: dc.descriptionUniv Sao Paulo, Fac Med Ribeirao Preto, Hosp Clin, Unidade Pesquisa Clin, Campus Univ S-N,Bloco G Subsolo 2, Ribeirao Preto, Brazil-
Descrição: dc.descriptionUniv Fed Maranhao, Clin Hosp Univ, Ctr Pesquisa, Rua Almirante Tamandare,01 Ctr, Sao Luis, Maranhao, Brazil-
Descrição: dc.descriptionHosp Ernesto Dornelles, Ave Ipiranga 1801,7 Andar, Porto Alegre, RS, Brazil-
Descrição: dc.descriptionAve Mandacaru,1590, Maringa, Parana, Brazil-
Descrição: dc.descriptionUNESP, Campus Botucatu,Rua Prof Dr Armanda Alves,S-N, Botucatu, SP, Brazil-
Descrição: dc.descriptionOutclin 5, Marechal Campos Ave 1355, Vitoria, ES, Brazil-
Descrição: dc.descriptionUNESP, Campus Botucatu,Rua Prof Dr Armanda Alves,S-N, Botucatu, SP, Brazil-
Formato: dc.format7-
Idioma: dc.languageen-
Publicador: dc.publisherElsevier B.V.-
Relação: dc.relationAnnals Of Hepatology-
???dc.source???: dc.sourceWeb of Science-
Palavras-chave: dc.subjectAntiviral agents-
Palavras-chave: dc.subjectBrazil-
Palavras-chave: dc.subjectHepatitis C-
Palavras-chave: dc.subjectLiver cirrhosis-
Palavras-chave: dc.subjectGlecaprevir and pibrentasvir-
Título: dc.titleEfficacy and safety of glecaprevir/pibrentasvir in treatment-naive adults with chronic hepatitis C virus genotypes 1-6 in Brazil-
Tipo de arquivo: dc.typelivro digital-
Aparece nas coleções:Repositório Institucional - Unesp

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