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

Detalhes bibliográficos
Autor(a) principal: Gonzalez, Mario Peribanez
Data de Publicação: 2021
Outros Autores: Cheinquer, Hugo, Rodrigues, Lino, Lima, Maria Patelli Juliani S., Álvares-da-Silva, Mário Reis, Madruga, José V., Parise, Edison Roberto, Pessôa, Mário Guimarães, Furtado, Juvencio José Duailibe, Villanova, Marcia Guimarães, Ferreira, Adalgisa de Souza Paiva, Mazzoleni, Felipe, Nascimento, Ecio Alves do, Silva, Giovanni Faria, Fredrick, Linda, Krishnan, Preethi, Burroughs, Margaret Helen, Reuter, Tania Queiroz
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFRGS
Texto Completo: http://hdl.handle.net/10183/247313
Resumo: Introduction 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-naïve Brazilian adults without cirrhosis or with compensated cirrhosis. Patients and methods: EXPEDITION-3 was a Phase 3, open-label, multicenter study in treatment-naïve 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 beingheadache (18.0%). Four patients reported serious adverse events; none were considered drug related orled to study drug discontinuation. No hepatic decompensations were observed.Conclusions: Glecaprevir/pibrentasvir was effective and well tolerated in treatment-naïve Brazilianpatients with hepatitis C infection without cirrhosis and with compensated cirrhosis.
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spelling Gonzalez, Mario PeribanezCheinquer, HugoRodrigues, LinoLima, Maria Patelli Juliani S.Álvares-da-Silva, Mário ReisMadruga, José V.Parise, Edison RobertoPessôa, Mário GuimarãesFurtado, Juvencio José DuailibeVillanova, Marcia GuimarãesFerreira, Adalgisa de Souza PaivaMazzoleni, FelipeNascimento, Ecio Alves doSilva, Giovanni FariaFredrick, LindaKrishnan, PreethiBurroughs, Margaret HelenReuter, Tania Queiroz2022-08-19T04:43:02Z20211665-2681http://hdl.handle.net/10183/247313001146721Introduction 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-naïve Brazilian adults without cirrhosis or with compensated cirrhosis. Patients and methods: EXPEDITION-3 was a Phase 3, open-label, multicenter study in treatment-naïve 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 beingheadache (18.0%). Four patients reported serious adverse events; none were considered drug related orled to study drug discontinuation. No hepatic decompensations were observed.Conclusions: Glecaprevir/pibrentasvir was effective and well tolerated in treatment-naïve Brazilianpatients with hepatitis C infection without cirrhosis and with compensated cirrhosis.application/pdfengAnnals of hepatology. Ciudad de México. Vol. 20 (Jan./Feb. 2021), 100257, 7 p.AntiviraisHepatite CCirrose hepáticaBrasilAntiviral agentsBrazilHepatitis CLiver cirrhosisGlecaprevir and pibrentasvirEfficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in BrazilEstrangeiroinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSTEXT001146721.pdf.txt001146721.pdf.txtExtracted Texttext/plain39599http://www.lume.ufrgs.br/bitstream/10183/247313/2/001146721.pdf.txt3616411f1e9c750aa0f8766f06dc4dedMD52ORIGINAL001146721.pdfTexto completo (inglês)application/pdf440761http://www.lume.ufrgs.br/bitstream/10183/247313/1/001146721.pdf56081f16b6ff72077c242553cbdfa2b4MD5110183/2473132022-08-20 04:52:59.040726oai:www.lume.ufrgs.br:10183/247313Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2022-08-20T07:52:59Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false
dc.title.pt_BR.fl_str_mv Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil
title Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil
spellingShingle Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil
Gonzalez, Mario Peribanez
Antivirais
Hepatite C
Cirrose hepática
Brasil
Antiviral agents
Brazil
Hepatitis C
Liver cirrhosis
Glecaprevir and pibrentasvir
title_short Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil
title_full Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil
title_fullStr Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil
title_full_unstemmed Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil
title_sort Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil
author Gonzalez, Mario Peribanez
author_facet Gonzalez, Mario Peribanez
Cheinquer, Hugo
Rodrigues, Lino
Lima, Maria Patelli Juliani S.
Álvares-da-Silva, Mário Reis
Madruga, José V.
Parise, Edison Roberto
Pessôa, Mário Guimarães
Furtado, Juvencio José Duailibe
Villanova, Marcia Guimarães
Ferreira, Adalgisa de Souza Paiva
Mazzoleni, Felipe
Nascimento, Ecio Alves do
Silva, Giovanni Faria
Fredrick, Linda
Krishnan, Preethi
Burroughs, Margaret Helen
Reuter, Tania Queiroz
author_role author
author2 Cheinquer, Hugo
Rodrigues, Lino
Lima, Maria Patelli Juliani S.
Álvares-da-Silva, Mário Reis
Madruga, José V.
Parise, Edison Roberto
Pessôa, Mário Guimarães
Furtado, Juvencio José Duailibe
Villanova, Marcia Guimarães
Ferreira, Adalgisa de Souza Paiva
Mazzoleni, Felipe
Nascimento, Ecio Alves do
Silva, Giovanni Faria
Fredrick, Linda
Krishnan, Preethi
Burroughs, Margaret Helen
Reuter, Tania Queiroz
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Gonzalez, Mario Peribanez
Cheinquer, Hugo
Rodrigues, Lino
Lima, Maria Patelli Juliani S.
Álvares-da-Silva, Mário Reis
Madruga, José V.
Parise, Edison Roberto
Pessôa, Mário Guimarães
Furtado, Juvencio José Duailibe
Villanova, Marcia Guimarães
Ferreira, Adalgisa de Souza Paiva
Mazzoleni, Felipe
Nascimento, Ecio Alves do
Silva, Giovanni Faria
Fredrick, Linda
Krishnan, Preethi
Burroughs, Margaret Helen
Reuter, Tania Queiroz
dc.subject.por.fl_str_mv Antivirais
Hepatite C
Cirrose hepática
Brasil
topic Antivirais
Hepatite C
Cirrose hepática
Brasil
Antiviral agents
Brazil
Hepatitis C
Liver cirrhosis
Glecaprevir and pibrentasvir
dc.subject.eng.fl_str_mv Antiviral agents
Brazil
Hepatitis C
Liver cirrhosis
Glecaprevir and pibrentasvir
description Introduction 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-naïve Brazilian adults without cirrhosis or with compensated cirrhosis. Patients and methods: EXPEDITION-3 was a Phase 3, open-label, multicenter study in treatment-naïve 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 beingheadache (18.0%). Four patients reported serious adverse events; none were considered drug related orled to study drug discontinuation. No hepatic decompensations were observed.Conclusions: Glecaprevir/pibrentasvir was effective and well tolerated in treatment-naïve Brazilianpatients with hepatitis C infection without cirrhosis and with compensated cirrhosis.
publishDate 2021
dc.date.issued.fl_str_mv 2021
dc.date.accessioned.fl_str_mv 2022-08-19T04:43:02Z
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dc.relation.ispartof.pt_BR.fl_str_mv Annals of hepatology. Ciudad de México. Vol. 20 (Jan./Feb. 2021), 100257, 7 p.
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