Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil
Autor(a) principal: | |
---|---|
Data de Publicação: | 2021 |
Outros Autores: | , , , , , , , , , , , , , , , , |
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. |
id |
UFRGS-2_dac035644cc9d58e77ae0c5fdfac9561 |
---|---|
oai_identifier_str |
oai:www.lume.ufrgs.br:10183/247313 |
network_acronym_str |
UFRGS-2 |
network_name_str |
Repositório Institucional da UFRGS |
repository_id_str |
|
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 |
dc.type.driver.fl_str_mv |
Estrangeiro info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10183/247313 |
dc.identifier.issn.pt_BR.fl_str_mv |
1665-2681 |
dc.identifier.nrb.pt_BR.fl_str_mv |
001146721 |
identifier_str_mv |
1665-2681 001146721 |
url |
http://hdl.handle.net/10183/247313 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.ispartof.pt_BR.fl_str_mv |
Annals of hepatology. Ciudad de México. Vol. 20 (Jan./Feb. 2021), 100257, 7 p. |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.source.none.fl_str_mv |
reponame:Repositório Institucional da UFRGS instname:Universidade Federal do Rio Grande do Sul (UFRGS) instacron:UFRGS |
instname_str |
Universidade Federal do Rio Grande do Sul (UFRGS) |
instacron_str |
UFRGS |
institution |
UFRGS |
reponame_str |
Repositório Institucional da UFRGS |
collection |
Repositório Institucional da UFRGS |
bitstream.url.fl_str_mv |
http://www.lume.ufrgs.br/bitstream/10183/247313/2/001146721.pdf.txt http://www.lume.ufrgs.br/bitstream/10183/247313/1/001146721.pdf |
bitstream.checksum.fl_str_mv |
3616411f1e9c750aa0f8766f06dc4ded 56081f16b6ff72077c242553cbdfa2b4 |
bitstream.checksumAlgorithm.fl_str_mv |
MD5 MD5 |
repository.name.fl_str_mv |
Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS) |
repository.mail.fl_str_mv |
|
_version_ |
1815447802050772992 |