Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil
dc.contributor.author | Gonzalez, Mario Peribanez | pt_BR |
dc.contributor.author | Cheinquer, Hugo | pt_BR |
dc.contributor.author | Rodrigues, Lino | pt_BR |
dc.contributor.author | Lima, Maria Patelli Juliani S. | pt_BR |
dc.contributor.author | Álvares-da-Silva, Mário Reis | pt_BR |
dc.contributor.author | Madruga, José V. | pt_BR |
dc.contributor.author | Parise, Edison Roberto | pt_BR |
dc.contributor.author | Pessôa, Mário Guimarães | pt_BR |
dc.contributor.author | Furtado, Juvencio José Duailibe | pt_BR |
dc.contributor.author | Villanova, Marcia Guimarães | pt_BR |
dc.contributor.author | Ferreira, Adalgisa de Souza Paiva | pt_BR |
dc.contributor.author | Mazzoleni, Felipe | pt_BR |
dc.contributor.author | Nascimento, Ecio Alves do | pt_BR |
dc.contributor.author | Silva, Giovanni Faria | pt_BR |
dc.contributor.author | Fredrick, Linda | pt_BR |
dc.contributor.author | Krishnan, Preethi | pt_BR |
dc.contributor.author | Burroughs, Margaret Helen | pt_BR |
dc.contributor.author | Reuter, Tania Queiroz | pt_BR |
dc.date.accessioned | 2022-08-19T04:43:02Z | pt_BR |
dc.date.issued | 2021 | pt_BR |
dc.identifier.issn | 1665-2681 | pt_BR |
dc.identifier.uri | http://hdl.handle.net/10183/247313 | pt_BR |
dc.description.abstract | 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. | en |
dc.format.mimetype | application/pdf | pt_BR |
dc.language.iso | eng | pt_BR |
dc.relation.ispartof | Annals of hepatology. Ciudad de México. Vol. 20 (Jan./Feb. 2021), 100257, 7 p. | pt_BR |
dc.rights | Open Access | en |
dc.subject | Antivirais | pt_BR |
dc.subject | Antiviral agents | en |
dc.subject | Hepatite C | pt_BR |
dc.subject | Brazil | en |
dc.subject | Hepatitis C | en |
dc.subject | Cirrose hepática | pt_BR |
dc.subject | Brasil | pt_BR |
dc.subject | Liver cirrhosis | en |
dc.subject | Glecaprevir and pibrentasvir | en |
dc.title | Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil | pt_BR |
dc.type | Artigo de periódico | pt_BR |
dc.identifier.nrb | 001146721 | pt_BR |
dc.type.origin | Estrangeiro | pt_BR |
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