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

• Main Author: Gonzalez, Mario Peribanez
• Publication Date: 2021
• Other Authors: 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
• Format: Article
• Language: eng
• Source: Repositório Institucional da UFRGS
• Download full: http://hdl.handle.net/10183/247313
• topic: Antivirais; Hepatite C; Cirrose hepática; Brasil; Antiviral agents; Brazil; Hepatitis C; Liver cirrhosis; Glecaprevir and pibrentasvir

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.