Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1-6 in Brazil
Mario Peribañez-Gonzalez, Hugo Cheinquer, Lino Rodrigues, Maria Patelli Lima, Mário Reis Álvares-da-Silva, José Madruga, Edison Roberto Parise, Mário Guimarães Pessoa, Juvencio Furtado, Marcia Villanova, Adalgisa Ferreira, Felipe Mazzoleni, Ecio Nascimento, Giovanni Faria Silva, Linda Fredrick, Preethi Krishnan, Margaret Burroughs, Tania Reuter, Mario Peribañez-Gonzalez, Hugo Cheinquer, Lino Rodrigues, Maria Patelli Lima, Mário Reis Álvares-da-Silva, José Madruga, Edison Roberto Parise, Mário Guimarães Pessoa, Juvencio Furtado, Marcia Villanova, Adalgisa Ferreira, Felipe Mazzoleni, Ecio Nascimento, Giovanni Faria Silva, Linda Fredrick, Preethi Krishnan, Margaret Burroughs, Tania Reuter
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 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-naïve Brazilian patients with hepatitis C infection without cirrhosis and with compensated cirrhosis.
Trial registration: ClinicalTrials.gov NCT03219216.
Keywords: Antiviral agents; Brazil; Glecaprevir and pibrentasvir; Hepatitis C; Liver cirrhosis.
Copyright © 2020. Published by Elsevier España, S.L.U.
Source: PubMed