| Autor: |
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 |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
|
| Zdroj: |
Annals of Hepatology, Vol 20, Iss , Pp 100257- (2021) |
| Druh dokumentu: |
article |
| ISSN: |
1665-2681 |
| DOI: |
10.1016/j.aohep.2020.09.002 |
| Popis: |
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. |
| Databáze: |
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| Externí odkaz: |
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