An integrated analysis of elbasvir/grazoprevir in Korean patients with hepatitis C virus genotype 1b infection
Clinical and Molecular Hepatology
; : 400-407, 2019.
Article
de En
| WPRIM
| ID: wpr-785649
Bibliothèque responsable:
WPRO
ABSTRACT
BACKGROUND/AIMS: In the Republic of Korea, an estimated 231,000 individuals have chronic hepatitis C virus (HCV) infection. The aim of the present analysis was to evaluate the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) administered for 12 weeks in Korean patients who were enrolled in international clinical trial phase 3 studies.METHODS: This was a retrospective, integrated analysis of data from patients with HCV genotype (GT) 1b infection enrolled at Korean study sites in four EBR/GZR phase 3 clinical trials. Patients were treatment-naive or had previously failed interferon-based HCV therapy, and included those with human immunodeficiency virus coinfection or Child-Pugh class A cirrhosis. All patients received EBR 50 mg/GZR 100 mg once daily for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after completion of therapy (SVR12, HCV RNA <15 IU/mL).RESULTS: SVR12 was achieved by 73 of 74 (98.6%) patients. No patients had virologic failure and one discontinued from the study after withdrawing consent. SVR12 rates were uniformly high across all patient subgroups. A total of 16 patients had nonstructural protein 5A resistance-associated substitutions at baseline (16/73, 22%), all of whom achieved SVR12. Adverse events (AEs) reported in >5% of patients were fatigue (6.8%), upper respiratory tract infection (5.4%), headache (5.4%), and nausea (5.4%). Thirteen patients (17.6%) reported drug-related AEs, two serious AEs occurred, and two patients discontinued treatment owing to an AEs.CONCLUSIONS: In this retrospective analysis, EBR/GZR administered for 12 weeks was well-tolerated and highly effective in Korean patients with HCV GT1b infection.
Mots clés
Texte intégral:
1
Indice:
WPRIM
Sujet Principal:
Antiviraux
/
Infections de l'appareil respiratoire
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Fibrose
/
ARN
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Études rétrospectives
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VIH (Virus de l'Immunodéficience Humaine)
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Hépatite C
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Hepacivirus
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Hépatite C chronique
/
Fatigue
Type d'étude:
Observational_studies
Limites du sujet:
Humans
Pays comme sujet:
Asia
langue:
En
Texte intégral:
Clinical and Molecular Hepatology
Année:
2019
Type:
Article