期刊
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
卷 66, 期 2, 页码 -出版社
AMER SOC MICROBIOLOGY
DOI: 10.1128/aac.02003-21
关键词
transplantation; chronic kidney disease; chronic hepatitis C; immunosuppressant; tacrolimus; everolimus; sirolimus; interaction; antivirals; protease inhibitor
资金
- Merck Sharp & Dohme, MSD (MISP) [57745]
- Merck Sharp Dohme
- Gilead Sciences
The GZR/EBR single-tablet regimen for 12 weeks is highly effective and well tolerated in GT-1b HCV-infected liver or kidney transplant recipients, with generally easy management of drug-drug interactions.
More options regarding the choice of direct-acting antivirals (DAAs) are helpful for avoiding individual limitations in treating hepatitis C virus (HCV) infection. We aimed to assess the efficacy and tolerability of grazoprevir (GZR)/elbasvir (EBR) treatment in genotype-1b (GT-1b) HCV-infected liver or kidney transplant recipients. In this phase 4, single-arm, open-label, multicenter trial, patients received GZR 100 mg/ EBR 50 mg daily for 12 weeks. Patients with any HCV infection other than GT-1b, liver decompensation, human immunodeficiency virus, or hepatitis B virus co-infection, a history of NS5A inhibitor exposure, or any severe drug-drug interactions (DDIs), was excluded. The primary endpoint was sustained virologic response at 12 weeks post-treatment (SVR12). Of the 14 patients (10 kidney and 4 liver transplant subjects) enrolled in this study, 9 (64%) were females; the median age was 64.0 (range: 43-73) years. The regularly used immunosuppressants were tacrolimus (93%), everolimus (29%), and sirolimus (7%), with patient blood levels easily managed and generally stable (all P > 0.05 in quantile regression analysis). The rate of SVR12 was 100% in intent-to-treat analysis. Only one patient discontinued GZR/EBR therapy at 6 weeks post-treatment, due to a treatment-unrelated adverse event (AE); however, this patient remained, achieving SVR12. Most AEs were mild in severity and deemed to be not treatment-related. No organ rejection episodes or deaths occurred during the study period. The single-tablet regimen of GZR/EBR for 12 weeks is highly effective and well tolerated in GT-1b HCV-infected liver or kidney transplant recipients, and its DDIs are generally easy to manage.
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