Grazoprevir/Elbasvir Treatment in Liver or Kidney Transplant Recipients with Genotype 1b Hepatitis C Virus Infection

Abstract

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 100mg/EBR 50mg daily for 12 weeks. Patients with any HCV infection other than genotype-1b (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) were excluded. The primary endpoint was sustained virologic response at 12 weeks posttreatment (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 posttreatment 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.

A Systematic Review of Direct-Acting Antivirals for Hepatitis C in Advanced CKD

“…We found 29 studies pertaining to KTRs. 29 , 30 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 , 108 , 109 , 110 , 111 , 112 , 113 , 114 , 115 , 116 , 117 , 118 , 119 , 120 , 121 , 122 , 123 , 124 , 125 The studies evaluated the following: GLE/PIB (1 study, N = 20), GZR/EBR (2 studies, N = 21), PrO ± D (2 studies, N = 33), SOF (6 studies, N = 117), SOF/DCV (7 studies, N = 351), SOF/LDV (9 studies, N = 300), and SOF/VEL (1 study, N = 10). Three retrospective, unadjusted studies also compared a variety of DAA regimens ( N = 86), mostly SOF/LDV or SOF/DCV, to no DAA treatment ( N = 63).…”

Chronic Hepatitis C Virus Infection in Chronic Kidney Disease

“…A previous study discovered that kidney transplant recipients with GFR ≥ 40 mL/min/1.73 m 2 had a 100% SVR after receiving the sofosbuvir/ledipasvir regimen [42]. Lai and colleagues [42] reported that grazoprevir/elbasvir for 12 weeks is highly effective in genotype 1b HCV-infected liver and kidney transplant recipients [43].…”