Abstract
BACKGROUND: Direct-acing antiviral agents are highly efficient treatment options for chronic hepatitis C virus (HCV) infection after renal allograft transplantation. Treatment options for patients with impaired graft function remain limited. Therefore, we assessed the effectiveness and safety of grazoprevir/elbasvir therapy for patients with chronic HCV infection and impaired renal allograft function. METHODS: Eleven renal allograft recipients with therapy-naïve HCV genotype (GT) 1a, 1b, or 4 were treated with the fixed-dose combination of elbasvir/grazoprevir without ribavirin for 12 weeks. All recipients exhibited impaired graft function with an average glomerular filtration rate lower than 30 mL/min per 1.73 m(2). Clinical data were retrospectively reviewed for renal and liver function parameters. Patients were closely monitored for trough levels of immunosuppressive agents, viral load, laboratory values, and potential adverse effects. RESULTS: Seven (64%) patients exhibited a rapid virologic response within 4 weeks (HCV GT1a, n = 2; HCV GT1b, n = 5). The other 4 patients exhibited a virologic response within 8 weeks (HCV GT1b, n = 3; HCV GT 4, n = 1). All patients exhibited a sustained virologic response at week 12 after the end of treatment. Clinical measures of liver function improved substantially for all patients. Few adverse effects were reported. Impaired renal allograft function and proteinuria remained stable. For most patients, only moderate adjustments to the tacrolimus dosage were necessary for maintaining sufficient trough levels. CONCLUSIONS: This treatment appears to be safe and effective for renal transplant recipients with impaired allograft function and is a promising treatment option for eradicating HCV infection in this patient population.