Direct-Acting Antivirals for the Treatment of Kidney Transplant Patients with Chronic Hepatitis C Virus Infection in Spain: A Long-Term Prospective Observational Study

Kidney Transplantation; Hepatitis C; Direct-acting antivirals therapy Trasplante de riñón; Hepatitis C; Terapia antiviral de acción directa Trasplantament de ronyó; Hepatitis C; Teràpia antiviral d’acció directa Background. Direct-acting antivirals (DAA) allow effective and safe eradication of hepatitis C virus (HCV) in most patients. There are limited data on the long-term effects of all-oral, interferon-free DAA combination therapies in kidney transplant (KT) patients infected with HCV. Here we evaluated the long-term tolerability, efficacy, and safety of DAA combination therapies in KT patients with chronic HCV infection. Methods. Clinical data from KT patients treated with DAA were collected before, during, and after the treatment, including viral response, immunosuppression regimens, and kidney and liver function. Results. Patients (N = 226) were mostly male (65.9%) aged 56.1 ± 10.9 years, with a median time from KT to initiation of DAA therapy of 12.7 years and HCV genotype 1b (64.6%). Most patients were treated with sofosbuvir-based therapies. Rapid virological response at 1 month was achieved by 89.4% of the patients and sustained virological response by week 12 by 98.1%. Liver function improved significantly after DAA treatment. Tacrolimus dosage increased 37% from the beginning of treatment (2.5 ± 1.7 mg/d) to 1 year after the start of DAA treatment (3.4 ± 1.9 mg/d, P < 0.001). Median follow-up was 37.0 months (interquartile range, 28.4–41.9) and death-censored graft survival was 91.1%. Adverse events resulting from DAA treatment, especially anemia, were reported for 31.0% of the patients. Conclusions. Chronic HCV infection can be treated efficiently and safely with DAA therapy in KT patients. Most patients retained stable kidney function and improved liver function. Tacrolimus dose had to be increased in most patients, potentially as a result of better liver function. This work was partially supported by a grant from the Instituto de Salud Carlos III co-funded by the Fondo Europeo de Desarrollo Regional-FEDER, RETICS (REDinREN RD16/0009). Astellas Pharma S.A. provided financial support for medical writing and editing of the manuscript.