Abstract
Background The use of direct antiviral agents (DAA) has radically modified the course of HCV hepatitis in renal patients. Aim of this study was to assess the effects of HCV eradication on quality of life (QOL) in renal transplant recipients (RTR), measured by CLDQ and SF-36. Methods Sixteen RTR with well preserved GFR (mean: 60.3±19.3 ml/min) and chronic HCV infection with moderate liver stiffness (9.3±1.7 kPa) were given a sofosbuvir-based regimen for 12 weeks and had a 1 year follow-up. Results At end of treatment (EOT) a complete viral clearance was observed in all the patients, with normalization of most laboratory data and a consistent reduction in liver stiffness. All these parameters remained stable after 1 year, as well as renal function and proteinuria. Questionnaire data showed consistent amelioration in different “emotional” domains at EOT, which persisted after 1 year and were associated with a globally improved QOL, although there was no change in most of the “physical” domains in both questionnaires. One patient under ribavirin developed an acute anemia and withdrew from the study, but no further adverse episode was observed throughout the study. Conclusions Our data, while confirming the efficacy of oral DAA, show that HCV infection represents a heavy psychological burden in renal transplant recipients, greatly alleviated by viral eradication, which determines a significant improvement in QOL that represents an important outcome in management of all transplant recipients. This trial is registered with ISRCTN97560076.
Highlights
The use of direct antiviral agents (DAA) has radically modified the course of hepatitis by C virus infection (HCV) hepatitis in renal patients
The recent introduction of second-generation direct antiviral agents (DAA) has dramatically changed the therapeutic scenario of HCV infection in general population, as well as in renal patients [9, 10], and mostly in renal transplant recipients (RTR), in whom interferon-based regimens are contraindicated because of the risk of acute graft rejection [8]; these new regimens have evidenced an optimal response in terms of either viral clearance or patients’ tolerability [2, 11,12,13,14,15,16,17,18]
The etiology of renal disease was undetermined in 57% of patients; six patients had biopsy proven glomerular diseases (2 focal and segmental glomerular sclerosis, 1 IgAnephropathy, 1 postinfectious, and 2 not defined), and proteinuria exceeded 1 g/24 hours in 2 patients; 3 patients were affected by posttransplant diabetes
Summary
The use of direct antiviral agents (DAA) has radically modified the course of HCV hepatitis in renal patients. While confirming the efficacy of oral DAA, show that HCV infection represents a heavy psychological burden in renal transplant recipients, greatly alleviated by viral eradication, which determines a significant improvement in QOL that represents an important outcome in management of all transplant recipients. Improvements in QOL represent a widely accepted measure of treatment outcome in any chronic disease, since patients require greater attention to their physical and emotional well-being in everyday life To this extent a small cohort of RTR underwent a 12-week sofosbuvir-based regimen and was prospectively followed up for one year, with repeated evaluation of QOL questionnaires. Our working hypothesis was that eradication of HCV may determine consistent improvements in QOL
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