Effectiveness and safety of sofosbuvir-based therapy against chronic hepatitis C infection after successful kidney transplantation.

Background Direct-acting antivirals (DAAs), including sofosbuvir (SOF), are recommended for treatment of chronic hepatitis C virus (HCV) infection. However, few studies have investigated the effectiveness and safety of new DAAs in kidney transplant recipients (KTRs). Objectives To assess the effectiveness and safety of SOF-based therapy in stable KTRs. Patients and methods Forty KTRs were treated with SOF-based regimens. Rapid, end-therapeutic, and sustained virologic responses were assessed, as was liver stiffness by elastometry. Safety was monitored by measuring the estimated glomerular filtration rate (eGFR), blood hemoglobin (Hb) concentration, proteinuria, and blood trough levels of calcineurin inhibitors (CNIs). Other side effects were also recorded. Results The effectiveness of DAAs was 100% at all time points. The therapy did not significantly influence eGFR or proteinuria, but significantly decreased mean blood Hb levels (13.5 +/- 2.0 vs 11.6 +/- 1.9, respectively, P < 0.001), which required a dose reduction or cessation of ribavirin (RBV) in 50% of patients. A profound, significant decrease in initial CNI concentrations was also observed during treatment in the majority of patients within the first month of therapy. Conclusions In this cohort of KTRs, the new SOF-based therapies were characterized by 100% effectiveness and good safety profiles. However, in patients co-treated with RBV, close blood Hb monitoring and early RBV dose reduction are necessary. In the majority of KTRs, antiviral therapy leads to a substantial and early decrease in CNIs levels, thus frequent measurement of CNI levels is necessary during SOF-based therapy.