Musialik Joanna, Kolonko Aureliusz, Kwiecień Katarzyna, Owczarek Aleksander J, Więcek Andrzej
Department of Nephrology, Transplantation and Internal Medicine, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland.
Department of Statistics, School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, Medical University of Silesia, Katowice, Poland.
Transpl Infect Dis. 2019 Jun;21(3):e13090. doi: 10.1111/tid.13090. Epub 2019 Apr 25.
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).
To assess the effectiveness and safety of SOF-based therapy in stable KTRs.
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.
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.
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.
包括索磷布韦（SOF）在内的直接抗病毒药物（DAAs）被推荐用于治疗慢性丙型肝炎病毒（HCV）感染。然而，很少有研究调查新型DAAs在肾移植受者（KTRs）中的有效性和安全性。
评估基于SOF的治疗方案在稳定的KTRs中的有效性和安全性。
40例KTRs接受了基于SOF的治疗方案。评估了快速、治疗结束时和持续病毒学应答，以及通过弹性成像测量的肝脏硬度。通过测量估算肾小球滤过率（eGFR）、血红蛋白（Hb）浓度、蛋白尿和钙调神经磷酸酶抑制剂（CNIs）的血药谷浓度来监测安全性。还记录了其他副作用。
DAAs在所有时间点的有效性均为100%。该治疗对eGFR或蛋白尿无显著影响，但显著降低了平均血Hb水平（分别为13.5±2.0和11.6±1.9，P<0.001），50%的患者需要减少利巴韦林（RBV）剂量或停药。在大多数患者治疗的第一个月内，治疗期间还观察到初始CNI浓度显著大幅下降。
在这组KTRs中，新型基于SOF的治疗方案具有100%的有效性和良好的安全性。然而，在联合使用RBV的患者中，需要密切监测血Hb水平并尽早减少RBV剂量。在大多数KTRs中，抗病毒治疗会导致CNIs水平在早期大幅下降，因此在基于SOF的治疗期间需要频繁测量CNIs水平。
