Kwok Ryan M, Ahn Joseph, Schiano Thomas D, Te Helen S, Potosky Darryn R, Tierney Amber, Satoskar Rohit, Robertazzi Suzanne, Rodigas Colleen, Lee Sang Michelle, Wiegel Joshua, Patel Neal, Gripshover Janet, Hassan Mohamed A, Branch Andrea, Smith Coleman I
Medstar Georgetown Transplant Institute, Georgetown University School of Medicine, Washington, DC.
Oregon Health and Science University, Portland, OR.
Liver Transpl. 2016 Nov;22(11):1536-1543. doi: 10.1002/lt.24614.
Hepatitis C virus (HCV) recurrence after liver transplantation (LT) is associated with worse outcomes. The combination of ledipasvir (LDV) and sofosbuvir (SOF) has been approved for HCV treatment after LT, but there are limited data on the effectiveness and safety of LDV/SOF in the "real-world" setting. This multicenter study is the largest report to date on the effectiveness and safety of LDV/SOF in the post-LT setting. A total of 204 patients (72% male, 68% Caucasian, 66% genotype [GT] 1a, 21% METAVIR F3-F4, 49% treatment-experienced) were treated with LDV/SOF. The mean duration from LT to treatment initiation was 4.8 years. The overall sustained virological response rate 12 weeks after completion of therapy (SVR12) was 96%. Patients treated with 8 or 12 weeks of LDV/SOF without RBV experienced an SVR12 rate of 100% and 96%, respectively. Calcineurin inhibitors were used in 89% of patients, and 32% of patients underwent adjustment in immunosuppression during treatment. One episode of mild rejection, responsive to an increase in immunosuppression dosage, was observed. There was no graft loss attributed to HCV treatment. Four deaths occurred unrelated to HCV treatment, and no significant serious adverse events were documented. In conclusion, SOF and LDV with or without RBV for 8, 12, or 24 weeks in post-LT patients was effective and safe with a high SVR12 rate across a spectrum of GTs and stages of fibrosis. Liver Transplantation 22 1536-1543 2016 AASLD.
肝移植（LT）后丙型肝炎病毒（HCV）复发与更差的预后相关。来迪派韦（LDV）和索磷布韦（SOF）联合用药已被批准用于LT后HCV的治疗，但关于LDV/SOF在“现实世界”中的有效性和安全性的数据有限。这项多中心研究是迄今为止关于LDV/SOF在LT后环境中有效性和安全性的最大规模报告。共有204例患者（72%为男性，68%为白种人，66%为基因1a型[GT]，21%为METAVIR F3 - F4级，49%有治疗史）接受了LDV/SOF治疗。从LT到开始治疗的平均时间为4.8年。治疗完成后12周的总体持续病毒学应答率（SVR12）为96%。接受8周或12周不含利巴韦林（RBV）的LDV/SOF治疗的患者，其SVR12率分别为100%和96%。89%的患者使用了钙调神经磷酸酶抑制剂，32%的患者在治疗期间进行了免疫抑制调整。观察到1例轻度排斥反应，增加免疫抑制剂量后有反应。没有因HCV治疗导致移植物丢失。发生了4例与HCV治疗无关的死亡，未记录到显著的严重不良事件。总之，对于LT后患者，SOF和LDV联合或不联合RBV治疗8、12或24周是有效且安全的，在一系列GT和纤维化阶段中SVR12率都很高。《肝脏移植》22 1536 - 1543 2016美国肝病研究学会
