Department of Endemic Medicine and Hepatology, Faculty of Medicine, Cairo University, Cairo, Egypt.
National Hepatology and Tropical Medicine Research Institute, Cairo Governorate, Egypt.
J Med Virol. 2019 Apr;91(4):668-676. doi: 10.1002/jmv.25362. Epub 2018 Dec 14.
Direct acting antiviral has offered treatment of hepatitis C virus (HCV) recurrence post liver transplantation (LT) with an all-oral regimen for short duration, excellent safety profile, and high sustained virological response (SVR). The aim of this study was to evaluate the efficacy and safety of sofosbuvir (SOF)-based regimens in the real world among a cohort of Egyptian patients with recurrent HCV post living donor LT (LDLT).
Patients with HCV-G4 recurrence post-LDLT were recruited from National Committee of Control of Viral Hepatitis, Egypt, from November 2014 to May 2017. They received different SOF-based regimens according to the treatment protocols available during this period. Patients' outcome and Adverse effects (AE) were evaluated.
One hundred ninety patients (170 males, mean age 56.8 ± 7.9 years) were included. Calcineurin inhibitors were the main immunosuppression used (173 patients). Out of 190, 119 (62.6%) received SOF/ribavirin (RBV), 38 (20%) SOF/simeprevir (SMV), 22 (11.6%) SOF/daclatasvir (DSV)/ ± RBV, and 11 (5.8%) received SOF/LDV/ ± RBV. Overall SVR12 was 89.5%, 84.9% in SOF/RBV group, 94.7% in SOF/SMV, 100% in SOF/DCV, and 100% in SOF/LDV with no statistically significant difference ( P = 0.104). The AE reported were as follows: anemia (n = 65, 34.4%) mainly in SOF/RBV group, transient hyperbilirubinemia during SOF/SMV in 13 patients (34%), mild Acute cellular rejection in eight patients (4.2%), and hepatocellular carcinoma in two patients (1%) mainly driven by underlying liver condition. Two deaths were unlikely related to HCV therapy.
Different SOF-based regimens were effective with high SVR12 rates in a difficult-to-treat population, recurrent HCV post LDLT.
直接作用抗病毒药物(DAA)为肝移植(LT)后丙型肝炎病毒(HCV)复发患者提供了一种全口服、短疗程、安全性好、持续病毒学应答(SVR)率高的治疗方案。本研究旨在评估索磷布韦(SOF)为基础的方案在埃及肝移植后丙型肝炎病毒复发(LDLT)患者中的疗效和安全性。
2014 年 11 月至 2017 年 5 月,从埃及国家病毒肝炎控制委员会招募了丙型肝炎病毒 G4 复发的 LDLT 后患者。他们根据这期间可用的治疗方案接受了不同的 SOF 为基础的方案。评估患者的结局和不良反应(AE)。
共纳入 190 例患者(170 例男性,平均年龄 56.8±7.9 岁)。钙调神经磷酸酶抑制剂是主要的免疫抑制剂(173 例)。190 例患者中,119 例(62.6%)接受 SOF/利巴韦林(RBV),38 例(20%)SOF/西美瑞韦(SMV),22 例(11.6%)SOF/达卡他韦(DCV)/±RBV,11 例(5.8%)接受 SOF/雷迪帕韦(LDV)/±RBV。总体 SVR12 为 89.5%,SOF/RBV 组为 84.9%,SOF/SMV 组为 94.7%,SOF/DCV 组为 100%,SOF/LDV 组为 100%,差异无统计学意义(P=0.104)。报告的不良反应为:贫血(n=65,34.4%)主要见于 SOF/RBV 组,13 例(34%)SOF/SMV 期间出现短暂性高胆红素血症,8 例(4.2%)轻度急性细胞性排斥反应,2 例(1%)肝细胞癌主要由潜在的肝脏疾病引起。2 例死亡可能与 HCV 治疗无关。
在 LDLT 后丙型肝炎病毒复发的难治性患者中,不同的 SOF 为基础的方案有效,SVR12 率高。