Beijing Friendship Hospital, Capital Medical University, 95 Yongan Road, Xicheng District, Beijing, China.
Beijing key laboratory of Tolerance Induction and Organ Protection in Transplantation, Beijing, China.
BMC Infect Dis. 2019 Jul 19;19(1):645. doi: 10.1186/s12879-019-4217-7.
Long-term outcome of DAAs therapy in kidney transplant recipients was unknown. Thus, we aimed to evaluate it in a Chinese cohort of HCV-infected kidney transplant recipients.
Single-center and retrospective study of HCV-infected kidney transplant recipients initiating an DAAs regimen between January 2015 and December 2017 was conducted. Totally 26 KTX recipients were divided into three groups, including KTX-HD Group, DAA-KTX Group and KTX-DAA Group. On-treatment response was defined as target not detected within 12 weeks. SVR 48, 96 were defined as HCV-RNA negativity 48, 96 weeks after treatment cessation, respectively.
HCV genotype was predominantly 1b (80.8%), followed by 2a. All (100%) patients achieved on-treatment response. Time to first TnD was 1.9 ± 0.6 weeks, with no significant difference among the three groups. All patients achieved SVR, with an SVR rate of 100.0% (26/26) among the patients who were followed up over 48 weeks after treatment cessation, and the same SVR rate (24/24) among the patients who were followed up over 96 weeks. Trough levels of Tac remained stable under DAAs therapy, without any dose adjustment. Two patients with abnormal GFR before treatment experienced serum creatinine elevation. Other adverse events included nausea, diarrhea, acid regurgitation, bilirubin elevation and edema of lower limbs. All patients recovered after treatment cessation without reductions in dose, or withdrawal of DAAs or immunosuppressive agents.
HCV genotype 1b and 2a are the only genotypes and 1b is predominant in our center. Antiviral treatment with DAAs in HCV-infected kidney transplant recipients is persistently effective and well tolerated during long-term follow-up. A regular monitoring of renal function in patients who receive DAAs regimens with preexisting impaired renal function is strongly recommended. Furthermore, the trough CNIs levels were recommended to be frequently monitored.
直接抗病毒药物（DAAs）治疗在肾移植受者中的长期疗效尚不清楚。因此，我们旨在对中国 HCV 感染的肾移植受者进行评估。
对 2015 年 1 月至 2017 年 12 月期间接受 DAA 治疗方案的 HCV 感染肾移植受者进行了单中心回顾性研究。总共 26 例肾移植受者分为 KTX-HD 组、DAA-KTX 组和 KTX-DAA 组。治疗期间应答定义为治疗 12 周内未检测到目标。SVR48、96 分别定义为治疗结束后 48、96 周 HCV-RNA 阴性。
HCV 基因型主要为 1b（80.8%），其次为 2a。所有（100%）患者均获得治疗应答。首次发生移植物功能丧失的时间为 1.9±0.6 周，三组间无显著差异。所有患者均获得 SVR，治疗结束后随访超过 48 周的患者 SVR 率为 100.0%（26/26），随访超过 96 周的患者 SVR 率为 100.0%（24/24）。在 DAA 治疗期间，他克莫司谷浓度保持稳定，无需调整剂量。两名治疗前 GFR 异常的患者出现血肌酐升高。其他不良事件包括恶心、腹泻、胃酸反流、胆红素升高和下肢水肿。所有患者停药后均恢复，无需减少剂量或停止使用 DAA 或免疫抑制剂。
在本中心，HCV 基因型 1b 和 2a 是唯一的基因型，且以 1b 为主。在长期随访中，HCV 感染肾移植受者接受 DAA 抗病毒治疗持续有效且耐受性良好。强烈建议对接受 DAA 方案治疗且存在肾功能受损的患者进行定期肾功能监测。此外，建议频繁监测他克莫司的谷浓度。
