Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
Nephrology Department, Port-Said University, Port Said, Egypt.
Int Urol Nephrol. 2019 Dec;51(12):2295-2304. doi: 10.1007/s11255-019-02272-5. Epub 2019 Sep 17.
Hepatitis C virus (HCV) infection in kidney transplant recipients (KTRs) is common and can impact on patient and graft survival rates. The efficacy and safety of direct-acting antivirals (DAAs) to treat genotype-4 HCV-infected KTRs have not been fully established.
A prospective, single-arm, single-center study was conducted at Mansoura Urology/Nephrology Center (Mansoura University, Egypt). 114 HCV RNA(+) genotype 4 KTRs were enrolled in this study after a hepatology consultation and consented to start treatment with interferon-free DAAs. A sofosbuvir-based regimen was given to 109 recipients that had creatinine clearance (Crcl) of > 30 mL/min/1.73 m. Ritonavir-boosted paritaprevir/ombitasvir was prescribed to five recipients with Crcl < 30 mL/min/1.73 m.
The mean age of the cohort was 45.2 ± 11.2 years; most were male. The mean duration with a transplant was 14.2 ± 3.5 years, with different immunosuppressive regimens, mostly based on calcineurin inhibitors. A rapid virological response (RVR), i.e., clearance of viral load, was achieved in 100% at 4 weeks after starting treatment. All patients had a sustained virological response (SVR) at 12 and 24 weeks posttreatment, with one exception. During DAA therapy serum creatinine increased in 12 patients. In three, this was concomitant with elevated calcineurin inhibitor and sirolimus trough levels. Graft biopsies were performed in 8 of these 12 patients: these revealed an acute rejection in 4 cases (acute cellular rejection grade-1A: n = 2, and grade-1B: n = 2). The rejection episodes occurred at 4-6 weeks after starting treatment.
DAAs were highly efficacious and safely treated genotype-4 HCV-infected KTRs and had no significant adverse effects on graft function/survival.
丙型肝炎病毒（HCV）感染在肾移植受者（KTR）中很常见，会影响患者和移植物的存活率。直接作用抗病毒药物（DAA）治疗基因型 4 HCV 感染 KTR 的疗效和安全性尚未完全确定。
在曼苏拉泌尿肾病中心（埃及曼苏拉大学）进行了一项前瞻性、单臂、单中心研究。在进行肝脏病学咨询并同意开始使用无干扰素 DAA 治疗后，本研究纳入了 114 例 HCV RNA(+)基因型 4 KTR。109 例肾小球滤过率（Crcl）>30 ml/min/1.73 m 的受者给予索非布韦为基础的方案。5 例 Crcl<30 ml/min/1.73 m 的受者给予利托那韦增强的帕利昔韦/奥贝他韦。
队列的平均年龄为 45.2±11.2 岁；大多数为男性。移植后平均时间为 14.2±3.5 年，使用不同的免疫抑制剂方案，主要基于钙调神经磷酸酶抑制剂。开始治疗后 4 周时，100%的患者达到快速病毒学应答（RVR），即病毒载量清除。所有患者在治疗后 12 和 24 周时均获得持续病毒学应答（SVR），但有 1 例例外。在 DAA 治疗期间，12 例患者的血清肌酐升高。其中 3 例同时伴有钙调神经磷酸酶抑制剂和西罗莫司谷浓度升高。对这 12 例患者中的 8 例进行了移植活检：其中 4 例（急性细胞性排斥反应 1A 级：n=2，1B 级：n=2）显示急性排斥反应。排斥反应发生在开始治疗后 4-6 周。
DAA 对基因型 4 HCV 感染的 KTR 非常有效且安全，对移植物功能/存活无显著不良影响。
