Department of Hepatology and Liver Transplatation, Institute of Liver and Biliary Sciences, New Delhi, India.
Department of Nephrology, Institute of Liver and Biliary Sciences, New Delhi, India.
Liver Int. 2018 Dec;38(12):2137-2148. doi: 10.1111/liv.13863. Epub 2018 May 14.
BACKGROUND & AIMS: There is scant data on use of sofosbuvir containing directly acting antiviral (DAA) regimens in chronic kidney disease (CKD) patients. Recently generic versions of DAAs have become available in low-income countries including India. The aim of this study was to study the efficacy and safety of generic sofosbuvir in combination with generic ribavirin, ledipasvir or daclatasvir in HCV-infected patients with CKD including patients with advanced CKD (CKD stage 4 or 5 with an estimated glomerular filtration rate (GFR) <30 mL/min or those on dialysis).
Seventy-one CKD patients (76% male, 84.5% on maintenance haemodialysis, 23.9% cirrhosis) with HCV infection were included in the study. Full-dose sofosbuvir was used in combination with ribavirin (n = 26, for 24 weeks, 69.2% genotype 1, 30.8% genotype 3), ledipasvir (n = 26, for 12 weeks, all genotype 1) and daclatasvir (n = 19, for 12 weeks, all genotype 3).
Sustained virological response (SVR) (HCV RNA <12 IU/mL) at 12 weeks after stopping treatment was seen in 100% of the patients in all the 3 groups. At 24-week follow-up after end of therapy, 1 patient in sofosbuvir plus ledipasvir group relapsed. At 48-week follow-up after end of therapy, 1 more patient in sofosbuvir plus ribavirin group relapsed.
Full-dose sofosbuvir-based DAA therapy using generics is highly effective for individuals with HCV infection and CKD including advanced CKD (CKD stage 4 or 5 with an e-GFR <30 mL/min or those on dialysis).
关于慢性肾脏病（CKD）患者使用直接作用抗病毒药物（DAA）方案的数据很少。最近，包括印度在内的低收入国家都出现了 DAA 的仿制药。本研究旨在评估以仿制药索菲布韦为基础的 DAA 联合利巴韦林、雷迪帕韦或达卡他韦治疗方案在慢性丙型肝炎病毒（HCV）感染合并 CKD 患者中的疗效和安全性，包括晚期 CKD 患者（eGFR<30ml/min 的 CKD 4 或 5 期或透析患者）。
本研究纳入了 71 例 CKD 患者（76%为男性，84.5%在维持性血液透析，23.9%有肝硬化）。研究中使用全剂量索菲布韦联合利巴韦林（n=26，24 周，69.2%为基因 1 型，30.8%为基因 3 型）、雷迪帕韦（n=26，12 周，所有患者均为基因 1 型）和达卡他韦（n=19，12 周，所有患者均为基因 3 型）。
所有患者在治疗结束后 12 周时 SVR（HCV RNA<12IU/ml）均为 100%。在治疗结束后 24 周的随访中，索菲布韦联合雷迪帕韦组有 1 例患者复发。在治疗结束后 48 周的随访中，索菲布韦联合利巴韦林组有 1 例患者复发。
以全剂量索菲布韦为基础的 DAA 治疗方案对慢性丙型肝炎病毒感染合并 CKD 患者（包括晚期 CKD[肾小球滤过率（eGFR）<30ml/min 的 CKD 4 或 5 期或透析患者]）有效。
