Aggarwal Avin, Yoo Eric R, Perumpail Ryan B, Cholankeril George, Kumari Radhika, Daugherty Tami J, Lapasaran Alex S, Ahmed Aijaz
Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, CA, USA.
Department of Medicine, University of Illinois College of Medicine, Chicago, IL, USA.
J Clin Transl Hepatol. 2017 Mar 28;5(1):23-26. doi: 10.14218/JCTH.2016.00060. Epub 2017 Feb 22.
Patients with chronic hepatitis C (CHC) and end-stage renal disease (ESRD) who are dialysis-dependent form a unique group, in which safety, tolerability and efficacy of sofosbuvir (SOF)-based direct-acting antivirals (DAAs) need further evaluation. We performed a retrospective analysis of 14 patients with CHC and ESRD on dialysis who received 15 courses of SOF-based therapy. We evaluated dose escalation to standard-dose SOF in this proof-of-principle experience. Sustained virological response (defined as undetectable viral load at 12 weeks, SVR-12) was achieved in 13 out of the 15 (86.7%) treatment courses. Seven (46.6%) patients received reduced half dose as conservative proof-of-principal to mitigate potential toxicity. In 13 out of 15 treatment courses, patients completed the designated treatment duration. One patient was treated twice and developed SVR-12 with the retreatment. One patient was lost to follow-up and counted as a non-responder. Premature discontinuations were not due to DAA-related adverse effects. There were no reports of severe adverse effects or drug interactions. We treated CHC patients with ESRD using dose escalation to standard-dose SOF in this proof-of-principle experience and achieved SVR rates comparable to general population.
依赖透析的慢性丙型肝炎(CHC)和终末期肾病(ESRD)患者构成了一个独特的群体,在这个群体中,基于索磷布韦(SOF)的直接抗病毒药物(DAA)的安全性、耐受性和疗效需要进一步评估。我们对14例接受透析的CHC和ESRD患者进行了回顾性分析,这些患者接受了15个疗程的基于SOF的治疗。在这个原理验证试验中,我们评估了剂量递增至标准剂量SOF的情况。15个治疗疗程中有13个(86.7%)实现了持续病毒学应答(定义为12周时病毒载量不可检测,SVR-12)。7例(46.6%)患者接受了减半剂量作为保守的原理验证,以减轻潜在毒性。在15个治疗疗程中的13个疗程中,患者完成了指定的治疗疗程。1例患者接受了两次治疗,再次治疗后实现了SVR-12。1例患者失访,被计为无应答者。提前停药并非由于DAA相关的不良反应。没有严重不良反应或药物相互作用的报告。在这个原理验证试验中,我们通过剂量递增至标准剂量SOF治疗了ESRD的CHC患者,并获得了与普通人群相当的SVR率。