DAA-based antiviral treatment of patients with chronic hepatitis C in the pre- and postkidney transplantation setting

DAA-based antiviral treatment of patients with chronic hepatitis C in the pre- and postkidney transplantation setting
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DOI:
10.1111/tri.12799
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发表时间:
2016-09-01
影响因子:
3.1
通讯作者:
Maieron, Andreas
Maieron, Andreas
中科院分区:
医学3区
文献类型:
--
作者:
Beinhardt, Sandra;Al Zoairy, Ramona;Maieron, Andreas

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基于DAA的慢性丙型肝炎感染治疗方案鼓励治疗“难治性”队列。本研究调查了透析或肾移植或肝/肾移植后HCV患者中基于DAA的方案的有效性和安全性。评价了25例接受DAA联合治疗的患者:10例接受透析(8例:血液透析,2例:腹膜透析),8例为肾移植受者,7例为肝/肾移植受者。除了一名患者接受达卡他韦([DCV]/60 mg/QD)/西米普韦([SMV]/150 mg/QD)治疗外,其他患者接受基于索非布韦的方案([SOF]; 400 mg/QD)联合SMV:8,DCV:13或ledipasvir([LDV] 90 mg/QD),利巴韦林([RBV];基于体重)或聚乙二醇干扰素/RBV。通过Abbott RealTime(LLOQ:12 IU/ml)或Roche AmpliPrep/COBAS TaqMan检测试剂盒(LLOQ:15 IU/ml)测定HCV-RNA;每4周一次、治疗结束时以及此后4周和12周评价治疗反应。24例(96%)患者达到SVR 12/24(ITT分析)。平均治疗持续时间为15.1 +/- 5.1周(+/- SD),2例患者提前终止-均达到SVR 12。6例患者因基础疾病并发症住院。1例患者达到SVR 24,但再次感染(第27周)。肾功能保持稳定;仅1例患者的血清肌酐升高- SOF降至400 mg/48 h。DAA联合治疗肾功能受损的HCV患者非常有效,耐受性良好。这些发现需要进一步的对照试验和来自现实生活队列的数据。
DAA-based regimens for chronic hepatitis C infection encourage treatment of "difficult-to-treat" cohorts. This study investigated efficacy and safety of DAA-based regimens in HCV patients on dialysis or postkidney or liver/kidney transplantation. Twenty-five patients treated with DAA combinations were evaluated: 10 were on dialysis (eight: hemodialysis, two: peritoneal dialysis), eight were kidney transplant recipients, and seven were liver/kidney transplant recipients. Except for one patient treated with daclatasvir ([DCV]/60 mg/QD)/simeprevir ([SMV]/150 mg/QD), the others received sofosbuvir-based regimens ([SOF]; 400 mg/QD) combined with SMV: eight, DCV: 13 or either ledipasvir ([LDV] 90 mg/QD), ribavirin ([RBV]; weight based) or pegylated interferon/RBV. HCV-RNA was determined by Abbott RealTime (LLOQ]: 12 IU/ml) or Roche AmpliPrep/COBAS TaqMan assay (LLOQ: 15 IU/ml); treatment response evaluated every 4 weeks, at the end of treatment, and 4 and 12 weeks thereafter. Twenty-four (96%) patients achieved SVR 12/24 (ITT-analysis). Mean treatment duration was 15.1 +/- 5.1 weeks (+/- SD), and two patients terminated prematurely - both reached SVR12. Six patients were hospitalized due to complications of underlying disease. One patient achieved SVR24 but was re-infected (week 27). Kidney function remained stable; serum creatinine increased in only one patient - SOF was reduced to 400 mg/48 h. Treatment with DAA combinations in renally impaired HCV patients is highly effective and well tolerated. These findings call for further controlled trials and data from real-life cohorts.