Digestive Disease Service, Hospital Universitario 12 de Octubre, Madrid, Spain.
Digestive Disease Service, Hospital Universitario 12 de Octubre, Madrid, Spain.
J Hepatol. 2017 Apr;66(4):718-723. doi: 10.1016/j.jhep.2016.12.020. Epub 2016 Dec 28.
BACKGROUND & AIMS: The development of direct-acting antiviral agents (DAAs) is a major step forward in the treatment of hepatitis C (HCV). The aims of the study were to evaluate the efficacy and tolerability of DAAs in kidney transplant (KT) recipients.
Hepa-C is a Spanish registry of patients treated with DAAs in which clinical, virological and analytical data were prospectively included. We report on the data from 103 KT recipients who received DAAs.
The most commonly used DAAs combinations were sofosbuvir/ledipasvir (n=59, 57%) and sofosbuvir+daclatasvir (n=18, 17%). Ribavirin was used in 41% of patients. Sustained viral response after 12weeks (SVR12) rate was 98%. Grade 2 or 3 anemia appeared in 14 (33%) of patients receiving ribavirin and in 9 (15%) without (p=0.03). There were three episodes of acute humoral graft rejection. No patient discontinued therapy due to adverse events. Importantly, 57 (55%) patients required immunosuppression dose adjustment. Overall, there were no statistically significant differences in the mean level of serum creatinine, eGFR and proteinuria before and after treatment. Nonetheless, seventeen (16%) patients experienced renal dysfunction (increase in serum creatinine >25%) during antiviral therapy, of whom 65% were cirrhotic in comparison with only 29% cirrhotic patients who did not develop significant renal dysfunction (p=0.004).
Antiviral therapy with DAAs was highly efficacious and safe in KT recipients. Nevertheless, a non-negligible number of patients, most of them cirrhotic, developed mild allograft dysfunction and a significant proportion of patients required immunosuppression dose adjustment, warranting a close follow-up during therapy.
Infection by hepatitis C virus is often found in kidney transplant patients and its presence increases mortality and graft failure. We investigated the efficacy and safety of the new direct-acting hepatitis C antivirals in this population, in which previous information is scarce. Our data shows that, as occurs in the non-transplant setting, new anti-HCV antivirals are highly efficacious kidney transplant patients. Overall, this therapy is also quite safe, although worsening of renal function is observed in 16% of patients warranting a close follow-up observation of graft function during antiviral therapy.
直接作用抗病毒药物（DAA）的发展是丙型肝炎（HCV）治疗的一大进步。本研究的目的是评估 DAA 在肾移植（KT）受者中的疗效和耐受性。
Hepa-C 是一个西班牙登记处，登记了接受 DAA 治疗的患者，其中前瞻性地纳入了临床、病毒学和分析数据。我们报告了 103 名接受 DAA 治疗的 KT 受者的数据。
最常用的 DAA 联合治疗方案为索非布韦/雷迪帕韦（n=59，57%）和索非布韦/达拉他韦（n=18，17%）。41%的患者使用利巴韦林。12 周后持续病毒学应答（SVR12）率为 98%。接受利巴韦林治疗的患者中有 14 例（33%）出现 2 或 3 级贫血，而未接受利巴韦林治疗的患者中有 9 例（15%）出现贫血（p=0.03）。发生 3 例急性体液性移植物排斥反应。没有患者因不良事件而停止治疗。重要的是，57 名（55%）患者需要调整免疫抑制剂量。总体而言，治疗前后血清肌酐、eGFR 和蛋白尿的平均水平无统计学显著差异。尽管如此，17 名（16%）患者在抗病毒治疗期间出现肾功能障碍（血清肌酐升高>25%），其中 65%为肝硬化患者，而无显著肾功能障碍的肝硬化患者仅占 29%（p=0.004）。
DAA 抗病毒治疗在 KT 受者中具有高度疗效和安全性。然而，相当数量的患者，大多数为肝硬化患者，出现轻度移植物功能障碍，相当比例的患者需要调整免疫抑制剂量，这需要在治疗期间进行密切随访。
丙型肝炎病毒感染在肾移植患者中很常见，其存在会增加死亡率和移植物失功。我们调查了新型直接作用抗丙型肝炎病毒药物在这一人群中的疗效和安全性，因为以前的信息很少。我们的数据表明，与非移植环境一样，新型抗 HCV 抗病毒药物对肾移植患者也非常有效。总体而言，这种治疗方法也相当安全，尽管 16%的患者出现肾功能恶化，需要在抗病毒治疗期间密切观察移植物功能。
