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直接作用抗病毒药物治疗实体器官移植患者丙型肝炎病毒的安全性和有效性。

Safety and effectiveness of direct acting antivirals for treatment of hepatitis C virus in patients with solid organ transplantation.

作者信息

Mansour Marlina, Hill Lucas, Kerr Janice

机构信息

Department of Pharmacy Services, UC San Diego Health, La Jolla, California.

Department of Hepatology, UC San Diego Health, San Diego, California.

出版信息

Transpl Infect Dis. 2018 Dec;20(6):e12972. doi: 10.1111/tid.12972. Epub 2018 Aug 22.

Abstract

BACKGROUND

The direct acting antivirals (DAAs) for treatment of hepatitis C virus (HCV) infection have sustained virologic response (SVR) rates of greater than 90% in most patients. However, data evaluating DAA use in transplant patients are limited. The goal of this study was to evaluate the effectiveness and safety of HCV treatment in this high-risk population.

METHODOLOGY

This single-center retrospective study included liver, kidney, lung, and/or heart transplant patients who were treated for HCV infection with DAAs. The primary objective was to identify drug-drug interactions between DAAs and immunosuppressants by comparing immunosuppression dosages and levels at baseline and week 4 of HCV treatment. As secondary objectives, we described the percentage of patients with new or worsening rejection and/or graft dysfunction during HCV treatment, and the percentage of study patients who achieved SVR.

RESULTS

Of the 108 patients included, the majority had liver (76%) or kidney (13%) transplants. Simeprevir plus sofosbuvir was the most commonly prescribed HCV treatment (33.9%) and tacrolimus was the most common immunosuppressant (91%). We did not detect a statistically significant difference in immunosuppression dosages or levels during HCV treatment. Furthermore, only one patient (<1%) experienced rejection and five patients (4.6%) had six episodes of graft dysfunction while on DAAs. Efficacy was high with 98% of patients achieving SVR.

CONCLUSION

DAAs appear to be safe and effective for HCV treatment in patients with a history of liver and/or kidney transplantation. More data are needed to evaluate DAAs in lung and/or heart transplant patients.

摘要

背景

用于治疗丙型肝炎病毒(HCV)感染的直接抗病毒药物(DAA)在大多数患者中具有超过90%的持续病毒学应答(SVR)率。然而,评估DAA在移植患者中使用情况的数据有限。本研究的目的是评估在这一高风险人群中进行HCV治疗的有效性和安全性。

方法

这项单中心回顾性研究纳入了接受DAA治疗HCV感染的肝、肾、肺和/或心脏移植患者。主要目的是通过比较HCV治疗基线和第4周时的免疫抑制剂量和水平,确定DAA与免疫抑制剂之间的药物相互作用。作为次要目的,我们描述了HCV治疗期间出现新的或恶化的排斥反应和/或移植物功能障碍的患者百分比,以及实现SVR的研究患者百分比。

结果

在纳入的108例患者中,大多数为肝移植(76%)或肾移植(13%)。西米普明加索非布韦是最常用的HCV治疗方案(33.9%),他克莫司是最常用的免疫抑制剂(91%)。我们未检测到HCV治疗期间免疫抑制剂量或水平有统计学显著差异。此外,在使用DAA期间,只有1例患者(<1%)发生排斥反应,5例患者(4.6%)出现6次移植物功能障碍发作。疗效很高,98%的患者实现了SVR。

结论

DAA对于有肝和/或肾移植病史的患者治疗HCV似乎是安全有效的。需要更多数据来评估DAA在肺和/或心脏移植患者中的情况。

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