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索磷布韦与利巴韦林联合治疗24周是活体肝移植后复发性丙型肝炎感染的一种有效治疗方案。

Sofosbuvir and Ribavirin for 24 Weeks Is An Effective Treatment Option for Recurrent Hepatitis C Infection After Living Donor Liver Transplantation.

作者信息

Anand Anil C, Agarwal Shaleen K, Garg Hitendra K, Khanna Sudeep, Gupta Subhash

机构信息

Department of Hepatology & Gastroenterology, Indraprastha Apollo Hospital, Sarita Vihar, Mathura Road, New Delhi 110076, India.

出版信息

J Clin Exp Hepatol. 2017 Sep;7(3):165-171. doi: 10.1016/j.jceh.2017.06.007. Epub 2017 Jun 28.

DOI:10.1016/j.jceh.2017.06.007
PMID:28970701
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5620355/
Abstract

BACKGROUND

Recurrent hepatitis C virus (HCV) has been a serious problem after liver transplantation (LT). We report our experience of 24-week therapy with sofosbuvir (SOF) and ribavirin (RBV) in post-LT recurrent HCV in living donor liver transplantation (LDLT) setting in South Asia.

METHODS

Data from all patients treated for post-transplantation HCV recurrence in a single center were analyzed. Treatment regimen was 24 weeks of SOF 400 mg daily and RBV (starting at 800 mg daily, increased as tolerated). Sustained virological response (SVR) was assessed 12 weeks and 24 weeks after completion of treatment.

RESULTS

63 patients (median age 52 [range 30-69] years; 80% males) were treated. Most (76.2%) were treatment experienced and predominant HCV genotype was 3 (77.7%) followed by 1 (20.6%). Median transient elastography (Fibroscan) score was 7 (range 3-11) kPa and none of the patients had cirrhosis. SVR12 was achieved in 60 of 63 patients (95.2%) while SVR24 was noted in 59 (93.7%). SVR12 rates were as good in genotype-3 as in genotype-1. Older age, longer period after transplantation, higher Fibroscan value and higher need for erythropoietin were likely to be associated with relapse. Adverse effects were noted in 34 patients and weakness and fatigue were the commonest side effects. Significant drop in hemoglobin (<8 g/dL) was seen in 6 patients.

CONCLUSIONS

SOF + RBV combination therapy for 24 weeks was safe and effective in treatment of for post-LT recurrent HCV in a single LT center and remains relevant due to its low cost and lack of drug interactions.

摘要

背景

丙型肝炎病毒(HCV)复发一直是肝移植(LT)后一个严重的问题。我们报告了在南亚活体肝移植(LDLT)环境下,使用索磷布韦(SOF)和利巴韦林(RBV)进行24周治疗复发性HCV的经验。

方法

分析了在单一中心接受移植后HCV复发治疗的所有患者的数据。治疗方案为每日服用400毫克SOF和RBV(开始时每日800毫克,根据耐受情况增加剂量),疗程为24周。在治疗完成后12周和24周评估持续病毒学应答(SVR)。

结果

共治疗了63例患者(中位年龄52岁[范围30 - 69岁];80%为男性)。大多数患者(76.2%)有治疗史,主要的HCV基因型为3型(77.7%),其次是1型(20.6%)。瞬时弹性成像(Fibroscan)评分中位数为7(范围3 - 11)kPa,且所有患者均无肝硬化。63例患者中有60例(95.2%)实现了SVR12,59例(93.7%)实现了SVR24。SVR12率在3型基因型患者中与1型基因型患者中一样好。年龄较大、移植后时间较长、Fibroscan值较高以及对促红细胞生成素的需求较高可能与复发有关。34例患者出现了不良反应,虚弱和疲劳是最常见的副作用。6例患者血红蛋白显著下降(<8 g/dL)。

结论

在单一肝移植中心,SOF + RBV联合治疗24周对于治疗肝移植后复发性HCV是安全有效的,并且由于其成本低和无药物相互作用,仍然具有重要意义。

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Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016.印度国家肝脏研究协会(INASL)丙型肝炎病毒感染抗病毒治疗指南:2016年更新版
J Clin Exp Hepatol. 2016 Jun;6(2):119-45. doi: 10.1016/j.jceh.2016.07.001. Epub 2016 Jul 2.
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Management of post liver transplantation recurrent hepatitis C infection with directly acting antiviral drugs: a review.直接作用抗病毒药物治疗肝移植术后丙型肝炎复发感染的研究综述
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Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial.雷迪帕韦和索非布韦联合利巴韦林治疗基因型 1 或 4 型丙型肝炎病毒感染和晚期肝病患者:一项多中心、开放标签、随机、2 期临床试验。
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Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post-liver transplantation recurrence.达卡他韦联合索磷布韦和利巴韦林用于治疗伴有晚期肝硬化或肝移植后复发的丙型肝炎病毒感染。
Hepatology. 2016 May;63(5):1493-505. doi: 10.1002/hep.28446. Epub 2016 Mar 7.
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Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection in 2015.印度国家肝脏研究协会(INASL)2015年丙型肝炎病毒感染抗病毒治疗指南。
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A SPECIAL MEETING REVIEW EDITION: Highlights in the Treatment of Hepatitis C Virus From the 2014 Liver Meeting: A Review of Selected Presentations From the 2014 Liver Meeting November 7-11, 2014 • Boston, MassachusettsSpecial Reporting on:• Evaluation of Sofosbuvir and Simeprevir-Based Regimens in the TRIO Network• Safety and Efficacy of New DAA-Based Therapy for Hepatitis C Post-Transplant: Interval Results From the HCV-TARGET Longitudinal, Observational Study• Efficacy and Safety of MK-5172 and MK-8742 ± Ribavirin in Hepatitis C Genotype 1 Infected Patients With Cirrhosis or Previous Null Response: Final Results of the C-WORTHY Study (Parts A & B)• Safety and Efficacy of Sofosbuvir in Combination With Simeprevir + Ribavirin in Patients With Genotype 1: Interim Results of a Prospective, Observational Study• All-Oral Fixed-Dose Combination Therapy With Daclatasvir/Asunaprevir/BMS-791325, ± Ribavirin, for Patients With Chronic HCV Genotype 1 Infection and Compensated Cirrhosis: UNITY-2 Phase 3 SVR-12 Results• TURQUOISE-II: Regimens of ABT-450/R/Ombitasvir and Dasabuvir With Ribavirin Achieve High SVR12 Rates in HCV Genotype 1-Infected Patients With Cirrhosis, Regardless of Baseline CharacteristicsPLUS Meeting Abstract Summaries With Expert Commentary by: Ira M. Jacobson, MDChief of the Division of Gastroenterology and HepatologyVincent Astor Distinguished Professor of MedicineWeill Cornell Medical CollegeAttending PhysicianNewYork-Presbyterian HospitalNew York, New York.特别会议回顾版:2014年肝脏会议丙型肝炎病毒治疗亮点:2014年肝脏会议精选报告回顾,2014年11月7日至11日,马萨诸塞州波士顿。特别报道:•TRIO网络中基于索非布韦和西米普明的治疗方案评估;•基于新型直接抗病毒药物的丙型肝炎移植后治疗的安全性和有效性:HCV-TARGET纵向观察性研究的中期结果;•MK-5172和MK-8742±利巴韦林在丙型肝炎基因1型感染的肝硬化患者或既往无应答患者中的疗效和安全性:C-WORTHY研究(A和B部分)的最终结果;•索非布韦联合西米普明+利巴韦林在基因1型患者中的安全性和有效性:一项前瞻性观察性研究的中期结果;•达卡他韦/阿舒瑞韦/BMS-791325全口服固定剂量联合治疗,±利巴韦林,用于慢性丙型肝炎基因1型感染和代偿性肝硬化患者:UNITY-2 3期SVR-12结果;•TURQUOISE-II:ABT-450/R/奥比他韦和达沙布韦联合利巴韦林方案在丙型肝炎基因1型感染的肝硬化患者中实现了高SVR12率,无论基线特征如何。另外还有会议摘要及专家评论:医学博士 Ira M. Jacobson,胃肠病学和肝病科主任,威尔康奈尔医学院医学Vincent Astor杰出教授,纽约长老会医院主治医师,纽约,纽约。
Gastroenterol Hepatol (N Y). 2014 Dec;10(12 Suppl 6):1-19.
7
Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease.来迪派韦索磷布韦与利巴韦林联合治疗晚期肝病患者的 HCV 感染。
Gastroenterology. 2015 Sep;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. Epub 2015 May 15.
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Sofosbuvir and simeprevir is effective for recurrent hepatitis C in liver transplant recipients.索磷布韦和西米普明对肝移植受者复发性丙型肝炎有效。
Liver Int. 2015 Nov;35(11):2442-7. doi: 10.1111/liv.12856. Epub 2015 May 12.
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Sofosbuvir compassionate use program for patients with severe recurrent hepatitis C after liver transplantation.索磷布韦同情用药项目用于肝移植后严重复发性丙型肝炎患者。
Hepatology. 2015 May;61(5):1485-94. doi: 10.1002/hep.27681. Epub 2015 Mar 20.
10
Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation.索磷布韦联合利巴韦林治疗肝移植后代偿期复发丙型肝炎病毒感染
Gastroenterology. 2015 Jan;148(1):108-17. doi: 10.1053/j.gastro.2014.10.001. Epub 2014 Oct 7.