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【资讯翻译】Prevention of Hepatitis C Virus (HCV) Recurrence with Peri-...

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发表于 2014-10-21 09:50:13 | 显示全部楼层 |阅读模式
Prevention of Hepatitis C Virus (HCV) Recurrence with Peri-Transplant Hepatitis C Immune Globulin Combined with Pre-Transplant (Pre-LT) Antiviral Therapy (AVT)

Background and Aims: Safer HCV AVTs are available to treat wait-listed patients to prevent post-LT HCV recurrence, but such therapies are not uniformly effective and the optimal duration of pre-LT AVT unknown. We evaluated the safety and efficacy of Biotest-HCIG, a human hepatitis C immune globulin to prevent HCV recurrence by neutralizing remaining HCV reservoirs in patients on pre-LT HCV AVT at the time of LT.

Methods: In this phase 3, open-label randomized study, wait-listed patients with chronic HCV infection (all genotypes) treated with any AVT and who achieved HCV RNA <100 IU/ml prior to LT were eligible. In total, 84 patients will be randomized 1:1:1 to Biotest-HCIG (200 mg/kg or 300 mg/kg given on the day of LT and for 10 weeks post-LT) or observation. The primary endpoint is post-LT sustained virologic response (pTVR), defined as HCV RNA <43 IU/ml at 12 wks post-LT treatment. Post-transplant immunosuppression is site-specific.

Results: To date, 17 subjects (all male, median age 59 yrs, 100% genotype 1, 94% with hepatocellular carcinoma, 12% with living donors) have undergone LT. Pre-LT AVT was telaprevir/peginterferon/ribavirin (RBV) (12%), sofosbuvir/RBV (76%) or sofosbuvir/simeprevir (12%) given for a median of 51 days (range 14-164 days) pre-LT with all patients achieving HCV RNA <43 IU/mL pre-LT (71% also undetectable). With median post-LT follow-up of 8 wks, post-LT HCV recurrence has been documented in 2 patients - at wk 2 (control) and wk 3 (200 mg Biotest-HCIG) post-LT. Overall, 11/12 (92%) of Biotest-HCIG-treated patients have maintained undetectable HCV RNA compared to 4/5 (80%) of controls (Table). Among 4 patients who were viremic at the time of LT and randomized to Biotest-HCIG, all have undetectable HCV RNA at median 9 wks follow-up. Biotest-HCIG-related side effects were infrequent and there were no discontinuations due to adverse events.

Conclusion: Biotest-HCIG is safe and well-tolerated. To date, HCV recurrence rates in patients on pre-LT AVT are lower in Biotest-HCIG-treated patients compared with controls (8% vs 20%) and all patients viremic at LT who received Biotest-HCIG have undetectable HCV RNA. These preliminary results suggest Biotest-HCIG may be beneficial as an adjuvant therapy for HCV patients on AVT undergoing LT.

信源地址:http://onlinelibrary.wiley.com/doi/10.1002/hep.27451/full

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发表于 2014-10-21 09:54:03 | 显示全部楼层

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发表于 2014-10-21 16:17:02 | 显示全部楼层
使用围移植丙型肝炎免疫球蛋白联合移植前(预LT)抗病毒疗法(AVT)预防丙型肝炎病毒(HCV)复发

背景和目的
安全的丙肝病毒(HCV)抗病毒疗法(AVT)可以用于待移植患者,预防移植后HCV复发,但这些治疗方法没有统一有效性,移植前AVT的最佳时间也未知。研究人员评估了Biotest-HCIG的安全性和疗效,它是一种人类丙型肝炎免疫球蛋白,对接受移植前HCV AVT的患者,在移植时通过中和残留的HCV来预防HCV复发。

方法
在这项三期、开放标签的随机试验中,符合条件的患者是:接受任意AVT的慢性HCV感染的待移植患者(所有基因型),且移植前HCV RNA < 100 IU/ml。共有84例患者按1:1:1随机分配接受Biotest-HCIG(移植当天和移植后的10周中给予200或300 mg/kg)或空白对照。主要终点是移植后持续的病毒学应答(pTVR),定义为移植后12周时HCV RNA < 43 IU/ml。移植后的免疫抑制性是位点特异的。

结果
截止本文发表,17例患者进行了移植(均为男性,平均年龄59岁,100%是基因型1,94%有肝细胞癌,12%为活体捐赠者)。移植前AVT是在移植前平均给予51天(范围14-164天)telaprevir /聚乙二醇干扰素/利巴韦林(RBV)(12%)、sofosbuvir/RBV(76%)、或sofosbuvir/simeprevir (12%),所有患者均实现了移植前HCV RNA < 43 IU/mL(71%不能检测到)。移植后平均8周的随访期,移植后HCV复发2例,分别在移植后2周(对照组)和3周(200 mg Biotest-HCIG组)。总体来说,11/12(92%)Biotest-HCIG治疗的患者检测不到HCV RNA,而对照组为4/5(80%)(表)。移植时4例病毒血症患者随机分配接受Biotest-HCIG,在平均9周的随访中均检测不到HCV RNA。Biotest-HCIG相关的副作用很少见,没有因不良反应而停药的情况。

结论
Biotest-HCIG安全且耐受性良好。截止本文发表,Biotest-HCIG治疗的患者与对照组相比,移植前AVT的患者的HCV复发率较低(8% vs 20%),移植时患有病毒血症的患者给予了Biotest-HCIG,均检测不到HCV RNA。这些初步的研究结果表明,作为一种辅助治疗,Biotest-HCIG可能有益于HCV患者接受移植时AVT。
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