Human monoclonal antibody MBL-HCV1 delays HCV viral rebound following liver transplantation: a randomized controlled study.
Human monoclonal antibody MBL-HCV1 delays HCV viral rebound following liver transplantation: a randomized controlled study.
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人类单克隆抗体MBL-HCV1延迟肝移植后HCV病毒反弹：一项随机对照研究。
DOI：
10.1111/ajt.12083
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发表时间：
2013-04
期刊：
影响因子：
--
通讯作者：
Molrine DC
中科院分区：
文献类型：
--
作者：
Chung RT;Gordon FD;Curry MP;Schiano TD;Emre S;Corey K;Markmann JF;Hertl M;Pomposelli JJ;Pomfret EA;Florman S;Schilsky M;Broering TJ;Finberg RW;Szabo G;Zamore PD;Khettry U;Babcock GJ;Ambrosino DM;Leav B;Leney M;Smith HL;Molrine DC
丙型肝炎病毒（HCV）感染患者的肝移植（LT）并发快速移植物感染。LT后使用聚乙二醇干扰素-α和利巴韦林治疗具有明显的毒性和有限的疗效。抗丙型肝炎病毒E2糖蛋白人源单克隆抗体的作用在一项随机、双盲、安慰剂对照的初步研究中，在接受LT的HCV基因型1a感染患者中检查了MBL-HCV 1对病毒清除的作用。受试者接受了11次50 mg/kg MBL-HCV 1（n=6）或安慰剂（n=5）静脉输注，在移植当天输注3次，LT后第1 - 7天单次输注，第14天一次输注。MBL-HCV 1耐受良好，并在7 - 28天内降低病毒载量。移植后第3 - 6天，抗体治疗组（范围-3.07至-3.34）的病毒载量（log 10 IU/ml）较基线的中位变化显著大于安慰剂组（范围-0.331至-1.01）（P=0.02）。与安慰剂治疗相比，MBL-HCV 1治疗显著延迟了病毒反弹的中位时间（18.7天vs.2.4天，P <0.001）。与其他HCV单药治疗一样，抗体治疗受试者在病毒反弹时存在耐药相关变异。MBL-HCV 1与直接作用的抗病毒药物的联合研究正在进行中。ClinicalTrials.gov标识符：NCT 01121185，由MassBiologics资助
Rapid allograft infection complicates liver transplantation (LT) in patients with hepatitis C virus (HCV). Pegylated interferon-α and ribavirin therapy after LT has significant toxicity and limited efficacy. The effect of a human monoclonal antibody targeting the HCV E2 glycoprotein (MBL-HCV1) on viral clearance was examined in a randomized, double-blind, placebo-controlled pilot study in patients infected with HCV genotype 1a undergoing LT. Subjects received 11 infusions of 50 mg/kg MBL-HCV1 (n=6) or placebo (n=5) intravenously with three infusions on day of transplant, a single infusion on days 1 through 7 and one infusion on day 14 after LT. MBL-HCV1 was well-tolerated and reduced viral load for a period ranging from 7 to 28 days. Median change in viral load (log10 IU/ml) from baseline was significantly greater (P=0.02) for the antibody-treated group (range −3.07 to −3.34) compared to placebo group (range −0.331 to −1.01) on days 3 through 6 post-transplant. MBL-HCV1 treatment significantly delayed median time to viral rebound compared to placebo treatment (18.7 days vs. 2.4 days, P <0.001). As with other HCV monotherapies, antibody-treated subjects had resistance-associated variants at the time of viral rebound. A combination study of MBL-HCV1 with a direct-acting antiviral is underway. ClinicalTrials.gov Identifier: NCT01121185 funded by MassBiologics
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DOI：
10.1084/jem.20090766
发表时间：
2010-08-30
期刊：
The Journal of experimental medicine
影响因子：
--
作者：
Fafi-Kremer S;Fofana I;Soulier E;Carolla P;Meuleman P;Leroux-Roels G;Patel AH;Cosset FL;Pessaux P;Doffoël M;Wolf P;Stoll-Keller F;Baumert TF
通讯作者：
Baumert TF
影响因子：
6.7
作者：
Morin TJ;Broering TJ;Leav BA;Blair BM;Rowley KJ;Boucher EN;Wang Y;Cheslock PS;Knauber M;Olsen DB;Ludmerer SW;Szabo G;Finberg RW;Purcell RH;Lanford RE;Ambrosino DM;Molrine DC;Babcock GJ
通讯作者：
Babcock GJ
影响因子：
5.4
作者：
Lavillette, D;Morice, Y;Cosset, FL
通讯作者：
Cosset, FL
影响因子：
29.4
作者：
Carrion, Jose A.;Navasa, Miquel;Forns, Xavier
通讯作者：
Forns, Xavier
影响因子：
13.5
作者：
KNODELL, RG;ISHAK, KG;WOLLMAN, J
通讯作者：
WOLLMAN, J