1期试验显示Lenvervimab治疗HBV有希望的结果

StephenW

Phase 1 Trial Shows Promising Results for Lenvervimab for HBV Treatment
Virginia A. Schad, PharmD, RPh
Lenvervimab, a recombinant human immunoglobulin, is well tolerated and reduces levels of hepatitis B surface antigen (HBsAg) to below undetectable levels for up to 1 month in patients with chronic hepatitis B virus (HBV) infection, according to an open-label, dose-escalation phase 1 trial published in Clinical Gastroenterology and Hepatology.

A phase 2 study with patients receiving a nucleoside analog is ongoing, entailing 6 months of lenvervimab administration and a 6-month follow-up period.

Research has suggested that hepatitis B immunoglobulin (HBIG) therapy may be beneficial for patients with chronic hepatitis B. Lenvervimab is a recombinant monoclonal HBIG therapy developed by GC Pharma (Yongin, South Korea) that researchers hypothesized might induce rapid reduction of HBsAg and subsequent immune restoration to resolve chronic hepatitis B.

In study part A, patients were given a single intravenous injection of lenvervimab (doses from 80,000 to 240,000 IU) and followed for 4 weeks. In study part B, patients were given injections of lenvervimab each week for 4 weeks and followed for 7 weeks. Patients in study part A and B were followed up only to 4 and 7 weeks, respectively, from the final administration of lenvervimab. The study authors found that HBsAg titers decreased after each administration but tended to rebound. In addition, they found that there was no dose-limiting toxicity at any dose and that no adverse drug reactions were observed in study parts A or B.

“In conclusion, lenvervimab is well tolerated and reduces levels of HBsAg to below undetectable levels for up to 1 month in patients with chronic HBV infection,” stated the authors. They added that, “The combination of lenvervimab and antiviral agents might lead to sustained clearance of HBsAg in patients with chronic HBV infection.”

Disclosure: This study was sponsored by GC Pharma Co. Ltd. Sang Hoon Ahn, MD, PhD, declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of his disclosures.

Reference

Lee HW, Park JY, Hong T, Park MS, Ahn SH. Efficacy of lenvervimab, a recombinant human immunoglobulin, in treatment of chronic HBV infection [published online October 4, 2019]. Clin Gastroenterol Hepatol. doi:10.1016/j.cgh.2019.09.038

StephenW

1期试验显示Lenvervimab治疗HBV有希望的结果
弗吉尼亚·夏德（Virginia A.
Lenvervimab是一种重组人免疫球蛋白，具有良好的耐受性，可将慢性乙型肝炎病毒（HBV）感染患者的乙型肝炎表面抗原（HBsAg）水平降低至不可检测的水平，长达1个月。 -逐步升级的1期临床试验发表在《临床胃肠病学和肝病学》上。

正在进行一项正在接受核苷类似物治疗的患者的2期研究，这需要lenvervimab的6个月给药和6个月的随访期。

研究表明，乙型肝炎免疫球蛋白（HBIG）治疗可能对慢性乙型肝炎患者有益。Lenvervimab是由GC Pharma（韩国Yongin）开发的一种重组单克隆HBIG治疗方法，研究人员假设该方法可能会引起HBsAg的快速降低和随后的免疫反应。恢复以解决慢性乙型肝炎。

在研究A部分中，给患者静脉注射lenvervimab（剂量为80,000至240,000 IU），并随访4周。在研究B部分中，患者每周接受lenvervimab注射4周，然后进行7周。 lenvervimab的最终给药后，分别仅对研究A和B部分中的患者进行了长达4周和7周的随访。研究作者发现，每次给药后，HBsAg滴度下降，但趋于反弹。此外，他们发现在任何剂量下都没有剂量限制性毒性，并且在研究部分A或B中未观察到药物不良反应。

这组作者说：“总的来说，lenvervimab具有良好的耐受性，可将慢性HBV感染患者的HBsAg水平降低至不可检测的水平，长达1个月。”他们补充说：“ lenvervimab和抗病毒药物的组合可能会导致慢性HBV感染患者的HBsAg持续清除。”

披露：该研究由GC Pharma Co. Ltd.赞助。医学博士Sang Hoon Ahn宣布与制药行业有从属关系。请参阅原始参考资料以获取其披露的完整列表。

参考

Lee HW，Park JY，Hong T，Park MS，Ahn SH。重组人免疫球蛋白Lenvervimab在治疗慢性HBV感染中的功效[于2019年10月4日在线发布]。 Castro Gastroenterol Hepatol。 doi：10.1016 / j.cgh.2019.09.038

乙肝人1949

这个是不是三明治疗法，先用药品中和HbsAg，然后再疫苗打入人体中，看能否有抗体出来?

aiyayao

单降HbsAg都是会反弹，估计得联合治疗，并得刺激免疫反应才行

齐欢畅

不错