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作者: StephenW 时间: 2019-12-13 12:03
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。