College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia.
King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.
Medicine (Baltimore). 2023 Apr 21;102(16):e33609. doi: 10.1097/MD.0000000000033609.
Vesatolimod is a toll-like receptor (TLR) agonist that is thought to suppress chronic hepatitis B (HBV) infection. This systematic review aimed to assess the safety and efficacy of vesatolimod in treating chronic hepatitis B.
We included randomized clinical trials (RCTs) that assessed vesatolimod in patients with hepatitis B infection without hepatocellular carcinoma or liver transplantation and with reported levels of hepatitis B surface antigen (HBsAg) or liver transaminases post-intervention. We searched MEDLINE, SCOPUS, Springer, Google Scholar, ClinicalTrials.gov, and Cochrane Central Register of Clinical Trials for all related articles during May 2022. Two independent authors screened articles for inclusion, and discrepancies were resolved by consensus and a third reviewer. Two independent reviewers assessed studies included in this systematic review using the Critical Appraisal Skills Programme checklist for RCTs.
Only 4 were considered eligible from 391 articles identified through our search. All eligible studies did not report any clinically significant outcomes following the use of vesatolimod, as evidenced by the persistence of HBsAg. However, vesatolimod was associated with induction of interferon-stimulated genes (ISGs) and only mild side effects, warranting further studies to evaluate its potential for future use as a safe, tolerable anti-HBV medication. No significant differences were noted amongst trials included in either of Vesatolimod doses (Vesatolimod 1 mg, RR = 0.99, 95% CI 0.76-1.30, P = .95, I2 = 0%; Vesatolimod 2 mg, RR = 1.06, 95% CI 0.82-1.37, P = .66, I2 = 0%; Vesatolimod 4 mg, RR = 1.06, 95% CI 0.82-1.37, P = .66, I2 = 0%;), further suggesting its comparable safety in comparison to oral antiviral agents.
Vesatolimod 是一种 Toll 样受体（TLR）激动剂，被认为可抑制慢性乙型肝炎（HBV）感染。本系统评价旨在评估 vesatolimod 治疗慢性乙型肝炎的安全性和疗效。
我们纳入了评估乙型肝炎感染患者（无肝细胞癌或肝移植且报告干预后乙型肝炎表面抗原[HBsAg]或肝转氨酶水平）使用 vesatolimod 的随机临床试验（RCT）。我们于 2022 年 5 月在 MEDLINE、SCOPUS、施普林格、谷歌学术、ClinicalTrials.gov 和 Cochrane 临床试验中心注册库中搜索了所有相关文章。两名独立作者筛选纳入的文章，意见分歧通过共识和第三名审稿人解决。两名独立审稿人使用 RCT 的关键评估技能计划清单评估本系统评价中纳入的研究。
仅从我们的搜索中确定的 391 篇文章中筛选出 4 篇符合条件的文章。所有符合条件的研究均未报告使用 vesatolimod 后出现任何有临床意义的结果，这表明 HBsAg 持续存在。然而，vesatolimod 与诱导干扰素刺激基因（ISGs）相关，且仅出现轻微的副作用，这需要进一步的研究来评估其作为一种安全、耐受的抗乙型肝炎药物的潜力。在 vesatolimod 两种剂量（Vesatolimod 1mg，RR=0.99，95%CI0.76-1.30，P=0.95，I2=0%；Vesatolimod 2mg，RR=1.06，95%CI0.82-1.37，P=0.66，I2=0%；Vesatolimod 4mg，RR=1.06，95%CI0.82-1.37，P=0.66，I2=0%）的试验中均未观察到显著差异，这进一步表明其与口服抗病毒药物相比具有相当的安全性。
