免疫调节和抗病毒疗法改善了CHB患者高HBsAg水平的功能治愈率,经历了NA
Hongyu Jia1,2, Guodong Yu1, Jiong Yu1
1State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, National Medical Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Research Units of Infectious disease and Microecology, Chinese Academy of Medical Sciences, Hangzhou, Zhejiang, China.
在慢性乙型肝炎中实现乙型肝炎表面抗原 (HBsAg) 损失是具有挑战性的. 结合花细胞-巨细胞殖民地刺激因子 (GM-CSF) 与HBV疫苗接种以及抗病毒治疗,可显著改善HBsAg损失和血清转化率.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 免疫学 免疫学 免疫学
- 病毒学 病毒学
背景情况:
- 乙型肝炎病毒 (HBV) 表面抗原 (HBsAg) 损失,一种功能治愈,对于HBeAg阳性慢性乙型肝炎患者来说仍然是困难的.
- 之前的研究表明,HBV疫苗接种和粒细胞巨细胞殖民地刺激因子 (GM-CSF) 可能有助于降低HBsAg水平并促进HBsAg损失.
研究的目的:
- 为了评估基化干扰素-α2b (PEGIFN-α2b) 和特诺福维尔二醇烟酸 (TDF) 在实现HBsAg损失方面的疗效.
- 评估GM-CSF和HBV疫苗接种对HBeAg阳性慢性乙型肝炎B患者PEGIFN-α2b+TDF治疗的额外益处.
主要方法:
- 这是一项前性随机试验,涉及287名HBeAg阳性慢性乙型肝炎患者,此前接受过核侧类比治疗.
- 患者被随机分为三个组:单独TDF (对照组),PEGIFN-α2b + TDF和PEGIFN-α2b + TDF + GM-CSF + HBV疫苗,持续48周.
- 主要终点包括48周和72周实现HBsAg损失和血清转化的患者比例.
主要成果:
- 在第48周累积HBsAg损失率为0.0% (对照),28.3% (PEGIFN-α2b + TDF) 和41.1% (PEGIFN-α2b + TDF + GM-CSF + HBV疫苗).
- 在第48周累计HBsAg血清转化率为0.0% (对照),21.7% (PEGIFN-α2b + TDF) 和33.9% (PEGIFN-α2b + TDF + GM-CSF + HBV疫苗).
- 多变量分析表明GM-CSF加HBV疫苗接种与HBsAg损失 (p=0.017) 和血清转化 (p=0.030) 有显著相关性.
结论:
- 免疫调节和抗病毒治疗方案显著改善了HBsAg损失在HBeAg阳性慢性乙型肝炎患者谁实现了血清转化.
- 将GM-CSF和HBV疫苗与PEGIFN-α2b + TDF结合在一起,在实现HBsAg损失和血清转化方面表现出最高的疗效.
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