替诺福韦富马酸二甲氧萘普胺和聚乙二醇化干扰素-α2a联合

StephenW

Pilot study of tenofovir disoproxil fumarate and pegylated interferon-alpha 2a add-on therapy in Japanese patients with chronic hepatitis B

    Akihiro Matsumoto, Shuhei Nishiguchi, […]Eiji Tanaka

Journal of Gastroenterology volume 55, pages977–989(2020)Cite this article

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Abstract
Background

A prospective pilot study of tenofovir disoproxil fumarate (TDF) and pegylated interferon alpha 2a (P-IFN) add-on therapy was conducted to evaluate its efficacy in reducing viral antigen levels in Japanese patients with chronic hepatitis B (UMIN 000020179).
Methods

Patients with chronic hepatitis B receiving maintenance TDF therapy and exhibiting hepatitis B surface antigen (HBsAg) level > 800 IU/ml were divided into two arms. P-IFN was added for 48 weeks in the add-on arm (n = 32), while TDF monotherapy was maintained in the control arm (n = 51). Both groups were followed for 96 weeks after baseline measurements.
Results

Almost all patients in the control arm displayed a slow and constant reduction in HBsAg during follow-up. In contrast, roughly half of the add-on arm exhibited a sharp decline in HBsAg during P-IFN administration, which disappeared after halting P-IFN. At 96 weeks after baseline, 41% (13/32) of patients in the add-on arm had shown a rapid decrease in HBsAg, versus 2% (1/51) in the control arm (p < 0.001). Add-on therapy and increased cytotoxic T-cell response were significant factors associated with a rapid decrease in HBsAg according to multivariate analysis. In addition, higher HB core-related antigen (HBcrAg) level at baseline (p = 0.001) and add-on therapy (p = 0.036) were significant factors associated with a rapid reduction in HBcrAg.
Conclusions

TDF and P-IFN add-on therapy in Japanese patients with chronic hepatitis B facilitated rapid decreases in HBsAg and HBcrAg. Further studies are needed to improve early HBsAg clearance rate.

StephenW

替诺福韦富马酸二甲氧萘普胺和聚乙二醇化干扰素-α2a联合治疗在日本慢性乙型肝炎患者中的初步研究

    松本明弘（Akihiro Matsumoto），西口树平（Sheiei Nishiguchi），[…]田中荣司（Eiji Tanaka）

胃肠病学杂志第55卷，第977–989页（2020年）

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抽象
背景

进行了替诺福韦富马酸替诺福韦（TDF）和聚乙二醇化干扰素α2a（P-IFN）联合治疗的前瞻性先导研究，以评估其在日本慢性乙型肝炎患者中降低病毒抗原水平的功效（UMIN 000020179）。
方法

接受维持性TDF治疗并表现出乙型肝炎表面抗原（HBsAg）水平>> 800 IU / ml的慢性乙型肝炎患者分为两部分。 P-IFN在附加组中添加48周（n = 32），而TDF单一疗法则在对照组中使用（n = 51）。基线测量后，两组均进行了96周的随访。
结果

在随访期间，对照组的几乎所有患者均显示出缓慢而持续的HBsAg降低。相反，在P-IFN给药期间，大约有一半的附加臂显示HBsAg急剧下降，在停止P-IFN后消失。在基线后96周，附加组中41％（13/32）的患者HBsAg迅速降低，而对照组中2％（1/51）的患者显着降低（p <0.001）。根据多变量分析，追加治疗和增加的细胞毒性T细胞反应是与HBsAg迅速降低有关的重要因素。此外，基线时较高的HB核心相关抗原（HBcrAg）水平（p = 0.001）和附加治疗（p = 0.036）是与HBcrAg快速降低相关的重要因素。
结论

日本慢性乙型肝炎患者的TDF和P-IFN附加疗法促进HBsAg和HBcrAg的快速下降。需要进一步研究以提高早期HBsAg清除率。