预测HBeAg阳性慢性乙型肝炎患者对聚乙二醇干扰素α-2a反应的

StephenW

A baseline tool for predicting response to peginterferon alfa‐2a in HBeAg‐positive patients with chronic hepatitis B
H. L. Y. Chan
D. Messinger
G. V. Papatheodoridis
M. Cornberg
Q. Xie
T. Piratvisuth
H. Ren
P. T. Kennedy
A. Thompson
A. Caputo
G. Bakalos
V. Pavlovic
P. Lampertico
First published: 29 June 2018
https://doi.org/10.1111/apt.14862

Funding informationThis research was funded by F. Hoffmann‐La Roche Ltd, Basel, Switzerland.

The Handling Editor for this article was Professor Geoffrey Dusheiko, and it was accepted for publication after full peer‐review.

Authors’ complete affiliations are listed in Appendix section.
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Summary
Background

Peginterferon induces off‐treatment responses in approximately one‐third of patients with hepatitis B e antigen (HBeAg)‐positive chronic hepatitis B.
Aim

To develop an easy‐to‐use baseline prediction score to identify hepatitis B virus (HBV) genotype B‐/C‐infected HBeAg‐positive Asian patients likely to respond to peginterferon alfa‐2a.
Methods

Generalised additive models, multiple logistic regression (MLR) analysis and internal validation methods were applied to data from 647 HBeAg‐positive patients from China, Hong Kong and Taiwan to develop a scoring system to predict response 24 weeks after completing a 48‐week course of peginterferon alfa‐2a.
Results

Five baseline factors (age, sex, alanine aminotransferase ratio, hepatitis B surface antigen (HBsAg) level and HBV DNA level) were retained in the final MLR for HBeAg seroconversion and used to develop a scoring system from 0 to 7. Among patients with scores of 0‐1, 2‐3, 4 or ≥5, HBeAg seroconversion was achieved in 6.4% (6/94), 23.0% (61/265), 36.4% (67/184) and 54.8% (57/104), respectively, and a combined response (HBeAg seroconversion plus HBV DNA <2000 IU/mL) in 5.3% (5/94), 12.8% (34/265), 25.0% (46/184) and 36.5% (38/104), respectively. Among patients with scores of 0‐1, 2‐3, 4 or ≥5, 57.0% (53/93), 12.3% (31/253), 3.4% (6/178) and 1.0% (1/100) had HBsAg ≥20 000 IU/mL at treatment Week 12; only 3/91 (3.3%) with HBsAg ≥20 000 IU/mL experienced a combined response at 24 weeks post‐treatment (negative predictive value = 97% [88/91]).
Conclusion

A pre‐treatment scoring system using readily available baseline characteristics identifies HBeAg‐positive Asian patients likely to experience sustained HBeAg seroconversion after treatment with peginterferon alfa‐2a.

StephenW

预测HBeAg阳性慢性乙型肝炎患者对聚乙二醇干扰素α-2a反应的基线工具
H. L. Y. Chan
D. Messinger
G. V. Papatheodoridis
M. Cornberg
谢谢。谢
T. Piratvisuth
H. Ren
P. T. Kennedy
A.汤普森
A.卡普托
G.巴卡洛斯
V. Pavlovic
P. Lampertico
首次发表：2018年6月29日
https://doi.org/10.1111/apt.14862

资助信息该研究由瑞士巴塞尔的F. Hoffmann-La Roche Ltd资助。

本文的处理编辑器是Geoffrey Dusheiko教授，经过全面的同行评审后被接受发表。

作者的完整从属关系列于附录部分。
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概要
背景

聚乙二醇干扰素诱导大约三分之一的乙型肝炎e抗原（HBeAg）阳性慢性乙型肝炎患者的治疗后反应。
目标

开发易于使用的基线预测评分，以确定乙型肝炎病毒（HBV）基因型B / C感染的HBeAg阳性亚洲患者可能对聚乙二醇干扰素α-2a有反应。
方法

广义加性模型，多重逻辑回归（MLR）分析和内部验证方法应用于来自中国，香港和台湾的647名HBeAg阳性患者的数据，以开发评分系统，以在完成48周疗程后24周预测反应。聚乙二醇干扰素α-2a。
结果

五个基线因素（年龄，性别，丙氨酸氨基转移酶比率，乙型肝炎表面抗原（HBsAg）水平和HBV DNA水平）保留在HBeAg血清学转换的最终MLR中，并用于开发从0到7的评分系统。 0-1,2-3,4或≥5，HBeAg血清学转换率分别为6.4％（6/94），23.0％（61/265），36.4％（67/184）和54.8％（57/104）和HBeAg血清转换加HBV DNA <2000 IU / mL的联合应答分别为5.3％（5/94），12.8％（34/265），25.0％（46/184）和36.5％（38/104） ）， 分别。在分数为0-1,2-3,4或≥5,57.0％（53/93），12.3％（31/253），3.4％（6/178）和1.0％（1/100）的患者中治疗第12周时HBsAg≥20000IU / mL;只有3/91（3.3％）HBsAg≥20000IU/ mL在治疗后24周时出现综合反应（阴性预测值= 97％[88/91]）。
结论

使用容易获得的基线特征的治疗前评分系统鉴定了在用聚乙二醇干扰素α-2a治疗后可能经历持续HBeAg血清转换的HBeAg阳性亚洲患者。

StephenW

https://onlinelibrary.wiley.com/doi/full/10.1111/apt.14862