一种易于使用的基线评分系统，用于预测资源有限环境中慢

StephenW

Antivir Ther. 2018 Jul 4. doi: 10.3851/IMP3251. [Epub ahead of print]
An easy-to-use baseline scoring system to predict response to peginterferon alfa-2a in patients with chronic hepatitis B in resource-limited settings.
Lampertico P1, Messinger D2, Oladipupo H3, Bakalos G4, Castillo M4, Asselah T5.
Author information

1
    AM and A Migliavacca Center for Liver Disease, Gastroenterology and Hepatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
2
    Prometris GmbH, Mannheim, Germany.
3
    F. Hoffmann-La Roche Ltd, Lagos, Nigeria.
4
    F. Hoffmann-La Roche Ltd, Basel, Switzerland.
5
    Service d'Hépatologie Chief and Viral Hepatitis Team, INSERM UMR 1149, Centre de Recherche sur l'Inflammation, Paris Diderot University, Hôpital Beaujon, Clichy, France.

Abstract
BACKGROUND:

Approximately one-third of patients have durable responses after finite (48-week) treatment with peginterferon alfa-2a. The ability to identify patients likely to respond would be particularly useful in resource-limited settings.
METHODS:

Data from 1,363 peginterferon alfa-2a recipients (955 hepatitis B 'e' antigen [HBeAg]-positive and 408 -negative) in six studies were analyzed. Baseline scoring systems were developed using generalized additive models and multiple logistic regression analysis to predict virological response (VR, hepatitis B virus [HBV] DNA <2,000 IU/mL), alone or combined with alanine aminotransferase (ALT) normalization (CR) at 24 weeks post-treatment.
RESULTS:

Based on the final models, points were assigned for age ≥45 (0) or <45 years (1); male (0) or female (1); hepatitis B surface antigen (HBsAg) >25,000 (0), >7,500-≤25,000 (1), >1,250-≤7,500 (2), or ≤1,250 IU/mL (4); HBV DNA >5 (0) or ≤5-log10 IU/mL (2), and ALT ratio >1-7 (0) or either ≤1 or >7 (1). Higher total scores (range 0-9) indicate higher likelihood of response. VR and CR rates were 28.5% (388/1,363) and 24.4% (332/1,363), respectively, and increased with increasing score: score 0-1 (n=257), VR 14.8%, CR 12.8%; score 2-3 (n=711), VR 23.1%, CR 20.1%; score ≥4 (n=395), VR 47.1%, CR 39.5%.
CONCLUSIONS:

An easy-to-use baseline scoring system for use in settings where HBeAg status and HBV genotypes are unavailable would allow clinicians to identify patients with a low or high chance of achieving a durable post-treatment response to peginterferon alfa-2a. The tool can be used to inform treatment decisions in resource-limited settings.

PMID:
    29972138
DOI:
    10.3851/IMP3251

StephenW

Antivir Ther。 2018年7月4日doi：10.3851 / IMP3251。 [提前打印]
一种易于使用的基线评分系统，用于预测资源有限环境中慢性乙型肝炎患者对聚乙二醇干扰素α-2a的反应。
Lampertico P1，Messinger D2，Oladipupo H3，Bakalos G4，Castillo M4，Asselah T5。
作者信息

1
    AM和A Migliavacca肝病，胃肠病学和肝病学中心，Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico，米兰大学，米兰，意大利。
2
    Prometris GmbH，德国曼海姆。
3
    F. Hoffmann-La Roche Ltd，尼日利亚拉各斯。
4
    F. Hoffmann-La Roche Ltd，瑞士巴塞尔。
五
    Service d'Hépatologie首席和病毒性肝炎小组，INSERM UMR 1149，中心炎症中心，巴黎狄德罗大学，HôpitalBeaujon，Clichy，法国。

抽象
背景：

在聚乙二醇干扰素α-2a治疗有限（48周）后，大约三分之一的患者有持久的反应。识别可能响应的患者的能力在资源有限的环境中特别有用。
方法：

分析了6项研究中1,363名聚乙二醇干扰素α-2a受体（955名乙型肝炎'e'抗原[HBeAg]阳性和408-阴性）的数据。使用广义加性模型和多重逻辑回归分析开发基线评分系统，以预测病毒学应答（VR，乙型肝炎病毒[HBV] DNA <2,000 IU / mL），单独或与丙氨酸氨基转移酶（ALT）标准化（CR）联合应用于24治疗后数周。
结果：

根据最终模型，指定年龄≥45（0）或<45岁（1）;男性（0）或女性（1）;乙型肝炎表面抗原（HBsAg）> 25,000（0），> 7,500-≤25,000（1），> 1,250-≤7,500（2），或≤1,250IU/ mL（4）; HBV DNA> 5（0）或≤5-log10 IU / mL（2），ALT比率> 1-7（0）或≤1或> 7（1）。较高的总分（范围0-9）表示较高的响应可能性。 VR和CR率分别为28.5％（388 / 1,363）和24.4％（332 / 1,363），随着评分的增加而增加：0-1（n = 257），VR 14.8％，CR 12.8％;得分2-3（n = 711），VR 23.1％，CR 20.1％;得分≥4（n = 395），VR 47.1％，CR 39.5％。
结论：

易于使用的基线评分系统适用于HBeAg状态和HBV基因型不可用的环境，可让临床医生识别出对聚乙二醇干扰素α-2a实现持久治疗后反应的机会低或高的患者。该工具可用于在资源有限的环境中为治疗决策提供信息。

结论：
    29972138
DOI：
    10.3851 / IMP3251