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.
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：