Lampertico Pietro, Messinger Diethelm, Oladipupo Hameed, Bakalos Georgios, Castillo Marco, Asselah Tarik
AM and A Migliavacca Center for Liver Disease, Gastroenterology and Hepatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
Prometris GmbH, Mannheim, Germany.
Antivir Ther. 2018;23(8):655-663. doi: 10.3851/IMP3251.
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.
Data from 1,363 peginterferon alfa-2a recipients (955 hepatitis B 'e' antigen [HBeAg]-positive and 408 -negative) in six studies were analysed. Baseline scoring systems were developed using generalized additive models and multiple logistic regression analysis to predict virological response (VR; HBV DNA <2,000 IU/ml), alone or combined with alanine aminotransferase (ALT) normalization (CR) at 24 weeks post-treatment.
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 log 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%.
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.
约三分之一的患者在接受聚乙二醇化干扰素α-2a有限疗程（48周）治疗后有持久应答。在资源有限的情况下，识别可能产生应答的患者的能力将特别有用。
分析了六项研究中1363例接受聚乙二醇化干扰素α-2a治疗的患者（955例乙肝e抗原[HBeAg]阳性和408例阴性）的数据。使用广义相加模型和多元逻辑回归分析建立基线评分系统，以预测病毒学应答（VR；HBV DNA<2000 IU/ml），单独或与治疗后24周时丙氨酸氨基转移酶（ALT）恢复正常（CR）情况相结合。
根据最终模型，对年龄≥45岁（0分）或<45岁（1分）；男性（0分）或女性（1分）；乙肝表面抗原（HBsAg）>25000（0分）、>7500至≤25000（1分）、>1250至≤7500（2分）或≤1250 IU/ml（4分）；HBV DNA>5（0分）或≤5 log IU/ml（2分）以及ALT比值>1至7（0分）或≤1或>7（1分）进行评分。总分越高（范围0至9分）表明应答可能性越高。VR和CR率分别为28.5%（388/1363）和24.4%（332/1363），且随评分增加而升高：评分0至1分（n = 257），VR为14.8%，CR为12.8%；评分2至3分（n = 711），VR为23.1%，CR为20.1%；评分≥4分（n = 395），VR为47.1%，CR为39.5%。
在无法获得HBeAg状态和HBV基因型的情况下，一种易于使用的基线评分系统可使临床医生识别出接受聚乙二醇化干扰素α-2a治疗后获得持久应答可能性低或高的患者。该工具可用于为资源有限环境下的治疗决策提供参考。
