Hong Kong, China.
Mannheim, Germany.
Aliment Pharmacol Ther. 2018 Sep;48(5):547-555. doi: 10.1111/apt.14862. Epub 2018 Jun 29.
Peginterferon induces off-treatment responses in approximately one-third of patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B.
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.
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.
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]).
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.
聚乙二醇干扰素可诱导约三分之一的乙肝 e 抗原（HBeAg）阳性慢性乙型肝炎患者停药后应答。
建立一种易于使用的基线预测评分系统，以识别 HBV 基因型 B/C 感染的 HBeAg 阳性亚洲患者，这些患者可能对聚乙二醇干扰素 alfa-2a 治疗有应答。
应用广义加性模型、多变量逻辑回归（MLR）分析和内部验证方法，对来自中国、中国香港和中国台湾的 647 例 HBeAg 阳性患者的数据进行分析，建立了一个评分系统，以预测接受 48 周聚乙二醇干扰素 alfa-2a 治疗后 24 周的应答情况。
在最终的 MLR 中，有 5 个基线因素（年龄、性别、丙氨酸氨基转移酶比值、乙肝表面抗原（HBsAg）水平和 HBV DNA 水平）保留用于 HBeAg 血清学转换，并用于建立 0-7 分的评分系统。在评分 0-1、2-3、4 或≥5 的患者中，HBeAg 血清学转换分别为 6.4%（94/148）、23.0%（265/1146）、36.4%（184/508）和 54.8%（104/190），联合应答（HBeAg 血清学转换+HBV DNA<2000 IU/mL）分别为 5.3%（94/1784）、12.8%（34/265）、25.0%（46/184）和 36.5%（38/104）。在评分 0-1、2-3、4 或≥5 的患者中，分别有 57.0%（53/93）、12.3%（31/253）、3.4%（6/178）和 1.0%（1/100）在治疗第 12 周时 HBsAg≥20000IU/mL；仅有 3/91（3.3%）HBsAg≥20000IU/mL 的患者在治疗 24 周时出现联合应答（阴性预测值=97%[88/91]）。
使用易于获得的基线特征建立的治疗前评分系统，可以识别出接受聚乙二醇干扰素 alfa-2a 治疗后可能持续发生 HBeAg 血清学转换的 HBeAg 阳性亚洲患者。
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