Effect of Pegylated Interferon Plus Tenofovir Combination on Higher Hepatitis B Surface Antigen Loss in Treatment-naive Patients With Hepatitis B e Antigen -positive Chronic Hepatitis B: A Real-world Experience
Effect of Pegylated Interferon Plus Tenofovir Combination on Higher Hepatitis B Surface Antigen Loss in Treatment-naive Patients With Hepatitis B e Antigen -positive Chronic Hepatitis B: A Real-world Experience
复制标题
聚乙二醇化干扰素加替诺福韦组合对初治乙型肝炎 e 抗原阳性慢性乙型肝炎患者乙型肝炎表面抗原损失较高的影响：真实经验
DOI：
10.1016/j.clinthera.2020.12.022
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发表时间：
2021-04-16
影响因子：
3.2
通讯作者：
Zhou, Yuanping
中科院分区：
文献类型：
--
作者：
Hu, Chengguang;Song, Yangda;Zhou, Yuanping
目的：慢性B型肝炎（CH B）患者血清B表面抗原（HBsAg）的丢失被认为是理想的临床结局，但在当前的标准治疗中很少实现。我们评估了在一个真实世界的CHB患者临床队列中诱导HBsAg血清清除的有效性，这些患者接受聚乙二醇化干扰素（Peg-IFN）与富马酸替诺福韦酯（TDF）联合治疗或单药治疗。方法：共330例慢性乙型肝炎患者被分配接受聚乙二醇干扰素加TDF治疗48周（Peg-IFN + TDF组）、单独使用Peg-IFN 48周（Peg-IFN组）或单独使用TDF 144周（TDF组）。主要终点是第72周达到HBsAg血清清除的患者百分比。使用卡方（2）检验（分类变量）或单因素方差分析（连续变量）比较与基线特征和治疗数据的差异。进行Kaplan-Meier检验以比较3组之间的HBsAg丢失。使用AUC曲线量化应答者与无应答者的区分。根据Youden J统计量选择最佳临界值，定义为J =灵敏度+特异性-1。结果：在第72周，Peg-IFN + TDF组的Kaplan-Meier累积HBsAg丢失率为11.5%，Peg-IFN组为5.7%，TDF组为0%。Peg-IFN + TDF组和Peg-IFN组HBsAg丢失的患者百分比相似（P = 0.143），但均显著高于TDF组（P = 0.000和P = 0.010）。此外，联合治疗组和聚乙二醇干扰素组中血清HBsAg为
Purpose: The loss of serum hepatitis B surface antigen (HBsAg) in patients with chronic hepatitis B (CHB) is considered an ideal clinical outcome but rarely achieved with current standard of care. We evaluated the effectiveness in inducing HBsAg seroclearance in a real-world clinical cohort of Chinese patients with CHB treated with a combination of pegylated interferon (Peg-IFN) with tenofovir disoproxil fumarate (TDF) or monotherapy with each agent.Methods: A total of 330 patients with CHB were assigned to receive Peg-IFN plus TDF for 48 weeks (Peg-IFN plus TDF group), Peg-IFN alone for 48 weeks (Peg-IFN group), or TDF alone for 144 weeks (TDF group). The primary end point was the percentages of patients who achieved HBsAg seroclearance at week 72. Differences from the baseline characteristics and treatment data were compared using the chi(2) test for categorical variables or 1-way ANOVA for continuous variables. A Kaplan-Meier test was performed to compare the HBsAg loss among the 3 groups. Discrimination of responders versus nonresponders was quantified using AUC curves. Optimal cut-offs were selected based on Youden's J statistic defined as J = sensitivity + specificity-1.Findings: At week 72, the Kaplan-Meier cumulative HBsAg loss was 11.5% in the Peg-IFN plus TDF group, 5.7% in the Peg-IFN group, and 0% in the TDF group. The percentage of patients with HBsAg loss was comparable in the Peg-IFN plus TDF and Peg-IFN groups (P = 0.143), but both were significantly higher than that in the TDF group (P = 0.000 and P = 0.010). In addition, a significantly higher percentage of patients in the combination group and Peg-IFN group had serum HBsAg of