AASLD2018[430]聚乙二醇化干扰素α-2a治疗的疗效 对于HBsAg≤1500IU

StephenW

430
Efficacy of Pegylated Interferon α-2a Therapy
for HBsAg ≤1500 IU/Ml CHB Patients with a
Prior Nas History
Fengping Wu, Yaping Li, Mei Li, Wenjun Wang, Xiaoli Jia,
Xin Zhang, Juanjuan Shi and Shuangsuo Dang, The Second
Affiliated Hospital of Xi’an Jiaotong University
Background: HBsAg clearance with or without
seroconversion is a ideal goal of antiviral therapy for chronic
hepatitis B virus (CHB) patients. However, the clearance
rate is extremely low with nucleos(t)ide analogs (NAs) or
interferon monotherapy. We comprehensively evaluated
that the efficacy of pegylated interferon α-2a (Peg-IFNα-2a)
therapy for HBsAg ≤1500 IU/mL CHB patients with a prior
NAs history, which will provide a more optimized treatment
plan for CHB patients. Methods: 185 HBeAg-negtive CHB
patients under persistent virological suppression and HBsAg
≤1500 IU/mL after more than 1 year of NAs therapy were
enrolled, which were randomly divided into the trial group
(n=85) and the control group (n=100). Patients in trial group
received NAs combined with Peg-IFNα-2a treatment for 48
weeks and followed-up for 24 weeks. Patients in control group
received NAs monotherapy continuously. HBsAg clearance
and seroconversion rates at week 72 were used to evaluate
the therapeutic efficacy. Results: Per-protocol (PP) analysis
showed that HBsAg clearance and seroconversion rate in the
trial group were 28.2% and 20.0% at week 48, increased to
40.0% and 32.0% at week 72. However, the HBsAg clearance
rate in control group were 1.0% at week 48 and 2.0% at week
72, and no patient achieved seroconversion (Figure 1). In the
trial group, the proportions of patients who achieved HBsAg
≤1000 IU/mL, ≤ 100 IU/mL, ≤ 10 IU/mL at week 72 were
100.0%, 76.0%, 58.0%, respectively, while the proportions
were 25.0%, 17.0%, 9.0% in the control group, respectively.
Baseline HBsAg <500 IU/mL, HBsAg <200 IU/mL at 24
weeks treatment, ALT≥2 ULN at the early 12 weeks treatment
were independent predictors of HBsAg clearance. The
incidence of common adverse events (including headache,
alopecia, and pyrexia) were similar to previous studies and
all patients had good tolerance to these treatments in the trial
group. Conclusion: For HBeAg-negtive CHB patients under
persistent virological suppression and HBsAg ≤1500 IU/mL
after more than 1 year of NAs therapy, combining with Peg-
IFNα-2a therapy for 48 weeks is a more optimized treatment
plan for CHB patients

StephenW

430
聚乙二醇化干扰素α-2a治疗的疗效
对于HBsAg≤1500IU/ Ml CHB患者
之前的Nas历史
吴凤平，李亚萍，李梅，王文君，贾晓莉，
张昕，胡娟娟，双朔党，二
西安交通大学附属医院
背景：HBsAg清除有无
血清转换是慢性病的抗病毒治疗的理想目标
乙型肝炎病毒（CHB）患者。但是，通关
核苷（酸）类似物（NAs）或核素（nAs）的速率极低
干扰素单药治疗。我们全面评估
聚乙二醇干扰素α-2a（Peg-IFNα-2a）的功效
治疗前HBsAg≤1500IU/ mL CHB患者
NAs的历史，将提供更优化的治疗
计划为CHB患者。方法：185 HBeAg阴性CHB
持续病毒学抑制和HBsAg的患者
在超过1年的NAs治疗后≤1500IU/ mL
登记，随机分为试验组
（n = 85）和对照组（n = 100）。试验组患者
接受NAs联合Peg-IFNα-2a治疗48
数星期，随访24周。对照组患者
持续接受NAs单药治疗。 HBsAg清除
第72周的血清转换率用于评估
治疗效果。结果：按方案（PP）分析
表明HBsAg清除率和血清转换率在
试验组在第48周分别为28.2％和20.0％，增加至
第72周为40.0％和32.0％。但是，HBsAg清除率
对照组的比率在第48周为1.0％，在第一周为2.0％
72，没有患者实现血清学转换（图1）。在里面
试验组，达到HBsAg的患者比例
第72周≤1000IU/ mL，≤100IU/ mL，≤10IU/ mL
比例为100.0％，76.0％，58.0％
对照组分别为25.0％，17.0％，9.0％。
基线HBsAg <500 IU / mL，HBsAg <200 IU / mL，24
治疗周，治疗12周时ALT≥2ULN
是HBsAg清除的独立预测因子。该
常见不良事件（包括头痛，
脱发和发热（pyrexia）与以前的研究相似
所有患者在试验中对这些治疗都有良好的耐受性
组。结论：HBeAg阴性的CHB患者
持续病毒学抑制和HBsAg≤1500IU/ mL
经过超过1年的NAs治疗，结合Peg-
IFNα-2a治疗48周是更优化的治疗
计划为CHB患者

齐欢畅

Results: Per-protocol (PP) analysis
showed that HBsAg clearance and seroconversion rate in the
trial group were 28.2% and 20.0% at week 48, increased to
40.0% and 32.0% at week 72. However, the HBsAg clearance
rate in control group were 1.0% at week 48 and 2.0% at week
72, and no patient achieved seroconversion (Figure 1).
说明效果不错啊！！信心很重要。