AASLD2016[1892]血清HBsAg与肝炎flare相关的动力学 在直接抗病毒治

StephenW

1892
Serum HBsAg kinetics in relation to hepatitis flare
during first 6 months of direct antiviral therapy
Rachel Wen-Juei Jeng1,2, Yun -Fan Liaw1,2; 1Liver research unit,
Chang-Gung Memorial Hospital, Linko, Taipei, Taiwan; 2Chang
Gung University, Taoyuan, Taiwan
Background: The decline of hepatitis B surface antigen
(HBsAg) level during nucleos(t)ide analog (Nuc) therapy in
chronic hepatitis B is usually slow and small. However, earlier
study showed “rapid HBsAg decline” ≥0.5 log10 IU/mL
by month 6 of entecavir therapy in over 50% of the patients
with pretherapy alanine aminotransferase (ALT) > 5X upper
limit of normal (ULN). Of note, “rapid HBsAg decline” was
also observed in 7% of the patients with pretherapy ALT < 5X
ULN. Aim: To investigate who and why patients with pretherapy
ALT <5X ULN showed “rapid HBsAg decline” during Nuc
treatment Patients and methods: Patients with pretherapy ALT
<5X ULN and HBsAg quantification at baseline, month 6 and
12 of Nuc therapy were included. “Significant ALT elevation”
was defined as >10% increase above baseline level and >2X
ULN during first 6 months of Nuc therapy. “Hepatitis flare”
was defined as an event with abrupt ALT elevation to >5X
ULN. Serum HBV DNA was measured using Cobas Amplicor
HBV Monitor(Roche Diagnostics, Pleasanton, California; detection
range 20-1.7*108IU/ml). HBsAg was measured using
Roche Elecsys® II kit. (detection range 0.05-52000 IU/mL)
Results: Among 263 patients meeting the inclusion criteria,
55 experienced transient “significant ALT elevation” [Group
A], including 33 (12.6%) with peak ALT of 2-5X ULN [group
A-1] and 22 (8.4%) > 5X ULN (hepatitis flare) [group A-2].
The remaining 208 patients showed no ”significant ALT elevation”
[group B]. HBsAg decline at month 6 was significantly
greater in group A than in group B (-0.364 vs -0.047 log10
IU/mL; P=0.000), greatest in group A-2 and smallest in group
B-1 (-0.523 vs -0.025 log10 IU/mL; P=0.000). “Rapid HBsAg
decline” by month 6 was documented in 38.2% of group A
and 9.6% of group B patients (P=0.000), highest in group A-2
and lowest in group B-1 patients (50% vs 2.2%). Of the group
B patients, those with a baseline ALT of 2-5X ULN (group B-2)
showed greater HBsAg decline (-0.104 vs -0.025 log10 IU/
mL, P=0.000) and more frequent rapid HBsAg decline (15.3%
vs 2.2%; P=0.001) at month 6 of therapy than those with a
baseline ALT of <2X ULN (group B-1). Conclusion: Hepatitis
B flare (ALT>5X ULN) developed during Nuc therapy in 8.4%
of the patients with prehterapy ALT<5XULN, and 50% of the
patients developing hepatitis flare showed “rapid HBsAg
decline” >-0.5 log10 IU/mL by moth 6 of Nuc therapy. Only
10% of the patients without ”significant ALT elevation” showed
“rapid HBsAg decline” which occurred mainly in those with
pretherapy ALT of 2-5X ULN. These findings suggest the importance
of immune factor(s) for HBsAg decline during Nuc therapy.
Disclosures:
Yun -Fan Liaw - Advisory Committees or Review Panels: Roche; Grant/Research
Support: Roche
The following people have nothing to disclose: Rachel Wen-Juei Jeng

StephenW

AASLD2016 [1892]血清HBsAg与肝炎flare相关的动力学
在直接抗病毒治疗的首先6个月
Rachel Wen-Juei Jeng1,2，Yun
血清HBsAg与肝炎flare相关的动力学
在直接抗病毒治疗的前6个月
Rachel Wen-Juei Jeng1,2，Yun -Fan Liaw1,2; 1肝研究单位，
台湾台北市林口市长庚纪念医院; 2Chang
Gung大学，桃园，台湾
背景：乙型肝炎表面抗原的下降
（HBsAg）水平在nucleos（t）ide模拟（Nuc）治疗
慢性乙型肝炎通常缓慢而小。但是，早
研究显示“快速HBsAg下降”≥0.5log10IU / mL
在第6个月的恩替卡韦治疗超过50％的患者
与治疗前丙氨酸氨基转移酶（ALT）> 5X上
正常极限（ULN）。值得注意的是，“快速HBsAg下降”是
也在7％的治疗前ALT <5X的患者中观察到
ULN。目的：调查谁和谁为什么病人治疗
ALT <5X ULN在Nuc期间显示“快速HBsAg下降”
治疗患者和方法：治疗前ALT的患者
<5X ULN和HBsAg定量在基线，第6个月和
包括Nuc治疗12。 “显着ALT升高”
被定义为高于基线水平> 10％的增加和> 2X
ULN在Nuc治疗的前6个月。 “肝炎flare”
被定义为具有突然的ALT升高至> 5X的事件
ULN。使用Cobas Amplicor测量血清HBV DNA
HBV监测器（Roche Diagnostics，Pleasanton，California;检测
范围20-1.7 * 10 8 IU / ml）。使用测量HBsAg
RocheElecsys®II试剂盒。 （检测范围0.05-52000IU / mL）
结果：符合纳入标准的263例患者中，
55经历短暂的“显着ALT升高”[组
A]，包括33（12.6％），具有2-5X ULN [组的峰值ALT
A-1]和22（8.4％）> 5X ULN（肝炎flare）[A-2组]。
其余208例患者无“显着ALT升高”
[B组]。第6个月的HBsAg下降显着
A组大于B组（-0.364 vs -0.047 log10）
IU / mL; P = 0.000），A-2组最大，组最小
B-1（-0.523vs -0.025log10IU / mL; P = 0.000）。 “快速HBsAg
下降“在第6个月记录在A组的38.2％
和9.6％的B组患者（P = 0.000），A-2组最高
，B-1组最低（50％vs 2.2％）。组中
B组，基线ALT为2-5X ULN（B-2组）
显示更大的HBsAg下降（-0.104对-0.025log10 IU /
mL，P = 0.000）和更频繁的HBsAg快速下降（15.3％
vs 2.2％; P = 0.001）
基线ALT <2X ULN（B-1组）。结论：肝炎
在Nuc治疗期间发生的B火厥（ALT> 5X ULN）在8.4％
的患有术前ALT <5XULN的患者，和50％的患者
发生肝炎的患者显示“快速HBsAg
下降“> -0.5log10 IU / mL，通过Nuc治疗的蛾6。只要
10％无“显着ALT升高”的患者显示
“快速HBsAg下降”主要发生在那些与
预处理ALT 2-5X ULN。这些发现表明了重要性
的免疫因子对HBsAg下降在Nuc治疗期间。
披露：
云藩 - 咨询委员会或审查小组：罗氏;资助/研究
支持：罗氏
以下人士没有透露：Rachel Wen-Juei Jeng