AASLD2018[458A]验证治疗结束HBsAg截止值 在Off-Nuc治疗中的水平为2

StephenW

s 458A
Validation of End-of-Treatment HBsAg Cut-Off
Level As 200 IU/Ml in Off-Nuc Therapy Hbeag
Negative Chronic Hepatitis B Patients
Wen-Juei Jeng1,2, Yi-Cheng Chen1,2, Rong-Nan Chien1,2,
I-Shyan Sheen1,2 and Yun-Fan Liaw1,3, (1)College of Medicine,
Chang Gung University, (2)Department of Gastroenterology
and Hepatology, Chang Gung Memorial Hospital, Linkou, (3)
Liver Research Unit, Chang Gung Memorial Hospital
Background: Recent ILC-2018 congress has proposed that
HBeAg negative chronic hepatitis B (CHB) patients treated
with Nuc and whose end of treatment (EOT) HBsAg level had
achieved a level < 200IU/ml might consider stopping therapy.
However, the EOT HBsAg < 200IU/ml was achieved only in
< 30% patients during Nuc therapy. The aim of this study
is to vailidate the outcome of patients whose EOT HBsAg
≥ 200IU/ml. Methods: HBeAg negative CHB patients who
discontinued Nuc by the APASL stopping rule (consecutive
HBV DNA undetectable > 1 year) with an EOT HBsAg ≥200IU/
ml and had already followed-up ≥ 1 year were recruited. The
scheduled follow-up protocol after stopping Nuc was monthly
in the first 3 months, then every 1-3 months. Baseline age,
gender, cirrhosis, prior treatment history, HBV genotype,
pretherapy serum ALT, HBsAg and HBV DNA levels, duration
of therapy, consolidation duration, on-treatment viral kinetics,
and EOT HBsAg level were analyzed Serum HBV DNA was
assayed by Cobas Amplicor HBV Monitor (Roche Diagnostics,
negative < 20IU/ml). Serum HBsAg was measured by Roche
Elecsys II kit (negative < 0.05 IU/ml). Results: Of these 430
patients, (age: 50.9, male: 84.9%, cirrhosis: 41.9%), the
independent predictors for clinical relapse was age older than
55 (aHR: 1.319 (1.035-1.680), P=0.025), cirrhosis (aHR: 1.275
(95%CI: 1.012-1.605), P=0.0394), male (aHR: 1.524 (1.066-
2.180), P=0.0210), non-ETV Nuc therapy (aHR: 1.646 (1.232-
2.199), P=0.0007), and time to ALT normalization (aHR: 1.005
(1.000-1.009), P=0.0416). Off-therapy HBsAg loss rate in the
430 patients was 0.8% per year, 0%/year in 216 patients with
clinical relapse who were retreated, 0.8%/year in 73 patients
with viral relapse and not retreated. 1.5%/year in 102 patients
with clinical relapse without retreatment, and 3.7%/year in 39
patients with sustained response. Conclusion: There are still
26% of the patients whose EOT HBsAg ≥200IU/ml maintained
sustained response off Nuc therapy. In addition, the overall
off-Nuc HBsAg loss rate was 0.8% per year, while patients
with sustained response or relapse remained untreated had
HBsAg loss rate up to 3.72% per year. Therefore, patients
with EOT HBsAg ≥200IU/ml still have options considering
finite Nuc therapy.

StephenW

s 458A
验证治疗结束HBsAg截止值
在Off-Nuc治疗中的水平为200 IU / Ml Hbeag
负性慢性乙型肝炎患者
Wen-Juei Jeng1,2，Yi-Cheng Chen1,2，Rong-Nan Chien1,2，
I-Shyan Sheen1,2和Yun-Fan Liaw1,3，（1）医学院，
长庚大学，（2）消化内科
林口长庚纪念医院和肝病学，（3）
长庚纪念医院肝病研究室
背景：最近的ILC-2018大会提出了这一点
HBeAg阴性慢性乙型肝炎（CHB）患者接受治疗
与Nuc及其治疗结束时（EOT）HBsAg水平有关
达到<200IU / ml的水平可考虑停止治疗。
然而，EOT HBsAg <200IU / ml仅在
Nuc治疗期间<30％的患者。本研究的目的
是为了对EOT HBsAg患者的结果进行治疗
≥200IU/ ml。方法：HBeAg阴性CHB患者
通过APASL停止规则终止Nuc（连续
HBV DNA检测不到> 1年），EOTHBsAg≥200IU/
毫升，已经随访≥1年被招募。该
每月停止Nuc后预定的后续协议
在前3个月，然后每1-3个月。基线年龄，
性别，肝硬化，既往治疗史，HBV基因型，
治疗前血清ALT，HBsAg和HBV DNA水平，持续时间
治疗，巩固期，治疗病毒动力学，
分析血清HBV DNA和EOT HBsAg水平
由Cobas Amplicor HBV Monitor（Roche Diagnostics，
阴性<20IU / ml）。通过Roche测量血清HBsAg
Elecsys II试剂盒（阴性<0.05 IU / ml）。结果：其中430
患者，（年龄：50.9，男性：84.9％，肝硬化：41.9％），
临床复发的独立预测因子年龄大于
55（aHR：1.319（1.035-1.680），P = 0.025），肝硬化（aHR：1.275）
（95％CI：1.012-1.605），P = 0.0394），男性（aHR：1.524（1.066-）
2.180），P = 0.0210），非ETV Nuc疗法（aHR：1.646（1.232-）
2.199），P = 0.0007），以及ALT正常化的时间（aHR：1.005
（1.000-1.009），P = 0.0416）。治疗中HBsAg的治疗失败率
430例患者中，430例患者为每年0.8％，每年0例患者为0％
73例患者复发率为0.8％/年
病毒复发而不是复发。 102例患者每年1.5％
没有再次治疗的临床复发，39％的年复一年
患者持续反应。结论：还有
维持EOTHBsAg≥200IU/ ml的患者中有26％
Nuc疗法的持续反应。另外，整体而言
off-Nuc HBsAg的丢失率为每年0.8％，而患者
持续反应或复发仍未得到治疗
HBsAg的丢失率高达每年3.72％。因此，患者
EOTHBsAg≥200IU/ ml仍可考虑选择
有限的Nuc疗法。