AASLD2020[804]慢性乙型肝炎患者的HBsAg损失没有增加 PEG干扰素和

StephenW

804
NO INCREASED HBsAg LOSS IN CHB PATIENTS WITH
LOW VIRAL LOAD TREATED WITH PEGINTERFERON AND
NUCLEOTIDE ANALOGUE COMPARED TO NO TREATMENT; A 5
YEAR FOLLOW-UP
Robin Erken, Gastroenterology, Academic Medical Centre
Amsterdam, Vladimir Loukachov, Experimental Immunology,
Amsterdam Umc, Location AMC, Jeltje Helder, Department
of Gastroenterology and Hepatology, Amsterdam University
Medical Center, Location AMC, Martine Peters, Hepatology,
Amsterdam University Medical Centers, Location AMC, Hans
L Zaaijer, Virology, Academic Medical Centra Amsterdam,
Neeltje Kootstra, Department of Experimental Immunology,
Amsterdam Umc, Location AMC, Henk W. Reesink,
Academic Medical Center, Amsterdam and Sophie Willemse,
Gastroenterology and Hepatology, Amsterdam University
Medical Centers, Location AMC
Background: Currently available treatment options for
chronic hepatitis B (CHB) are not recommended for HBeAg
negative patients with a low viral load These patients may
however benefit from achieving functional cure, defined by
HBsAg loss The aim of this study was to evaluate the longterm
clinical outcome and especially the rate of HBsAg loss
after combination treatment with peg-interferon-alpha-2a
(peg-IFN) and adefovir (ADV) or tenofovir (TDF) compared to
no treatment in CHB patients with a low viral load Methods:
In a prospective open-label randomized controlled trial
described earlier, 151 HBeAg negative CHB patients were
included and treated with peg-IFN 180 μg/week + ADV 10 mg/
day (n=52), peg-IFN 180 μg/week + TDF 245 mg/day (n=51),
or no treatment (n=48) for 48 weeks All patients had HBVDNA
levels below 20,000 IU/mL at inclusion For the longterm
follow-up, patients were monitored for 5 years after end
of treatment The primary outcome was HBsAg loss and the
secondary objective was to study dynamics of HBsAg and
HBV-DNA levels over time Results: Of the initial intention-to treat
population who completed the study (134), 105 patients
completed the 5-year follow-up Of these 105 patients, HBsAg
loss was achieved in 6/35 (17 1%) patients treated with peg-
IFN/ADV, in 4/31 (12 9 %) patients treated with peg-IFN/TDF
and in 6/39 (15 4%) of the untreated patients HBsAg levels at
baseline were an independent predictor of HBsAg loss (odds
ratio 0 039, CI-95% 0 004-0 366, p=0 014) in the groups of
patients treated with peg-IFN and ADV/TDF combined, while
this association was not found in the untreated group HBsAg
levels of 2 61 Log10 IU/mL as cut-off resulted in a negative
predictive value of 98 1% and a positive predictive value of
75% for HBsAg loss after treatment In the peg-IFN/ADV,
peg-IFN/TDF and no-treatment group, HBsAg levels declined
with -0 38, -0 45 and -0 79 Log10 IU/mL respectively and HBVDNA
levels with -0 54, -0 035, -0 37 Log10 IU/mL respectively
No significant differences were found between treated and
untreated patients regarding HBsAg loss, HBsAg-decline
or HBV-DNA decline Conclusion: This study shows that,
in CHB patients with a low viral load, combination therapy
with peg-IFN and ADV or TDF does not lead to an increase
of HBsAg loss compared to no treatment Baseline HBsAg
levels are, as previously observed in patients with high viral
load, an independent predictor of HBsAg loss after treatment
in low viral load CHB patients.

StephenW

804
慢性乙型肝炎患者的HBsAg损失没有增加
PEG干扰素和
核苷酸类似物相比没有治疗； A 5
年度跟进
罗宾·艾肯（Robin Erken），学术医学中心胃肠病学
阿姆斯特丹，弗拉基米尔·卢卡乔夫（Vladimir Loukachov），实验免疫学，
阿姆斯特丹Umc，地点AMC，Jeltje Helder，部门
阿姆斯特丹大学胃肠病学和肝病学
医疗中心，位置AMC，马丁·彼得斯，肝病科，
阿姆斯特丹大学医学中心，地点AMC，汉斯
L Zaaijer，阿姆斯特丹学术医学中心病毒学，
实验免疫学系Neeltje Kootstra，
阿姆斯特丹Umc，地点AMC，Henk W. Reesink，
阿姆斯特丹学术医学中心和Sophie Willemse，
阿姆斯特丹大学胃肠病学和肝病学
医疗中心，地点AMC
背景：目前可用于的治疗选择
不建议将慢性乙型肝炎（CHB）用于HBeAg
病毒载量低的阴性患者这些患者可能
但是受益于实现功能性固化，其定义如下：
HBsAg丢失这项研究的目的是评估长期
临床结果，尤其是HBsAg丢失率
聚乙二醇干扰素α-2a联合治疗后
（peg-IFN）和阿德福韦（ADV）或替诺福韦（TDF）相比
低病毒载量的CHB患者无需治疗方法：
在一项前瞻性开放标签随机对照试验中
前面已经描述，151例HBeAg阴性CHB患者为
包含并用peg-IFN 180μg/周+ ADV 10 mg /治疗
每天（n = 52），peg-IFN 180μg/周+ TDF 245 mg / day（n = 51），
或连续48周未接受治疗（n = 48）所有患者均患有HBVDNA
长期低于20,000 IU / mL的水平
随访，结束后对患者进行监测5年
治疗的主要结果是HBsAg丢失和
次要目标是研究HBsAg和
结果：最初的治疗意图
完成研究的人口（134），105位患者
完成了这105位患者的HBsAg的5年随访
接受钉钉固定的患者中有6/35（17 1％）的患者实现了骨质疏松
peg-IFN / TDF治疗的4/31（12 9％）患者中的IFN / ADV
在未经治疗的患者中，有6/39（15 4％）的HBsAg水平为
基线是HBsAg丢失的独立预测因素
比率组中的比率0 039，CI-95％0 004-0 366，p = 0 014）
接受peg-IFN和ADV / TDF联合治疗的患者
未经治疗的HBsAg组未发现这种关联
阈值为2 61 Log10 IU / mL，导致阴性
预测值为98 1％，阳性预测值为
治疗后HBsAg损失的75％在peg-IFN / ADV中，
peg-IFN / TDF和未治疗组，HBsAg水平下降
分别为-0 38，-0 45和-0 79 Log10 IU / mL和HBVDNA
水平分别为-0 54，-0 035，-0 37 Log10 IU / mL
在治疗和治疗之间没有发现显着差异。
未经治疗的HBsAg丢失，HBsAg下降的患者
或HBV-DNA下降结论：这项研究表明，
病毒载量低的CHB患者，联合治疗
与peg-IFN和ADV或TDF结合使用不会增加
与未治疗基线相比，HBsAg丢失的情况
如先前在高病毒患者中观察到的
负荷，治疗后HBsAg丢失的独立预测因子
在低病毒负荷CHB患者中。