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ADDITION OF PEGINTERFERON ALFA-2a INCREASES
HBsAg DECLINE IN HBEAG-NEGATIVE CHRONIC HEPATITIS
B PATIENTS TREATED WITH LONG-TERM NUCLEOS(T)IDE
ANALOGUE THERAPY: RESULTS FROM A MULTICENTER
RANDOMIZED CONTROLLED TRIAL. (PAS STUDY)
Mina S. Farag1,2, Scott K Fung1, Margo Van Campenhout3,
Karel J. Van Erpecum4, David KH Wong1, Andre Boonstra5,
Elke Verhey3, Robert A. De Man3, Kin Seng Liem1,3, Bettina
E. Hansen1,6 and Harry L. A. Janssen1, (1)Toronto Centre
for Liver Disease, Toronto General Hospital, University
Health Network, (2)Institute of Medical Science, University of
Toronto, (3)Department of Gastroenterology & Hepatology,
Erasmus Medical Centre Rotterdam, (4)Department of
Gastroenterology and Hepatology, University Medical Center
Utrecht, (5)Department of Gastroenterology & Hepatology,
Erasmus University Medical Center Rotterdam, (6)Institute
of Health Policy, Management and Evaluation, University of
Toronto
Background: Pegylated-interferon (PEG-IFN) treatment
has been associated with higher Hepatitis B surface antigen
(HBsAg) decline rates in chronic hepatitis B (CHB) It is
essential to assess this decline as PEG-IFN add-on to NA
is increasingly used in new regimens aiming for a functional
cure In addition, PEG-IFN add-on therapy may help to reach
HBsAg loss allowing to stop NA Therefore, we investigated
in a randomized, controlled trial the dynamics of HBsAg in
HBeAg-negative CHB patients on long-term NA therapy who
received add-on PEG-IFN Methods: In this investigatorinitiated
randomized controlled trial conducted in Europe and
Canada, HBeAg-negative patients with compensated liver
disease treated with NA therapy > 12 months and had HBV
DNA <200 IU/mL were enrolled. Patients were randomized 2:1
(baseline) to 48 weeks of add-on PEG-IFN alfa-2a (180 μg per
week) or continued NA monotherapy with subsequent followup
to week 72. The primary endpoint was HBsAg decline >
1 log IU/ml at week 48 from baseline and HBsAg loss was a
secondary endpoint. Week 48 interim results are presented
here, and final results from week 72 will be presented during
the meeting Results: Of the 89 patients in the modified
intention-to-treat analysis, 58 patients received PEG-IFN
add-on, and 31 continued NA monotherapy At present, 71
patients have reached week 72 At baseline, the mean age
was 48 years, 86% male, 66% Asian, and 25% Caucasian
Median baseline HBsAg level was 2 9 log10 IU/mL At week
48, 6 (10%) patients achieved HBsAg > 1 log10 decline in
the add-on arm compared to none on NA monotherapy
(P<0 0001) Compared to NA monotherapy, PEG-IFN add-on
resulted in significant HBsAg decline at week 48 (mean [SD]:
-0.84 [1.1] vs. -0.2 [0.3] log10, P=0.001; see Figure). At week
48, HBsAg clearance was observed in 5 (8 6%) of patients
who received PEG-IFN add-on therapy versus none of the
NA monotherapy patients (P<0 0001) PEG-IFN was safe
and well-tolerated in the majority of patients Severe adverse
events were reported in three patients Conclusion: At week
48, the addition of PEG-IFN to long term NA is associated
with substantial HBsAg decline and limited HBsAg clearance
in HBeAg-negative CHB patients Therefore, the future role
of PEG-IFN add-on appears to be mainly in new regimens
aiming for a functional cure of CHB 作者: StephenW 时间: 2019-10-24 20:10
PEG干扰素ALFA-2a的增加
HBsAg阴性慢性乙型肝炎患者HBsAg下降
B长期核苷治疗的患者
模拟疗法：来自多中心的结果
随机对照试验。 （PAS研究）
Mina S.Farag1,2，Scott K Fung1，Margo Van Campenhout3，
Karel J. Van Erpecum4，David KH Wong1，Andre Boonstra5，
Elke Verhey3，Robert A.De Man3，Kin Seng Liem1,3，Bettina
E. Hansen1,6和Harry L.A. Janssen1，（1）多伦多中心
大学多伦多总医院肝病科
卫生网络，（2）医科大学医学研究所
多伦多（3）胃肠病学和肝病学系
鹿特丹伊拉斯姆斯医疗中心（4）
大学医学中心胃肠病学和肝病学
乌特勒支（5）胃肠病学和肝病学系
鹿特丹伊拉斯姆斯大学医学中心，（6）
大学卫生政策，管理与评估学院
多伦多
背景：聚乙二醇干扰素（PEG-IFN）治疗
与更高的乙型肝炎表面抗原有关
慢性乙型肝炎（CHB）的（HBsAg）下降率
对评估这种下降至关重要，因为NA中使用PEG-IFN
越来越多地用于针对功能的新疗法中
此外，PEG-IFN附加疗法可能有助于达到
HBsAg丢失允许停止NA因此，我们调查了
在一项随机对照试验中，HBsAg的动力学
长期接受NA治疗的HBeAg阴性CHB患者
收到附加的PEG-IFN方法：在此研究人员发起下
在欧洲和欧洲进行的随机对照试验
加拿大，HBeAg阴性的代偿性肝病患者
NA治疗> 12个月且患有HBV的疾病
入<200 IU / mL的DNA。患者被随机分配2：1
（基线）至48周内加入PEG-IFN alfa-2a（每片180μg
周）或继续进行NA单药治疗，并随后进行随访
至第72周。主要终点为HBsAg下降>
从基线开始第48周时1 log IU / ml，HBsAg丢失为
次要终点。介绍了第48周的中期结果
在这里，第72周的最终结果将在
会议结果：经改良的89例患者
意向治疗分析，58例患者接受了PEG-IFN
附加，还有31种继续进行NA单药治疗目前，有71种
患者已经达到第72周的基线，平均年龄
是48岁，男性86％，亚洲66％，白人25％
一周中基线HBsAg水平中位数为2 9 log10 IU / mL
48，6（10％）例患者的HBsAg> 1 log10下降
与NA单一疗法相比，没有附加臂
（P <0 0001）与NA单药相比，PEG-IFN附加
导致第48周HBsAg明显下降（平均值[SD]：
-0.84 [1.1]对-0.2 [0.3] log10，P = 0.001；见图）。在一周
48，在5（8 6％）患者中观察到HBsAg清除
谁接受了PEG-IFN附加疗法，谁都没有
NA单药治疗患者（P <0 0001）PEG-IFN安全
多数患者耐受良好，严重不良
三例患者报告了事件。结论：每周
48，将PEG-IFN添加到长期NA中是相关的
HBsAg大量下降且HBsAg清除受限
在HBeAg阴性CHB患者中的应用，因此，未来的作用
PEG-IFN附加剂似乎主要在新方案中
致力于CHB的功能性治疗作者: 齐欢畅 时间: 2019-10-25 08:14
