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AASLD2019[480]研究PEG-IFNα在HBEAG中的功效 停药后阴性慢性乙型 [复制链接]

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发表于 2019-10-29 17:54 |只看该作者 |倒序浏览 |打印
480
TO STUDY THE EFFICACY OF PEG-IFN ALPHA IN HBEAG
NEGATIVE CHRONIC HEPATITIS B PATIENTS AFTER STOPPING
NUCLEOTIDE ANALOGUE THERAPYCLINICAL TRAILS.GOV
IDENTIFIER NO: NCT03123653
Karan Kumar1, Shiv Kumar Sarin2, Manoj K Sharma3, Ankur
Jindal4, Manjul Mishra Jr.5, Harsh Vardhan Tevethia3, Apurva
Pande3 and Guresh Kumar Sr.6, (1)Institute of Liver and
Biliary Sciences,New Delhi, India, (2)Institute of Liver and
Biliary Sciences, (3)Institute of Liver and Biliary Sciences,
New Delhi, India, (4)Hepatology, Institute of Liver and Biliary
Sciences, New Delhi,India, (5)Ilbs, (6)Clinical Research,
Institute of Liver and Biliary Sciences
Background: As per APASL guidelines, amongst HBeAg
negative chronic hepatitis B (CHB) patients, nucleot(s)
ide analogues (NAs) can be stopped after ≥2 years with
undetectable HBV DNA on three occasions 6 months apart.
Clinical relapse may occur in 30-50% of these depending
on the race and geography. Whether Peg-IFN therapy can
improve outcomes and viral clearance in post-NA stoppage
has not been adequately studied. We assessed the incidence
and predictors of relapse in HBeAg negative CHB after
stopping NAs and assessed the efficacy and safety of peg-
IFNα-2b (PEG-IFN) therapy Methods: HBeAg negative CHB
patients on long-term NAs (tenofovir or entecavir) and fulfilling
stopping rules for NAs were enrolled, and patients with >F2
fibrosis on biopsy or LSM>8 were excluded. NAs were stopped
and patients were followed for a median of 96 weeks Patients
with clinical relapse (DNA >2000 IU/mL, ALT >80 IU/mL)
were started on Peg-IFN (1 5mcg/kg) therapy for 48 weeks
Results: NA therapy was stopped in 118 HBeAg negative
CHB patients (87 1% male) with mean age of 41 46±12 01
years , mean LSM-5 78±1 14 and having baseline mean
HBsAg levels of 1 55x10^4 ± 1 27x10^3 Forty four (37 3%)
patients developed clinical relapse, all within 6 months of
stopping NAs On multivariate analysis, predictors of relapse
included prior treatment with Peg-IFN [ OR (95% CI) :0.22
(0.05-0.93).], time taken to achieve undetectable HBV DNA
[OR (95%CI): 1.6 (1.35-1.89)] and duration of consolidation
therapy with NAs [OR (95%CI): 0.78 (0.63-0.97)]. ROC
analysis revealed optimum duration of consolidation therapy
as >5.5 years. Relapse occured in 12(20.3%) patients having
consolidation therapy >5.5 years compared to 32 (54.05%)
with < 5 5 years (p-0 03) Six months after the end of 48 week
peg-IFN therapy, of 44 patients, HBV DNA < 2000 IU/mL, >2
Log10 decline in HBsAg, HBsAg <1000 IU/mL, HBsAg <100
IU/mL and HBsAg loss was seen in 44 (100%), 23(52 27%),
19(43 18%), 7(15 4%) and 4 (9 09%) patients respectively
Amongst 74 patients who did not develop clinical relapse
after stopping NAs, > 2 Log10 decline in HBsAg levels, HBsAg
<1000 IU/mL, HBsAg <100 IU/mL and HBsAg loss was
seen in 2 (2 6%),5(6 75%), 1(1 35%) and 0(0%) patients
respectively, after a median follow-up of 22 months after
stopping NAs (Table1) All 44 patients were able to complete
their interferon therapy Adverse events seen with Peg-IFN
therapy were fatigue and malaise(79 54%), anemia (25%),
thrombocytopenia(50%) and leucopenia(34%) Conclusion:
Clinical relapse rate after stopping NAs was seen in 37 3%
Indian eAg-veCHB patients Shorter consolidation period was
a significant predictor of clinical relapse. Peg-IFN therapy
for 48 weeks resulted in >2 Log10 decline in HBsAg levels in
52 7% and HBsAg loss in 9 1%, and thus can be used as
finite duration therapeutic option.

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发表于 2019-10-29 17:54 |只看该作者
480
研究PEG-IFNα在HBEAG中的功效
停药后阴性慢性乙型肝炎患者
核苷酸类似物治疗临床TRAILS.GOV
编号:NCT03123653
Karan Kumar1,Shiv Kumar Sarin2,Manoj K Sharma3,Ankur
Jindal4,Manjul Mishra Jr.5,Harsh Vardhan Tevethia3,Apurva
Pande3和Guresh Kumar Sr.6,(1)肝病研究所
印度新德里,胆科学(2)
胆科学,(3)肝脏与胆科学研究所,
印度新德里(4)肝胆病研究所肝病学
科学,印度新德里,(5)磅,(6)临床研究,
肝胆科学研究所
背景:根据APASL指南,在HBeAg中
慢性乙型肝炎(CHB)阴性患者,核苷酸
ide类似物(NAs)可以在≥2年后停止使用
间隔6个月的三种情况中均未检测到HBV DNA。
其中30-50%可能会发生临床复发
在种族和地理上。 Peg-IFN治疗是否可以
在NA停药后改善结局和病毒清除率
尚未充分研究。我们评估了发病率
并预测HBeAg阴性CHB复发后复发
停止使用NA并评估钉钉的有效性和安全性
IFNα-2b(PEG-IFN)治疗方法:HBeAg阴性CHB
长期使用NAs(替诺福韦或恩替卡韦)且病情令人满意的患者
登记了NA的停止规则,并且> F2的患者
活检纤维化或LSM> 8除外。 NA被停止
并且对患者进行了平均96周的随访。
临床复发(DNA> 2000 IU / mL,ALT> 80 IU / mL)
开始接受Peg-IFN(1 5mcg / kg)治疗48周
结果:118例HBeAg阴性的NA治疗被停止
CHB患者(87%1%男性)平均年龄为41 46±12 01
年,平均LSM-5 78±1 14且具有基线平均
HBsAg水平为1 55x10 ^ 4±1 27x10 ^ 3四十四(37 3%)
所有患者在6个月内都出现了临床复发
停止NAs在多变量分析中,复发的预测因子
包括先前使用Peg-IFN [OR(95%CI):0.22的治疗
(0.05-0.93)。],达到无法检测到的HBV DNA所需的时间
[OR(95%CI):1.6(1.35-1.89)]和合并持续时间
NAs治疗[OR(95%CI):0.78(0.63-0.97)]。鹏
分析显示巩固治疗的最佳持续时间
大于5.5年。复发发生在12名(20.3%)患者中
巩固疗法> 5.5年,相比32年(54.05%)
少于5年(p-0 03)48周结束后六个月
Peg-IFN治疗,共44例,HBV DNA <2000 IU / mL,> 2
HBsAg,HBsAg <1000 IU / mL,HBsAg <100的Log10下降
IU / mL和HBsAg丢失的比例分别为44(100%),23(52 27%),
分别为19(43 18%),7(15 4%)和4(9 09%)患者
在74例未发生临床复发的患者中
停止NAs后,HBsAg,HBsAg> 2 Log10下降
<1000 IU / mL,HBsAg <100 IU / mL和HBsAg丢失
在2(2 6%),5(6 75%),1(1 35%)和0(0%)的患者中出现
之后,经过22个月的中位随访
停止NAs(表1)所有44例患者均能够完成
他们的干扰素治疗Peg-IFN不良反应
治疗方法为疲劳和不适(79 54%),贫血(25%),
血小板减少症(50%)和白细胞减少症(34%)结论:
停止使用NAs后的临床复发率为37 3%
印度eAg-veCHB患者合并期缩短
临床复发的重要预测指标。聚乙二醇干扰素治疗
48周内,HBsAg水平下降> 2 Log10
52 7%,HBsAg损失为9 1%,因此可以用作
持续时间有限的治疗选择。

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