验证停止规则第12周时干扰素α-2a治疗HBeAg阴性患者

StephenW

验证停止规则第12周时聚乙二醇干扰素α-2a治疗HBeAg阴性患者:采用HBsAg和HBV DNA。
J Hepatol. 2012 May;56(5):1006-11. doi: 10.1016/j.jhep.2011.12.007. Epub
2012 Jan 13.

Validation of a stopping rule at week 12 using HBsAg and HBV DNA for
HBeAg-negative patients treated with peginterferon alfa-2a.

Rijckborst V, Hansen BE, Ferenci P, Brunetto MR, Tabak F, Cakaloglu Y,
Lanza AG, Messina V, Iannacone C, Massetto B, Regep L, Colombo M, Janssen
HL, Lampertico P.

Source
Dept. of Gastroenterology and Hepatology, Erasmus MC, University Medical
Center, Rotterdam, The Netherlands.

Abstract
BACKGROUND & AIMS:
It was recently demonstrated that none of the hepatitis B e antigen
(HBeAg)-negative patients without any serum hepatitis B surface antigen
(HBsAg) decline and with <2log hepatitis B virus (HBV) DNA decline at week
12 of a 48-week peginterferon alfa-2a (PEG-IFN) treatment course achieved a
sustained response (SR). We aimed at validating this stopping rule in two
independent trials. METHODS: HBeAg-negative patients receiving 48 or 96
weeks of PEG-IFN in the phase III registration trial (N=85) and PegBeLiver
study (N=75) were stratified according to the presence of any HBsAg decline
and/or 2log HBV DNA decline at week 12. SR was defined as HBV DNA
<2000IU/ml and normal alanine aminotransferase 24 weeks after treatment.
RESULTS: The original PARC trial included 102 patients (genotype A/D/other:
14/81/7), 25 (25%) had an SR. The validation dataset consisted of 160
patients (genotype A/B/C/D/other: 10/18/34/91/7), 57 (36%) achieved an SR.
The stopping rule performed well across the two studies (p=0.001) and its
negative predictive value [NPV] was 95% in the validation dataset
harbouring genotypes A-D. Its performance was best for genotype D.
Moreover, among the 34 patients treated for 96 weeks, none of the 7 (21%)
without HBsAg decline and with <2log HBV DNA decline at week 12 achieved an
SR (NPV 100%). CONCLUSIONS: We confirmed in two independent studies that
the combination of HBsAg and HBV DNA levels at week 12 identifies
HBeAg-negative patients with a very low chance of SR to either 48 or 96
weeks of PEG-IFN therapy. Copyright © 2012 European Association for the
Study of the Liver. Published by Elsevier B.V. All rights reserved.

StephenW

这是最近展示 ，没有一个（HBeAg）阴性的患者, 12周没有任何血清乙肝表面抗原
（HBsAg）的下降 和 <2log B型肝炎病毒（HBV）DNA 的下降
取得了48周的聚乙二醇干扰素α-2a干扰素（PEG-IFN）治疗过程
持续应答（SR）。我们的目的是在验证两个规则在此停止
独立试验。方法：HBeAg阴性患者接受48或96
周的PEG-IFN的III期注册临床试验（N = 85）和PegBeLiver
研究（N = 75）进行分层的任何HBsAg的下降中的存在所述
和/或12周时，的2log HBV DNA下降。 SR被定义为HBV DNA
<2000IU/ml和正常的谷丙转氨酶治疗后24周。
结果：原来的PARC试验包括102例患者（基因型A / D /其他：
14/81/7），25（25％）的SR。验证数据集包括160个
患者（基因型A / B / C / D /其他：10/18/34/91/7），57例（36％）取得了SR。
停止执行，在这两个研究（P = 0.001），其
阴性预测值[NPV为95％，验证数据集
窝藏基因型A-D。它的性能是最好的基因型D.
此外，在96周治疗的34例患者中，7（21％）
无HBsAg的下降<2log在第12周达到HBV DNA下降的
SR（NPV 100％）。结论：我们在两个独立的研究证实，
在第12周时HBsAg和HBV DNA水平相结合的识别
HBeAg阴性患者与48或96的机会非常低的SR
周的PEG-IFN治疗。版权©2012年欧洲协会
肝脏研究。出版商爱思唯尔B.V.保留所有权利。

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回复 StephenW 的帖子

能简单点说明一下是什么意思吗，是不是说派罗欣对小三阳无效？

StephenW

回复 阳光的未来 的帖子

小三阳接受干扰素治疗 -
在第12周, 如果没有HBsAg水平下降  或 没有 2log(100倍) HBVDNA水平下降, 在结束48周的干扰素治疗后,患者不太可能实现持续应答（SR, HBV DNA<2000IU/ml和正常的谷丙转氨酶, 治疗后24周。).

因此可以考虑停止干扰素治疗.