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Validation of a stopping rule at week 12 using HBsAg and HBV DNA for HBeAg-negat [复制链接]

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发表于 2012-4-22 01:29 |只看该作者 |倒序浏览 |打印
http://www.journal-of-hepatology.eu/article/S0168-8278%2812%2900045-1/abstract
Validation of a stopping rule at week 12 using HBsAg and HBV DNA for HBeAg-negative patients treated with peginterferon alfa-2a

Received 16 September 2011; received in revised form 18 November 2011; accepted 14 December 2011.  published online 16 January 2012.

Background & AimsIt 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.
MethodsHBeAg-negative patients receiving 48 or 96weeks 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 24weeks after treatment.
ResultsThe 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 96weeks, none of the 7 (21%) without HBsAg decline and with <2log HBV DNA decline at week 12 achieved an SR (NPV 100%).
ConclusionsWe 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 96weeks of PEG-IFN therapy.

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才高八斗

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发表于 2012-4-22 01:29 |只看该作者
在第12周停止使用聚乙二醇干扰素α-2a治疗HBeAg阴性患者HBsAg和HBV DNA的规则验证

    文森特Rijckborst
    ,
    贝蒂娜大肠杆菌汉森
    ,
    彼得Ferenci
    ,
    maurizia河Brunetto
    ,
    fehmi塔巴克
    ,
    耶尔马兹Cakaloglu
    ,
    A. Galeota兰扎
    ,
    蒙特拉墨西拿
    ,
    克劳迪奥Iannacone
    ,
    benedetta马赛托
    ,
    loredana Regep
    ,
    马西莫·科伦坡
    ,
    哈利洛杉矶Janssenemail地址
    ,
    彼得罗Lampertico

收到2011年9月16日,在2011年11月18日收到; 2011年12月14日。 2012年1月16日网上公布。

背景与目的

这是最近表明,没有B型肝炎e抗原(HBeAg)阴性患者无任何血清乙型肝炎表面抗原(HBsAg)下降<2log B型肝炎病毒(HBV)DNA的跌幅在12周48周的聚乙二醇干扰素α-2a(PEG-干扰素)治疗过程中实现了持续应答(SR)。我们的目的是验证这两个独立的试验停止规则。
方法

HBeAg阴性患者接受第三阶段的登记试验(n = 85)和PegBeLiver的研究(n = 75),48或PEG干扰素96周的分层根据存在任何HBsAg的下降和/或周2log的HBV DNA下降12。被定义为血清HBV DNA <2000IU/ml和正常的丙氨酸转氨酶24周治疗后的简。
结果

原来的帕洛阿尔托研究中心的试验包括102例患者(基因型的A / D /其他:14/81/7),25(25%),有一个SR。验证数据集包括160例患者(基因型的A / B / / /其他:10/18/34/91/7),57(36%)实现的SR。停止规则进行横跨两个研究(P = 0.001)和阴性预测值[净现值]是在验证集窝藏基因型A至D的95%。其表现是最好的D基因型此外,为96周治疗的34例中,没有无HBsAg的下降与<2log 12周时HBV DNA下降7(21%)实现的SR(净现值100%)。
结论

我们在两个独立的研究证实,12周时HBsAg和HBV DNA水平的组合标识与HBeAg阴性患者的SR 48或PEG-干扰素治​​疗96周的机会非常低。

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