NATAP/EASL: 替诺福韦在不同的患者人群的HBsAg下降

StephenW

> Subject: NATAP/EASL: Tenofovir HBsAg Declines in Different Patient Populations
>
> Comparison of Serum HBsAg Declines During Tenofovir Disoproxil Fumarate (TDF) Treatment in Different Chronic Hepatitis B (CHB) Patient Populations
>
>  - see attached full poster report
>
>  

>
> Reported by Jules Levin
>
> EASL Amsterdam April 24-28 2013
>
> Henry LY Chan1, Maria Buti2, Patrick Marcellin3, Graham R. Foster4, Lanjia Lin5, Benedetta Massetto5, John Flaherty5, Anuj Gaggar5, G. Mani Subramanian5, John McHutchison5, Scott Fung6, Alexander J. Thompson7, Pietro Lampertico8
>
>
> Introduction & Objective
> Serum HBsAg levels vary across different stages of chronic hepatitis B virus (HBV) infection1,2
>
> Predictive factors of HBsAg decline/HBsAg loss have been extensively investigated during interferon (IFN) therapy
>        – Limited data are available with nucleos(t)ide inhibitor therapy3,4
>
> We analyzed the kinetics of HBsAg decline in different chronic HBV populations during controlled clinical trials with TDF
>        – HBeAg+ immune tolerant: alanine aminotransferase (ALT) ≤ upper limit of normal (ULN)
>        – HBeAg+ immune active: ALT >2 x ULN and ≤10 x ULN
>         – HBeAg−: ALT >ULN and ≤10 x ULN
> The primary aim was to define predictors of response (HBsAg loss and HBsAg seroconversion) during TDF therapy
>
> CONCLUSIONS
>
> In CHB patients treated with TDF:
> – Greater reductions in qHBsAg levels were seen in HBeAg+ immune active patients compared with HBeAg– and HBeAg+ immune tolerant patients
>
> – In HBeAg+ immune active patients, an absolute decline in qHBsAg level of ≥1 log10 IU/mL and a ≥75% decline in
> qHBsAg at Week 24 had similar PPV (29.2–41.4%) and NPV (97.2–98.4%) for HBsAg loss
>
> – Immune modulatory strategies to enhance the magnitude of HBsAg decline may improve the likelihood of achieving
> HBsAg loss in CHB patients

StephenW

>简介及目的
>血清HBsAg水平各不相同不同阶段的慢性乙型肝炎病毒（HBV），2 infection1
>
>预测因素已经被广泛地研究干扰素（IFN）治疗期间的HBsAg下降/ HBsAg消失
> - 有限的数据可与核苷（酸）IDE，4抑制剂therapy3
>
我们分析了与TDF对照临床试验期间在不同的慢性乙肝人群的HBsAg下降动力学
> - 大三阳+免疫耐受：谷丙转氨酶（ALT）≤上限（ULN正常）
> - 大三阳+免疫激活：ALT>2×ULN且≤10倍ULN
> - 大三阳：ALT> ULN≤10×ULN
> TDF治疗期间的主要目的是定义预测响应（HBsAg消失和HBsAg血清学转换）
>
>结论
>
在TDF治疗的慢性乙型肝炎患者：
> - 大减少qHBsAg水平大三阳+免疫活性患者的HBeAg和HBeAg+免疫耐受患者相比
>
>  - 对于HBeAg+免疫活性的患者，绝对下降在qHBsAg水平≥1 log10的国际单位/毫升和≥75％的跌幅
> qHBsAg24周也有类似的PPV（29.2-41.4％）和净现值（97.2-98.4％），HBsAg消失
>
>  - 免疫调节策略，以加强对HBsAg下降的幅度可能会提高实现的可能性
> CHB患者的HBsAg消失

StephenW

咬牙硬挺

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