new marker of immune response to determine those with hbsag clearance

StephenW

A new HBsAg/anti-HBs immune complex assay for prediction of treatment outcome in chronic hepatitis B patients.

Annikki de Niet1, Ursula Klause2, Bart Takkenberg1, Hans Zaaijer4, Tom Chu3, Rosemary Petric3, Hendrik  Reesink1

Background and aim:  Quantitation of HBsAg has become a predictor of response in the treatment of chronic hepatitis B (CHB) patients. The clinical relevance of HBsAg/anti-HBs immune complexes however has not been studied yet. A technique to determine HBsAg/anti-HBs immune complex formation has been developed as an early indication of host immune response. It is of interest to know the relationship between HBsAg, anti-HBs, complex levels and treatment outcome. Therefore serum samples of a selection of CHB patients treated with peg-interferon and adefovir for 48 weeks with 24-weeks of follow up were analyzed with this new assay.
Methods:
Samples of HBeAg positive (n=15) and negative (n=11) patients were analyzed for HBsAg, anti-HBs, and complex levels at 4 time points. (BL, wk12, 2-6 wks before and after HBsAg clearance). Patients that did not clear HBsAg served as matched controls. To determine complex levels an array-based assay was used (IMPACT - Immunological Multi-Parameter Chip Technology, Roche Diagnostics). HBsAg and anti-HBs levels were quantified using the same novel technology. Both assays were standardized using WHO-standard material as reference.
Results: Four of 15 HBeAg positive and 5 of 11 HBeAg negative patients cleared HBsAg.  Complex levels at BL and wk 12 did not differ between patients who cleared HBsAg and those who did not.  A positive correlation was found between HBsAg and complex levels in HBeAg positive patients who achieved HBeAg seroconversion (R=0.69, p<0.05) or who lost HBsAg (R=0.55, p=<0.05) and in HBeAg negative patients who lost HBsAg (R=0.64, P<0.05). No correlation was found in patients with HBsAg or HBeAg persistence. No correlation was observed between complex levels and anti-HBs levels. In one HBeAg positive patient with HBsAg clearance, complex levels increased as HBsAg declined. In the other HBeAg positive and negative patients that cleared HBsAg, complex levels followed the same pattern of decline as HBsAg, with HBsAg negativity preceding undetectable HBsAg complex levels.  
Discussion:
We analyzed for the first time the dynamics of HBsAg/anti-HBs immune complexes and the relation to treatment outcome in CHB patients. Complexes were present in all patients at baseline. Although, complex formation varied between patients, in general complex patterns followed the decline in HBsAg in patients with HBsAg clearance after therapy. Complexes became negative in all patients just weeks after HBsAg clearance, while free anti-HBs antibodies were not yet detectable. Further research is necessary to better understand the context of antigen-antibody complexes in CHB to determine its value for prediction of treatment outcome.



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StephenW

免疫反应的新标记，以确定那些与HBsAg清除


一个新的乙肝表面抗原/抗- HBs免疫复合物的检测在慢性乙型肝炎患者的治疗结果的预测。
Annikki DE Niet1，乌苏拉Klause2，巴特Takkenberg1，汉斯Zaaijer4，汤Chu3，迷迭香Petric3，亨德里克Reesink1
背景和目的：HBsAg的定量已成为治疗慢性乙型肝炎（CHB）患者的反应的预测。然而，乙肝表面抗原/抗- HBs的免疫复合物的临床意义还尚未研究。免疫复合物形成的一种技术，以确定表面抗原/抗- HBs已发展为宿主的免疫反应的早期迹象。它是知道HBsAg，抗- HBs的，复杂的水平和治疗结果之间的关系的兴趣。因此选择PEG -干扰素和阿德福韦治疗48周，随访24周的慢性乙型肝炎患者的血清样品进行了分析这种新的检测。
方法：对HBeAg阳性（N = 15）和负（N = 11）患者的样本进行HBsAg，抗- HBS和复杂程度，在4个时间点分析。 （“基本”，wk12，之前和之后的2-6周HBsAg清除）。担任病人，没有明确的乙肝表面抗原相匹配的对照。要确定复杂的水平，基于阵列的检测（影响 - 免疫学的多参数的芯片技术，罗氏诊断）。 HBsAg和抗- HBs水平进行了量化，使用相同的新技术。这两个实验进行了规范使用世卫组织的标准作为参考材料。
结果：4 15 HBeAg阳性和HBeAg阴性患者的5 11清除乙肝表面抗原。病人谁清除HBsAg和那些没有在“基本法”和12周的复杂程度没有差别。之间，在HBeAg阳性患者实现HBeAg血清学转换（R = 0.69，P <0.05），或失去了乙肝表面抗原（R = 0.55，P = <0.05）和HBeAg阴性患者失去了乙肝表面抗原（HBsAg和复杂程度呈正相关R = 0.64，P <0.05）。无相关性，发现患者HBsAg或HBeAg的持久性。没有复杂的水平和抗- HBs水平之间的相关性观察。在一个e抗原阳性患者HBsAg清除，上升为乙肝表面抗原的复杂水平下降。在其他HBeAg阳性和阴性的患者，清除乙肝表面抗原，复杂程度为乙肝表面抗原下降相同的模式，与HBsAg前检测不到HBsAg的复杂水平的消极。
讨论：我们第一次的HBsAg /抗- HBs的免疫复合物及在慢性乙型肝炎患者的治疗结果的关系的动态分析。复合物存在于所有的患者在基线。虽然，形成复合物不同病人之间，一般复杂的图案，随后在与HBsAg清除治疗后患者HBsAg的下降。配合物呈现负增长，在仅仅几周后，所有患者HBsAg清除，而免费的抗- HBs抗体尚未检出。进一步的研究是必要的，以便更好地了解慢性乙肝抗原抗体复合物的背景下，以确定其治疗结果的预测值。

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Four of 15 HBeAg positive and 5 of 11 HBeAg negative patients cleared HBsAg.