Accelerated Decrease in HBsAg Seen Before HBV Clearance

StephenW

http://www.internalmedicinenews.com/single-view/accelerated-decrease-in-hbsag-seen-before-hbv-clearance/38e3a2aa5a.html
Accelerated Decrease in HBsAg Seen Before HBV Clearance

By: DENISE NAPOLI, Internal Medicine News Digital Network

Serum hepatitis B surface antigen (HBsAg) seroclearance is preceded by significant, accelerated decreases in serum HBsAg levels during the 3 years leading up to seroclearance, wrote Dr. Yi-Cheng Chen and colleagues in the March issue of Clinical Gastroenterology and Hepatology.

Moreover, serum HBsAg levels of less than 200 IU/mL are highly predictive of spontaneous seroclearance.

"It is therefore recommended to quantify HBsAg every 2 years in hepatitis B e antigen-negative HBsAg carriers with persistently normal alanine aminotransferase levels to detect who requires yearly HBsAg assay for the anticipated HBsAg seroclearance" (Clin. Gastroenterol. Hepatol. 2012 [doi:10.1016/j.cgh.2011.08.029]).

Dr. Chen of the Liver Research Unit at Chang Gung University, Taipei, Taiwan, studied 46 patients who had undergone spontaneous HBsAg seroclearance, defined as "loss of serum HBsAg documented on two occasions at least 6 months apart and maintained to the last visit."

Prior to clearance, all patients were hepatitis B e antigen (HBeAg)–negative for between 8 and 28 years, and most had persistently normal alanine aminotransferase (PNALT) for a mean of 14.2 years, except seven patients with mild ALT elevation.

Their median age at clearance was 48 years, and 87% were male.

"Considering that sustained remission is a prerequisite of HBsAg seroclearance, a group of 46 HBeAg-negative, noncirrhotic HBV carriers with PNALT for greater than 10 years were selected as [a] control group for comparison," wrote the researchers.

Controls were matched for age, gender, and genotype and all had PNALT for greater than 10 years but remained HBsAg seropositive.

Levels of HBsAg were assessed in saved serum specimens collected at 5 years, 3 years, and 1 year before HBsAg seroclearance (or, for controls, the last examination).

The authors found that median HBsAg levels at all time points were significantly lower in the seroclearance group, compared with controls.

For example, at 5 years before seroclearance, the study group’s median HBsAg level was 154.8 IU/mL, vs. 1,361 IU/mL for controls; at 3 years, the median values were 56.3 IU/mL vs. 1,063.3 IU/mL; and at 1 year prior to HBsAg seroclearance, levels were 1.6 IU/mL vs. 642.6 IU/mL (P less than .0001 for all time points).

Not only were the values much lower in the study group at all time points, but also the rate of change from year to year was significantly greater in the seroclearance group, compared with controls.

Indeed, the authors calculated the estimated annual decline of HBsAg to be 0.53 log10 IU/mL for the study group, significantly higher than 0.09 log10 IU/mL per year in the matched controls (P less than .0001).

Finally, the authors looked at the link between the serum HBsAg levels themselves and achievement of clearance.

"In the study group, HBsAg levels declined to less than 200 and less than 100 IU/mL in 55% and 37% of the patients, respectively, at 5 years prior to HBsAg seroclearance," wrote the authors.

"The proportion of patients reaching these levels of HBsAg increased to 81% and 64% at 3 years; [and to] 100% and 98% at 1 year prior to HBsAg seroclearance."

Taken together, "A greater than 1 log10 IU/mL decline in HBsAg during a 2-year period, combined with a single time point HBsAg level less than or equal to 200 IU/mL, can best predict HBsAg seroclearance in 1 and 3 years," with a positive predictive value for clearance in 1 year of 97%, and the positive predictive value for clearance at 3 years of 100%.

The authors mentioned several limitations. "Matching age, gender, and HBV genotype for this study might mask the potential influence of these factors on HBsAg seroclearance," they wrote.
Additionally, some stored serum specimens were of insufficient volume for analysis.

"Nevertheless, more than 90% of stored serum specimens were available at the 1- and 3-year time points, with 83% being available at the 5-year time point."

The authors stated that the study was supported by grants from the Chang Gung Medical Research Fund and the Prosperous Foundation. One of the researchers disclosed serving as a global advisory board member or being involved with clinical trials sponsored by Roche, Bristol-Myers Squibb, Novartis, and Gilead Sciences.




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StephenW

病毒清除前,HBsAg加速减少

由丹尼斯那不勒斯，内科新闻数字网

血清乙型肝炎表面抗原（HBsAg）廓清血清HBsAg水平显着，在加速下跌以廓清在3年之前，易博士，郑陈和他的同事写在3月的临床胃肠病学和肝病问题。

此外，血清HBsAg水平低于200 IU / mL的高度预测自发廓清。

“因此，建议量化HBsAg的每2年在B型肝炎e抗原阴性乙肝表面抗原，谷丙转氨酶水平持续正常的运营商可以检测人需要每年预期的HBsAg廓清乙肝表面抗原检测”（Clin.胃肠肝胆病杂志2012年[期刊论文。： 10.1016/j.cgh.2011.08.029]）。

陈博士在长庚大学，台北，台湾，肝病研究组研究了46病人谁经历了乙肝表面抗原自发廓清，定义为“记录两次相隔至少6个月，并保持到最后访问血清HBsAg的损失。 “

清拆前，所有患者B型肝炎e抗原（HBeAg）阴性为8和28岁之间，大多有持续正常平均为14.2岁，除7轻度ALT升高的患者，谷丙转氨酶（PNALT）。

他们在通关的年龄中位数为48岁，87％为男性。

“考虑到持续缓解是乙肝表面抗原血清廓清的一个先决条件，一组46 HBeAg阴性，非肝硬化与PNALT乙肝病毒携带者大于10年被选定为[A]对照组进行比较，”研究人员写道。

对照组年龄，性别和基因型相匹配，都大于10岁的PNALT，但仍然是乙肝表面抗原阳性。

在5年内收集保存的血清标本，3年来，和HBsAg的廓清（或控制，最后检查）前1年HBsAg水平进行了评估。

笔者发现，在所有时间点HBsAg水平中位数在廓清组均显着降低，与对照组相比。

例如，在廓清前5年，研究组的HBsAg水平中位数为154.8 IU / mL时，与1361国际单位/毫升控制在3年内，中值分别为56.3 IU / mL和1,063.3 IU /毫升;在1年之前，乙肝表面抗原血清廓清，水平分别为1.6 IU / mL和642.6 IU /毫升（比0.0001，为所有的时间点）。

不仅是在研究组在所有时间点的值要低得多，但也从每年的变化率显着更大的廓清组，与对照组相比。

事实上，计算乙肝表面抗原是0.53 log10的国际单位/毫升的研究组，显着高于估计每年下降0.09 log10的匹配的对照每年IU /毫升（小于0.0001）。

最后，作者看着血清HBsAg水平和实现通关之间的联系。

作者写道：“”在研究组中，HBsAg水平下降到低于200低于100 IU /毫升55％和37％的患者，分别在5年之前，乙肝表面抗原血清廓清。

“达到这些水平的HBsAg的患者的比例提高到81％和64％，在3年; [和] 100％和98％，在1年之前，乙肝表面抗原血清廓清。”

两者合计，大于1 log10的国际单位/毫升，在2年期间HBsAg的下降，与一个单一的时间点HBsAg水平小于或等于200 IU / mL的结合，最能预测在1年和3年HBsAg的廓清，“间隙在1年的97％，阳性预测值和清除阳性预测值100％，在3年。

作者提到的几个限制。 “这项研究的匹配年龄，性别，HBV基因型可能掩盖了这些因素对HBsAg廓清的潜在影响，”他们写道。
此外，一些存储的血清标本进行分析的不足量。

“尽管如此，超过90％的存储的血清标本可在1  -  3年的时间点，83％在5年的时间点。”

作者指出，这项研究是由长庚医学研究基金和繁荣基金会赠款支持。研究人员之一透露，作为一个全球性的咨询委员会成员，或参与由罗氏，百时美施贵宝，诺华公司，Gilead Sciences公司赞助的临床试验。

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