一项纵向队列研究表明，HBV RNA迅速下降可预测HBeAg阳性患者

StephenW

Rapidly decreased HBV RNA predicts responses of pegylated interferons in HBeAg-positive patients: a longitudinal cohort study

    Min Zhang, Guangdi Li, Jia Shang, Chen Pan, Minxiang Zhang, Zhibiao Yin, Qing Xie, Yanzhong Peng, Qing Mao, Xinqiang Xiao, Yongfang Jiang, Kaizhong Luo, Yun Xu, Hai Ding, Wenzhou Fan, Vidaurre Diego, Mahmoud Reza Pourkarim, Erik De Clercq, Guiqiang Wang & Guozhong Gong

Hepatology International volume 14, pages212–224(2020)Cite this article

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Abstract
Background

As an important anti-HBV drug, pegylated interferon α (PegIFNα) offers promising clinical efficacy, but biomarkers that accurately forecast treatment responses are yet to be elucidated. Here, we evaluated whether HBV RNA could act as an early monitor of pegylated interferon responses.
Methods

We analyzed a phase 3, multicenter, randomized cohort of 727 HBeAg-positive non-cirrhotic patients receiving a 48-week treatment of PegIFNα-2a or PegIFNα-2b and a 24-week treatment-free follow-up. Serum levels of HBV RNA, HBV DNA, HBeAg, and HBsAg were measured at weeks 0, 12, 24, 48, and 72.
Results

HBeAg seroconversion and HBsAg loss at week 72 were observed in 217 (29.8%) and 21 (2.9%) patients, respectively. During the 48-week treatment, HBV RNA decreased more rapidly than HBV DNA and HBsAg, but HBV RNA and HBeAg shared similar dynamics with positive correlations. Multivariate regression analyses consistently revealed the significance of HBV RNA at weeks 0, 12, 24, and 48 to monitor HBeAg seroconversion but not HBsAg loss. Although baseline HBV RNA only showed a modest AUC performance, HBV RNA with a significant increase of AUC at week 12 outperformed other HBV biomarkers to forecast HBeAg seroconversion (p value < 0.05). HBV RNA ≤ 1000 copies/mL was an optimized cutoff at week 12 that offered better prediction than other HBV biomarkers. This optimized cutoff plus patient age, HBV genotype B, and HBeAg offered a strong estimation of HBeAg seroconversion (accuracy 95.2%, true negative rate 99.8%).
Conclusion

HBV RNA at week 12 is an effective monitor of HBeAg seroconversion in HBeAg-positive patients treated with pegylated interferons.

StephenW

一项纵向队列研究表明，HBV RNA迅速下降可预测HBeAg阳性患者的聚乙二醇化干扰素的反应

    张敏，李光第，贾尚，陈盼，张敏祥，尹志标，谢庆，彭延中，毛青，肖新强，姜永芳，罗开中，罗芸，海丁，范温范，维达乌雷·迭戈，马哈茂德·雷扎Pourkarim，Eri​​k De Clercq，王桂强和龚国忠

《国际肝病学》第14卷，第212-224页（2020年）

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抽象
背景

作为一种重要的抗HBV药物，聚乙二醇化干扰素α（PegIFNα）具有良好的临床疗效，但尚无法阐明可准确预测治疗反应的生物标志物。在这里，我们评估了HBV RNA是否可以作为聚乙二醇化干扰素反应的早期监测者。
方法

我们分析了接受PegIFNα-2a或PegIFNα-2b治疗48周和无治疗24周随访的727名HBeAg阳性非肝硬化患者的3期，多中心，随机队列。在第0、12、24、48和72周时测量血清HBV RNA，HBV DNA，HBeAg和HBsAg。
结果

在第72周时，分别有217（29.8％）和21（2.9％）患者观察到HBeAg血清转化和HBsAg丢失。在48周的治疗期间，HBV RNA的下降速度比HBV DNA和HBsAg快，但是HBV RNA和HBeAg具有相似的动力学关系，并具有正相关关系。多变量回归分析一致地揭示了在第0、12、24和48周时HBV RNA监测HBeAg血清转化但不监测HBsAg丢失的重要性。尽管基线HBV RNA仅显示出适度的AUC性能，但在第12周时AUC显着增加的HBV RNA优于其他HBV生物标志物，可预测HBeAg血清转化（p值<0.05）。 HBVRNA≤1000拷贝/ mL是第12周的最佳临界值，比其他HBV生物标记物提供了更好的预测。该优化的临界值加上患者年龄，HBV基因型B和HBeAg提供了对HBeAg血清转化的有力估计（准确度为95.2％，真实阴性率为99.8％）。
结论

在用聚乙二醇化干扰素治疗的HBeAg阳性患者中，第12周的HBV RNA是HBeAg血清转化的有效监测器。

StephenW

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