DDW2012:Combination of HBsAg Level and Hepatitis B Viral Load At Week 12 Is the

StephenW

Combination of HBsAg Level and Hepatitis B Viral Load At Week 12 Is the Best Stopping Rule for Chronic Hepatitis B, HBeAg Positive Patients Treated With Peginterferon ALPHA-2A
Sa1047 |                                                                                                                                    
Pochamana Phisalprapa, Tawesak Tanwandee                                         
Affiliation
Department of Medicine, Division of Gastroenterology, Siriraj Hospital, Mahidol University, Bangkok, Thailand
Abstract:
Background/Aims: Treatment with peginterferon alpha-2a (PEG-IFN) can achieve sustained virological response (SVR) and had high rate of HBsAg loss than nucleos(t)ide analogues. Many predictors of SVR didnot strong enough to change treatment decision. This study aimed to evaluate the usefulness of HBsAg level and HBV DNA reduction during treatment as early predictors of SVR.
Methods: HBeAg positive patients were enrolled to receive PEG-IFN 180 mcg/week for 48 weeks prospectively. Serum HBV DNA, HBsAg quantitation and HBeAg index were serially assessed at baseline and every 12 weeks to week 72. Treatment endpoints were HBeAg seroconversion and HBV DNA less than 2,000 IU/mL at week 72 (SVR).
Results: There were 44 patients, mean age of 41 years and 57% were male. Mean baseline of log10 HBV DNA (IU/mL) and HBsAg (IU/mL) were 7.2, 4.1 and 2.5, respectively. HBsAg level were strong correlated with serum HBV DNA (Spearman’s correlation coefficient=0.75, P <0.001) and HBeAg index (Spearman’s correlation coefficient=0.71, P <0.001). Six patients (13.6%) were genotype B and 38 patients (86.4%) were genotype C. At week 48, there were 11 (25%) HBeAg seroconversion and 4 (9%) HBsAg loss. At week 72, there were 12 (27.3%) HBeAg seroconversion and 5 (11.4%) HBsAg loss (1 genotype B and 4 genotype C). There was no different in baseline characteristic between responders and nonresponders. Responders had more rapid decline of all 3 parameters. No reduction of HBsAg level combined with less than 1 log10 decline of HBV DNA at week 12 is the best early predictor of nonresponder revealed very high negative predictive value (NPV) and sensitivity (100% and 100%, respectively) with higher positive predictive value (PPV) and specificity (40% and 44%, respectively).
Conclusions: This study suggests that treatment with peginterferon alpha-2a had high rate of HBsAg loss even in genotype C. Combination of HBsAg level and Hepatitis B viral load reduction at week 12 is very useful to predict SVR. With very high NPV, these values may be useful for early stopping rule.

Disclosure(s):
The following people have nothing to disclose: Pochamana Phisalprapa, Tawesak Tanwandee

StephenW

12周时乙肝表面抗原水平与乙肝病毒载量的结合，是治疗慢性乙型肝炎的最佳停止规则，e抗原阳性患者治疗聚乙二醇干扰素α-2A Sa1047 | Pochamana Phisalprapa，Tawesak Tanwandee


医学系，胃肠病科，Siriraj医院，玛希隆大学，曼谷，泰国

摘要：

背景/目的：与聚乙二醇干扰素α-2a的（PEG-干扰素），可以实现持续病毒学应答（SVR）和乙肝表面抗原比核苷（酸）IDE类似物损失率很高的待遇。许多预测的SVR，因此未强大到足以改变处理决定。本研究旨在评估在治疗早期预测的SVR的HBsAg水平与HBV DNA减少的效用。
方法：例HBeAg阳性患者接受48周的前瞻性PEG-干扰素180微克/周。评估基准和每12个星期，HBsAg的血清HBV DNA定量和HBeAg指数连续72周。治疗终点是HBeAg血清转换和HBV DNA低于2000 IU /毫升（SVR）72周。
结果：有44例，平均年龄41岁，57％为男性。平均基线LOG10乙型肝炎病毒DNA（IU /毫升）和HBsAg（国际单位/毫升），分别为7.2，4.1和2.5。 HBsAg水平强烈相关（Spearman相关系数= 0.75，P <0.01）与血清HBV DNA和HBeAg指数（Spearman相关系数= 0.71，P <0.01）。 6例（13.6％）为B基因型和38例（86.4％），C基因型48周时，有11（25％），HBeAg血清转换和4（9％）HBsAg消失。在72周时，有12（27.3％）HBeAg血清转换，5（11.4％）（1 B基因型和C基因型4）HBsAg消失。有没有不同的反应和无反应者之间的基线特征。反应了所有3个参数更加迅速下降。不小于1 log10的下降，在12周的HBV DNA结合的HBsAg水平下降是最好的无应答的早期预测显示非常高的阴性预测值（NPV）和灵敏度（分别为100％和100％，具有较高的阳性预测值） （PPV）和特异性（分别是40％和44％）。
结论：这项研究表明，聚乙二醇干扰素α-2a治疗率高HBsAg的损失，即使在C基因型乙肝表面抗原的水平和B型肝炎病毒载量下降12周的组合是非常有用的预测SVR的。具有很高的净现值，这些值可能是有用的早期停止规则。

披露（S）：
下面的人有没有透露：Pochamana Phisalprapa，Tawesak Tanwandee

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