EASL2012:EXTENDED PEGYLATED INTERFERON ALFA-2A THERAPY IN CHINESE PATIENTS WITH

StephenW

Abstract               
                                

Title	EXTENDED PEGYLATED INTERFERON ALFA-2A THERAPY IN CHINESE PATIENTS WITH HBEAG-NEGATIVE CHRONIC HEPATITIS B: A SINGLE-CENTER, PROSPECTIVE, RANDOMIZED OPEN-LABELLED STUDY
Speaker:	Xue Fu   Chen
Author:	X.P. Chen, X.F. Chen*, J. Huang, W.L. Chen, R. Chen, X.J. Ma, X.D. Luo
Affiliation:	Guangdong General Hospital, Academy of Medical Sciences, Guangdong, China. *[email protected]
Background and objective: Unlike the commonly seen off-treatment relapse in patients treated with nucleos(t)ide analogues, a finite course of PEG-IFN provides sustained immune control in HBeAg-negative chronic hepatitis B (CHB)patients. The aim of this study is to investigate whether extended pegylated interferon alfa-2a(PEG-IFN) therapy can improve long-term response in HBeAg-negative patients and identify optimal endpoint for this population. Methods: In this single-center, prospective, open-labeled study, totally 66 HBeAg-negative treatment-naïve patients with ALT ≥2×ULN and HBV DNA≥2000IU/ml but < 200000IU/ml were enrolled. All patients were randomized into 2 groups, treated with PEG-IFN 180 µg/week for 48 weeks in standard therapy group(N=30) or PEG-IFN 180 µg/week for 60 or 72 weeks in extended therapy group(N=36) and followed for 48 weeks post-treatment. The variance analysis, Wilcoxon test, student's t-test, χ 2, exact probability test and CMH analysis were used in this study. Results: At end of treatment, 94.4%(N=34) in extended therapy group achieved HBV DNA suppression(HBV DNA< 60 IU/ml) which was significantly higher than standard therapy group (73.3%, N=22 , P< 0.05). When followed up to 24 and 48 weeks post-treatment, the response rates reached 88.9% and 77.8% in extended therapy group, both significantly higher than standard therapy group (63.3% and 53.3%, both P< 0.05). At 48 weeks post-treatment, 36.1%(N=13) in extended therapy group has cleared HBsAg, which was significantly higher than standard therapy group(13.3%, N=4 , P< 0.05). At end of treatment, in the patients with HBV DNA < 60IU/ml, the cutoff of HBsAg< 1000IU/ml had a PPV of 92% and a NPV of 48.78% for predicting achieving sustained HBV DNA suppression at 48 weeks post-treatment, and HBsAg>1000IU/ml had a PPV of 35.48% and a NPV of 68.57% for predicting not achieving sustained HBV DNA suppression at 48 weeks post-treatment. Conclusion: Extended PEG-IFN treatment provides significant higher rates of HBV DNA suppression and HBsAg clearance post-treatment in HBeAg-negative CHB. HBsAg level at end of treatment, predictive of sustained response post-treatment, may be an indicator for stopping treatment.

StephenW

标题扩展在中国HBeAg阴性慢性乙型肝炎患者的聚乙二醇干扰素α-2a治疗：一项单中心，前瞻性，随机，开放标记研究
主讲人：陈薛福成
作者：X.P.陈，X.F.陈*，J.黄，工作长度陈，陈河，X.J.马，X.D.罗
单位：广东省总医院，中国医学科学院，广东。 * [email protected]
背景与目的：不同于常见的治疗外与核苷（酸）IDE类似物，PEG-干扰素有限疗程治疗的患者复发提供持续HBeAg阴性慢性乙型肝炎（CHB）患者的免疫控制。本研究的目的是探讨是否延长聚乙二醇干扰素α-2a（PEG-干扰素）治疗可改善长期在HBeAg阴性患者的反应，并确定对这个群体的最佳端点。
方法：在这种单中心，前瞻性，开放标记研究，共66 HBeAg阴性治疗过的患者ALT≥2×ULN和HBV DNA≥2000IU/ml但200000IU/ml <被录取。所有患者随机分为2组，治疗PEG-干扰素180微克/周48周标准治疗组（n = 30）或PEG-干扰素180微克/ 60或72周延长治疗组（n = 36周）和48周的治疗后。 Wilcoxon检验，方差分析，学生t检验，χ2，确切概率试验和CMH的分析，在这项研究中使用。
结果：在治疗结束后，在延长治疗组达到HBV DNA抑制94.4％（n = 34）（HBV DNA <60 IU /毫升），这是明显高于标准治疗组（73.3％，n = 22，P <0.01 ）。随访至24日和48周的治疗后，回应率达到88.9％和77.8％，在延长治疗组，都显着高于标准治疗组（63.3％和53.3％，均P <0.05）。
延长治疗组（n = 13）的36.1％，在48周的治疗后，已清除乙肝表面抗原，这是明显高于标准治疗组（13.3％，N = 4时，P <0.01）。
在治疗结束后，在患者与乙型肝炎病毒DNA，乙肝表面抗原截止60IU/ml <1000IU/ml预测在48周治疗后实现持续HBV DNA抑制PPV为92％和48.78％，净现值，和HBsAg> 1000IU/ml预测没有实现持续48周治疗后HBV DNA抑制了35.48％，PPV和NPV的68.57％。
结论：扩展的聚乙二醇干扰素治疗提供了显着高于HBV DNA抑制和HBsAg清除HBeAg阴性的慢性乙型肝炎治疗后的利率。乙肝表面抗原在治疗结束时的水平，持续反应治疗后的预测，可能会停止治疗的一个指标。

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