EASL2012:Finite peginterferon results in higher serological, but not virological

StephenW

Abstract               
                                

Title	Finite peginterferon results in higher serological, but not virological, response rates when compared to continuous entecavir in HBeAg-positive chronic hepatitis B
Speaker:	Roeland   Zoutendijk
Author:	R. Zoutendijk1*, M. Sonneveld1, B. Hansen2, H. Janssen2
Affiliation:	1Erasmus MC, 2Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands. *[email protected]
Background and aims: Hepatitis B e Antigen (HBeAg) seroconversion and Hepatitis B surface Antigen (HBsAg) seroclearance confer an improved prognosis. Both endpoints are more often achieved with one year peginterferon (PEG-IFN) compared to one year of nucleos(t)ide analogues (NA), but prolonged NA therapy may result in serological response rates similar to those achieved with PEG-IFN. Materials and methods: A total of 266 HBeAg-positive CHB patients were treated with PEG-IFN±lamivudine for one year and 91 NA-naïve patients were treated with prolonged entecavir (ETV). Follow-up was terminated in patients retreated with NA after PEG-IFN. Results: Median follow-up was 92 weeks (IQR 78-198) for PEG-IFN patients, and 92 (IQR 50-132) for ETV patients. Groups were balanced for HBV genotype, age, sex and previous IFN therapy. Baseline HBV DNA and ALT were higher in PEG-IFN patients (9.1 vs. 8.0 log copies/mL (p< 0.001) and 4.3 vs. 3.1xULN (p=0.004)). One-hundred-fourteen (32%) patients achieved HBeAg seroconversion after 78 weeks (IQR 52-120). The cumulative probability of HBeAg seroconversion was higher in PEG-IFN treated patients (p=0.007). PEG-IFN was an independent determinant of HBeAg seroconversion in a Cox model; hazard rate (HR) for PEG-IFN versus ETV was 3.16 (95%CI: 1.57-6.36, p< 0.001), adjusted for HBV genotype, age, ALT and HBV DNA. Thirty (8%) patients cleared HBsAg in 92 (78-170) weeks. The cumulative probability of HBsAg loss was higher in patients receiving PEG-IFN (p=0.032). PEG-IFN therapy was independently associated with HBsAg clearance, with a HR of 5.66 (95%CI: 0.76-42.40, p=0.027) after adjustment for genotype, age and previous IFN. However, HBV DNA undetectability (HBV DNA < 80 IU/mL) at week 78 (6 months post-treatment in patients treated with PEG-IFN) was only achieved in 8% of patients treated with PEG-IFN versus 77% for ETV (p< 0.001). At last follow-up evaluation (≥ week 78) HBV DNA undetectability was achieved in 15% of PEG-IFN treated patients versus 92% of patients on ETV (p< 0.001). Conclusions: PEG-IFN results in higher rates of HBsAg clearance, and thus sustained remission of CHB, than prolonged ETV therapy, also after adjustment for baseline factors. However, continuous ETV results in higher rates of virological suppression compared with PEG-IFN.

StephenW

标题有限的聚乙二醇在较高的血清，但不病毒学反应率结果相比连续恩替卡韦在HBeAg阳性慢性乙型肝炎
主讲人：Roeland Zoutendijk
作者：河Zoutendijk1 *，M. Sonneveld1，B. Hansen2，H. Janssen2
单位：1Erasmus MC，2Erasmus MC大学医学中心，鹿特丹，鹿特丹，荷兰。 * r.zoutendijk @ erasmusmc.nl
背景和目的：乙型肝炎e抗原（HBeAg）血清转换和乙肝表面抗原（HBsAg）廓清赋予改善预后。更多的时候，两个端点实现一年聚乙二醇（PEG-干扰素）相比，核苷（酸）IDE类似物（NA）的一年，但长期无治疗可能会导致类似PEG-干扰素取得的血清学反应率。
材料和方法：共有266 HBeAg阳性CHB患者与PEG-干扰素±拉米夫定治疗一年，长期恩替卡韦（ETV）治疗91例NA初治患者。后续终止与Na撤退后，PEG-干扰素的患者。
结果：平均随访92周PEG-干扰素的患者，教育电视患者和92（IQR 50-132）（IQR为78-198）。乙型肝炎病毒基因型，年龄，性别和以前的干扰素治疗组进行平衡。基线HBV DNA和ALT高于PEG-干扰素的患者（9.1  -  8.0log拷贝/ ml（P <0.001）和4.3与3.1xULN（P = 0.004））。有一百十四（32％）患者实现HBeAg血清转换后，78周（​​IQR 52-120）。 HBeAg血清转换的累积概率明显高于PEG-干扰素治​​疗的患者（P = 0.007）。 PEG-干扰素是在Cox模型的HBeAg血清转换的独立因素; PEG-干扰素与教育电视的危险率（HR）为3.16（95％CI：1.57-6.36，P <0.001），乙型肝炎病毒基因型，年龄，ALT调整和HBV DNA。第三（8％）患者清除乙肝表面抗原92（78-170）周。 HBsAg消失的累积概率是较高的患者在接受聚乙二醇干扰素（P = 0.032）。独立与HBsAg的清除与HR为5.66（95％CI：0.76-42.40，P = 0.027），调整后的基因型，年龄和以前的干扰素聚乙二醇干扰素治疗。然而，HBV DNA的不可检测（血清HBV DNA <80 IU / mL）的78周（PEG-干扰素治​​疗的患者治疗后6个月）只取得了PEG-干扰素治​​疗的患者在8％与77％，ETV（ P <0.001）。在最后的后续评价（≥78周）HBV DNA的不可检测达到15％PEG-干扰素与92％的患者治疗的患者ETV（P <0.001）。
结论：PEG-干扰素在HBsAg清除率较高，从而持续缓解，也为基线因素调整后，较长期的ETV治疗慢性乙型肝炎的结果。然而，持续的ETV病毒学抑制率较高的结果相比，PEG-干扰素。

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