EASL 2013: 聚乙二醇干扰素添加到长期核苷类似物（T）增强了

StephenW

Abstract 735

PEGINTERFERON ADDED TO LONG-TERM NUCLEOS(T)IDE ANALOGUES ENHANCES THE DECLINE OF SERUM HBEAG AND HBSAG LEVELS IN CHRONIC HEPATITIS B P. Arends1*, V. Rijckborst1, B.E. Hansen1,2, A.J. van Vuuren1, H.L.A. Janssen1 1Department of Gastroenterology and Hepatology, 2Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. *[email protected] Background: Although treatment with nucleos(t)ide analogues (NA) for chronic hepatitis B (CHB) is effective and safe, response will probably not sustain off treatment and most patients therefore require long-term treatment. This pilot study investigated the effect of Peginterferon (PEG-IFN) add-on therapy on serum HBeAg and HBsAg levels in HBeAg positive CHB patients who are on long-term NA-treatment. Methods: Eleven patients stably suppressed with an HBV DNA< 200IU/mL during NA treatment (5ETV/6TDF±LAM/FTC) were studied. Five patients were randomized to receive 24 weeks of PEG-IFN α-2b add-on treatment and were compared with 6 patients who continued NA-monotherapy. Follow-up (FU) was 48 weeks. Quantitative HBsAg and HBeAg was measured at week 0, 12, 24 & 48 using the Cobas E411 (Roche). Results: Patients were predominantly male (82%) and of Asian (55%) or Caucasian (45%) origin. Mean age was 34 years. Seven patients (64%) had previously been treated with IFN. Patients harboured HBV genotypes B/C/D/other in 36/28/27/18%. At baseline mean HBeAg and HBsAg were 1.0logIU/mL and 3.8logIU/mL, respectively, and did not differ between groups (p-values>0.2). HBVDNA remained < 200IU/mL in all patients. Patients who received PEG-IFN add-on therapy showed more HBeAg decline at end of treatment (0.84 vs. 0.14IU/mL), and end of FU (0.93 vs. 0.29IU/mL) than those who remained on NA monotherapy. One patient (PEG-IFN arm) achieved HBeAg seroconversion. HBsAg decline was more profound in patients who received PEG-IFN add-on at end of treatment (0.35 vs. 0.12IU/mL), and end of FU (0.26 vs. 0.18IU/mL). HBsAg loss was not observed. Conclusion: Twenty-four weeks of PEG-IFN added to long-term NA treatment may improve HBeAg and HBsAg decline in HBeAg positive CHB. PEG-IFN add-on treatment should therefore be further investigated as an option to finalize long-term NA therapy in CHB. [Serum HBsAg and HBeAg decline per treatment arm] Assigned speakers: Ms. Pauline Arends, Erasmus MC, University Medical Center Rotterdam , Rotterdam , The Netherlands Assigned in sessions: 26.04.2013, 09:00-18:00, Poster Session, P02-07c, Category 07c: Viral Hepatitis B & D: Clinical (therapy, new compounds, resistance), Poster Area

StephenW

背景：虽然是有效和安全的治疗核苷（酸）类似物（NA）治疗慢性乙型肝炎（CHB），响应可能会无法维持关闭处理，因此，大多数患者需要长期治疗。这项试验研究的影响，聚乙二醇干扰素（PEG-IFN）治疗对血清HBeAg和HBsAg水平在HBeAg阳性慢性乙型肝炎患者长期NA治疗。
方法：11例稳定抑制HBV DNA <200IU/mL NA治疗期间（5ETV/6TDF±LAM / FTC）进行了研究。 5例患者随机接受24周的PEG-IFNα-2b中添加治疗，并进行了比较，6例继续NA-单药治疗。后续（FU）为48周。定量测定HBsAg和HBeAg在0周，12日，24日和48使用的COBAS E411（Roche公司）。
结果：患者以男性为主（82％）和亚洲（55％），白人（45％）原产地。平均年龄为34岁。以前一直干扰素治疗7例（64％）。患者窝藏HBV基因型B / C / D /其他36/28/27/18％。在基线平均HBsAg和HBeAg 1.0logIU/mL 3.8logIU/mL，分别，并没有不同群体之间（p值> 0.2）。所有患者的HBVDNA仍是<200IU/mL。患者接受PEG-IFN治疗较e抗原在治疗结束（0.84与0.14IU/mL），下降和结束的FU（0.93 0.29IU/mL）比留在NA单药治疗的人。其中一名病人（PEG-IFN组）实现HBeAg血清学转换。乙肝表面抗原下降更深刻在收到PEG-IFN添加的在治疗结束（0.35与0.12IU/mL）的患者，和最终的FU（0.26与0.18IU/mL）。 HBsAg消失，没有观察到。
结论：PEG-IFN 24周的长期NA治疗HBeAg阳性CHB提高HBeAg和HBsAg下降。 PEG-IFN附加的治疗，因此，进一步的研究作为一个选项来完成长期NA治疗慢性乙型肝炎。
血清HBsAg和HBeAg每个治疗组下降]

宁静温泉

一共有11位接受核苷类似物治疗的HBeAg阳性患者，55%亚洲人，45%高加索白人。中位年龄34岁。有部分患者曾经使用过干扰素治疗。在研究基线时都只单用核苷类似物并且达到HBV DNA< 200IU/mL。

研究方法：其中5例患者在继续服用核苷类似物治疗的过程中，添加了为期24周的PEG-IFN干扰素治疗。其他6例患者则继续单用核苷类似物治疗。两组患者的基线HBeAg和HBsAg无较大差异。研究数据如下：
HBeAg：
  - 加用PEG-IFN干扰素的患者，在24周（即停止干扰素）时，HbeAg相对研究开始时下降了0.84IU/ML，在研究结束时（48周），HbeAg相对研究开始时下降了0.93IU/ML
   - 继续单用核苷类似物的患者，24周和48周时的HbeAg下降数值平均为0.14IU/mL和0.29IU/ML

HBsAg：
  - 加用PEG-IFN干扰素的患者，在24周（即停止干扰素）时，HbsAg相对研究开始时下降了0.35IU/ML，在研究结束时（48周），HbsAg相对研究开始时下降了0.26IU/ML。其中一位患者实现HBeAg血清学转换。
   - 继续单用核苷类似物的患者，24周和48周时的HbeAg下降数值平均为0.12IU/mL和0.18IU/ML。无患者实现HBeAg血清学转换。

结论：HBeAg阳性患者在长期的核苷类似物治疗过程中，加用24个月的PEG-IFN干扰素，可以促进HBeAg和HBsAg定量数值的下降。

宁静温泉

倒数第二段复制黏贴出错。。。那里说的应该都是HBsAg。不好意思

宁静温泉

这个研究挺有意义，就是样本太小，才11个。

宁静温泉

所以研究者也没下肯定的定论，只是说值得进一步研究

咬牙硬挺

感谢分享

StephenW

回复 宁静温泉 的帖子

意大利科学家认为，长期使核苷类降低HBVDNA到检测不到，添加干扰素会导致大多数患者HBsAg清除。
这一战略的成功将被HBsAg水平指导.

styxl

宁静温泉的hbsag很低，或许符合你所说的这一战略。

宁静温泉

哈哈，可以考虑哦