EASL 2013 拉米夫定改用恩替卡韦, 96周的随机试验

StephenW

Abstract 747
     
A 96-WEEK RANDOMIZED TRIAL OF SWITCHING TO ENTECAVIR IN CHRONIC HEPATITIS B PATIENTS WITH A COMPLETE VIROLOGIC RESPONSE TO LAMIVUDINE
     
J. Heo1*, S.H. Ahn2, J.Y. Park2, H.Y. Woo1, H.J. Lee3, W.Y. Tak4, S.H. Um5, K.T. Yoon1, S.Y. Park4, Y.S. Seo5, C.W. Kim6, K.H. Han2, M. Cho1
1Internal Medicine, Pusan National University School of Medicine, Pusan, 2Internal Medicine, Yonsei University College of Medicine, Seoul, 3Internal Medicine, Yeungnam University College of Medicine, 4Internal Medicine, Kyungpook National University College of Medicine, Daegu, 5Internal Medicine, Korea University College of Medicine, 6Internal Medicine, Catholic University College of Medicine, Seoul, Republic of Korea. *[email protected]

Backgrounds and aims: Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than Lamivudine in nucleoside-naïve chronic hepatitis B (CHB) patients. The switch from Lamivudine to Entecavir in patients who have undetectable hepatitis B virus DNA (HBV DNA < 60 IU/mL) may lead to more prolonged viral suppression to undetectable level by PCR method, compared to patients with continuous Lamivudine treatment. This prospective, 96 week study investigated the antiviral efficacy, safety and tolerability of switching to Entecavir versus maintaining Lamivudine in CHB patients with virologic response to Lamivudine.
Patients and methods: A total of 73 HBeAg-positive patients, with serum HBV DNA < 60 IU/mL after at least 6 months Lamivudine monotherapy were randomized 1:1 into either switching to Entecavir 0.5 mg/day, or continuing with Lamivudine 100 mg/day.
Results: Mean duration of prior Lamivudine treatment (n=35) was 25.7 months in the Lamivudine-maintained, and 27.4 months in the Entecavir-switch patients. At 96 weeks of follow-up, 20/35 (57.1%) patients in the Lamivudine arm had persistently undetectable HBV DNA, compared with 37/38 (97.4%) patients in the Entecavir arm (P< 0.001). Out of total 16 patients with HBV DNA rebound, 8/15 in the Lamivudine arm had HBV DNA of more than 1000 IU/mL during rebound, while none in Entecavir arm. Genotypic resistance to assigned intervention emerged in 28.6% (10/35) of Lamivudine-maintained patients, and in 0% (0/38) of Entecavir-switched patients during 96 weeks (P< 0.001). Seventeen Entecavir-switched (45.9%) and seven Lamivudine-maintained (21.2%) patients achieved HBeAg loss (P=0.043), and nine Entecavir (24.3%) and five Lamivudine (15.2%) patients achieved HBeAg seroconversion.
Conclusion: Switching to Entecavir in patients with undetectable HBV DNA to Lamivudine resulted in maintained virologic response without antiviral resistance at 96 week compared with maintaining Lamivudine.


Assigned speakers:
Prof. Jeong Heo, Pusan National University School of Medicine , Pusan , Republic of Korea

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

背景和目的：恩替卡韦具有较高的有效抗病毒药物的疗效和较低的耐药率比拉米夫定核苷初治慢性乙型肝炎（CHB）患者。开关从拉米夫定，恩替卡韦的患者有检测不到乙肝病毒DNA（HBV DNA <60 IU / mL）的可能会导致到更长期病毒抑制到检测不到的水平用PCR方法相比，连续拉米夫定治疗的患者。这项前瞻性的，96周的研究抗病毒药物的疗效，安全性和耐受性，改用恩替卡韦与在病毒学应答拉米夫定慢性乙型肝炎患者维持拉米夫定。
患者和方法：共73例HBeAg阳性患者，血清HBV DNA <60 IU / mL的1:1随机分为切换到恩替卡韦0.5 mg /天，或继续用拉米夫定100毫克拉米夫定单药治疗至少6个月后/天。
结果：之前拉米夫定治疗组（n = 35）的平均时间为25.7个月的保持拉米夫定，恩替卡韦开关患者和27.4个月。在96周的随访，20/35（57.1％）患者在拉米夫定臂坚持不到HBV DNA，比37/38（97.4％），恩替卡韦组患者（P <0.001）。共有16例HBV DNA反弹，8/15拉米夫定臂超过1000 IU / mL的反弹过程中，HBV DNA，而恩替卡韦的手臂。基因型耐药性出现的分配干预拉米夫定维持患者的28.6％（10/35），0％（0/38），恩替卡韦交换的病人在96周后（P <0.001）。十七恩替卡韦交换（45.9％）和七拉米夫定维护（21.2％）患者获得HBeAg消失（P = 0.043），九恩替卡韦（24.3％）和五的贺普丁（15.2％）患者达到HBeAg血清学转换。
结论：开关患者恩替卡韦对拉米夫定导致维持病毒学应答，而不与维护拉米夫定相比，在96周的抗病毒耐药检测不到HBV DNA。

9病成医

看这半生不熟汉语文字,真是受罪.

宁静温泉

研究目的：拉米夫定应答的患者改用恩替卡韦的效果。
共有73例HBeAg阳性患者，接收拉米夫定治疗至少6个月（治疗中位数大约在26个月），HBVDNA都小于60IU/ML。按照1:1随机分配到两个组，一个组继续接受拉米夫定治疗，一个组改用恩替卡韦治疗。经过96周的观察，数据如下：

HBVDNA
   - 继续拉米夫定组：20个（57.1%）患者保持HBVDNA小于60IU/ML。剩下的15个（43%）DNA反弹，其中8个（23%）反弹到1000IU/ML以上
   - 改用恩替卡韦组：37个（97.4%) 患者保持HBVDNA小于60IU/ML。只有一个反弹，并且不超过1000IU/ML
耐药：
   - 继续拉米夫定组有28.6％（10/35个）耐药
   - 改用恩替卡韦组没有发现耐药
HBeAg：
   - 继续拉米夫定组有7个（21.2％）达到HBeAg消失，5个（15.2％）出现HBeAg血清转换
   - 改用恩替卡韦组有有17个（45.9％）达到HBeAg消失，9个（24.3％）出现HBeAg血清转换


结论：采用拉米夫定治疗达到HBVDNA阴性的患者，如果改用恩替卡韦，可以实现更持久的应答，并且大大降低耐药风险。

9病成医

谢谢宁静温泉!你应该叫及时雨.

宁静温泉

哈哈，这个星期太忙了。。。
以后争取每天“翻译”一篇。

咬牙硬挺

回复 宁静温泉 的帖子

施蒂芬和温泉珠连璧合！翻译很辛苦的，不必强制每日一篇的，向你们的无私奉献致敬

9病成医

施蒂芬加宁静温泉,如拉米加阿德,英语盲网友的"天仙配".