以前用拉米夫定,改用替比夫定治疗功效

StephenW

<http://onlinelibrary.wiley.com/doi/10.1111/j.1478-3231.2010.02360.x/abstract>

Efficacy of switching to telbivudine in chronic hepatitis B patients
treated previously with lamivudine

Rifaat Safadi1,2, Qing Xie3, Yagang Chen4, You-Kuan Yin5, Lai Wei6, Seong
Gyu Hwang7, Eli Zuckerman8, Ji-Dong Jia9, Patricia Lopez10

Article first published online: 29 OCT 2010
DOI: 10.1111/j.1478-3231.2010.02360.x
© 2010 John Wiley & Sons A/S
Issue

Liver International
Volume 31, Issue 5, pages 667–675, May 2011

Abstract

Background: Telbivudine showed greater antiviral suppression than
lamivudine in phase II and III clinical trials.

Aims: The present phase IIIb, randomized, double-blind, multicentre global
trial assessed the antiviral efficacy and safety of telbivudine switch in
chronic hepatitis B (CHB) patients who exhibited persistent viraemia under
lamivudine therapy.

Methods: HBeAg-positive and HBeAg-negative adult patients (N=246) with
persistent viraemia [hepatitis B virus (HBV) DNA>3 log10 copies/ml] under
lamivudine treatment for 12–52 weeks were randomized (1:1) to continue
lamivudine 100 mg/day or switch to telbivudine 600 mg/day for 1 year.
Primary endpoint was the reduction in serum HBV DNA levels from baseline at
Week 24.

Results: The mean reduction in serum HBV DNA levels from baseline with
telbivudine was significantly higher than lamivudine at Week 24 (−1.9 ±
0.18 vs. −0.9 ± 0.27 log10 copies/ml; P<0.001) and maintained through 1
year. The rate of treatment failure was significantly lower (P<0.001) for
patients who switched to telbivudine (5%) compared with those who continued
lamivudine (20%) after 52 weeks of treatment. In the telbivudine group,
treatment failure occurred in only five patients with >24 weeks of prior
lamivudine treatment, all associated with pre-existent lamivudine-resistant
mutations. Genotypic resistance rates were higher in patients continuing
lamivudine compared with those who switched to telbivudine with <24 weeks
of lamivudine exposure. Both treatments were well tolerated with similar
safety profiles.

Conclusions: Early (≤24 weeks) switch to telbivudine improves virological
outcomes in CHB patients with persistent viral replication under lamivudine
treatment.



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StephenW

<http://onlinelibrary.wiley.com/d ... 0.x/abstract&gt;

改用替比夫定疗效慢性乙型肝炎患者
以前与拉米夫定治疗

Rifaat Safadi1，2，清Xie3，鸦岗Chen4，你宽Yin5赖Wei6，晟
圭Hwang7，礼Zuckerman8，继东Jia9，帕特里夏Lopez10

文章首先发表时间：2010年10月29日
分类号：10.1111/j.1478-3231.2010.02360.x
© 2010约翰Wiley＆Sons出版A / S公司
发行

国际肝病
第31卷，第5期，页667-675，2011年5月

摘要

背景：替比夫定比表现出更大的病毒抑制
拉米夫定在第二和第三阶段的临床试验。

目的：本阶段的IIIb，随机，双盲，多中心的全球
试验评估替比夫定的抗病毒疗效和安全开关
慢性乙型肝炎（CHB）患者病毒血症持续展出谁下
拉米夫定治疗。

方法：HBeAg阳性和HBeAg阴性的成年患者（n = 246）与
持续的病毒血症[乙型肝炎病毒（HBV）的DNA“3 log10拷贝/毫升]下
拉米夫定治疗12-52周的随机（1:1）继续
拉米夫定100 mg /天或改用替比夫定1年600毫克/天。
主要终点是血清HBV DNA水平从基线减少在
第24周。

结果：血清HBV DNA水平与治疗前平均下降
替比夫定是在第24周显着高于拉米夫定高（-1.9 ±
0.18主场迎战-0.9 ± 0.27 log10拷贝/毫升;磷“0.001），并维持到1
一年。治疗的失败率显着降低（P“0.001）为
谁的病人改用替比夫定（5％）相比，那些谁继续
拉米夫定（20％）后52周的治疗。在替比夫定组，
治疗失败发生在只有5例> 24周前
拉米夫定治疗，与所有前存在拉米夫定耐药
突变。基因型耐药率在持续增高
拉米夫定相比，与那些谁改用替比夫定与<24周
拉米夫定曝光。这两种治疗的耐受性良好类似
安全配置文件。

结论：早期（≤24周）切换到提高病毒学替比夫定
慢性乙型肝炎患者的预后与永存拉米夫定病毒复制
治疗。

StephenW

[附加. Stephen 10/3/2011]

Safadi R et al. - Early (≤24 weeks) switch to telbivudine improves
virological outcomes in chronic hepatitis B(CHB) patients with persistent
viral replication under lamivudine treatment.

Methods • HBeAg-positive and HBeAg-negative adult patients (N=246) with
persistent viraemia under lamivudine treatment for 12-52 weeks were
randomized (1:1) to continue lamivudine 100 mg/day or switch to telbivudine
600 mg/day for 1 year.

• Primary endpoint was the reduction in serum hepatitis B virus(HBV) DNA
levels from baseline at Week 24.

Results • Mean reduction in serum HBV DNA levels from baseline with
telbivudine was significantly higher than lamivudine at Week 24 and
maintained through 1 year.

• Rate of treatment failure was significantly lower for patients who
switched to telbivudine (5%) compared with those who continued lamivudine
(20%) after 52 weeks of treatment.

• In telbivudine group, treatment failure occurred in only five patients
with >24 weeks of prior lamivudine treatment, all associated with
pre-existent lamivudine-resistant mutations.

• Genotypic resistance rates were higher in patients continuing
lamivudine compared with those who switched to telbivudine with <24 weeks
of lamivudine exposure.

• Both treatments were well tolerated with similar safety profiles.
Safadi R等。 - 早期（≤24周）开关替比夫定改善
在慢性乙型肝炎（CHB）患者的病毒学成果与持久性
在拉米夫定治疗病毒复制。

方法•HBeAg阳性和HBeAg阴性的成年患者（n= 246）与
拉米夫定治疗下持续血症分别为12-52周
随机（1:1）继续拉米夫定100 mg /天或改用替比夫定
600毫克/1年的一天。

•初级终点是血清中乙肝病毒数量减少（HBV）的DNA
从24周时的水平基线。

•从基线结果与血清HBV DNA水平平均减少
替比夫定是在第24周显着高于拉米夫定高，
1年来维持。

•治疗失败率显着降低患者谁
改用替比夫定（5％）相比，那些谁继续拉米夫定
（20％）后52周的治疗。

•在替比夫定组，治疗失败的病人发生在只有五
与>拉米夫定治疗24周之前，所有相关的
前存在拉米夫定耐药突变。

•基因型耐药率在持续增高
拉米夫定相比，与那些谁改用替比夫定与<24周
拉米夫定曝光。

•这两种治疗方法均能很好的耐受性同样安全。