Telbivudine+adefovir v adefovir in HBeAg+, Lamivudine-resistant patients

StephenW

<http://www.springerlink.com/content/u22221225l0783r5/>

Hepatology International
DOI: 10.1007/s12072-011-9314-7

Online First™

Original Article

Telbivudine in combination with adefovir versus adefovir monotherapy in
HBeAg-positive, lamivudine-resistant chronic hepatitis B

Sang-Hoon Ahn, Young-Oh Kweon, Seung-Woon Paik, Joo-Hyun Sohn, Kwan-Sik
Lee, Dong Joon Kim, Teerha Piratvisuth, Man Fung Yuen, Anuchit Chutaputti
and You-Chen Chao, et al.

Abstract
Purpose
Lamivudine (LAM) resistance is common on lamivudine monotherapy for chronic
hepatitis B. This study examined the safety and efficacy of telbivudine
(LDT) given with adefovir (ADV) versus ADV monotherapy in patients with
chronic, lamivudine-resistant HBV infection. Methods An open-label, 96 week
study with planned recruitment of 150 HBeAg-positive,
lamivudine-experienced Asian patients with a confirmed YMDD resistance
mutation, randomized 1:1 to receive ADV alone or with LDT. The study was
terminated early due to difficulty in enrolling monotherapy patients. At
termination, 42 patients had received study medication for 8–61 weeks.
Due to incomplete enrolment, summary statistics only were prepared, without
significance testing. Results A total of 42 patients underwent rescue
therapy (switch to ADV or LDT + ADV; n = 21 per group). Median treatment
duration was 48 weeks in both groups. HBV DNA changes from baseline were
greater in the LDT + ADV arm at all time points (Week 48: −7.4 log10 vs.
−4.9 log10 copies/ml), and serum DNA was undetectable (<300 copies/mL) at
week 48 in 38.5% (5/13) on LDT + ADV versus 0% (0/9) on ADV monotherapy Two
patients (9.6%) on ADV monotherapy experienced virologic breakthrough
without evidence of ADV resistance, but none on LDT + ADV; and no confirmed
ADV resistance was observed in any on-treatment sample. HBeAg loss occurred
in three patients on LDT + ADV and one patient on ADV monotherapy through
week 48. Safety profiles were similar between the arms. Conclusion LDT +
ADV combination treatment showed better outcomes against lamivudine
resistant HBV than ADV alone, with a similar safety profile.




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StephenW

[谷歌翻译是不是100％正确，仅供参考使用。]

肝病国际
DOI：10.1007/s12072-011-9314-7

在线第一™

原创文章

替比夫定与阿德福韦与阿德福韦单一治疗相结合
HBeAg阳性，拉米夫定耐药的慢性乙型肝炎

安相勋，杨哦Kweon，承焕白宙铉孙某，群植
李，董金俊Teerha Piratvisuth，文凤园，Anuchit Chutaputti
赵有诚，等。

摘要
目的
拉米夫定（LAM）耐药拉米夫定单一治疗常见的慢性
B型肝炎研究的替比夫定的安全性和有效性
（LDT），阿德福韦（ADV）与ADV单药治疗的患者
拉米夫定耐药的慢性乙肝病毒感染。开放标签的方法，96周
研究与计划招聘150 HBeAg阳性，
经验丰富的亚洲患者证实YMDD变异性与拉米夫定
突变，随机1:1接受ADV单独或与LDT中。这项研究是
提前终止因招收单药治疗的患者困难。在
终止，已收到42例为8-61周的研究药物。
因报名人数不完全统计，仅汇总统计数据编制，不
显着性检验。结果共有42例患者接受抢救
治疗（ADV或LDT + ADV切换到N =每组21）。平均治疗
时间为48周，在这两个群体。 HBV - DNA从基线的变化
在LDT + ADV ARM在所有时间点（第48周：-7.4 LOG10与
-4.9 LOG10拷贝/毫升），血清DNA检测不到（<300拷贝/ ml）
48周的LDT + ADV与ADV单药治疗的0％（0 / 9）的38.5％（5 / 13）
ADV单药治疗的患者（9.6％）出现病毒学突破
没有ADV阻力，但没有上的LDT + ADV的证据，并没有证实
ADV耐药性观察在任何处理的样本。发生HBeAg消失
在三个患者的LDT + adv和ADV单药治疗的病人，通过
第48周。安全配置文件之间的武器类似。结论的LDT +
ADV联合治疗显示对拉米夫定更好的结果
仅比ADV耐药HBV，具有相似的安全性。