Entecavir (Baraclude) Less Effective for Patients with Multidrug-Resistant Hepat

StephenW

http://www.hivandhepatitis.com/hepatitis-b/hepatitis-b-topics/hbv-treatment/3263-entecavir-baraclude-less-effective-for-patients-with-multidrug-resistant-hepatitis-b
Entecavir (Baraclude) Less Effective for Patients with Multidrug-Resistant Hepatitis B                                                   
Category: HBV Treatment   Published on Tuesday, 04 October 2011 00:00                          Written by Liz Highleyman               
                                                                                                

HBV © Russell Kightley

                                       
               
               
The nucleoside analog antiviral drug entecavir (Baraclude) was minimally effective against hepatitis B virus (HBV) that had already developed resistance to lamivudine (Epivir-HBV) and adefovir (Hepsera), researchers reported in the October 2011 Journal of Viral Hepatitis. Patient who achieved good early response, however, can do well if they stay on entecavir.
         Korean researchers looked at the long-term outcome of switching to entecavir for chronic hepatitis B patients who had developed multidrug resistance after sequential therapy using lamivudine and adefovir.
        The study included 33 patients with HBV infection who showed evidence of active viral replication (HBV DNA > 105 copies/mL) or a history of treatment failure with lamivudine/adefovir sequential therapy between April 2007 and July 2009. Participants were treated with 1.0 mg/day entecavir for at least 48 weeks and some for 96 weeks.
        Results

• 66.7% of entecavir-treated patients experienced alanine aminotransferase (ALT) normalization at 48 weeks.
• Initial HBV viral load was the only factor significantly associated with undetectable HBV DNA after 48 weeks on entecavir, with lower viral load predicting better response.
• At 96 weeks, 77.8% of participants experienced ALT normalization.
• The proportion with undetectable viral load fell to 16.7% at 96 weeks.
• 21.2% of patients experienced viral breakthrough by week 48, rising to 78.9% by week 96.
• Participants who achieved HBV DNA < 4 log copies/mL at 48 weeks maintained similar viral load and normal ALT through 96 weeks.
  

Based on these findings, the researchers concluded, "Entecavir monotherapy for 96 weeks was not efficacious for patients with lamivudine/adefovir-resistant HBV. The initial HBV DNA level was the only predictive factor for antiviral efficacy."
However, they continued, "patients who achieved a HBV DNA level of < 4 log10 copies/mL with a normal ALT level at 48 weeks should maintain, rather than stop, entecavir therapy."
Investigator affiliations: Department of Internal Medicine, National Health Insurance Corporation Ilsan Hospital; Department of Internal Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
10/4/11
Reference
MS Kwak, JW Choi, JS Lee, et al. Long-term efficacy of entecavir therapy in chronic hepatitis B patients with antiviral resistance to lamivudine and adefovir. Journal of Viral Hepatitis 18(10): e432-e438 (abstract). October 2011.

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2893.2011.01461.x/abstract
        





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StephenW

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恩替卡韦（博路定）与多药耐药的乙肝患者效果较差


详情
    分类：乙肝治疗
    周二公布，2011年10月04日00:00
    书面LIZ Highleyman



核苷类似物抗病毒药物恩替卡韦（博路定）是微创有效的抗乙型肝炎病毒（HBV）耐拉米夫定（Epivir - HBV）和阿德福韦（Hepsera）已制订，研究人员报告在2011年10月病毒性肝炎杂志。的病人，取得了良好的早期反应，但是，可以做得很好，如果他们留在恩替卡韦。

韩国研究人员观察的顺序使用拉米夫定和阿德福韦治疗后多药耐药的慢性乙型肝炎患者改用恩替卡韦的长期结果。

这项研究包括33例HBV感染者，表明病毒复制活跃的证据（HBV - DNA> 105拷贝/ ml）或与拉米夫定/阿德福韦2007年4月至2009年7月的序贯疗法治疗失败的历史。与会者分别用1.0毫克/天至少48周和96周恩替卡韦。

结果

    经历了48周的66.7％恩替卡韦治疗的患者丙氨酸转氨酶（ALT）正常化。
    24.2％，达到48周HBV - DNA检测不到。
    初步HBV病毒载量是显著降低病毒负荷预测更好的响应与恩替卡韦治疗48周后检测不到乙肝病毒DNA与唯一的因素。
    在96周，77.8％的参与者经验丰富的ALT正常化。
    病毒载量检测不到的比例下降到16.7％，在96周。
    21.2％的患者经历病毒突破48周，96周上升到78.9％。
    与会者达到48周HBV DNA <4日志拷贝/ ml保持类似的通过96周的病毒载量和ALT正常。

基于这些发现，研究人员得出结论，“恩替卡韦单药治疗96周，拉米夫定/阿德福韦耐药HBV患者是不灵验。最初的HBV DNA水平是预测抗病毒疗效的唯一因素。”

不过，他们继续说，“实现了与正常的ALT水平在48周的HBV DNA水平<4 log10拷贝/毫升的患者应保持，而不是停止，恩替卡韦治疗。”

调查背景：内科部，国民健康保险一山医院内科，一山白医院，仁济大学医学院，高阳，韩国。

11年10月4日

参考

MS郭某，JW财，JS李，等。恩替卡韦治疗慢性乙型肝炎患者抗病毒耐拉米夫定和阿德福韦的远期疗效。中国病毒性肝炎18（10）：e432 - e438（摘要）。 2011年10月。