The 104-Week Efficacy and Safety of Telbivudine-Based Optimization Strategy in Chronic Hepatitis B Patients: A Randomized, Controlled Study
The 104-Week Efficacy and Safety of Telbivudine-Based Optimization Strategy in Chronic Hepatitis B Patients: A Randomized, Controlled Study
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DOI：
10.1002/hep.26885
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发表时间：
2014-04-01
期刊：
影响因子：
13.5
通讯作者：
Hou, Jinlin
中科院分区：
文献类型：
--
作者：
Sun, Jian;Xie, Qing;Hou, Jinlin
基于路线图概念的优化策略有望改善抗病毒反应不佳患者的临床结果。本研究的目的是通过多中心、开放标签、随机对照研究来证明这一概念。总共有 606 名乙型肝炎 e 抗原 (HBeAg) 阳性、未接触过核苷（酸）的慢性乙型肝炎患者被随机分配到 Optimize 组或 Mono 组。 Optimize组中的患者接受替比夫定治疗24周，之后第24周时HBV DNA≥300拷贝/mL的次优反应者接受替比夫定加阿德福韦治疗直至第104周，而早期病毒学反应者则继续替比夫定单药治疗。单药组患者接受替比夫定单药治疗。如果出现病毒突破，所有接受替比夫定单药治疗的患者均需加用阿德福韦。优化组中 68% (204/300) 的患者由于反应欠佳而添加了阿德福韦。在第 104 周，与 Mono 组相比，Optimize 组中有更多患者获得了 HBV DNA
An optimization strategy based on the Roadmap concept is supposed to improve the clinical outcomes of patients with suboptimal antiviral response. The aim of this study was to prove the concept with a multicenter, open-label, randomized, controlled study. In all, 606 hepatitis B e antigen (HBeAg)-positive, nucleos(t)ide-naive chronic hepatitis B patients were randomized to the Optimize or Mono group. Patients in the Optimize group were treated with telbivudine for 24 weeks, after which those suboptimal responders with HBV DNA >= 300 copies/mL at week 24 received telbivudine plus adefovir until week 104, while the early virological responders continued telbivudine monotherapy. Patients in theMono group received telbivudine monotherapy. All patients with telbivudine monotherapy had adefovir added if viral breakthrough developed. Sixty-eight percent (204/300) of patients in theOptimize group had adefovir added due to suboptimal response. At week 104, compared to theMono group, more patients in the Optimize group achieved HBV DNA