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首页> 外文期刊>Liver international : >Efficacy of switching to telbivudine in chronic hepatitis B patients treated previously with lamivudine.
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Efficacy of switching to telbivudine in chronic hepatitis B patients treated previously with lamivudine.

机译：在先前接受拉米夫定治疗的慢性乙型肝炎患者中，转用替比夫定的疗效。

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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 log(10) 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 log(10) 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 (
机译：背景：替比夫定在II和III期临床试验中显示出比拉米夫定更大的抗病毒抑制作用。目的：目前的IIIb期，随机，双盲，多中心全球临床试验评估了替比夫定转换对在拉米夫定治疗下表现出持续病毒血症的慢性乙型肝炎（CHB）患者的抗病毒疗效和安全性。方法：将接受拉米夫定治疗的持续性病毒血症[乙型肝炎病毒（HBV）DNA> 3 log（10）拷贝/ ml]的HBeAg阳性和HBeAg阴性的成年患者（N = 246）随机分组（12:52周）（1： 1）继续使用拉米夫定100毫克/天或改用替比夫定600毫克/天，持续1年。主要终点是在第24周时血清HBV DNA水平较基线水平降低。结果：在第24周时，替比夫定与基线水平相比血清HBV DNA水平平均降低幅度显着高于拉米夫定（-1.9 +/- 0.18 vs -0.9 + /-0.27 log（10）拷贝/ml;P<0.001）并维持1年。与接受52周治疗后继续使用拉米夫定的患者（20％）相比，转用替比夫定（5％）的患者治疗失败率显着降低（P <0.001）。在替比夫定组中，只有五名先前接受拉米夫定治疗> 24周的患者发生治疗失败，所有患者均与先前存在的拉米夫定耐药性突变有关。连续拉米夫定患者中的基因型耐药率高于接受拉米夫定暴露少于24周的患者转用替比夫定的患者。两种治疗均具有相似的安全性，耐受性良好。结论：在拉米夫定治疗下，早期（

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