A comparison of 48-week treatment efficacy between clevudine and entecavir in treatment-na⟨ve patients with chronic hepatitis B
A comparison of 48-week treatment efficacy between clevudine and entecavir in treatment-na⟨ve patients with chronic hepatitis B
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DOI：
10.1007/s12072-010-9238-7
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发表时间：
2011-06-01
影响因子：
6.6
通讯作者：
Paik, Seung Woon
中科院分区：
文献类型：
--
作者：
Shin, Su Rin;Yoo, Byung Chul;Paik, Seung Woon
目前，在韩国，阿曲布丁和恩替卡韦可用作抗慢性B型肝炎（CH B）的抗病毒药物。我们的目的是比较克来夫定和恩替卡韦治疗的疗效。对接受克来夫定30 mg或恩替卡韦0.5 mg/d治疗的初治CHB患者进行分析。观察克来夫定组59例和恩替卡韦组61例患者治疗48周时的HBV DNA平均下降率、病毒学完全应答（cVR，实时荧光PCR检测不到HBV DNA）、生化应答（ALT恢复至正常水平）和HBeAg血清转换率。克拉夫定组和恩替卡韦组的平均HBV DNA较基线下降幅度相似，HBeAg阳性患者为-6.4对-6.8 log（10）拷贝/mL（p = 0.417），HBeAg阴性患者为-6.9对-7.0 log（10）拷贝/mL（p = 0.640）。两组达到cVR的患者比例无差异，HBeAg阳性患者为53% vs 55%（p = 1.000），HBeAg阴性患者为100% vs 95%（p = 0.452）。两组的生化应答率和HBeAg血清转换率也相似。克来夫定组有2例（3.4%）患者经直接测序分析显示病毒学突破，出现rtM 204 I突变。克来夫定组有2例（3.4%）患者发生临床肌病，48周内克来夫定组和恩替卡韦组病毒载量的平均下降相似。然而，病毒学突破和显著的肌病仅在克来夫定治疗的患者中观察到。因此，应更多地关注接受克来夫定的患者。
Clevudine and entecavir are currently available in Korea as antiviral drugs against chronic hepatitis B (CHB). We aimed to compare the efficacy of clevudine and entecavir therapy.Treatment-na < ve CHB patients who received 30 mg of clevudine or 0.5 mg of entecavir a day were analyzed. Mean reduction of hepatitis B virus (HBV) DNA levels, complete virological response (cVR, undetectable HBV DNA by real-time PCR), biochemical response (recovery to normal ALT level), and hepatitis B e antigen (HBeAg) seroconversion rate at the 48th week of treatment were assessed.A number of 59 patients in clevudine group and 61 patients in entecavir group were included. Mean HBV DNA reductions from baseline were similar in the clevudine and entecavir groups, -6.4 versus -6.8 log(10) copies/mL in HBeAg-positive (p = 0.417) and -6.9 versus -7.0 log(10) copies/mL in HBeAg-negative patients (p = 0.640). The proportion of patients who achieved cVR was not different between the two groups, 53 versus 55% in HBeAg-positive (p = 1.000) and 100 versus 95% in HBeAg-negative patients (p = 0.452). Biochemical response rates and HBeAg seroconversion rates were also similar in both the groups. Two (3.4%) patients in clevudine group showed virologic breakthrough with rtM204I mutation using direct sequencing analysis. Clinical myopathy occurred in two (3.4%) patients in clevudine group.Mean reduction of viral loads was similar between clevudine and entecavir groups during 48 weeks. However, virologic breakthrough and significant myopathy were noted only in clevudine-treated patients. Therefore, more attention should be paid to patients receiving clevudine.