Bae Suk Hyang, Baek Yang Hyun, Lee Sung Wook, Han Sang Young
Department of Gastroenterology, Dong-A University College of Medicine, Busan, Korea.
Korean J Gastroenterol. 2010 Dec;56(6):365-72. doi: 10.4166/kjg.2010.56.6.365.
BACKGROUND/AIMS: clevudine is a potent antiviral agent that has demonstrated efficacy in patients with chronic hepatitis B. This study compared the efficacy of clevudine (C), entecavir (E) and lamivudine (L) in treatment-naive patient with HBeAg-positive chronic hepatitis B.
a total of 146 treatment-naive patients with HBeAg-positive chronic hepatitis B received clevudine, entecavir or lamivudine. C group (n=39) received 30 mg of clevudine, E group (n=39) received 0.5 mg of entecavir and L group (n=68) received 100 mg of lamivudine once a day for more than 48 weeks. The efficacy analysis estimated the mean changes of the HBV DNA levels as a virologic response, the normalization of the ALT levels (less than 35 IU/L) as a biochemical response and loss of HBeAg or seroconversion as a serologic response. The serum HBV DNA level was quantified by hybrid capture and real-time PCR assay.
before the administration of clevudine, entecavir and lamivudine, the mean HBV DNA and ALT levels and the gender and age were well balanced among the three groups (p>0.05). For the virologic response at 48 weeks, the mean changes of the HBV DNA levels from baseline of the C, E and L groups were -3.8+/-2.2, -4.5+/-1.9 and -2.5+/-2.1 log copies/mL. C and E group showed superior antiviral activity compared to that of L group (p<0.0001), but no significant differences in antiviral response were noted between C and E groups. For the biochemical response at 48 weeks, the normalization of the ALT levels (less than 35 IU/L) among the C, E and L groups was 82%, 74% and 71%, respectively (p=0.46). The rates of undetectable serum HBV DNA (less than 300 copies/mL) of the C, E and L groups were 39%, 69% and 27%, respectively (p<0.0001). For the serologic response at 48 weeks, the loss of HBeAg was 13%, 31% and 24% and the seroconversion was 10%, 23% and 17%, respectively. There was no difference of efficacy among the three groups regarding ALT normalization or serologic response (p>0.05). Viral breakthrough in C group was noted at 24 weeks (5%) and 48 weeks (21%), but no biochemical breakthrough was noted. The elevation of the serum CK level was noted in only 1 patient of group C at 48 weeks (2.56%) after therapy. For the patients without or with liver cirrhosis (LC), C and E group showed superior antiviral activity compared to that of the L group, but the antiviral activity was more effective in non- LC group than LC group (p<0.0001 vs p=0.036).
clevudine therapy compared with lamivudine for 48 weeks showed significantly potent antiviral efficacy in treatment-naive patients with HBeAg-positive chronic hepatitis B, and especially in the non-LC patients. However, the antiviral efficacy of clevudine was similar to that of entecavir even though taking into account relatively short follow up period and retrospective study.
背景/目的：克来夫定是一种强效抗病毒药物，已在慢性乙型肝炎患者中显示出疗效。本研究比较了克来夫定（C）、恩替卡韦（E）和拉米夫定（L）在初治HBeAg阳性慢性乙型肝炎患者中的疗效。
共有146例初治HBeAg阳性慢性乙型肝炎患者接受克来夫定、恩替卡韦或拉米夫定治疗。C组（n = 39）接受30mg克来夫定，E组（n = 39）接受0.5mg恩替卡韦，L组（n = 68）接受100mg拉米夫定，每日一次，疗程超过48周。疗效分析评估了HBV DNA水平的平均变化作为病毒学反应，ALT水平正常化（低于35IU/L）作为生化反应，以及HBeAg消失或血清学转换作为血清学反应。血清HBV DNA水平通过杂交捕获和实时PCR测定进行定量。
在给予克来夫定、恩替卡韦和拉米夫定之前，三组患者的平均HBV DNA和ALT水平以及性别和年龄均衡良好（p>0.05）。在48周时的病毒学反应方面，C组、E组和L组HBV DNA水平相对于基线的平均变化分别为-3.8±2.2、-4.5±1.9和-2.5±2.1 log拷贝/mL。C组和E组显示出比L组更强的抗病毒活性（p<0.0001），但C组和E组之间在抗病毒反应上没有显著差异。在48周时的生化反应方面，C组、E组和L组中ALT水平正常化（低于35IU/L）的比例分别为82%、74%和71%（p = 0.46）。C组、E组和L组血清HBV DNA不可检测（低于300拷贝/mL）的比例分别为39%、69%和27%（p<0.0001）。在48周时的血清学反应方面，HBeAg消失率分别为13%、31%和24%，血清学转换率分别为10%、23%和17%。三组在ALT正常化或血清学反应方面的疗效没有差异（p>0.05）。C组在24周（5%）和48周（21%）时出现病毒突破，但未观察到生化突破。治疗后48周时，C组仅1例患者（2.56%）血清CK水平升高。对于无肝硬化或有肝硬化（LC）的患者，C组和E组显示出比L组更强的抗病毒活性，但在非LC组中的抗病毒活性比LC组更有效（p<0.0001对p = 0.036）。
与拉米夫定相比，克来夫定治疗48周在初治HBeAg阳性慢性乙型肝炎患者中显示出显著更强的抗病毒疗效，尤其是在非LC患者中。然而，尽管随访期相对较短且为回顾性研究，但克来夫定的抗病毒疗效与恩替卡韦相似。
