Moon Young Myoung, Hwang Seong Gyu, Kim Boo Sung, Rim Kyu Sung, Cho Mong, Kim Dong Joon, Han Joon Yeol, Kim Young Seok, Choi Ho Soon, Ahn Sang Hoon
Department of Internal Medicine, Kwandong University College of Medicine, Gangneung, Korea.
Korean J Hepatol. 2007 Dec;13(4):503-12. doi: 10.3350/kjhep.2007.13.4.503.
Telbivudine is an L-nucleoside analogue with potent antiviral activity against hepatitis B virus (HBV). Clinical trials have shown that telbivudine is more potent than lamivudine for suppressing virus.
A total 101 Korean patients among 1,367 patients who participated in the phase III GLOBE trial were randomized in this study. All 101 HBeAg positive or HBeAg negative patients were assigned to treatment with 600 mg of telbivudine or 100 mg of lamivudine once daily. The primary efficacy endpoint (the "therapeutic response") was defined as suppression of the serum HBV DNA to less than 5 log10 copies/mL coupled with either normalization of the serum alanine aminotransferase level or loss of HBeAg. The secondary endpoints included the histologic response, serum HBV DNA reduction, serum alanine aminotransferase normalization and HBeAg loss for the HBeAg positive patients. This analysis includes the data collected at 52 weeks of treatment.
Fifty four of 101 patients were assigned to telbivudine treatment and 47 patients were assigned to lamivudine treatment. At week 52, significantly more patients who were treated with telbivudine than those treated with lamivudine had a therapeutic response (83% vs 62%, respectively, P=0.017), their mean serum HBV DNA levels were more reduced (6.6 vs 5.6 log10 copies/mL, respectively, P=0.027), and they more often achieved PCR-undetectable levels of serum HBV DNA (74% vs 34%, P<0.0001). No virologic resistance to telbivudine was detected (0% vs 18%, respectively, P=0.001). Telbivudine was well tolerated and it had a safety profile comparable to lamivudine.
Patients treated with telbivudine achieved earlier and more profound viral suppression than those treated with lamivudine.
替比夫定是一种L核苷类似物，对乙型肝炎病毒（HBV）具有强大的抗病毒活性。临床试验表明，替比夫定在抑制病毒方面比拉米夫定更有效。
在参与III期GLOBE试验的1367例患者中，共有101例韩国患者被随机纳入本研究。所有101例HBeAg阳性或HBeAg阴性患者被分配接受每日一次600mg替比夫定或100mg拉米夫定治疗。主要疗效终点（“治疗反应”）定义为血清HBV DNA抑制至低于5 log10拷贝/mL，同时血清丙氨酸氨基转移酶水平正常化或HBeAg消失。次要终点包括HBeAg阳性患者的组织学反应、血清HBV DNA降低、血清丙氨酸氨基转移酶正常化和HBeAg消失。该分析包括治疗52周时收集的数据。
101例患者中，54例被分配接受替比夫定治疗，47例被分配接受拉米夫定治疗。在第52周时，接受替比夫定治疗的患者出现治疗反应的比例显著高于接受拉米夫定治疗的患者（分别为83%和62%，P=0.017），他们的平均血清HBV DNA水平降低得更多（分别为6.6和5.6 log10拷贝/mL，P=0.027），并且他们更常达到血清HBV DNA PCR检测不到的水平（74%对34%，P<0.0001）。未检测到对替比夫定的病毒耐药性（分别为0%和18%，P=0.001）。替比夫定耐受性良好，其安全性与拉米夫定相当。
与接受拉米夫定治疗的患者相比，接受替比夫定治疗的患者实现了更早、更深度的病毒抑制。
