一项随机， III期比较替比夫定与拉米夫定在中国患者试验为

StephenW

Hepatology International
January 2014, Volume 8, Issue 1, pp 72-82
Two-year results of a randomized, phase III comparative trial of telbivudine versus lamivudine in Chinese patients

    Ji-Dong Jia,
    Jin-Lin Hou,
    You-Kuan Yin,
    De-Ming Tan,
    Daozhen Xu,
    Jun-Qi Niu,
    Xia-Qiu Zhou,
    Yu-Ming Wang,
    Li-Min Zhu,
    Cheng-Wei Chen,
    … show all 19


Abstract
Purpose

The burden of chronic hepatitis B infection is high in China, where prevalence exceeds 7 %. This was a randomized, double-blinded, phase III study of the efficacy and safety of telbivudine and lamivudine treatment at 104 weeks in Chinese patients with chronic hepatitis B.
Methods

Hepatitis B e antigen-positive (n = 290) and -negative (n = 42) adults with nucleoside analog–naïve compensated chronic hepatitis B were randomized to receive telbivudine 600 mg/day or lamivudine 100 mg/day for 104 weeks. The primary endpoint was reduction from baseline in serum hepatitis B virus (HBV) DNA at week 52. Week 104 analyses included HBV DNA reductions, undetectable HBV DNA (<300 copies/mL), ALT normalization, and e-antigen loss/seroconversion. Efficacy at week 104 was also assessed as a function of week 24 HBV DNA.
Results

In the intention-to-treat population (n = 332) at week 104, telbivudine was superior to lamivudine for reduction of HBV DNA [−5.48 vs. −4.00 log10 copies/mL; difference −1.49 log10 (95 % confidence interval −2.2, −0.8); p < 0.0001], for the proportion with undetectable HBV DNA (61.9 vs. 38.5 %; p < 0.0001), for ALT normalization (75.8 vs. 61.3 %; p = 0.0049), and for e-antigen loss (39.9 vs. 28.2 %; p = 0.0373). The cumulative probability of genotypic drug resistance was 15.4 % on telbivudine versus 23.6 % on lamivudine through week 104. Early virologic response at week 24 was associated with improved outcomes at week 104. Adverse events were similar to those seen in the GLOBE study.
Conclusions

Telbivudine is superior to lamivudine over 2 years of chronic hepatitis B treatment in Chinese patients.

StephenW

国际肝病
2014年1月，第8卷，第1期，页72-82
一项随机， III期比较替比夫定与拉米夫定在中国患者试验为期两年的结果

    贾继东，
    金麟后，
    你，观音，
    德明谭，
    道真旭，
    俊齐牛，
    夏秋舟，
    王宇明，
    李朱民，
    郑魏晨，
    ...显示所有19


摘要
目的

慢性B型肝炎感染的负担是高在中国，患病率超过7 ％ 。这是一项随机，双盲， III期临床研究替比夫定和拉米夫定治疗的疗效和安全性在104周中国慢性乙型肝炎
方法

乙肝e抗原阳性（ N = 290）和阴性（ 42例）成人核苷类似物初治的代偿性慢性乙型肝炎患者随机接受替比夫定600毫克/天或拉米夫定100 mg /天104周。主要终点是从基线降低血清乙肝病毒在第52周（ HBV）的DNA。第104周分析包括HBV-DNA下降，检测不到HBV DNA （ < 300拷贝/ ml ） ， ALT复常和e抗原损失/血清学转换。疗效在104周也评定为24周的HBV DNA的功能。
结果

在意向性治疗人群（n = 332 ）在104周，替比夫定优于拉米夫定降低HBV DNA [ -5.48 -4.00对比log10拷贝/毫升;差-1.49 log10的（ 95 ％可信区间-2.2 ， -0.8 ） ，P < 0.0001 ] ，用于检测不到HBV DNA （ 61.9对比38.5 ％的比例; P <0.0001） ，对于ALT复常（ 75.8对61.3 ％，P = 0.0049 ） ，而对于e抗原亏损（ 39.9对28.2 ％，P = 0.0373 ） 。基因型耐药的累积概率为15.4 ％，对替比夫定通过与104周23.6 ％的拉米夫定。在第24周早期病毒学应答是与改进的成果在本周104相关联。不良事件是相似，看到的GLOBE研究。
结论

替比夫定是优于拉米夫定2年以上的慢性乙肝治疗的中国患者。