Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
J Viral Hepat. 2013 Apr;20 Suppl 1:3-8. doi: 10.1111/jvh.12058.
Telbivudine, one of the oral anti-hepatitis B virus (HBV) nucleoside analogues, has been used for more than 5 years to treat HBeAg-positive and -negative chronic hepatitis B (CHB) patients. This includes not only global Phase II and III trials, but also Chinese Phase III trials and several real-world clinical practice studies from China. The present review will first focus on 1-, 2- and 3-year data of telbivudine therapy on HBV DNA suppression, alanine aminotransferase (ALT) normalization, hepatitis B e antigen (HBeAg) seroconversion, viral resistance and safety in HBeAg-positive and -negative CHB patients. Second, telbivudine treatment predictors, including HBV DNA undetectability, ALT level and other immune-related markers at 12 and 24 weeks will be summarized to optimize therapy. Besides several retrospective studies, the Chinese EFFORT prospective study adapted from telbivudine virological response at 24 weeks has shown very promising results. Finally, the Chinese experience of using telbivudine in the second and third trimesters of pregnancy to prevent perinatal transmission of HBV infection will be touched on citing the latest studies.
替比夫定是一种口服抗乙型肝炎病毒 (HBV) 核苷类似物，已用于治疗 HBeAg 阳性和阴性慢性乙型肝炎 (CHB) 患者超过 5 年。这不仅包括全球的 II 期和 III 期临床试验，还包括中国的 III 期临床试验和来自中国的几项真实世界临床实践研究。本综述将首先重点关注替比夫定治疗 1、2 和 3 年对 HBV DNA 抑制、丙氨酸氨基转移酶 (ALT) 正常化、乙型肝炎 e 抗原 (HBeAg) 血清学转换、病毒耐药性和 HBeAg 阳性和阴性 CHB 患者安全性的影响。其次，将总结替比夫定治疗的预测因素，包括 12 周和 24 周时 HBV DNA 不可检测、ALT 水平和其他免疫相关标志物，以优化治疗。除了几项回顾性研究外，中国 EFFORT 前瞻性研究根据 24 周时的替比夫定病毒学应答进行了改编，结果非常有前景。最后，将引用最新的研究，讨论中国在妊娠第二和第三 trimester 使用替比夫定预防乙型肝炎病毒感染的围产期传播的经验。
