Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China.
Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Clin Microbiol Infect. 2016 Mar;22(3):287.e1-9. doi: 10.1016/j.cmi.2015.10.024. Epub 2015 Nov 5.
There are few studies directly comparing the efficacy and safety of telbivudine and entecavir. The present prospective cohort study aimed to evaluate the long-term efficacy and safety of these compounds in 196 hepatitis B e antigen (HBeAg)-positive patients with chronic hepatitis B for a median follow-up period of 172 weeks; 97 were treated with telbivudine and 99 were treated with entecavir. Patients showing suboptimal responses could also take adefovir at 24-48 weeks and all patients with viral breakthrough were started on adefovir. The 240-week cumulative proportions of patients showing undetectable hepatitis B DNA levels and serum alanine transaminase (ALT) normalization were similar in the two study groups. Viral breakthrough developed in 14% of the telbivudine group and in 2% of the entecavir group (p 0.002). Interestingly, the cumulative proportions of patients treated with entecavir and telbivudine showing HBeAg seroconversion were 12% versus 21% at 48 weeks (p 0.041), 15% versus 38% at 96 weeks (p 0.001), 24% versus 50% at 144 weeks (p 0.001), 33% versus 53% at 192 weeks (p 0.004) and 36% versus 53% at 240 weeks (p 0.005), respectively. Patients treated with telbivudine were therefore significantly more likely to show HBeAg seroconversion than those receiving entecavir and similar results were observed in study sub-groups matched for age, serum ALT, and HBV DNA levels. A safety analysis identified no differences between grade 3/4 creatine kinase elevations in the study groups and only telbivudine was associated with improved kidney function.
目前尚缺乏比较替比夫定和恩替卡韦疗效和安全性的直接研究。本前瞻性队列研究旨在评估替比夫定和恩替卡韦治疗 196 例慢性乙型肝炎 e 抗原（HBeAg）阳性患者的长期疗效和安全性，中位随访时间为 172 周；其中 97 例患者接受替比夫定治疗，99 例患者接受恩替卡韦治疗。对于应答不佳的患者，在 24-48 周时可加用阿德福韦酯，所有病毒突破的患者均开始使用阿德福韦酯。两组患者在 240 周时，乙型肝炎病毒 DNA 水平和血清丙氨酸氨基转移酶（ALT）复常的患者累积比例相似。替比夫定组有 14%的患者发生病毒突破，恩替卡韦组有 2%的患者发生病毒突破（p 0.002）。有趣的是，在 48 周时，恩替卡韦和替比夫定组 HBeAg 血清学转换的患者累积比例分别为 12%和 21%（p 0.041），96 周时分别为 15%和 38%（p 0.001），144 周时分别为 24%和 50%（p 0.001），192 周时分别为 33%和 53%（p 0.004），240 周时分别为 36%和 53%（p 0.005）。与恩替卡韦组相比，接受替比夫定治疗的患者 HBeAg 血清学转换的可能性显著更高，并且在年龄、血清 ALT 和 HBV DNA 水平相匹配的研究亚组中观察到了相似的结果。安全性分析显示两组患者 3/4 级肌酸激酶升高的发生率无差异，只有替比夫定与肾功能改善相关。
