Gwak Geum-Youn, Eo Sung June, Shin Su Rin, Choi Moon Seok, Lee Joon Hyoek, Koh Kwang Cheol, Paik Seung Woon, Yoo Byung Chul
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Department of Medicine, Kangnam Sacred Heart Hospital, Hallym University, Seoul, South Korea.
Hepatol Int. 2013 Mar;7(1):106-10. doi: 10.1007/s12072-012-9368-1. Epub 2012 Apr 24.
This study was undertaken to compare the efficacy, safety, and resistance profile of clevudine (CLV) and entecavir (ETV) following a 2-year treatment period.
One hundred and eight Korean patients from the prior 48-week study were followed with continuous therapy for up to 2 years and monitored for hepatitis B virus (HBV) DNA levels, HBeAg seroconversion, serum ALT, emergence of drug-resistant mutant HBV, and drug-related adverse events.
A complete virological response during the 2-year treatment period occurred in 68.0 % in the CLV group and in 84.5 % in the ETV group (p = 0.043). The cumulative percentage of patients with sustained virological responses at 2 years was 54.0 and 77.6 % in the CLV and ETV group, respectively (p = 0.010). Virological breakthrough occurred in 12 patients in the CLV group; however, there were none in the ETV group (p < 0.001). HBeAg seroconversion rates were not different between the two groups. In patients who maintained sustained virological responses at 2 years, the mean reduction in HBsAg titer was -0.24 and -0.06 log IU/ml in the CLV and ETV group, respectively (p > 0.05). Clinical myopathy occurred in seven patients in the CLV group; however, this was not observed in the ETV group (p = 0.004).
ETV was associated with a significantly higher virological response rate than CLV at 2 years. ETV was superior to CLV in terms of the drug resistance profile and the development of clinical myopathy. Further studies to see whether the unique characteristic of CLV to reduce HBsAg titer is associated with the removal of ccc-DNA from hepatocytes and the remission of the disease are needed.
本研究旨在比较2年治疗期后克来夫定（CLV）和恩替卡韦（ETV）的疗效、安全性和耐药情况。
对先前48周研究中的108例韩国患者进行持续治疗长达2年，并监测乙肝病毒（HBV）DNA水平、HBeAg血清学转换、血清ALT、耐药性突变型HBV的出现以及药物相关不良事件。
CLV组在2年治疗期内的完全病毒学应答率为68.0%，ETV组为84.5%（p = 0.043）。CLV组和ETV组在2年时持续病毒学应答患者的累积百分比分别为54.0%和77.6%（p = 0.010）。CLV组有12例患者发生病毒学突破；然而，ETV组无此情况（p < 0.001）。两组间HBeAg血清学转换率无差异。在2年时维持持续病毒学应答的患者中，CLV组和ETV组HBsAg滴度的平均下降分别为-0.24和-0.06 log IU/ml（p > 0.05）。CLV组有7例患者发生临床肌病；然而，ETV组未观察到（p = 0.004）。
2年时ETV的病毒学应答率显著高于CLV。在耐药情况和临床肌病发生方面，ETV优于CLV。需要进一步研究以确定CLV降低HBsAg滴度的独特特性是否与从肝细胞中清除ccc-DNA及疾病缓解相关。
