Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.
Clin Mol Hepatol. 2017 Dec;23(4):331-339. doi: 10.3350/cmh.2016.0040. Epub 2017 Sep 26.
BACKGROUND/AIMS: Long-term data on antiviral therapy in Korean patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) are limited. This study evaluated the efficacy and safety of entecavir (ETV) and lamivudine (LAM) over 240 weeks.
Treatment-naive patients with HBeAg-negative CHB were randomized to receive ETV 0.5 mg/day or LAM 100 mg/day during the 96 week double-blind phase, followed by open-label treatment through week 240. The primary endpoint was the proportion of patients with virologic response (VR; hepatitis B virus [HBV] DNA<300 copies/mL) at week 24. Secondary objectives included alanine aminotransferase (ALT) normalization and emergence of ETV resistance (week 96), VR and log reduction in HBV DNA levels (week 240), and safety evaluation.
In total, 120 patients (>16 years old) were included (ETV, n=56; LAM, n=64). Baseline characteristics were comparable between the two groups. A significantly higher proportion of ETV-treated patients achieved VR compared to LAM at week 24 (92.9% vs. 67.2%, P=0.0006), week 96 (94.6% vs. 48.4%, P<0.0001), and week 240 (95.0% vs. 47.6%, P<0.0001). At week 96, ALT normalization was observed in 87.5% and 51.6% of ETV and LAM patients, respectively (P<0.0001). Virologic breakthrough occurred in one patient (1.8%) receiving ETV and 26 patients (42.6%) receiving LAM (P<0.0001) up to week 96. Emergence of resistance to ETV was not detected. The incidence of serious adverse events was low and unrelated to the study medications.
Long-term ETV treatment was superior to LAM, with a significantly higher proportion of patients achieving VR. Both treatments were well tolerated.
背景/目的：关于乙肝 e 抗原（HBeAg）阴性慢性乙型肝炎（CHB）韩国患者抗病毒治疗的长期数据有限。本研究评估了恩替卡韦（ETV）和拉米夫定（LAM）治疗 240 周的疗效和安全性。
未经治疗的 HBeAg 阴性 CHB 患者在 96 周双盲期随机接受 ETV 0.5 mg/天或 LAM 100 mg/天治疗，然后进入第 240 周的开放标签治疗。主要终点是第 24 周时病毒学应答（VR；HBV DNA<300 拷贝/mL）的患者比例。次要目标包括丙氨酸氨基转移酶（ALT）正常化和 ETV 耐药（第 96 周）、VR 和 HBV DNA 水平的对数降低（第 240 周）以及安全性评估。
共纳入 120 例（>16 岁）患者（ETV，n=56；LAM，n=64）。两组的基线特征相似。与 LAM 相比，接受 ETV 治疗的患者在第 24 周（92.9% vs. 67.2%，P=0.0006）、第 96 周（94.6% vs. 48.4%，P<0.0001）和第 240 周（95.0% vs. 47.6%，P<0.0001）时的 VR 比例更高。第 96 周时，分别有 87.5%和 51.6%的 ETV 和 LAM 患者的 ALT 正常化（P<0.0001）。在第 96 周时，1 例（1.8%）接受 ETV 治疗的患者和 26 例（42.6%）接受 LAM 治疗的患者发生病毒学突破（P<0.0001）。未检测到对 ETV 的耐药性。严重不良事件的发生率较低，与研究药物无关。
长期 ETV 治疗优于 LAM，VR 的患者比例显著更高。两种治疗方法均具有良好的耐受性。
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