Department of Internal Medicine, Dankook University College of Medicine, Cheonan 330-715, South Korea.
World J Gastroenterol. 2012 Dec 21;18(47):6943-50. doi: 10.3748/wjg.v18.i47.6943.
To evaluate the treatment outcomes of clevudine compared with entecavir in antiviral-naive patients with chronic hepatitis B (CHB).
We retrospectively analyzed the clinical data of CHB patients treated with clevudine 30 mg/d and compared their clinical outcomes with patients treated with entecavir 0.5 mg/d. The biochemical response, as assessed by serum alanine aminotransferase (ALT) activity, virologic response, as assessed by serum hepatitis B virus DNA (HBV DNA) titer, serologic response, as assessed by hepatitis B e antigen (HBeAg) status, and virologic breakthrough with genotypic mutations were assessed.
Two-hundred and fifty-four patients [clevudine (n = 118) vs entecavir (n = 136)] were enrolled. In clevudine-treated patients, the cumulative rates of serum ALT normalization were 83.9% at week 48 and 91.5% at week 96 (80.9% and 91.2% in the entecavir group, respectively), the mean titer changes in serum HBV DNA were -6.03 and -6.55 log(10) copies/mL (-6.35 and -6.86 log(10) copies/mL, respectively, in the entecavir group), and the cumulative non-detection rates of serum HBV DNA were 72.6% and 83.1% (74.4% and 83.8%, respectively, in the entecavir group). These results were similar to those of entecavir-treated patients. The cumulative rates of HBeAg seroconversion were 21.8% at week 48 and 25.0% at week 96 in patients treated with clevudine, which was similar to patients treated with entecavir (22.8% and 27.7%, respectively). The virologic breakthrough in the clevudine group occurred in 9 (7.6%) patients at weeks 48 and 15 (12.7%) patients at week 96, which primarily corresponded to genotypic mutations of rtM204I and/or rtL180M. There was no virologic breakthrough in the entecavir group.
In antiviral-naive CHB patients, long-term treatment outcomes of clevudine were not inferior to those of entecavir, except for virologic breakthrough.
评估拉米夫定与恩替卡韦在初治慢性乙型肝炎（CHB）患者中的治疗效果。
我们回顾性分析了接受拉米夫定 30mg/d 治疗的 CHB 患者的临床资料，并将其临床结局与接受恩替卡韦 0.5mg/d 治疗的患者进行了比较。通过血清丙氨酸氨基转移酶（ALT）活性评估生化应答，通过血清乙型肝炎病毒 DNA（HBV DNA）滴度评估病毒学应答，通过乙型肝炎 e 抗原（HBeAg）状态评估血清学应答，通过基因分型突变评估病毒学突破。
共纳入 254 例患者[拉米夫定（n=118）vs 恩替卡韦（n=136）]。在拉米夫定治疗组中，血清 ALT 正常化的累积率在第 48 周时为 83.9%，在第 96 周时为 91.5%（恩替卡韦组分别为 80.9%和 91.2%），血清 HBV DNA 平均滴度变化分别为-6.03 和-6.55log10 拷贝/ml（恩替卡韦组分别为-6.35 和-6.86log10 拷贝/ml），血清 HBV DNA 检测阴性的累积率分别为 72.6%和 83.1%（恩替卡韦组分别为 74.4%和 83.8%）。这些结果与恩替卡韦治疗组相似。拉米夫定治疗组患者在第 48 周和第 96 周时 HBeAg 血清学转换的累积率分别为 21.8%和 25.0%，与恩替卡韦治疗组相似（分别为 22.8%和 27.7%）。拉米夫定组有 9 例（7.6%）患者在第 48 周和 15 例（12.7%）患者在第 96 周发生病毒学突破，主要对应 rtM204I 和/或 rtL180M 基因型突变。恩替卡韦组未发生病毒学突破。
在初治 CHB 患者中，拉米夫定的长期治疗效果并不逊于恩替卡韦，除了病毒学突破。
