Inje University Ilsanpaik Hospital, Goyang, Korea.
Intervirology. 2010;53(2):83-6. doi: 10.1159/000264197. Epub 2009 Dec 3.
Clevudine has demonstrated antiviral potency in the treatment of naïve chronic hepatitis B patients in pivotal studies. The objectives of this study were to evaluate the safety and efficacy of a 1-year treatment with clevudine in chronic hepatitis B patients.
This is a post-marketing surveillance using case report forms which were submitted to the health authorities.
Analysis of individual data showed that hepatitis B virus (HBV) DNA after a 1-year treatment was <141,500 copies/ml in 96% of hepatitis B e antigen (HBeAg)-positive and 100% of HBeAg-negative patients. The proportion of patients with HBV DNA <2,000 copies/ml after a 1-year treatment was 74%: 71% of HBeAg-positive and 93% of HBeAg-negative patients. Most of the patients with HBV DNA below the detection limit with each assay at week 24 showed sustained viral suppression up to week 48. The proportion of patients who showed normal alanine aminotransferase at week 48 was 86% in HBeAg-positive patients and 87% in HBeAg-negative patients. The rates of HBeAg-loss were 21%. Two patients showed viral breakthrough during treatment.
Clevudine monotherapy demonstrates potent antiviral activity as well as biochemical and serological response with a 0.7% rate of viral breakthrough in naïve chronic hepatitis B patients.
在关键性研究中，克来夫定已显示出在治疗初治慢性乙型肝炎患者方面的抗病毒效力。本研究的目的是评估克来夫定治疗慢性乙型肝炎患者 1 年的安全性和疗效。
这是一项使用病例报告表进行的上市后监测，这些病例报告表已提交给卫生当局。
对个体数据的分析表明，在治疗 1 年后，96%的乙型肝炎 e 抗原（HBeAg）阳性和 100%的 HBeAg 阴性患者的乙型肝炎病毒（HBV）DNA<141,500 拷贝/ml。在治疗 1 年后 HBV DNA<2,000 拷贝/ml 的患者比例为 74%：71%的 HBeAg 阳性和 93%的 HBeAg 阴性患者。大多数在第 24 周每个检测都低于检测下限的患者在第 48 周时仍保持病毒抑制。在 HBeAg 阳性患者中，有 86%的患者在第 48 周时丙氨酸氨基转移酶正常，在 HBeAg 阴性患者中，有 87%的患者丙氨酸氨基转移酶正常。HBeAg 丢失率为 21%。有 2 例患者在治疗过程中出现病毒突破。
克来夫定单药治疗初治慢性乙型肝炎患者具有很强的抗病毒活性，以及生化和血清学应答，病毒突破率为 0.7%。
