Long-term treatment efficacy and safety of clevudine therapy in naïve patients with chronic hepatitis B.
Long-term treatment efficacy and safety of clevudine therapy in naïve patients with chronic hepatitis B.
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DOI：
10.5009/gnl.2012.6.4.486
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发表时间：
2012-10
期刊：
影响因子：
3.4
通讯作者：
Kim DG
中科院分区：
文献类型：
--
作者：
Choung BS;Kim IH;Jeon BJ;Lee S;Kim SH;Kim SW;Lee SO;Lee ST;Kim DG
曲马定（CLV）对慢性B型肝炎（CH B）病毒感染具有较强的抗病毒活性。研究了CLV治疗初治CHB患者的长期疗效和安全性。在这项回顾性研究中，研究了152例接受30 mg CLV每日一次至少12个月的韩国初治CHB患者。血清B病毒（HBV）DNA检测不到的累积率在12、24和36个月分别为65.8%、74.7%和74.7（<12 IU/mL）; 77.6%、86.2%和86.2%的血清丙氨酸氨基转移酶正常化（<40 IU/L）; B e抗原（HBeAg）丢失或血清转换分别为17.6%、23.5%和23.5%;病毒突破分别为6.6%、22.5%和30.0%。HBeAg阳性（p=0.010）、基线血清HBV DNA水平≥6 log 10 IU/mL（p=0.032）和第24周可检测到血清HBV DNA（≥12 IU/mL）（p=0.023）与病毒突破的发生独立相关。在随访期间，CLV诱导的肌病发生在5.9%的患者中。长期CLV治疗初治CHB患者的结果显示，抗病毒耐药和大量相关肌病的发生率很高。因此，我们建议CLV不应作为初治患者的一线治疗，因为有其他更有效、更安全的抗病毒药可用。
Clevudine (CLV) has potent antiviral activity against chronic hepatitis B (CHB) virus infection. The long-term efficacy and safety of CLV therapy in naïve patients with CHB were investigated. In this retrospective study, 152 naïve Korean patients with CHB who received 30 mg of CLV once daily for at least 12 months were investigated. The cumulative rates at months 12, 24, and 36, respectively, were 65.8%, 74.7%, and 74.7% for undetectable serum hepatitis B virus (HBV) DNA (<12 IU/mL); 77.6%, 86.2%, and 86.2% for normalization of serum alanine aminotransferase (<40 IU/L); 17.6%, 23.5%, and 23.5% for hepatitis B e antigen (HBeAg) loss or seroconversion; and 6.6%, 22.5%, and 30.0% for viral breakthrough. HBeAg positivity (p=0.010), baseline serum HBV DNA level ≥6 log10 IU/mL (p=0.032) and detectable serum HBV DNA (≥12 IU/mL) at week 24 (p=0.023) were independently associated with the development of viral breakthrough. During follow-up, CLV-induced myopathy developed in 5.9% of patients. The results of long-term CLV therapy for the treatment of naïve patients with CHB showed a high frequency of antiviral resistance and substantial associated myopathy. Therefore, we advise that CLV should not be used as a first-line treatment for naïve patients given the availability of other more potent, safer antiviral agents.
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