Three Years of Continuous Entecavir Therapy in Treatment-Naive Chronic Hepatitis B Patients: VIRAL Suppression, Viral Resistance, and Clinical Safety
Three Years of Continuous Entecavir Therapy in Treatment-Naive Chronic Hepatitis B Patients: VIRAL Suppression, Viral Resistance, and Clinical Safety
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DOI：
10.1038/ajg.2011.45
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发表时间：
2011-07-01
影响因子：
9.8
通讯作者：
Lai, Ching-Lung
中科院分区：
文献类型：
--
作者：
Yuen, Man-Fung;Seto, Wai-Kay;Lai, Ching-Lung
目的：研究恩替卡韦连续治疗3年的抗病毒效果、病毒耐药率和临床安全性。方法：我们测定了3年时HBVDNA(分别为8个对数拷贝数/毫升，未检测到HBVDNA)的累积率。3年恩替卡韦耐药变异率为1.2%。3例患者病毒学突破，1例出现耐药性，1例HBeAg血清转换，1例HBVDNA下降。两名基线rt204I突变的患者对恩替卡韦治疗有反应。没有发生严重的不良事件。结论：使用非常敏感的HBVDNA和病毒耐药性检测方法，恩替卡韦治疗初治的CHB患者连续治疗3年，90%的HBVDNA检测不到，而出现恩替卡韦耐药突变的可能性只有1.2%。
OBJECTIVES: We aimed to determine the antiviral potency, viral resistance rate, and clinical safety of 3-year continuous entecavir treatment.METHODS: We determined the cumulative rates of undetectable hepatitis B virus DNA (HBV DNA) levels (= 8 logs copies/ml, respectively, had undetectable HBV DNA at year 3. The cumulative rate of entecavir-resistant mutations was 1.2% at year 3. Three patients experienced virologic breakthrough, one with resistance development, one with subsequent HBeAg seroconversion, and one with subsequent decline in HBV DNA. Two patients with baseline rt204I mutations responded to entecavir treatment. There were no serious adverse events.CONCLUSIONS: Using very sensitive HBV DNA and viral resistance assays, continuous entecavir treatment for treatment-naive CHB patients for 3 years was associated with >90% chance of undetectable HBV DNA and only 1.2% chance of emergence of entecavir-resistant mutations.