治疗 12 个月时的病毒学应答可预测阿德福韦酯治疗的拉米夫定耐药慢性乙型肝炎患者的持续抗病毒疗效。

Virologic response at 12 months of treatment predicts sustained antiviral efficacy in patients with adefovir-treated Lamivudine-resistant chronic hepatitis B.

机构信息

Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.

出版信息

Gut Liver. 2010 Jun;4(2):212-8. doi: 10.5009/gnl.2010.4.2.212. Epub 2010 Jun 16.

DOI:10.5009/gnl.2010.4.2.212

PMID:20559524

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2886940/

Abstract

BACKGROUND/AIMS: The aim of our study was to define the potential role of virologic response at 12 months of treatment (VR12) in predicting subsequent virologic and clinical outcomes in adefovir (ADV)-treated lamivudine-resistant chronic hepatitis B.

METHODS

Two hundred and four patients with lamivudine-resistant chronic hepatitis B virus (HBV) treated with ADV monotherapy were included. Serum HBV DNA was quantified by real-time polymerase chain reactions. VR12 was defined as a HBV DNA level of less than 4 log(10) copies/mL after 12 months of ADV treatment.

RESULTS

VR12 was observed in 110 of the 204 patients (54%). The mean HBV DNA reductions from baseline after 12 months of ADV treatment were 3.8 and 1.9 log(10) copies/mL in patients with and without VR12, respectively (p<0.001). The hepatitis B "e" antigen (HBeAg) seroconversion rates in patients with and without VR12 were 32% and 14% at 12 months treatment, respectively (p=0.018), and 40% and 27% at 24 months of treatment (p=0.032). The genotypic mutation rates to ADV in patients with and without VR12 were 0% and 6% at 12 months of treatment, respectively (p=0.033), and 21% and 42% at 24 months (p=0.012). The rates of viral breakthrough in patients with and without VR12 were 0% and 7% at 12 months of treatment, respectively (p=0.072), and 9% and 25% at 24 months (p=0.006).

CONCLUSIONS

Patients without VR12 may need to switch to or add on other potent antiviral drugs in their medical regimens.

摘要

背景/目的：本研究旨在确定治疗 12 个月时的病毒学应答（VR12）在预测阿德福韦酯（ADV）治疗的拉米夫定耐药慢性乙型肝炎病毒（HBV）患者随后的病毒学和临床结局中的潜在作用。

方法

纳入 204 例接受 ADV 单药治疗的拉米夫定耐药慢性乙型肝炎患者。采用实时聚合酶链反应定量检测血清 HBV DNA。将 ADV 治疗 12 个月后 HBV DNA 水平小于 4 log10 拷贝/ml 定义为 VR12。

结果

204 例患者中有 110 例（54%）达到 VR12。ADV 治疗 12 个月后，分别有 VR12 和无 VR12 的患者 HBV DNA 平均降低 3.8 和 1.9 log10 拷贝/ml（p<0.001）。治疗 12 个月时，分别有 VR12 和无 VR12 的患者 HBeAg 血清学转换率为 32%和 14%（p=0.018），治疗 24 个月时为 40%和 27%（p=0.032）。治疗 12 个月时，分别有 VR12 和无 VR12 的患者 ADV 基因型耐药突变率为 0%和 6%（p=0.033），治疗 24 个月时为 21%和 42%（p=0.012）。治疗 12 个月时，分别有 VR12 和无 VR12 的患者病毒学突破率为 0%和 7%（p=0.072），治疗 24 个月时为 9%和 25%（p=0.006）。