Efficacy and safety of tenofovir-based rescue therapy for chronic hepatitis B patients with previous nucleo(s/t)ide treatment failure.

Efficacy and safety of tenofovir-based rescue therapy for chronic hepatitis B patients with previous nucleo(s/t)ide treatment failure.
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DOI:
10.5009/gnl.2014.8.1.64
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发表时间:
2014-01
期刊:
影响因子:
3.4
通讯作者:
Kim JH
Kim JH
中科院分区:
医学3区
文献类型:
--
作者:
Lee CI;Kwon SY;Kim JH;Choe WH;Lee CH;Yoon EL;Yeon JE;Byun KS;Kim YS;Kim JH

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我们研究了富马酸替诺福韦酯(TDF)为基础的治疗慢性B型肝炎(CH B)患者既往抗病毒治疗失败的疗效和安全性。纳入了17例在序贯抗病毒治疗期间未能达到病毒学应答的患者。患者接受TDF单药治疗(4例)或TDF和拉米夫定联合治疗(13例),中位治疗时间为42个月。检测B型肝炎病毒(HBV)DNA和B型肝炎e抗原(HBeAg),并监测肾功能。在TDF治疗前,检测到180个M、204个I/V/S、181个T/V、236个T和184个L突变。TDF治疗后,中位HBV DNA水平在12个月和24个月时分别从4.6 log 10 IU/mL降至2.0 log 10 IU/mL和1.6 log 10 IU/mL。治疗12、24和48个月后,HBV DNA检测不到(≤20 IU/mL)的患者比例分别为14.3%、41.7%和100%。2例患者HBeAg丢失。5名未服药的患者出现病毒突破。未观察到肾功能的显著变化。基于TDF的补救治疗可有效降低HBV DNA水平,对于既往抗病毒治疗失败的CHB患者是安全的。患者坚持服药与病毒反弹有关。
We investigated the efficacy and safety of tenofovir disoproxil fumarate (TDF)-based treatment in chronic hepatitis B (CHB) patients who failed previous antiviral therapies. Seventeen patients who failed to achieve virological responses during sequential antiviral treatments were included. The patients were treated with TDF monotherapy (four patients) or a combination of TDF and lamivudine (13 patients) for a median of 42 months. Hepatitis B virus (HBV) DNA and hepatitis B e antigen (HBeAg) were measured, and renal function was also monitored. Prior to TDF therapy, 180 M, 204 I/V/S, 181 T/V, 236 T, and 184 L mutations were detected. After TDF therapy, the median HBV DNA level decreased from 4.6 log10 IU/mL to 2.0 log10 IU/mL and to 1.6 log10 IU/mL at 12 and 24 months, respectively. HBV DNA became undetectable (≤20 IU/mL) in 14.3%, 41.7%, and 100% of patients after 12, 24, and 48 months of treatment, respectively. HBeAg loss was observed in two patients. Viral breakthrough occurred in five patients who had skipped their medication. No significant changes in renal function were observed. TDF-based rescue treatment is effective in reducing HBV DNA levels and is safe for patients with CHB who failed prior antiviral treatments. Patients' adherence to medication is related to viral rebound.
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