TAF治疗ETV经治的低病毒血症慢性乙型肝炎患者疗效研究*

doi:10.3969/j.issn.1672-5069.2024.04.007

摘要/Abstract

摘要： 目的观察应用丙酚替诺福韦(TAF)继续治疗经恩替卡韦(ETV)治疗的低病毒血症(LLV)的慢性乙型肝炎(CHB)患者的疗效。方法 2018年1月～2022年12月我院收治的CHB患者101例,纳入患者均接受ETV治疗至少48周,经检测符合LLV定义标准,被随机分为两组,其中50例继续应用ETV治疗48周,另51例换用TAF治疗48周。常规检测血清肌酐(sCr)、β₂微球蛋白(β₂-MG)和估算的肾小球滤过率(eGFR),完全病毒学应答率(CVR)定义为血清HBV DNA载量＜20 IU/mL。使用瞬时弹性成像探测仪行肝脏硬度检测(LSM)。结果在治疗48周末,TAF治疗组CVR为98.0%,显著高于ETV治疗组的24.0%(P<0.05),而两组血清HBeAg转阴率(17.7%对4.0%,P>0.05)和ALT复常率(96.1%对98.0,P>0.05)无显著性差异;TAF治疗组血清ALT、AST水平和LSM分别为(37.7±5.3)U/L、(34.8±5.7)U/L和(7.1±1.0)kPa,与ETV治疗组【分别为(36.2±4.8)U/L、(35.2±5.3)U/L和(7.8±1.1)kPa,P>0.05】比,无显著性差异; TAF组sCr和血清β₂-MG水平分别为(70.4±6.5)μmol/L和(1.3±0.3)mg/L,显著低于ETV治疗组【分别为(78.5±6.9)μmol/L和(1.6±0.2)mg/L,P<0.05】,而eGFR为(105.9±17.3)mL/min/1.73 m²,显著高于ETV治疗组【(98.0±16.7)mL/min/1.73 m²,P<0.05】。结论对于ETV经治后出现LLV的CHB患者转换为TAF继续治疗可提高病毒学应答率,安全性高,值得继续扩大验证。

关键词: 慢性乙型肝炎, 恩替卡韦, 经治, 低病毒血症, 丙酚替诺福韦, 完全病毒学应答, 治疗

Abstract: Objective The aim of this study was to investigate the antiviral efficacy of tenofovir alafenamide (TAF) in the re-treatment of patients with chronic hepatitis B (CHB) and low-level viremia (LLV) after entecavir (ETV) treatment. Methods 101 patients with CHB were recruited in our hospital between January 2018 and December 2022, and the enrollment included ETV-treated for longer than 48 weeks and LLV was confirmed by serum HBV DNA load detection. 50 patients toke oral ETV continuously for 48 weeks, and other 51 patients switched to TAF re-treatment for 48 weeks. Serum creatinine (sCr), β₂ microglobulin (β2-G) levels and estimated glomerular filtration rate (eGFR) were routinely detected, and the liver stiffness measurement (LSM) was measured by transient elastography. The complete virological response (CVR) was defined as serum HBV DNA negative, and less than 20 IU/mL quantitatively. Results At the end of 48 weeks, the CVR in the TAF-treated patients was 98.0%, much higher than 24.0%(P<0.05) in ETV-treated patients, while there were no significant differences as respect to serum HBeAg negative rates (17.7% vs. 4.0%, P>0.05) and serum ALT normalization rates (96.1% vs. 98.0, P>0.05) in two groups; serum ALT, AST levels and the LSM in patients receiving TAF were (37.7±5.3)U/L, (34.8±5.7)U/L and (7.1±1.0)kPa, all not significantly different compared to [(36.2±4.8)U/L, (35.2±5.3)U/L and (7.8±1.1)kPa, respectively, P>0.05] in patients taking ETV; serum Cr and β₂-MG levels were (70.4±6.5)μmol/L and (1.3±0.3)mg/L, both significantly lower than [(78.5±6.9)μmol/L and (1.6±0.2)mg/L, P<0.05], while the eGFR was (105.9±17.3)mL/min/1.73 m², much higher than [(98.0±16.7)mL/min/1.73 m², P<0.05] in ETV-treated patients. Conclusion We recommend the CHB patients with LLV after ETV treatment switch to TAF therapy, which could elevate virological response rate, and warrants further clinical investigation.

Key words: Hepatitis B, Entecavir, Low-level viremia, Tenofovir alafenamide, Re-treatment, Complete virological response

薛李娜, 诸国兵, 吴琳霖, 杨小星. TAF治疗ETV经治的低病毒血症慢性乙型肝炎患者疗效研究^*[J]. 实用肝脏病杂志, 2024, 27(4): 519-522.

Xue Lina, Zhu Guobing, Wu Linlin, et al. Virological response to tenofovir alafenamide in patients with low-level viremia chronic hepatitis B after entecavir treatment[J]. Journal of Practical Hepatology, 2024, 27(4): 519-522.

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TAF治疗ETV经治的低病毒血症慢性乙型肝炎患者疗效研究^*

Virological response to tenofovir alafenamide in patients with low-level viremia chronic hepatitis B after entecavir treatment

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