Objective: To compare the real-world efficacy and safety profile of tenofovir amibufenamid (TMF) and tenofovir alafenamide (TAF) tablets in the treatment of patients with chronic hepatitis B (CHB). Methods: This retrospective study included patients with chronic hepatitis B who received TMF and TAF antiviral treatment at the Infectious Disease Outpatient Department of the First Affiliated Hospital of Zhengzhou University from January 2021 to December 2023. The primary and secondary outcome was to study the patient HBV DNA conversion rate (<20 IU/ml), alanine aminotransferase (ALT) normalization rate, renal function, and lipid levels of patients at 48 weeks of treatment. The comparison of data between measurement data groups was differentiated using a t-test and Mann-Whitney U test. The inter-group comparison rate in count data was performed using the χ2 test or Fisher's exact probability. Results: A total of 440 cases were enrolled, including 220 in the TMF group (63 treatment-naïve and 157 treatment-experienced) and 220 cases in the TAF group (61 treatment-naïve and 159 treatment-experienced). In terms of efficacy, the HBV DNA seroconversion rates in the TMF group and TAF group were 90.5% and 85.2% (P=0.372), respectively, while the ALT normalization rates were 92.1% and 88.5% (P=0.505), respectively, at 48 weeks of treatment. The HBV DNA-negative conversion rate for the newly treated patients was 99.4% and 98.7%, respectively (P=1.000), while the rates of ALT normalization were 94.9% and 92.3%, respectively (P=0.863). In terms of safety profile, the serum creatinine level was lower in the TMF group than that in the TAF group at 48 weeks of treatment [TMF group 66.5 (56.3, 78.3) μmol/L, TAF group 70.6 (60.7, 77.8) μmol/L, Z=-2.282, P=0.022]. However, there was no statistically significant difference in other renal function and tubular function related indicators between the two groups of patients (P>0.05). The serum high-density lipoprotein levels were higher in the TMF group than those in the TAF group [TMF 1.4 (1.1, 1.6) mmol/L vs. TAF group 1.3 (1.1, 1.6) mmol/L, Z=-2.204, P=0.027] at 48 weeks of treatment. However, there was no statistically significant difference in other blood lipid indicators between the two groups of patients (P>0.05). Conclusion: There is no statistically significant difference in efficacy and safety profiles between TMF and TAF at 48 weeks in the treatment of patients with chronic hepatitis B, and the overall safety profile is favorable.
目的： 比较艾米替诺福韦（TMF）与富马酸丙酚替诺福韦（TAF）治疗慢性乙型肝炎（CHB）患者的真实世界疗效和安全性。 方法： 纳入2021年1月至2023年12月就诊于郑州大学第一附属医院感染科门诊抗病毒治疗的CHB患者，分别给予TMF和TAF治疗。主要研究结局是治疗48周时患者的HBV DNA转阴率（＜20 IU/ml），次要研究结局是治疗48周时患者的丙氨酸转氨酶（ALT）复常率及肾功能和血脂指标水平。计量资料组间数据比较采用t检验、Mann-Whitney U检验；计数资料组间率的比较采用χ2检验或Fisher精确概率法。 结果： 共入组患者440例，其中TMF组220例（初治63例和经治157例）；TAF组220例（初治61例和经治159例）。疗效方面，治疗48周时，TMF组和TAF组初治患者HBV DNA转阴率分别为90.5%、85.2%（P=0.372），ALT复常率分别为92.1%、88.5%（P=0.505）；经治患者HBV DNA转阴率分别为99.4%、98.7%（P=1.000），ALT复常率分别为94.9%、92.3%（P=0.863）。安全性方面，治疗48周时，TMF组患者血清肌酐水平低于TAF组［TMF组66.5（56.3，78.3）μmol/L，TAF组70.6（60.7，77.8）μmol/L，Z=-2.282，P=0.022］，两组患者的其他肾功能和肾小管功能相关指标的差异均无统计学意义（P值均＞0.05）；治疗48周时，TMF组患者血清高密度脂蛋白水平高于TAF组［TMF组1.4（1.1，1.6）mmol/L，TAF组1.3（1.1，1.6）mmol/L，Z=-2.204，P=0.027］，两组患者的其他血脂指标差异均无统计学意义（P值均＞0.05）。 结论： TMF和TAF治疗CHB患者48周时的疗效和安全性差异无统计学意义，总体安全性良好。.