[Real-world study on the efficacy and safety of first-line antiviral therapy for chronic hepatitis B].

Objective: To clarify the clinical efficacy of first-line oral antiviral drugs tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), and entecavir (ETV) in the treatment of chronic hepatitis B (CHB) and their safety profiles with lipid, bone, and kidney metabolism. Methods: 458 CHB cases diagnosed and treated at the Department of Hepatology of Integrated Traditional Chinese and Western Medicine of the Third Hospital of Hebei Medical University from February 2010 to November 2022 were selected. TAF (175 cases), TDF (124 cases), and ETV (159 cases) were used as therapies. At 24 and 48 weeks, the virology, biochemical response, changes in liver stiffness measurement (LSM), and bone, kidney, and blood lipid metabolism safety profiles were compared and analyzed. Results: After 24 and 48 weeks of TAF, TDF, and ETV therapy, HBV DNA load decreased by 3.28, 2.69, and 3.14 log10 IU/ml and 3.28, 2.83, and 3.65 log10 IU/ml, respectively, compared with the baseline, and the differences between the three groups were statistically significant, P < 0.001. The complete virological response rates were 73.95%, 66.09%, 67.19%, and 82.22%, 72.48%, and 70.49%, respectively. The incidence rates of low-level viremia were 16.67%, 21.70%, and 23.08%, while poor response rates were 1.11%, 3.67%, and 4.10%. ALT normalization rates were 64.00%, 63.89%, 67.96%, and 85.33%, 80.56%, 78.64%, respectively, and there was no statistically significant difference among the groups. LSM was significantly improved in patients treated with TAF for 48 weeks, P = 0.022. Serum phosphorus level gradually decreased with the prolongation of TDF treatment. The TAF treatment group had a good safety profile for kidney, bone, and phosphorus metabolism, with no dyslipidemia or related occurrences of risk. Conclusion: There are some differences in the therapeutic effects of first-line anti-HBV drugs. TAF has the lowest incidence of low-level viremia after 48 weeks of treatment and has a good safety profile in kidney, bone, and blood lipid metabolism.目的： 明确一线口服抗病毒药物富马酸丙酚替诺福韦（TAF）、富马酸替诺福韦二吡呋酯（TDF）及恩替卡韦（ETV）治疗慢性乙型肝炎（CHB）的临床效果和脂质代谢、骨骼、肾脏的安全性。 方法： 选择2010年2月至2022年11月河北医科大学第三医院中西医结合肝病科诊治的CHB 458例，分别采用TAF（175例）、TDF（124例）和ETV（159例）治疗，对比分析24、48周病毒学、生化学应答、肝脏硬度值（LSM）变化及骨骼、肾脏、血脂安全性。 结果： TAF、TDF、ETV治疗24、48周，HBV DNA载量分别较基线降低3.28、2.69、3.14 log(10) IU/ml和3.28、2.83、3.65 log(10) IU/ml，均较基线显著降低，3组间比较，差异均有统计学意义，P值均< 0.001；完全病毒学应答率依次为73.95%、66.09%、67.19%和82.22%、72.48%、70.49%；低病毒血症发生率为16.67%、21.70%、23.08%，应答不佳率依次为1.11%、3.67%、4.10%；ALT复常率依次为64.00%、63.89%、67.96%和85.33%、80.56%、78.64%，各组间差异无统计学意义。TAF治疗48周患者LSM显著改善，P = 0.022。随TDF治疗时间延长，血清磷水平逐渐降低，TAF治疗组肾脏、骨骼、磷代谢安全性好，未出现血脂异常及相关风险。 结论： 一线抗乙型肝炎病毒药物的治疗效果存在一定差异，TAF治疗48周低病毒血症发生率最低，肾脏、骨骼及血脂安全性好。.