Hao K Y, Jiang X, Dong Y, Sun H N, Yu Y C
Center of Hepatology and Department of Infectious Disease, Jinling Hospital (General Hospital of Eastern Theater Command), Affiliated to School of Medicine, Nanjing University, Nanjing210002, China.
Zhonghua Gan Zang Bing Za Zhi. 2024 Nov 30;32(S1):19-29. doi: 10.3760/cma.j.cn501113-20240904-00475.
To evaluate the efficacy and safety profile of tenofovir amibufenamide (TMF) at 48 weeks in patients with hepatitis B virus-related compensated and decompensated stage cirrhosis. Patients with treatment-naïve or treatment-experienced hepatitis B virus-related cirrhosis with nucleos(t)ide analogues (NA) who met the inclusion and exclusion criteria from 2022 to 2024 were retrospectively collected and divided into the tenofovir amibufenamide group (TMF, =25) and the tenofovir alafenamide fumarate group (TAF, =14). The conditional changes in hepatitis B virus DNA (HBV DNA), hepatitis B surface antigen (HBsAg), liver function indexes, serum creatinine (Cr), estimated glomerular filtration rate (eGFR), serum phosphorus, blood lipid profiles, and other variables were compared between and within the groups at baseline and 48 weeks. The -test or Kruskal-Wallis test was used to compare the measurement data among the groups. The test was used for the enumeration data. There were no statistically significant differences in baseline, age, gender, proportion of compensated/decompensated stage cirrhosis, proportion of NA-naive/treatment experienced, liver function indexes, serum Cr, and eGFR between the two groups (>0.05). There was no statistically significant difference in the proportion of patients with HBV DNA<30 IU/ml (=1.00) between the two groups, regardless of whether they were NA-naive (=0.52) or treatment experienced (=1.00) at 48 weeks. There was no statistically significant difference in HBsAg levels between the TMF and TAF groups (=0.18) at 48 weeks. There was no statistically significant difference in the decline of HBsAg within each group (>0.05). The levels of alanine aminotransferase (<0.001) and aspartate aminotransferase (=0.045) were significantly lower at 48 weeks than those at baseline, while the albumin level was higher than that at baseline (=0.004) among the TMF group. There were no statistically significant differences in the rest of the liver function indicators among the TMF and the TAF groups between baseline and 48 weeks (>0.05). There were no statistically significant differences in Cr (=0.34) and eGFR levels (=0.60) at 48 weeks between the TMF and TAF groups.There were no statistically significant differences in Cr (=0.89) and eGFR levels (=0.57) at 48 weeks in patients aged<40 years (=8) compared with baseline in the TMF group. There were no statistically significant differences (=0.09, =0.13) in patients with similar aged≥40 years (=17). The reduction in Cr level (<0.001) and the increase in eGFR (<0.001) at 48 weeks were statistically significant in patients aged<40 years (=3) among the TAF group. There were no statistically significant differences in Cr (=0.30) and eGFR (=0.13) at 48 weeks in patients aged≥40 years compared with baseline. There were no statistically significant differences in serum phosphorus, triglycerides, total cholesterol, high-density lipoprotein, low-density lipoprotein, and blood glucose levels at baseline and 48 weeks in the TMF and TAF groups (>0.05). TMF has a relatively better efficacy and safety profile than TAF at 48 weeks in patients with hepatitis B virus-related cirrhosis.
评估替诺福韦氨米芬胺（TMF）在乙肝病毒相关代偿期和失代偿期肝硬化患者中48周时的疗效和安全性。回顾性收集2022年至2024年符合纳入和排除标准的初治或经治的乙肝病毒相关肝硬化且使用核苷（酸）类似物（NA）的患者，分为替诺福韦氨米芬胺组（TMF，n = 25）和替诺福韦艾拉酚胺富马酸盐组（TAF，n = 14）。比较两组在基线和48周时乙肝病毒DNA（HBV DNA）、乙肝表面抗原（HBsAg）、肝功能指标、血清肌酐（Cr）、估算肾小球滤过率（eGFR）、血清磷、血脂谱及其他变量的组间和组内条件变化。采用t检验或Kruskal-Wallis检验比较组间计量资料。采用χ²检验进行计数资料分析。两组在基线时的年龄、性别、代偿期/失代偿期肝硬化比例、初治/经治NA比例、肝功能指标、血清Cr和eGFR方面无统计学差异（P>0.05）。48周时，无论初治（P = 0.52）还是经治（P = 1.00），两组中HBV DNA<30 IU/ml的患者比例无统计学差异（P = 1.00）。48周时替诺福韦氨米芬胺组和替诺福韦艾拉酚胺富马酸盐组的HBsAg水平无统计学差异（P = 0.18）。每组内HBsAg下降幅度无统计学差异（P>0.05）。替诺福韦氨米芬胺组48周时丙氨酸氨基转移酶水平（P<0.001）和天冬氨酸氨基转移酶水平（P = 0.045）显著低于基线水平，而白蛋白水平高于基线水平（P = 0.004）。替诺福韦氨米芬胺组和替诺福韦艾拉酚胺富马酸盐组在基线和48周时其余肝功能指标无统计学差异（P>0.05）。替诺福韦氨米芬胺组和替诺福韦艾拉酚胺富马酸盐组48周时Cr水平（P = 0.34）和eGFR水平（P = 0.60）无统计学差异。替诺福韦氨米芬胺组中年龄<40岁（n = 8）的患者48周时Cr水平（P = 0.89）和eGFR水平（P = 0.57）与基线相比无统计学差异。年龄≥40岁（n = 17）的患者中无统计学差异（P = 0.09，P = 0.13）。替诺福韦艾拉酚胺富马酸盐组中年龄<40岁（n = 3）的患者48周时Cr水平降低（P<0.001）和eGFR水平升高（P<0.001）有统计学意义。年龄≥40岁的患者48周时Cr水平（P = 0.30）和eGFR水平（P = 0.13）与基线相比无统计学差异。替诺福韦氨米芬胺组和替诺福韦艾拉酚胺富马酸盐组在基线和48周时血清磷、甘油三酯、总胆固醇、高密度脂蛋白、低密度脂蛋白和血糖水平无统计学差异（P>0.05）。在乙肝病毒相关肝硬化患者中，48周时替诺福韦氨米芬胺比替诺福韦艾拉酚胺富马酸盐具有相对更好的疗效和安全性。
