[Evaluation of the efficacy and safety profile of tenofovir amibufenamide at 48 weeks during the treatment of hepatitis B virus-related cirrhosis].

Abstract

Objective: 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. Methods: 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, n=25) and the tenofovir alafenamide fumarate group (TAF, n=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 t-test or Kruskal-Wallis H test was used to compare the measurement data among the groups. The χ² test was used for the enumeration data. Results: 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 (P>0.05). There was no statistically significant difference in the proportion of patients with HBV DNA<30 IU/ml (P=1.00) between the two groups, regardless of whether they were NA-naive (P=0.52) or treatment experienced (P=1.00) at 48 weeks. There was no statistically significant difference in HBsAg levels between the TMF and TAF groups (P=0.18) at 48 weeks. There was no statistically significant difference in the decline of HBsAg within each group (P>0.05). The levels of alanine aminotransferase (P<0.001) and aspartate aminotransferase (P=0.045) were significantly lower at 48 weeks than those at baseline, while the albumin level was higher than that at baseline (P=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 (P>0.05). There were no statistically significant differences in Cr (P=0.34) and eGFR levels (P=0.60) at 48 weeks between the TMF and TAF groups.There were no statistically significant differences in Cr (P=0.89) and eGFR levels (P=0.57) at 48 weeks in patients aged<40 years (n=8) compared with baseline in the TMF group. There were no statistically significant differences (P=0.09, P=0.13) in patients with similar aged≥40 years (n=17). The reduction in Cr level (P<0.001) and the increase in eGFR (P<0.001) at 48 weeks were statistically significant in patients aged<40 years (n=3) among the TAF group. There were no statistically significant differences in Cr (P=0.30) and eGFR (P=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 (P>0.05). Conclusion: TMF has a relatively better efficacy and safety profile than TAF at 48 weeks in patients with hepatitis B virus-related cirrhosis.