Effectiveness and safety of tenofovir amibufenamide in the treatment of chronic hepatitis B patients with low-level viremia: a retrospective real-world study

BACKGROUND: Tenofovir amibufenamide (TMF) and tenofovir alafenamide (TAF) are considered efficacious and safe nucleoside/nucleotide analogs (NAs) for patients with chronic hepatitis B (CHB). However, real-world data on TMF for CHB patients with low-level viremia (LLV) remain scarce. This study investigated the real-world effectiveness and safety of TMF combined with entecavir (ETV) in the treatment of CHB patients with LLV, and compared the efficacy and safety of TMF combined with ETV and tenofovir alafenamide (TAF) combined with ETV in the treatment of CHB patients with LLV. METHODS: This retrospective real-world study included CHB patients with LLV who received treatment with either TMF combined with ETV or TAF combined with ETV. After the 48-week follow-up, this study evaluated the differences between the two groups in terms of virological response rate (VR rate), ALT normalization rate, HBsAg and HBeAg seroclearance rate, liver fibrosis assessment, and safety endpoints (renal function and blood lipids). RESULTS: A total of 258 patients were enrolled: 123 in the experimental group (TMF combined with ETV) and 135 in the control group (TAF combined with ETV). The levels of HBV DNA and AST in both groups were significantly lower than the baseline levels after 48-week treatment period (P < 0.05). The VR rate at week 48 was 79.67% in the experimental group, while that in the control group was 72.59%, and there was no statistically significant difference between the two groups (P = 0.184). With respect to the ALT normalization rate, HBsAg seroclearance rate, HBeAg seroclearance rate and liver transient elastography (TE) results, no statistically significant differences were detected between the two groups (P > 0.05). Similarly, for the safety endpoints, including serum creatinine (Cr), glomerular filtration rate (eGFR), triglyceride (TG), total cholesterol (TC), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels, none of these indicators significantly differed between the two groups. CONCLUSION: TMF combined with ETV was found to be effective in CHB patients with LLV and appeared to have a favorable safety profile within the limitations of the available data. It exhibits robust antiviral activity and can improve the liver function of patients.