Efficacy and safety of tenofovir alafenamide in HBeAg-positive and negative chronic hepatitis B patients aged over 30 years with normal ALT and detectable HBV DNA: a 96-week retrospective two-center study.

BACKGROUND: The 2022 update of Chinese Guidelines for Chronic Hepatitis B (CHB) Management advocates initiating antiviral therapy regardless of alanine aminotransferase (ALT) status in HBV DNA-positive patients aged > 30 years. This study aimed to investigate the virological response and renal safety profile of tenofovir alafenamide (TAF) in this specific population through both short-term (48-week) and extended (96-week) observations. METHODS: In this multicenter retrospective cohort study, 122 treatment-naïve CHB patients meeting inclusion criteria from two tertiary hospitals (Yantai Qishan Hospital and Yantai Yuhuangding Hospital) underwent standard TAF monotherapy (25 mg/day). Serial assessments of virological parameters (HBV DNA quantification) and renal function markers (serum creatinine, estimated glomerular filtration rate) were conducted at baseline, week 48, and week 96. RESULTS: After 48 weeks of TAF treatment, 74.6% of the 122 enrolled patients achieved HBV DNA conversion (HBV DNA < 20 IU/mL), with the difference in conversion rates being statistically significant (P < 0.001). Among the 80 patients who completed 96 weeks of follow-up, a progressive increase in HBV DNA conversion rates was observed between week 48 and week 96, demonstrating statistically significant improvement over time (P < 0.001). Intergroup comparisons showed no statistically significant differences, and all safety parameters exhibited no clinically relevant changes during the trial. CONCLUSION: This real-world evidence demonstrates durable antiviral efficacy of TAF in guideline-defined CHB patients aged > 30 years with normal ALT and active viremia, accompanied by favorable renal tolerability throughout the 96-week treatment period. Extended follow-up is ongoing to establish long-term clinical outcomes.