Abstract: Objective The aim of this study was to investigate the early efficacy of tenofovir amibufenamide (TMF) in the treatment of naïve patients with chronic hepatitis B (CHB). Methods A total of 90 naïve patients with CHB were recruited in the First Affiliated Hospital, China University of Science and Technology between January 2020 and March 2022, and were divided into observation (n=50) and control group (n=40), receiving TMF or tenofovir disoproxil fumarate (TDF) treatment for 48 weeks. Serum alanine transaminase (ALT), HBV DNA loads, HBeAg and HBsAg levels were detected routinely. Results At 12, 24, 36 and 48 weeks of treatment, serum ALT levels in the observation group were 38.0(25.0,55.0)U/L, 31.5(23.8,35.0)U/L, 29.5(22.8,35.0) U/L and 26.0(21.8,34.0)U/L, all not significantly different compared to 38.5(25.0,60.0)U/L, 30.0(22.0,44.0)U/L, 31.0(22.8,44.5)U/L and 28.0(19.8,42.0)U/L (P>0. 05), serum HBV DNA loads were 0(0, 3)lgIU/ml, 0(0, 0.5)lgIU/ml, 0(0, 0)lgIU/ml and 0(0, 0)lgIU/ml, not significantly different compared to 2(0, 3)lgIU/ml, 0(0, 2)lgIU/ml, 0(0, 1.5)lgIU/ml and 0(0,0)lgIU/ml (P >0.05) in the control; serum HBV DNA loss were 58%, 76%, 78% and 88%, not significantly different compared to 45%, 65%, 75% and 85%(P >0.05) in the control; at 12, 24 and 36 week treatment, serum ALT normalization rates in the observation group were 56%, 80% and 92%, all not significantly different compared to 55%, 70% and 65%(P >0.05) , while at the end of treatment 48 week, serum ALT normalization rate in the observation group was 100.0%, much higher than 72.5%(P＜0.01) in the control; during the period of antiviral regimen, there was no obvious untoward effects in the two groups. Conclusion The antiviral performance of TMF in the treatment of naïve patients with CHB is as efficacious as of TDF, while the long-term efficacy and its impact on renal functions needs further clinical investigation.

Key words: Hepatitis B, Tenofovir amibufenamide, Therapy