Chinese Hepatolgy ›› 2023, Vol. 28 ›› Issue (1): 100-104.

• Viral Hepatitis • Previous Articles     Next Articles

Early efficacy of tenofovir amibufenamide (TMF) in the treatment of patients with chronic hepatitis B: a real-word multicenter clinical study

LI Ya-ping1, CUI Dan-dan1, GOU Guo-e1, LIN Yong-mei2, ZU Hong-mei3, XU Guang-hua4, GAO Xiao-hong4, DANG Shuang-suo1   

  1. 1. The Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi 710004, China;
    2. 3201 Hospital Affiliated to Xi'an Jiaotong University, Hanzhong 723000, China;
    3. The Fourth People's Hospital of Qinghai Province, Xining 810000, China;
    4. Affiliated Hospital of Yan'an University, Shaanxi 716000, China
  • Received:2022-10-30 Online:2023-01-31 Published:2023-02-21
  • Contact: DANG Shuang-suo,Email:dang212@126.com

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Abstract: Objective To evaluate the efficacy and safety of tenofovir amibufenamide (TMF) in the treatment of patients with chronic hepatitis B (CHB). Methods In this multicenter, prospective, real-world cohort study, we recruited 91 patients with CHB who attended the outpatient clinic of the Department of Infection of the 4 sites from August 2021 to August 2022 and were treated with TMF antiviral therapy. We collected clinical data, and compared the changes of HBV DNA, alanine transaminase (ALT), hepatitis B virus e antigen (HBeAg) and hepatitis B virus surface antigen (HBsAg) conversion, renal function and lipid metabolism at 12W and 24W. Results A total of 91 CHB patients were enrolled at 24W, 28 patients in treatment-naïve and 63 patients in previously treated. Complete virological response was achieved in 17.4% and 47.9% of treatment-naïve patients at 12W and 24W. The proportion of treated patients achieving complete virological response at 12W and 24W was 48.4% and 58.1%, respectively. HBV DNA [(4.88±0.54) lg IU/mL vs (2.69±0.35) lg IU/mL vs (2.40±0.39 lg IU/mL)] was significantly lower compared to baseline and 12W primary patients (F=24.51, P=0.000); HBV DNA in previously treated patients[(2.67±0.31) lg IU/mL vs (1.70±0.24) lg IU/mL vs (1.49±0.09) lg IU/mL decreased from before (F=5.83, P=0.009). The ALT recurrence rates based on laboratory criteria were 64% and 92% for 12W and 24W, respectively. And the ALT recurrence rates were 38.4% and 78.9% for 12W and 24W using AASLD 2018 criteria. After 24W of antiviral therapy 4.53% of patients had HBeAg conversion, 2.17% of patients had HBeAg seroconversion, 1.09% of patients had HBsAg conversion, no patients have yet had HBsAg seroconversion. In terms of safety, there was no significant change in blood Cr, eGFR and CysC at 24 weeks of antiviral therapy in CHB patients compared with baseline. 33 treated patients who had early kidney injury switched to TMF and continued antiviral therapy for 24W had a significant decrease in urinary α1-MG and urinary NAG and urinary β2-MG compared with baseline, with P values <0.05, which were statistically significant. Compared with baseline, there was a trend of decreasing TG and increasing TC, but the difference was not statistically significant.Conclusion TMF is effective and safe in the treatment of patients with CHB.

Key words: Chronic Hepatitis B, Tenofovir amibufenamide, Antiviral, Efficacy, Real world