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Summary: Background: Tenofovir amibufenamide (TMF) can provide more efficient delivery than tenofovir disoproxil fumarate (TDF). Aim: To compare the efficacy and safety of TMF and TDF for 48 weeks in patients with chronic hepatitis B (CHB). Methods: We performed a randomised, double‐blind, non‐inferiority study at 49 sites in China. Patients with CHB were assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo. The primary efficacy endpoint was the proportion of patients with hepatitis B virus (HBV) DNA less than 20 IU/mL at week 48. We also assessed safety, particularly bone, renal and metabolic abnormalities. Results: We randomised 1002 eligible patients. The baseline characteristics were well balanced between groups. After a median 48 weeks of treatment, the non‐inferiority criterion was met in all analysis sets. In the HBeAg‐positive population, 50.2% of patients receiving TMF and 53.7% receiving TDF achieved HBV DNA less than 20 IU/mL. In the HBeAg‐negative population, 88.9% and 87.8%, respectively, achieved HBV DNA less than 20 IU/mL in the TMF and TDF groups. Patients receiving TMF had significantly less decrease in bone mineral density at both hip (P < 0.001) and spine (P < 0.001), and a smaller increase in serum creatinine at week 48 (P < 0.05). Other safety results were similar between groups. Conclusion: TMF was non‐inferior to TDF in terms of anti‐HBV efficacy and showed better bone and renal safety. (NCT03903796). [ABSTRACT FROM AUTHOR]

Background and Aims: Tenofovir amibufenamide (TMF) is a novel phosphoramidated prodrug of tenofovir with noninferior efficacy and better bone and renal safety to tenofovir disoproxil fumarate (TDF) in 48 weeks of treatment. Here, we update 96-week comparison results., Methods: Patients with chronic hepatitis B were assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks. The virological suppression was defined as HBV DNA levels <20 IU/mL at week 96. Safety was evaluated thoroughly with focusing on bone, renal, and metabolic parameters., Results: Virological suppression rates at week 96 were similar between TMF and TDF group in both HBeAg-positive and HBeAg-negative populations. Noninferior efficacy was maintained in the pooled population, while it was first achieved in patients with HBV DNA ≥7 or 8 log10 IU/mL at baseline. Non-indexed estimated glomerular filtration rate for renal safety assessment was adopted, while a smaller decline of which was seen in the TMF group than in the TDF group ( p =0.01). For bone mineral density, patients receiving TMF displayed significantly lower reduction levels in the densities of spine, hip, and femur neck at week 96 than those receiving TDF. In addition, the lipid parameters were stable after week 48 in all groups while weight change still showed the opposite trend., Conclusions: TMF maintained similar efficacy at week 96 compared with TDF with continued superior bone and renal safety profiles (NCT03903796)., Competing Interests: ZL has served as a speaker for Bristol Myers Squibb (BMS), Gilead Sciences, and Hansoh Pharma. QJ has served as a speaker for Abbott, Amoytop Biotech, Chiatai Tianqing, Gilead, and has received research funding from Kawin Technology, Chiatai Tianqing, Hansoh Pharma, Johnson and Johnson (J&J), BMS, HEC Pharmaceutical, TaiGen Biotechnology, Gilead Science. JN has served as a speaker for and has received research funding from HEC Pharmaceutical, Xintong Pharmacy, Hansoh Pharma, Qilu Pharmaceutical, Kelun Industry, Roche, J&J, GlaxoSmithKline (GSK), Assembly, Gilead, Brii Biosciences, Huahui Health, Zhimeng Biopharma, Hengrui Medicine, Aligos, Hepu Pharmaceutical, Ascletis Pharma, Sanhome, Ginkgo pharma, Changzhou Yinsheng pharma. JH has received consulting fee from AbbVie, Arbutus, BMS, Gilead Sciences, J&J, Roche and received grants from BMS and J&J. QW, CP, WJ, CL, and CS are employees of Hansoh Pharmaceuticals Co., Ltd. JN has has been an associate editor of Journal of Clinical and Translational Hepatology since 2013, and JH has has been an executive associate editor of Journal of Clinical and Translational Hepatology since 2021. The other authors have no conflict of interests related to this publication., (© 2023 Authors.)