96-Week Treatment of Tenofovir Amibufenamide and Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients
Zhihong Liu, Qinglong Jin, Yuexin Zhang, Guozhong Gong, Guicheng Wu, Lvfeng Yao, Xiaofeng Wen, Zhiliang Gao, Yan Huang, Daokun Yang, En‐Qiang Chen, Qing Mao, Shide Lin, Jia Shang, Huanyu Gong, Lihua Zhong, Huafa Yin, Fengmei Wang, Peng Hu, Qiong Wu, Chao Pan, Wen Jia, Chuan Li, Changan Sun, Junqi Niu, Jinlin Hou, the TMF Study Group
Abstract
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: =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).