96-Week Treatment of Tenofovir Amibufenamide and Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients.

"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."

"This study was funded by Hansoh Pharmaceuticals Co., Ltd."

"This was a multicenter, randomized, double-blind, phase III noninferiority study. Eligible patients were randomly assigned in a 2:1 ratio to be orally treated with 25 mg of TMF (Hansoh Pharmaceuticals Co., Ltd, Jiangsu, China) or 300 mg of TDF (GlaxoSmithKline, Tianjin, China) once daily with a matching placebo of the unassigned study drug for the first 96 weeks. The details of the designs have been published. In brief, we enrolled patients 18–65 years of age with confirmed chronic hepatitis B diagnosed by HBV DNA levels of ≥20,000 IU/mL and alanine aminotransferase (ALT) levels 1–10 times the upper limit of normal (ULN), and those with clear decompensation or hepatocellular carcinoma were excluded. Full eligibility criteria are given in the Supplementary File 2 and the study was registered at ClinicalTrial.gov (NCT03903796)."