{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T16:39:35Z","timestamp":1791909575071,"version":"4.3.4"},"reference-count":48,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2021,9,29]],"date-time":"2021-09-29T00:00:00Z","timestamp":1632873600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Tenofovir amibufenamide (TMF) can provide more efficient delivery than tenofovir disoproxil fumarate (TDF).<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To compare the efficacy and safety of TMF and TDF for 48 weeks in patients with chronic hepatitis B (CHB).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed a randomised, double\u2010blind, non\u2010inferiority study at 49 sites in China. Patients with CHB were assigned (2:1) to receive either 25\u00a0mg TMF or 300\u00a0mg TDF with matching placebo. The primary efficacy endpoint was the proportion of patients with hepatitis B virus (HBV) DNA less than 20\u00a0IU\/mL at week 48. We also assessed safety, particularly bone, renal and metabolic abnormalities.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We randomised 1002 eligible patients. The baseline characteristics were well balanced between groups. After a median 48\u00a0weeks of treatment, the non\u2010inferiority criterion was met in all analysis sets. In the HBeAg\u2010positive population, 50.2% of patients receiving TMF and 53.7% receiving TDF achieved HBV DNA less than 20\u00a0IU\/mL. In the HBeAg\u2010negative population, 88.9% and 87.8%, respectively, achieved HBV DNA less than 20\u00a0IU\/mL in the TMF and TDF groups. Patients receiving TMF had significantly less decrease in bone mineral density at both hip (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.001) and spine (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.001), and a smaller increase in serum creatinine at week 48 (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.05). Other safety results were similar between groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>TMF was non\u2010inferior to TDF in terms of anti\u2010HBV efficacy and showed better bone and renal safety. (NCT03903796).<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.16611","type":"journal-article","created":{"date-parts":[[2021,9,30]],"date-time":"2021-09-30T03:41:20Z","timestamp":1632973280000},"page":"1134-1149","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["Randomised clinical trial: 48\u00a0weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B"],"prefix":"10.1111","volume":"54","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1142-3589","authenticated-orcid":false,"given":"Zhihong","family":"Liu","sequence":"first","affiliation":[{"name":"Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qinglong","family":"Jin","sequence":"additional","affiliation":[{"name":"Changchun 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