A real-world clinical study on the efficacy and safety of tenofovir amibufenamide for the treatment of patients with chronic hepatitis B

A real-world clinical study on the efficacy and safety of tenofovir amibufenamide for the treatment of patients with chronic hepatitis B | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Short Report A real-world clinical study on the efficacy and safety of tenofovir amibufenamide for the treatment of patients with chronic hepatitis B Rongshan Fan, Hongmei Fan, Linling Tan, Jun Zhang, Li Ai This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8280627/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective To analyze the efficacy and safety of tenofovir amibufenamide for the treatment of patients with chronic hepatitis B in the real world and to provide a reference for the subsequent selection of antiviral treatment for chronic hepatitis B. Method A total of 186 cases of patients with chronic hepatitis B were collected. Among them, 93 patients had been treated with TMF for 48 weeks, and 93 patients had been treated with TDF for 48 weeks. The primary indicator was the virological response rate. The secondary indicators included the normalization rate of serum alanine aminotransferase (ALT) levels and the changes in the levels of hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), creatinine, uric acid, calcium ions and phosphate. Results There was no significant difference in the virological response rate between the TMF group and the TDF group at 48 weeks of treatment ( P > 0.05). There was a significant difference in the normalization rate of ALT (83.31% vs. 52.01%) after 48 weeks of treatment between the TMF and TDF groups, respectively ( P < 0.05). Likewise, there was a significant difference in the HBeAg seroconversion rate (19.35% vs. 7.53%) after 48 weeks of treatment between the TMF and TDF groups, respectively ( P < 0.05). There was a significant difference in serum creatinine levels (77.36 ± 16.87 µmol/L vs. 83.13 ± 17.23 µmol/L) between the TMF and TDF groups after 48 weeks of treatment ( P < 0.05). However, there were no significant changes in the levels of uric acid, calcium ions or phosphate. Conclusion Tenofovir amibufenamide is effective and safe for the treatment of patients with chronic hepatitis B. Compared with tenofovir disoproxil fumarate, it has a higher ALT normalization rate and a higher HBeAg seroconversion rate. Chronic Hepatitis B Tenofovir amibufenamide Therapeutic effect Safety Full Text Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8280627","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Short Report","associatedPublications":[],"authors":[{"id":558492672,"identity":"26a5689d-9a15-46dd-9c14-005a171731a3","order_by":0,"name":"Rongshan 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Safety","lastPublishedDoi":"10.21203/rs.3.rs-8280627/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8280627/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eObjective\u003c/b\u003e\u003c/p\u003e\u003cp\u003eTo analyze the efficacy and safety of tenofovir amibufenamide for the treatment of patients with chronic hepatitis B in the real world and to provide a reference for the subsequent selection of antiviral treatment for chronic hepatitis B.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethod\u003c/b\u003e\u003c/p\u003e\u003cp\u003eA total of 186 cases of patients with chronic hepatitis B were collected. Among them, 93 patients had been treated with TMF for 48 weeks, and 93 patients had been treated with TDF for 48 weeks. The primary indicator was the virological response rate. The secondary indicators included the normalization rate of serum alanine aminotransferase (ALT) levels and the changes in the levels of hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), creatinine, uric acid, calcium ions and phosphate.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThere was no significant difference in the virological response rate between the TMF group and the TDF group at 48 weeks of treatment (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05). There was a significant difference in the normalization rate of ALT (83.31% vs. 52.01%) after 48 weeks of treatment between the TMF and TDF groups, respectively (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05). Likewise, there was a significant difference in the HBeAg seroconversion rate (19.35% vs. 7.53%) after 48 weeks of treatment between the TMF and TDF groups, respectively (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05). There was a significant difference in serum creatinine levels (77.36\u0026thinsp;\u0026plusmn;\u0026thinsp;16.87 \u0026micro;mol/L vs. 83.13\u0026thinsp;\u0026plusmn;\u0026thinsp;17.23 \u0026micro;mol/L) between the TMF and TDF groups after 48 weeks of treatment (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05). However, there were no significant changes in the levels of uric acid, calcium ions or phosphate.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusion\u003c/b\u003e\u003c/p\u003e\u003cp\u003eTenofovir amibufenamide is effective and safe for the treatment of patients with chronic hepatitis B. Compared with tenofovir disoproxil fumarate, it has a higher ALT normalization rate and a higher HBeAg seroconversion rate.\u003c/p\u003e","manuscriptTitle":"A real-world clinical study on the efficacy and safety of tenofovir amibufenamide for the treatment of patients with chronic hepatitis B","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-11 08:39:48","doi":"10.21203/rs.3.rs-8280627/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f5c1ec0b-3cff-4f73-b7c3-0da511b43d6f","owner":[],"postedDate":"December 11th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-12-11T08:40:49+00:00","versionOfRecord":[],"versionCreatedAt":"2025-12-11 08:39:48","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8280627","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8280627","identity":"rs-8280627","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}