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oai:recercat.cat:11351/111792025-10-24T10:29:22Zcom_2072_378070com_2072_378040col_2072_378092

Long-term Treatment With Tenofovir Alafenamide for Chronic Hepatitis B Results in High Rates of Viral Suppression and Favorable Renal and Bone Safety Lim, Young-Suk Marcellin, Patrick BRUNETTO, MAURIZIA ROSSANA Agarwal, Kosh Chan, Henry Lik Yuen Buti Ferret, Maria Institut Català de la Salut [Chan HLY] Faculty of Medicine, the Chinese University of Hong Kong, People's Republic of China. [Buti M] Vall d’Hebron Hospital Universitari, Barcelona, Spain. CIBEREHD del Instituto Carlos III, Barcelona, Spain. [Lim YS] Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. [Agarwal K] Institute of Liver Studies, King's College Hospital NHS Foundation Trust, London, United Kingdom. [Marcellin P] Hepatology Department, Hôpital Beaujon, APHP, INSERM, University of Paris, France. [Brunetto M] Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy Vall d'Hebron Barcelona Hospital Campus Avaluació de resultats (Assistència sanitària) Medicaments antivírics - Ús terapèutic Hepatitis B - Tractament CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents DISEASES::Virus Diseases::Virus Diseases::Hepatitis, Viral, Human::Hepatitis B::Hepatitis B, Chronic ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos ENFERMEDADES::virosis::virosis::hepatitis viral humana::hepatitis B::hepatitis B crónica TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento Chronic Hepatitis B; Viral suppression; Favorable renal Hepatitis B crònica; Supressió viral; Seguretat renal Hepatitis B crónica; Supresión viral; Seguridad renal INTRODUCTION: The results from 2 phase 3 studies, through 2 years, in chronic hepatitis B infection showed tenofovir alafenamide (TAF) had similar efficacy to tenofovir disoproxil fumarate (TDF) with superior renal and bone safety. We report updated results through 5 years. METHODS: Patients with HBeAg-negative or HBeAg-positive chronic hepatitis B infection with or without compensated cirrhosis were randomized (2:1) to TAF 25 mg or TDF 300 mg once daily in double-blind (DB) fashion for up to 3 years, followed by open-label (OL) TAF up to 8 years. Efficacy (antiviral, biochemical, and serologic), resistance (deep sequencing of polymerase/reverse transcriptase and phenotyping), and safety, including renal and bone parameters, were evaluated by pooled analyses. RESULTS: Of 1,298 randomized and treated patients, 866 receiving TAF (DB and OL) and 432 receiving TDF with rollover to OL TAF at year 2 (n = 180; TDF→TAF3y) or year 3 (n = 202; TDF→TAF2y) were included. Fifty (4%) TDF patients who discontinued during DB were excluded. At year 5, 85%, 83%, and 90% achieved HBV DNA <29 IU/mL (missing = failure) in the TAF, TDF→TAF3y, and TDF→TAF2y groups, respectively; no patient developed TAF or TDF resistance. Median estimated glomerular filtration rate (by using Cockcroft-Gault) declined <2.5 mL/min, and mean declines of <1% in hip and spine bone mineral density were seen at year 5 in the TAF group; patients in the TDF→TAF groups had improvements in these parameters at year 5 after switching to OL TAF. DISCUSSION: Long-term TAF treatment resulted in high rates of viral suppression, no resistance, and favorable renal and bone safety. Funding for this study was provided by Gilead Sciences, Inc. 2024-03-12T08:58:31Z 2024-03-12T08:58:31Z 2023 2024-03 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Chan HLY, Buti M, Lim YS, Agarwal K, Marcellin P, Brunetto M, et al. Long-term Treatment With Tenofovir Alafenamide for Chronic Hepatitis B Results in High Rates of Viral Suppression and Favorable Renal and Bone Safety. Am J Gastroenterol. 2024 Mar;119(3):486–96. 1572-0241 https://hdl.handle.net/11351/11179 10.14309/ajg.0000000000002468 37561058 http://hdl.handle.net/11351/11179 eng The American Journal of Gastroenterology;119(3) https://doi.org/10.14309/ajg.0000000000002468 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf Wolters Kluwer Health Scientia