2026-04-17T16:10:02Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/111792025-10-24T10:29:22Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Lim, Young-Suk
author
Marcellin, Patrick
author
BRUNETTO, MAURIZIA ROSSANA
author
Agarwal, Kosh
author
Chan, Henry Lik Yuen
author
Buti Ferret, Maria
2025-10-24T10:29:22Z
2025-10-24T10:29:22Z
2024-03-12T08:58:31Z2024-03-12T08:58:31Z20232024-03
http://hdl.handle.net/11351/11179
Chronic Hepatitis B; Viral suppression; Favorable renalHepatitis B crònica; Supressió viral; Seguretat renalHepatitis B crónica; Supresión viral; Seguridad renalINTRODUCTION:
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.
Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess
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
Long-term Treatment With Tenofovir Alafenamide for Chronic Hepatitis B Results in High Rates of Viral Suppression and Favorable Renal and Bone Safety
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion