2026-04-14T03:32:00Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/123562025-10-24T10:43:42Zcom_2072_378070com_2072_378040col_2072_378092
2025-10-24T10:43:42Z
urn:hdl:11351/12356
Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials
Marcellin, Patrick
Buti Ferret, Maria
Lim, Young-Suk
Chan, Henry Lik Yuen
Agarwal, Kosh
BRUNETTO, MAURIZIA ROSSANA
Avaluació de resultats (Assistència sanitària)
Hepatitis B - Tractament
Medicaments antivírics - Ús terapèutic
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents
Other subheadings::Other subheadings::/therapeutic use
DISEASES::Virus Diseases::Virus Diseases::Hepatitis, Viral, Human::Hepatitis B::Hepatitis B, Chronic
Other subheadings::Other subheadings::Other subheadings::/drug therapy
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos
Otros calificadores::Otros calificadores::/uso terapéutico
ENFERMEDADES::virosis::virosis::hepatitis viral humana::hepatitis B::hepatitis B crónica
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
Efficacy; Chronic infection; Hepatitis B virus
Eficacia; Infección crónica; Virus de la hepatitis B
Eficàcia; Infecció crònica; Virus de l'hepatitis B
Background
In two phase 3 studies, tenofovir alafenamide (TAF) showed non-inferior efficacy versus tenofovir disoproxil fumarate (TDF), with more favourable renal and bone safety in patients with chronic hepatitis B (CHB).
Aims
Here, we report the studies' final 8-year results.
Methods
CHB patients (hepatitis B e antigen [HBeAg]-negative and HBeAg-positive) were randomised (2:1) to double-blind TAF 25 mg/day or TDF 300 mg/day for up to 3 years, followed by open-label (OL) TAF through year 8. Virological, biochemical, serological and fibrosis responses, and safety, including bone and renal parameters, were evaluated. Resistance to TAF was assessed annually by deep sequencing of polymerase/reverse transcriptase and by phenotyping.
Results
Among 1298 patients randomised to double-blind TAF (n = 866) or double-blind TDF (n = 432), 775 in the TAF group and 382 in the TDF group received OL TAF, including 180 and 202 who switched from TDF to TAF at year 2 (TDF2y → TAF6y) or year 3 (TDF3y → TAF5y), respectively. At year 8, among patients in the TAF8y, TDF2y → TAF6y and TDF3y → TAF5y groups, 69%, 66% and 73% (missing-equals-failure analysis) and 95%, 94% and 97% (missing-equals-excluded) of patients, respectively, achieved HBV DNA <29 IU/mL. Estimated glomerular filtration rate (Cockcroft-Gault method; eGFRCG) and hip/spine bone mineral density (BMD) remained stable in patients receiving double-blind/OL TAF, with only small declines at year 8. Decreases in eGFRCG and hip/spine BMD observed during double-blind TDF improved after switching to OL TAF. No patients developed resistance to TAF.
Conclusion
Long-term TAF treatment exhibited favourable safety and tolerability with high rates of viral suppression and no development of resistance.
ClinicalTrials.gov numbers NCT01940341 and NCT01940471.
These studies were funded by Gilead Sciences, Inc.
2025-10-24T10:43:42Z
2025-10-24T10:43:42Z
2024-12-27T10:52:53Z
2024-12-27T10:52:53Z
2024-12
info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://hdl.handle.net/11351/12356
Alimentary Pharmacology & Therapeutics;60(11-12)
https://doi.org/10.1111/apt.18278
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
Wiley
Scientia