Sistema de Salut de Catalunya
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
2024-03-12T08:58:31Z
2024-03-12T08:58:31Z
2023
2024-03
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.
Article
Published version
English
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
Wolters Kluwer Health
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/
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