| |
著者: Henry L Y Chan, Maria Buti, Young-Suk Lim, Kosh Agarwal, Patrick Marcellin, Maurizia Brunetto, Wan-Long Chuang, Harry L A Janssen, Scott Fung, Namiki Izumi, Dzhamal Abdurakhmanov, Maciej Jabłkowski, Mustafa K Celen, Xiaoli Ma, Florin Caruntu, John F Flaherty, Frida Abramov, Hongyuan Wang, Gregory Camus, Anu Osinusi, Calvin Q Pan, Dr Shalimar, Wai-Kay Seto, Edward Gane
雑誌名: Am J Gastroenterol. 2023 Aug 10;119(3):486-96. doi: 10.14309/ajg.0000000000002468. Epub 2023 Aug 10.
Abstract/Text
OBJECTIVES: Results from two Phase 3 studies, through 2 years, in chronic hepatitis B infection (CHB) showed tenofovir alafenamide (TAF) had similar efficacy to tenofovir disoproxil fumarate (TDF) with superior renal and bone safety. Here, we report updated results through 5 years.
METHODS: Patients with HBeAg-negative or -positive CHB 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, serologic), resistance (deep sequencing of polymerase/reverse transcriptase and phenotyping), and safety, including renal and bone parameters, were evaluated by pooled analyses.
RESULTS: Of 1298 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 eGFR (by 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.
CONCLUSIONS: Long-term TAF treatment resulted in high rates of viral suppression, no resistance, and favorable renal and bone safety.
Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.
PMID 37561058 Am J Gastroenterol. 2023 Aug 10;119(3):486-96. doi: 10.14309/ajg.0000000000002468. Epub 2023 Aug 10.
|
