@article{0b557c3988e9450f9143025ddd16b5b4,
title = "Safety and Effectiveness of Tenofovir Alafenamide in Usual Clinical Practice Confirms Results of Clinical Trials: TARGET-HBV",
abstract = "Background: Nucleos(t)ide analogues, with a proven record of safety and efficacy, have been the therapy of choice for over a decade for the treatment of chronic hepatitis B. The approval of tenofovir alafenamide (TAF) in 2016 provided an additional treatment option. Aims: The aim of this study was to evaluate the characteristics and clinical outcomes of patients treated with TAF in usual clinical practice. Methods: Retrospective data from electronic health records was obtained from those enrolled in TARGET-HBV, a longitudinal observational cohort study of patients with chronic hepatitis B managed according to local practice standards at community and academic medical centers throughout the U.S. Results: Of 500 patients enrolled, most were male (66%) and of Asian race (66%) with median age of 55 years. Cirrhosis was evident in 15%. Most patients (82%) had switched to TAF after treatment with other antivirals. The perceived safety profile of TAF was cited as the primary reason for changing therapy (32%). TAF was well tolerated and only 4 patients discontinued therapy due to adverse event during a median duration of TAF dosing of 74 weeks. Among those with paired laboratory data 12–18 months after switching to TAF, biochemical response and HBV DNA suppression was maintained. Most patients had normal renal function which was essentially unchanged throughout follow-up. Conclusions: TAF is frequently utilized in routine clinical practice due to the perception of its improved safety profile. The current study supports the growing body of evidence regarding the safety and effectiveness of TAF. Trial Registration ClinicalTrials.gov identifier: NCT03692897, https://clinicaltrials.gov/ct2/show/NCT03692897.",
keywords = "Antiviral therapy, HBV DNA, Hepatitis B, Tenofovir disoproxil fumarate (TDF)",
author = "Bernstein, {David E.} and Trinh, {Huy N.} and Schiff, {Eugene R.} and Smith, {Coleman I.} and Mospan, {Andrea R.} and Zink, {Richard C.} and Fried, {Michael W.} and Lok, {Anna S.}",
note = "Funding Information: DEB: Receives grants from Gilead, Pfizer, Protagonist, Assembly Biosciences, Durect, Mallinckrodt, Novartis, Mirum, Pliant, Boehringer Ingelheim, Abbvie and serves as a consultant to Gilead, Abbvie. HNT: grants from Gilead, Assembly Biosciences, Intercept; speaker: Gilead, Abbvie; consultant: Gilead; stocks: Gilead. ERS: Grant support: Eiger, Galmed, Zydus, Celgene, Beckman, Biokit, Bristol Myers Squibb, Conatus, Celgene, Discovery Life Sciences, Genfit, Gilead, Intercept, Novartis, Novo Nordisk, Orasure Technologies, Ortho Diagnostics, Pfizer, Prometheus Lab, Roche Diagnostics, Shire, Siemens, Target RWE, Tobira, Glaxo Smith Kline; Royalties: Wiley. CIS: No relevant conflicts of interest. ARM, RCZ: Employee of Target RWE. MWF: Chief Medical Officer for Target RWE and receives personal fees and is a stockholder in the company. He reports grants paid to the University of North Carolina from Gilead, Abbvie, National Institutes of Health and Merck, outside the submitted work. ASL: Receives research grants from Bristol-Myers Squibb, Gilead and TARGET RWE (paid to University of Michigan), and serves as consultant/advisor for Ambys, Bristol-Myers Squibb, Huahui, Lilly, and TARGET RWE. Target RWE is the sponsor of the TARGET-HBV study and is solely responsible for data collection and analysis and the decision to publish, as well as preparation of the manuscript with co-authors. TARGET-HBV is a collaboration among academic and community investigators and the pharmaceutical industry and is supported in part by funding from Gilead. Publisher Copyright: {\textcopyright} 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.",
year = "2021",
doi = "10.1007/s10620-021-07033-y",
language = "English (US)",
journal = "Digestive Diseases and Sciences",
issn = "0163-2116",
publisher = "Plenum Publishers",
}