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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.

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Fig. 1

Abbreviations

TDF:

Tenofovir disoproxil fumarate

HBV:

Hepatitis B virus

HBeAg:

Hepatitis B e-antigen

TAF:

Tenofovir alafenamide

ALT:

Alanine aminotransferase

DEXA:

Dual-energy X-ray absorptiometry

HCV:

Hepatitis C virus

CrCl:

Creatinine clearance

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Authors and Affiliations

Authors

Corresponding author

Correspondence to Anna S. Lok.

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Conflict of interest

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.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Bernstein, D.E., Trinh, H.N., Schiff, E.R. et al. Safety and Effectiveness of Tenofovir Alafenamide in Usual Clinical Practice Confirms Results of Clinical Trials: TARGET-HBV. Dig Dis Sci 67, 2637–2645 (2022). https://doi.org/10.1007/s10620-021-07033-y

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  • DOI: https://doi.org/10.1007/s10620-021-07033-y

Keywords

  • Hepatitis B
  • Tenofovir disoproxil fumarate (TDF)
  • Antiviral therapy
  • HBV DNA