Safety and Effectiveness of Tenofovir Alafenamide in Usual Clinical Practice Confirms Results of Clinical Trials: TARGET-HBV.

Autor: Bernstein DE; Sandra Atlas Bass Center for Liver Diseases, Zucker School of Medicine at Hofstra/Northwell, 400 Community Drive, Manhasset, NY, 11030, USA., Trinh HN; San Jose Gastroenterology, 2331 Montpelier Dr., Suite B, San Jose, CA, 95116, USA., Schiff ER; University of Miami School of Medicine, 1500 N.W. 12 Ave., E-1101, Miami, FL, 33136, USA., Smith CI; Georgetown University Hospital, 3800 Reservoir Rd NW, 2PHC, Washington, DC, 20007, USA., Mospan AR; Target RWE, 2520 Meridian Pkwy, Suite 105, Durham, NC, 27713, USA., Zink RC; Target RWE, 2520 Meridian Pkwy, Suite 105, Durham, NC, 27713, USA., Fried MW; Target RWE, 2520 Meridian Pkwy, Suite 105, Durham, NC, 27713, USA., Lok AS; Division of Gastroenterology and Hepatology, University of Michigan, 1500 East Medical Center Drive, 3912 Taubman Center, SPC 5362, Ann Arbor, MI, 48109, USA. aslok@med.umich.edu.
Jazyk: angličtina
Zdroj: Digestive diseases and sciences [Dig Dis Sci] 2022 Jun; Vol. 67 (6), pp. 2637-2645. Date of Electronic Publication: 2021 May 31.
DOI: 10.1007/s10620-021-07033-y
Abstrakt: 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 .
(© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
Databáze: MEDLINE
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