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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B

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Trial Profile

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Dec 2023

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At a glance

  • Drugs Tenofovir alafenamide (Primary) ; Tenofovir disoproxil fumarate
  • Indications Hepatitis B
  • Focus Registrational; Therapeutic Use
  • Sponsors Gilead Sciences

Most Recent Events

  • 14 Nov 2023 Results of pooled data (n=1298) assessing to characterize factors associated with virologic failure after 8 years of treatment in a cohort of patients enrolled from GS-US-320-0108 and GS-US-320-0110 trials, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases.
  • 14 Nov 2023 Results assessing annual resistance surveillance from years 3 through 8 of tenofovir alafenamide treatment in patients from studies GS-US-320-0108 and Study GS-US-320-0110, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases.
  • 14 Nov 2023 Results of pooled analysis from two phase 3 studies assessing the safety of TAF, including in patients switched from TDF to TAF, who were considered to be at risk for adverse bone and/or renal effects from TDF based on EASL guidelines presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases.

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