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-Negative, Chronic Hepatitis B

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-Negative, Chronic Hepatitis B

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Oct 2017

At a glance

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

    • 24 Oct 2017 Results of whole genome HBV sequencing analysis in patients (n=1098) enrolled in two global phase 3 studies (GS-US-320-0108 and GS-US-320-0110), presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases.
    • 24 Oct 2017 Results assessing bone and renal safety at 1 year (through Week 144) after switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in patients from two identically-designed studies (Study 108 and Study 110), presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases.
    • 24 Oct 2017 Results (n=1298) from two phase III studies (GS-US- 320-0108 and GS-US-320-0110) assessing the efficacy and safety of TAF compared with TDF in patients considered to be at risk for adverse bone and/or renal effects from TDF, presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases
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