A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

Trial Profile

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

Completed
Phase of Trial: Phase III

Latest Information Update: 09 May 2017

At a glance

  • Drugs Sofosbuvir/velpatasvir (Primary) ; Ribavirin; Sofosbuvir
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ASTRAL-2
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 09 May 2017 Results (n=123) of a retrospective analysis evaluating the safety and efficacy of sofosbuvir/velpatasvir in patients aged 65 and older with HCV GT 1-6 from ASTRAL 1, 2 & 3 studies, presented at the Digestive Disease Week 2017.
    • 09 May 2017 Results of an integrated analysis from this and 10 other studies assessing efficacy and safety of various 12 and 16 week sofosbuvir based oral regimens for HCV GT2 infection, presented at the Digestive Disease Week 2017.
    • 14 Jul 2016 According to a Gilead Sciences, Health Canada has issued a Notice of Compliance approving EPCLUSA (sofosbuvir/velpatasvir) for the treatment of adults with genotype 1-6 chronic HCV based on results from ASTRAL 1-4 trials.
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