A phase 3, multicenter, randomized, open-label study to investigate the efficacy and safety of sofosbuvir/GS-5885 fixed-dose combination ± ribavirin for 12 and 24 weeks in treatment-experienced subjects with chronic genotype 1 HCV infection

Trial Profile

A phase 3, multicenter, randomized, open-label study to investigate the efficacy and safety of sofosbuvir/GS-5885 fixed-dose combination ± ribavirin for 12 and 24 weeks in treatment-experienced subjects with chronic genotype 1 HCV infection

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jul 2017

At a glance

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

    • 28 Jul 2017 According to a Gilead Sciences media release, the company announced an extension of the marketing authorization for Harvoni. Previously authorized for the treatment of adults with chronic HCV genotype 1, 3, 4, 5 or 6 infection, the indication for Harvoni has been extended to include the treatment of chronic HCV genotype 1, 3, 4, 5 and 6 infection in adolescents aged 12 to < 18 years.
    • 03 Dec 2016 Results of post treatment resistance analysis (n=51) using data from this and four other trials (NCT01260350, NCT01701401, NCT01726517, NCT01851330) published in the Journal of Hepatology
    • 12 Oct 2016 Results published in the Clinical Infectious Diseases
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