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A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination (FDC) +/- Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination (FDC) for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection

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Trial Profile

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination (FDC) +/- Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination (FDC) for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jan 2020

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At a glance

  • Drugs Ledipasvir/sofosbuvir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ION-3
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 24 Oct 2017 Results of ION 1,2 and 3 trials presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases
    • 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, NCT01768286) published in the Journal of Hepatology

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