A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive 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 (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Oct 2017

At a glance

  • Drugs Ledipasvir/sofosbuvir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ION-1
  • 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, NCT01726517, NCT01768286, NCT01851330) published in the Journal of Hepatology
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top