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.
Phase of Trial: Phase III
Latest Information Update: 31 Jan 2019
At a glance
- Drugs Ledipasvir/sofosbuvir (Primary) ; Ribavirin
- Indications Hepatitis C
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms ION-1
- Sponsors Gilead Sciences
- 01 Oct 2018 Results of a pooled analysis assessing patients reported outcomes from 11 studies, published in the Value in Health.
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History