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: 28 Jul 2017
At a glance
- Drugs Ledipasvir/sofosbuvir (Primary) ; Ribavirin
- Indications Hepatitis C
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms ION-1
- Sponsors Gilead Sciences
- 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
- 12 Oct 2016 Results of a phylogenetic analysis from this and 10 other phase III Sofosbuvir trials, published in the Clinical Infectious Diseases.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History