A Phase 3b, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination +/- Ribavirin in Treatment-Naive and Treatment-Experienced Japanese Subjects With Chronic Genotype 1 HCV Infection
Latest Information Update: 14 Jan 2020
At a glance
- Drugs Ledipasvir/sofosbuvir (Primary) ; Ribavirin
- Indications Hepatitis C
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Gilead Sciences
- 24 Dec 2015 Pooled data analysis results from ION-1, ION-2, ION-3 and GS-US337-0113 in genotype 1 HCV infected patients, published in the Hepatology
- 03 Jul 2015 The Japanese MHLW approved Harvoni (ledipasvir 90mg/sofosbuvir 400mg) for the treatment of chronic hepatitis C virus genotype 1 infection in adults, according to a Gilead Sciences media release.
- 01 Jun 2015 Results published in The Lancet Infectious Diseases.