A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and Cirrhosis
Phase of Trial: Phase III
Latest Information Update: 24 Dec 2015
At a glance
- Drugs Simeprevir (Primary) ; Sofosbuvir (Primary)
- Indications Hepatitis C
- Focus Registrational; Therapeutic Use
- Acronyms OPTIMIST-2
- Sponsors Janssen R&D Ireland
- 24 Dec 2015 Results published in the Hepatology
- 24 Jul 2015 According to a Medivir AB media release, Janssen has submitted a sNDA to the U.S.FDA to update the label for once-daily, all-oral OLYSIO (simeprevir), based on the results of this and OPTIMIST-1 trial.
- 23 Jul 2015 Results published in Janssen Therapeutics media release.