A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
Phase of Trial: Phase III
Latest Information Update: 24 Jan 2017
At a glance
- Drugs Sofosbuvir/velpatasvir/voxilaprevir (Primary) ; Sofosbuvir/velpatasvir
- Indications Hepatitis C
- Focus Adverse reactions; Therapeutic Use
- Acronyms POLARIS-4
- Sponsors Gilead Sciences
- 20 Jan 2017 According to an European Medicines Agency media release, Marketing Authorization Application (MAA) for once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients has been validated and is now under assessment by the European Medicines Agency (EMA), based on the data from POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4 trials.
- 17 Jan 2017 Status changed from active, no longer recruiting to completed.
- 08 Dec 2016 According to a Gilead Sciences media release, a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients based on the data from POLARIS-1, POLARIS-2, POLARIS-3and POLARIS-4 trials.