Drugs / SOF/VEL/VOX
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02607800 | Nov 2015 → Oct 2016 | chronic hepatitis C virus infection | Gilead Sciences | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2017-06-23 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Chronic Hepatitis C Genotypes gilead.com ↗
The CHMP positive opinion was adopted following an accelerated assessment procedure, reserved for medicinal products expected to be of major public health interest. |
| 2017-01-20 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) gilead.com ↗ |
| 2016-12-08 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for an investigational, 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. |
| 2016-10-20 | Gilead Sciences | Results Gilead Announces SVR12 Rates From Four Phase 3 Studies of a Once-Daily, Fixed-Dose Combination of Sofosbuvir, Velpatasvir and Voxilaprevir in Treatment-Naïve and Treatment-Experienced Genotype 1-6 Chronic HCV-Infected Patients gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced topline results from four international Phase 3 clinical studies (POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4) |
All press releases naming this drug 4 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SOF/VEL/VOX | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02607800 ↗ |
| Known as | sofosbuvir-velpatasvir-voxilaprevir | “In 2 phase 3, open-label trials, patients with HCV infection who had not been treated previously with a direct-acting antiviral agent were assigned randomly to groups given...” PMID 28390869 ↗ Apr 2017 |
| Action | Inhibit | “We assessed the efficacy of 8 weeks of treatment with sofosbuvir and velpatasvir plus the pangenotypic NS3/4A protease inhibitor voxilaprevir (sofosbuvir-velpatasvir-voxilaprevir).” PMID 28390869 ↗ Apr 2017 |
| Route | Oral | “400/100/100 mg tablet administered orally once daily with food” NCT02607800 ↗ |