Drugs / Sofosbuvir/velpatasvir
Sofosbuvir/velpatasvir
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | 2015-11-17 | “The data included in the application, which was submitted on November 17, 2015, support the use of SOF/VEL among patients with genotype 1-6 HCV infection” gilead.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2015-10-28 | “Gilead filed the NDA for SOF/VEL on October 28, 2015” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT03949764 | Sep 2019 → Jun 2025 | chronic hepatitis C virus infection, substance-related disorder | Jennifer Havens | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2026-07-28 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Meets Both Its Primary and Secondary Endpoints in the Phase 3 C-BEYOND North America Trial Evaluating Bemnifosbuvir/Ruzasvir for Hepatitis C Virus ateapharma.com ↗
BEM/RZR demonstrated statistical non-inferiority compared to the fixed-dose combination of sofosbuvir and velpatasvir (SOF/VEL) in the modified intent-to-treat (mITT) population, achieving the trial’s primary endpoint. |
| 2023-06-14 | Gilead Sciences | Results Gilead to Present Latest Liver Disease Research at the European Association for the Study of the Liver (EASL) Congress 2023 gilead.com ↗
Among patients with baseline DDI-related comedication use, those initiating treatment with Epclusa ® (sofosbuvir/velpatasvir) were less likely to discontinue their DDI-related comedication prior to DAA initiation than patients initiating treatment with glecaprevir/pibrentasvir. |
| 2022-11-01 | Gilead Sciences | Results Gilead to Present Data Across Viral Hepatitis and Liver Fibrosis at The Liver Meeting® 2022, Reinforcing Gilead as a Leader in Addressing Treatment Needs for People Living With Liver Disease gilead.com ↗
GS-2829 / GS-6779 HBV Therapeutic Vaccine Generates Robust, Polyfunctional, Genotype Cross-Reactive CD8 T Cell Responses Accompanied by High Titers of Anti-HBsAg Antibodies |
| 2021-06-10 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves New Formulation of Epclusa®, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric indication of Epclusa ® (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C virus (HCV) to now include children as young as 3 years of age, regardless of HCV genotype or liver disease severity. |
| 2020-03-19 | Gilead Sciences | Regulatory U.S. Food And Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection gilead.com ↗ |
| 2020-02-04 | Gilead Sciences | Regulatory Gilead Sciences Announces Fourth Quarter and Full Year 2019 Financial Results gilead.com ↗
Approval of Vosevi ® (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) by the China National Medical Products Administration for the treatment of chronic HCV infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral therapy. |
| 2019-11-11 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Presents Positive Data from U.S. Phase 2a Study of CC-31244 Demonstrating Ability to Identify Patients More Likely to Respond to Ultrashort Treatment of HCV cocrystalpharma.com ↗
Patients that achieved SVR had significantly higher frequencies of terminally differentiated effector memory CD8+ T cells compared with those who relapsed |
| 2019-10-30 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Announces New Data on CC-31244 and Abstract Acceptance for Poster Presentation at the AASLD 2019 Liver Meeting cocrystalpharma.com ↗
Eight of 12 patients achieved primary endpoint of sustained virologic response (SVR) 12, which is considered a cure, using only 6 weeks of Epclusa’s therapy combined with only 2 weeks of CC-31244 |
| 2019-04-11 | Gilead Sciences | Results Gilead Presents New Data on Viral Hepatitis at the International Liver Congress™ 2019 gilead.com ↗ |
| 2019-03-27 | Gilead Sciences | Results Gilead to Present New Data From Multiple Liver Disease Research and Development Programs at The International Liver Congress™ 2019 gilead.com ↗
High efficacy and improvement in CPT class with sofosbuvir/velpatasvir plus ribavirin for 12 weeks in patients with CPT C decompensated cirrhosis (poster #0138) |
| 2019-01-22 | Cocrystal Pharma, Inc. | Results Cocrystal Pharma Provides Update on Clinical Development Program Evaluating CC-31244 for Ultra-Short Treatment of Hepatitis C Virus cocrystalpharma.com ↗ |
| 2019-01-08 | Gilead Sciences | Regulatory Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) gilead.com ↗ |
| 2018-11-09 | Gilead Sciences | Results Gilead Presents Latest Data from Viral Hepatitis Research Programs at The Liver Meeting® 2018 gilead.com ↗
Data Demonstrate Sofosbuvir-Based Regimens Achieve High Cure Rates in Hepatitis C Patient Populations with Unmet Need |
| 2018-10-11 | Gilead Sciences | Results Gilead to Present Wide-Ranging New Data on Treatment and Diagnosis of Liver Diseases at The Liver Meeting® 2018 gilead.com ↗
Ledipasvir/sofosbuvir for 12 weeks is safe and effective in children 3 to |
| 2018-05-30 | Gilead Sciences | Regulatory China Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir), Gilead’s Pan-Genotypic Treatment for Chronic Hepatitis C Virus Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China Drug Administration (CDA) has approved Epclusa ® (sofosbuvir 400 mg/velpatasvir 100 mg) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. |
| 2017-10-20 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread® gilead.com ↗ |
| 2017-08-01 | Gilead Sciences | Regulatory U.S. FDA Approves Expanded Labeling for Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV gilead.com ↗ |
| 2016-06-28 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. |
| 2016-05-27 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗ |
| 2016-04-16 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies gilead.com ↗
The data presented this week continue to underscore the high cure rates and safety of our sofosbuvir-based HCV therapies, and support their utility across all patient HCV genotypes and disease stages |
| 2016-01-04 | Gilead Sciences | Regulatory Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection gilead.com ↗
The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. |
All press releases naming this drug 30 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sofosbuvir/velpatasvir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03949764 ↗ |
| Known as | Epclusa | “Sofosbuvir/velpatasvir (Epclusa®)” NCT03949764 ↗ |
| Known as | SOF/VEL | “KeY Treat is a phase IV, open-label, single-arm clinical trial of sofosbuvir/velpatasvir (SOF/VEL) for the treatment of viraemic HCV infections.” PMID 34226208 ↗ Jul 2021 |