Drugs / Sofosbuvir/Velpatasvir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2015-10-28 | “Based on these data, Gilead submitted a new drug application (NDA) for SOF/VEL to the FDA on October 28, 2015 .” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT03512210 | Oct 2018 → Jul 2020 | HIV infectious disease, hepatitis C virus infection | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| 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. |
| 2022-06-21 | Gilead Sciences | Results Gilead to Present Latest Data From Across Liver Disease Development Programs at the International Liver Congress™ 2022 gilead.com ↗
Real-world evidence from the Kaiser Permanente Southern California healthcare system will also be presented (Poster 2954), showing a reduction in HCV-related morbidity and mortality, and a significant improvement in quality-adjusted life-years (QALYs) in patients treated with DAAs like sofosbuvir/velpatasvir. |
| 2020-08-25 | Gilead Sciences | Results Gilead Announces Presentation of More Than 40 Abstracts From Extensive Liver Disease Programs at the Digital International Liver Congress™ 2020 gilead.com ↗
Additionally, an analysis of data from eight primary care clinics in Australia found that treatment with Epclusa for 12 weeks resulted in a 98% cure rate in a marginalized, diverse patient population, including those with compensated cirrhosis. |
| 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 |
All press releases naming this drug 12 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sofosbuvir/Velpatasvir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03512210 ↗ |
| Known as | SOF/VEL | “Sofosbuvir/Velpatasvir (SOF/VEL)” NCT03512210 ↗ |
| Route | Oral | “400/100 mg fixed-dose combination (FDC) tablet administered orally once daily with or without food.” NCT03512210 ↗ |