Drugs / Sofosbuvir/velpatasvir
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT03036852 | Mar 2017 → Aug 2018 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| 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 ↗
In the mITT analysis (n=905, cirrhotic and non-cirrhotic), BEM/RZR achieved a 93.9% sustained virologic response (SVR) rate vs. 94.8% for SOF/VEL (Epclusa) at Week 24, encompassing SVR at 12 weeks post-treatment (accepted definition of cure for HCV) in both arms. |
| 2025-04-29 | Gilead Sciences | Results Gilead to Present Latest Advancements Across Primary Biliary Cholangitis and Viral Hepatitis gilead.com ↗
The SVR10K Hepatitis C study: Final results show 98.9% SVR in 7,000 patients treated with SOF/VEL in Asia, Latin America, Middle East, Nordics, and Southern Europe |
| 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. |
| 2022-06-21 | Gilead Sciences | Results Gilead to Present Latest Data From Across Liver Disease Development Programs at the International Liver Congress™ 2022 gilead.com ↗
Of note, Gilead will present data from two analyses in Spain which found that scaling up testing and treatment with DAA’s reduced the prevalence and incidence of HCV over time (Poster 3205) and over five years, treatment with Epclusa ® (sofosbuvir/velpatasvir) significantly reduced morbidity and mortality (Poster 3201). |
| 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. |
| 2020-08-25 | 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. |
| 2019-11-08 | Gilead Sciences | Results Gilead Announces New Data from Viral Hepatitis Research Programs at The Liver Meeting® 2019 gilead.com ↗
sofosbuvir/velpatasvir) resulted in a cure rate (SVR12) of 95 percent (97/102) in patients 12 to < 12 years |
| 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 |
| 2019-03-27 | Gilead Sciences | Results Gilead to Present New Data From Multiple Liver Disease Research and Development Programs at The International Liver Congress™ 2019 gilead.com ↗
In vitro modulation by TLR8 agonist GS-9688 of multiple regulatory cell types in patients with chronic hepatitis B (poster #0132) |
| 2017-07-28 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorization for Vosevi ® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), as a once-daily single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. |
| 2016-07-08 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorization for Epclusa ® (sofosbuvir 400 mg/velpatasvir 100 mg), the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. |
| 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 ↗ |
| 2016-01-04 | 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. |
| 2015-12-04 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C gilead.com ↗ |
| 2015-10-28 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C gilead.com ↗ |
| 2015-09-21 | Gilead Sciences | Results Gilead Announces SVR12 Rates from Four Phase 3 Studies Evaluating a Once-Daily, Fixed-Dose Combination of Sofosbuvir (SOF) and Velpatasvir (VEL) (GS-5816) for the Treatment of All Six Hepatitis C Genotypes gilead.com ↗
The ASTRAL study results demonstrate that a 12-week course of therapy with the first fixed-dose combination of two pan-genotypic compounds can provide high cure rates for patients with all HCV genotypes, |
All press releases naming this drug 26 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 | “Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis.” PMID 31195062 ↗ Jun 2019 |
| Known as | SOF/VEL | “The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis...” NCT03036852 ↗ |
| Route | Oral | “400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily” NCT03036852 ↗ |