velpatasvir
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hepatitis C virus infection 1 milestone | |||||
| Filed | US (FDA) | — | hepatitis C virus infection | 2015-10-28 | “Announced that the company submitted a New Drug Application to FDA for an investigational, once-daily fixed-dose combination of SOF/VEL” gilead.com ↗ “Based on these data, Gilead submitted a new drug application (NDA) for SOF/VEL to the FDA on October 28, 2015 .” gilead.com ↗ “Gilead filed the NDA for SOF/VEL on October 28, 2015” gilead.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Epclusa | — | 2016-07-06 | europa.eu ↗ |
| Approved | US (FDA) | EPCLUSA | — | 2016-06-28 | fda.gov ↗ |
Trials 52
News releases announcing trial results or a regulatory action · 25
| 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 ↗
A large real-world dataset of 1,888 adults from 33 clinical cohorts found a 98% sustained virologic response (SVR) rate among the effectiveness population (defined as patients achieving SVR or having virologic failure) with Epclusa for 12 weeks across these key underserved patient populations. |
| 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 ↗
Epclusa is the first pan-genotypic, protease inhibitor-free regimen approved in the United States for adults and children. |
| 2019-12-20 | Gilead Sciences | Regulatory China National Medical Products Administration Approves Vosevi® (Sofosbuvir, Velpatasvir and Voxilaprevir) for People With Chronic Hepatitis C Infection Who Require Re-Treatment gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Vosevi ® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a once-daily single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral (DAA) therapy. |
| 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="" old. |
| 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 |
| 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 ↗
Sofosbuvir/velpatasvir for 12 weeks is safe and effective in patients undergoing dialysis |
| 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 ↗ |
| 2017-07-18 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Vosevi™ (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus gilead.com ↗ |
| 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 ↗ |
| 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 ↗ |
| 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 for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). |
| 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 ↗
Data were presented this week at The International Liver Congress TM 2016 in Barcelona, Spain . |
| 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, |
| 2015-04-23 | Gilead Sciences | Results Gilead Announces Data for Investigational, All-Oral, Pan-Genotypic Three-Drug Regimen of Sofosbuvir, GS-5816 and GS-9857 for Chronic Hepatitis C gilead.com ↗
demonstrated sustained virologic response (SVR12) rates following six weeks of treatment of 93 percent (n=14/15) among treatment-naïve, non-cirrhotic patients |
| 2014-11-11 | Gilead Sciences | Results Gilead Announces Phase 2 Data for Investigational All-Oral Regimen of Sofosbuvir Plus GS-5816 for the Treatment of Chronic Hepatitis C gilead.com ↗
Rates of sustained virologic response (SVR12) ranged from 88 percent to 100 percent among those receiving SOF plus GS-5816 100 mg for 12 weeks – the regimen selected for Phase 3 studies. |
| 2014-04-10 | Gilead Sciences | Results Gilead Announces Phase 2 Results for Two Investigational All-Oral Sofosbuvir-Based Regimens for the Treatment of Chronic Hepatitis C gilead.com ↗
Combination of Sofosbuvir and GS-5816 Demonstrates Efficacy Against HCV Genotypes 1-6 |
All press releases naming this drug 33 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 68 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | velpatasvir | “The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for...” NCT02300103 ↗55“Participants will be treated with the pan-genotypic therapeutic regimen "single-pill daily," at a fixed dose and duration: sofosbuvir/velpatasvir 400/100 mg (Epclusa, Gilead...” NCT06306300 ↗ “Fixed dose combination of sofosbuvir 400 mg plus velpatasvir 100 mg once daily plus ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight =\>75 kg) daily in two divided doses” NCT03483987 ↗ “Patients in each cohort were randomly assigned to 25 mg of velpatasvir once daily with or without ribavirin or 100 mg of velpatasvir once daily with or without ribavirin.” PMID 26551263 ↗ Nov 2015 “At 20 sites, 37 individuals with chronic HCV infection of any genotype and compensated cirrhosis received sofosbuvir-velpatasvir (400 mg/100 mg) daily for 12 weeks.” PMID 35802063 ↗ Aug 2022 “voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal” NCT02185794 ↗ “We assessed the efficacy and safety of the NS5B polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir for HCV in patients coinfected with HIV-1.” PMID 28369210 ↗ Jul 2017 “Relapse occurred post treatment in a single case of a non-cirrhotic male with genotype 3, who was treated with sofosbuvir/velpatasvir for 6 weeks.” PMID 33082372 ↗ Oct 2020 “a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).” NCT03222531 ↗ “Sofosbuvir With Velpatasvir in Treatment-Naive Noncirrhotic Patients With Genotype 1 to 6 Hepatitis C Virus Infection: A Randomized Trial.” PMID 26551051 ↗ Nov 2015 “Epclusa (Sofosbuvir/Velpatasvir 400mg/100mg) course initiated at same day of visit following a +ve HCV RNA result from the POC test.” NCT05264558 ↗ |
| Known as | GS-5816 | “sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks” NCT02671500 ↗3“velpatasvir (formerly GS-5816, a second generation NS5A inhibitor)” NCT02745535 ↗ |
| Known as | SOF/VEL | “Sofosbubir/velpatasvir (SOF/VEL) will be administered once daily for 12 weeks to eligible HCV treatment-naïve participants.” NCT03888729 ↗ |
| Known as | sofosbubir/velpatasvir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03888729 ↗ |
| Known as | sofosbuvir-velpatasvir | “Safety and efficacy of sofosbuvir-velpatasvir to treat chronic hepatitis C virus infection in treatment-naive patients in Rwanda (SHARED-3): a single-arm trial.” PMID 35248213 ↗ Mar 2022 |
| Known as | VEL | “sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.” NCT01858766 ↗12“The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)” NCT01909804 ↗ “voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal” NCT02185794 ↗ “Velpatasvir (VEL) is an HCV non-structural protein 5A (NS5A) inhibitor and sofosbuvir (SOF) is an HCV NS5B nucleotide polymerase inhibitor.” NCT03250910 ↗ “In India, four DAAs are available (sofosbuvir [SOF], daclatasvir [DCV], ledipasvir [LDV] and velpatasvir [VEL]).” NCT03483987 ↗ “Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC)” NCT04211909 ↗ “sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX)” NCT05467826 ↗ “voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC)” NCT02378935 ↗ “sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks” NCT02671500 ↗ “Velpatasvir (VEL) tablet(s) administered orally once daily” NCT01826981 ↗ “sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination” NCT02201901 ↗ |
| Known as | Velpatasvir component of epclusa | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545062 ↗ |
| Known as | Velpatasvir component of vosevi | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545062 ↗ |
| Action | Inhibit | “Velpatasvir (VEL, GS-5816) is a novel pan-genotypic hepatitis C virus (HCV) nonstructural protein 5A (NS5A) inhibitor with activity against genotype 1 (GT1) to GT6 HCV replicons.” PMID 27353271 ↗ Aug 2016 |
| Modality | Other / unclassified | “Sofosbuvir-velpatasvir, a pangenotypic direct-acting antiviral regimen” PMID 30946553 ↗ Apr 2019 |
| Route | Oral | “administered orally once daily” NCT01826981 ↗ |