drugset
Drugs / SOF/VEL
last change Mar 2020 re-read 2 minutes ago

SOF/VEL

also known as sofosbuvir/velpatasvir
Developed for
hepatitis C virus infection
Investigated by
Gilead Sciences

Trials 1 · a red edge is where a trial was stopped

today NCT02822794 · Ph 3
2017201820192020202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT02822794 Jul 2016 → Jun 2017 hepatitis C virus infection Gilead Sciences Completed No outcome recorded

Press releases naming this drug 16 releases

DateIssuerRelease
2020-03-19 Gilead Sciences 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 ↗
2019-01-08 Gilead Sciences Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) gilead.com ↗
2018-09-24 Gilead Sciences Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C gilead.com ↗
2018-05-30 Gilead Sciences China Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir), Gilead’s Pan-Genotypic Treatment for Chronic Hepatitis C Virus Infection gilead.com ↗
2017-08-01 Gilead Sciences 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 ↗
2017-07-28 Gilead Sciences European Commission Grants Marketing Authorization for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
2017-07-18 Gilead Sciences 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 ↗
2017-06-23 Gilead Sciences European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Chronic Hepatitis C Genotypes gilead.com ↗
2017-01-20 Gilead Sciences 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 Gilead Submits New Drug Application to U.S. Food and Drug Administration for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir gilead.com ↗
2016-07-08 Gilead Sciences 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 U.S. Food and Drug Administration Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as SOF/VEL ClinicalTrials.gov intervention name — accepted as the source's own label NCT02822794 ↗
Known as sofosbuvir/velpatasvir “sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV)” NCT02822794 ↗
Route Oral “400/100 mg tablet administered orally once daily” NCT02822794 ↗