drugset
Drugs / SOF/VEL
last change Jun 2022 re-read 9 days ago

SOF/VEL

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

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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 ↗

“Gilead filed the NDA for SOF/VEL on October 28, 2015” gilead.com ↗

Trials 1

today NCT02994056 · Ph 2
20172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT02994056 Jan 2017 → Sep 2018 chronic hepatitis C virus infection Gilead Sciences Completed No outcome recorded

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
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.
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 ↗
2016-05-27 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 ↗
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 ↗
SOF/VEL Granted an Accelerated Assessment by the European Medicines Agency
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 8 releases

DateIssuerRelease

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 NCT02994056 ↗
Known as sofosbuvir velpatasvir “treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks” NCT02994056 ↗
Route Oral “400/100 mg FDC tablet administered orally once daily” NCT02994056 ↗