drugset
Drugs / SOF/VEL
last change May 2024 re-read 9 days ago

SOF/VEL

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

“submitted a New Drug Application to FDA for an investigational, once-daily fixed-dose combination of SOF/VEL” gilead.com ↗

“Gilead submitted a new drug application (NDA) for SOF/VEL to the FDA on October 28, 2015” gilead.com ↗

“Gilead has also submitted a regulatory application for SOF/VEL in the United States” gilead.com ↗

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

Trials 1

today NCT02220998 · Ph 3
2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT02220998 Sep 2014 → Jul 2015 chronic hepatitis C virus infection Gilead Sciences Completed Met primary

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2024-05-22 Gilead Sciences Results Gilead to Present Latest Research Across Key Liver Disease Indications at the European Association for the Study of the Liver Congress 2024 gilead.com ↗
Tenofovir-based antiviral therapy reduces long-term incidence of hepatocellular carcinoma in chronic hepatitis B patients
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 ↗
New 96-week clinical data from a Phase 3 study in 488 virologically suppressed adults with chronic hepatitis B virus (HBV) infection demonstrated that once-daily Vemlidy ® (tenofovir alafenamide 25 mg, TAF) sustained viral suppression while improving markers of renal and bone health, after switching from once-daily tenofovir disoproxil fumarate 300 mg (TDF).
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 ↗
2016-04-16 Gilead Sciences Results Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies 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 6 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as SOF/VEL ClinicalTrials.gov intervention name — accepted as the source's own label NCT02220998 ↗
Action Inhibit “the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor velpatasvir” PMID 26575258 ↗ Nov 2015
Route Oral “FDC tablet administered orally once daily” NCT02220998 ↗