drugset
Drugs / Ledipasvir/Sofosbuvir
last change Dec 2018 re-read 3 minutes ago

Ledipasvir/Sofosbuvir

also known as LDV/SOF
Developed for
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 2014-02-10

“Gilead filed the NDA for LDV/SOF on February 10, 2014” gilead.com ↗

Trials 1

today NCT02301936 · Ph 2
2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT02301936 Mar 2015 → Apr 2016 hepatitis C virus infection Gilead Sciences Completed No outcome recorded

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2018-11-09 Gilead Sciences Results Gilead Presents Latest Data from Viral Hepatitis Research Programs at The Liver Meeting® 2018 gilead.com ↗
Early Data from Gilead’s Functional Hepatitis B Cure Program Suggest Activation of Immune Cells Crucial to Viral Clearance
2017-04-21 Gilead Sciences Results Gilead Announces Scientific Presentations Demonstrating Efficacy of Harvoni® (Ledipasvir/Sofosbuvir) in Special Patient Populations With HCV Infection gilead.com ↗
The studies demonstrated HCV cure rates of 99 percent in children aged 6 to 11 years (#PS-101), and 100 percent in adult patients co-infected with HCV and hepatitis B virus (HBV) (#PS-098).
2015-03-26 Gilead Sciences Regulatory Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Sovaldi® (sofosbuvir) for the Treatment of Genotype 2 Chronic Hepatitis C gilead.com ↗
2014-04-07 Gilead Sciences Regulatory Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection gilead.com ↗
The FDA has also assigned LDV/SOF a Breakthrough Therapy designation.
2014-03-27 Gilead Sciences Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Chronic Hepatitis C Infection gilead.com ↗
LDV/SOF Granted an Accelerated Assessment by the European Medicines Agency
2014-02-10 Gilead Sciences Regulatory Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C gilead.com ↗

All press releases naming this drug 14 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 Ledipasvir/Sofosbuvir “Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease” NCT02301936 ↗
Known as LDV/SOF “The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)...” NCT02301936 ↗
Route Oral “90/400 mg fixed dose combination (FDC) tablet administered orally once daily” NCT02301936 ↗