drugset
Drugs / Ledipasvir/Sofosbuvir
last change Mar 2019 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 · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed EU (EMA) — chronic hepatitis C virus infection 2014-02-27

“Announced that the company’s Marketing Authorisation Application for LDV/SOF has been fully validated and is now under assessment by the European Medicines Agency .” gilead.com ↗
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 NCT02457611 · Ph 2
201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT02457611 Jun 2015 → Jan 2016 hepatitis C virus infection Gilead Sciences Completed No outcome recorded

News releases announcing trial results or a regulatory action · 15

DateIssuerRelease
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 ↗
Ledipasvir/sofosbuvir for 8, 12, or 24 weeks is safe and effective in patients undergoing dialysis (poster #0144)
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 ↗
Ledipasvir/sofosbuvir for 12 weeks is safe and effective in children 3 to
2017-07-28 Gilead Sciences Regulatory European Commission Grants Marketing Authorization for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
European Commission Also Extends Marketing Authorization for Harvoni ® (sofosbuvir/ledipasvir), Enabling First Direct-Acting Antiviral Regimen for Adolescent Hepatitis C Patients
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).
2016-04-16 Gilead Sciences Results Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies gilead.com ↗
2016-02-16 Gilead Sciences Regulatory U.S. FDA Approves Two Supplemental Indications for Harvoni® in Chronic Hepatitis C Patients With Advanced Liver Disease gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved additional indications for Harvoni ® (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease.
2015-11-12 Gilead Sciences Regulatory U.S. FDA Approves New Indications for Harvoni®, Gilead’s Once-Daily Single Tablet Regimen for Chronic Hepatitis C gilead.com ↗
In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.
2015-07-03 Gilead Sciences Regulatory Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Harvoni®, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C gilead.com ↗
2014-09-24 Gilead Sciences Regulatory Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Fixed-Dose Combination of Ledipasvir/Sofosbuvir for Chronic Hepatitis C Genotype 1 Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval
2014-06-15 Gilead Sciences Results Gilead Announces Phase 3 Data Showing That the Fixed-Dose Combination of Ledipasvir/Sofosbuvir Achieved 100 Percent Sustained Virologic Response (SVR12) Among Patients with Chronic Hepatitis C in Japan gilead.com ↗
Among patients receiving 12 weeks of LDV/SOF without RBV, 100 percent (n=83/83) of treatment-naïve and 100 percent (n=88/88) of treatment-experienced patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12).
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 ↗

All press releases naming this drug 21 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 ledipasvir-sofosbuvir “The rate of cure with a fixed-dose combination of ledipasvir-sofosbuvir for patients with acute genotype 1 or 4 HCV infection and HIV-1 coinfection is similar to historic rates...” PMID 28397698 ↗ Mar 2017
1

“Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human...” NCT02457611 ↗
Known as LDV/SOF “Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human...” NCT02457611 ↗
Route Oral “90/400 mg FDC tablet administered orally once daily” NCT02457611 ↗