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

Ledipasvir/Sofosbuvir

also known as LDV/SOF
Developed for
chronic hepatitis C virus infection
Investigated by
Gilead Sciences

Trials 1

today NCT01701401 · Ph 3
201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT01701401 Sep 2012 → Mar 2014 chronic hepatitis C virus infection Gilead Sciences Completed Met primary

Press releases naming this drug 12 releases

DateIssuerRelease
2018-12-04 Gilead Sciences China’s National Medical Products Administration Approves Harvoni® (Ledipasvir/Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Genotype 1-6 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 ↗
2017-04-21 Gilead Sciences Gilead Announces Scientific Presentations Demonstrating Efficacy of Harvoni® (Ledipasvir/Sofosbuvir) in Special Patient Populations With HCV Infection gilead.com ↗
2014-11-18 Gilead Sciences European Commission Grants Marketing Authorization for Gilead’s Harvoni®▼ (Ledipasvir/Sofosbuvir), the First Single Tablet Regimen to Treat the Majority of Chronic Hepatitis C Patients With Genotype 1 and 4 gilead.com ↗
2014-10-16 Gilead Sciences Health Canada Issues Notice of Compliance for Gilead’s Harvoni™ (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C gilead.com ↗
2014-10-10 Gilead Sciences U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C gilead.com ↗
2014-09-26 Gilead Sciences European CHMP Adopts Positive Opinion for Gilead’s Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection in Adults gilead.com ↗
2014-09-24 Gilead Sciences 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 ↗
2014-06-15 Gilead Sciences 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 ↗
2014-04-07 Gilead Sciences Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection gilead.com ↗
2014-03-27 Gilead Sciences European Medicines Agency Validates Gilead’s Marketing Application for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Chronic Hepatitis C Infection gilead.com ↗
2014-02-10 Gilead Sciences Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C gilead.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as ledipasvir-sofosbuvir “Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin” PMID 27553375 ↗ Aug 2016
1

“ledipasvir-sofosbuvir plus ribavirin for 12 weeks” PMID 24725239 ↗ Apr 2014
Known as LDV/SOF “LDV/SOF 90/400 mg FDC tablet administered orally once daily” NCT01701401 ↗
Action Inhibit “the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir” PMID 24725239 ↗ Apr 2014
Route Oral “LDV/SOF 90/400 mg FDC tablet administered orally once daily” NCT01701401 ↗