drugset

Drugs / sofosbuvir/ledipasvir

Follow last change Aug 2020 re-read 3 minutes ago

sofosbuvir/ledipasvir

also known as LDV/SOF · ledipasvir/sofosbuvir

Developed for: chronic hepatitis C virus infection
Investigated by: Partners in Health

Trials 1

today NCT02964091 · Ph 4

20172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 4	NCT02964091	Oct 2016 → Aug 2020	chronic hepatitis C virus infection	Partners in Health	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 1

Date	Issuer	Release
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

All press releases naming this drug 7 releases

Date	Issuer	Release
2017-07-28	Gilead Sciences	European Commission Grants Marketing Authorization for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Genotypes 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 ↗
2014-09-24	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 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

Field	Value	Cited text
Known as	sofosbuvir/ledipasvir	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02964091 ↗
Known as	LDV/SOF	“medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults” NCT02964091 ↗
Known as	ledipasvir/sofosbuvir	“This is an open-label single arm study that will evaluate the antiviral efficacy, safety and tolerability of ledipasvir/sofosbuvir fixed dose combination administered for 12...” NCT02964091 ↗