drugset
Drugs / Ledipasvir/sofosbuvir
last change Oct 2024 re-read 2 minutes ago

Ledipasvir/sofosbuvir

also known as LDV/SOF

Trials 0

Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT02583685 Background May 2015 → Oct 2024 chronic hepatitis C virus infection Humanity and Health Research Centre Completed No outcome recorded

Press releases naming this drug 6 releases

DateIssuerRelease
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.

FieldValueCited text
Known as Ledipasvir/sofosbuvir “Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily” NCT02583685 ↗
Known as LDV/SOF “Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily” NCT02583685 ↗
Route Oral “fixed dose combination (FDC) tablet administered orally once daily” NCT02583685 ↗