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Drugs / LDV/SOF
last change Apr 2017 re-read 3 minutes ago

LDV/SOF

also known as ledipasvir (LDV)-SOF · ledipasvir-sofosbuvir · Sofosbuvir/Ledipasvir
Developed for
hepatitis C virus infection
Investigated by
Gilead Sciences

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed acute hepatitis C virus infection 1 milestone
Filed US (FDA) — acute hepatitis C virus infection 2014-02-10

“Gilead filed the NDA for LDV/SOF on February 10, 2014 , and the FDA has set a target action date” gilead.com ↗
Filed chronic hepatitis C virus infection 1 milestone
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 ↗

Trials 1

today NCT01987453 · Ph 2
2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT01987453 Jul 2014 → Nov 2015 hepatitis C virus infection Gilead Sciences Completed No outcome recorded

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
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).
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 LDV/SOF plus RBV, 96 percent (n=80/83) of treatment-naïve and 100 percent of treatment-experienced patients (n=87/87) achieved SVR12.
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 ↗
2013-12-18 Gilead Sciences Results Gilead Announces SVR12 Rates From Three Phase 3 Studies Evaluating a Once-Daily Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients gilead.com ↗
The results of the ION studies demonstrate that a simple, safe and short course of therapy with a single tablet regimen of sofosbuvir/ledipasvir can provide high cure rates among patients with genotype 1 HCV infection, while eliminating the need for both interferon and ribavirin,
2013-05-02 Gilead Sciences Results Gilead Reports Interim Data From Phase 2 LONESTAR Study gilead.com ↗
In this study, 19/19 patients in the 12-week arm had a sustained virologic response four weeks after completing therapy (SVR4)
2013-03-26 Gilead Sciences Results Gilead Announces Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients gilead.com ↗

All press releases naming this drug 8 releases

DateIssuerRelease

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as LDV/SOF ClinicalTrials.gov intervention name — accepted as the source's own label NCT01987453 ↗
Known as ledipasvir (LDV)-SOF “We conducted an open-label trial to assess the efficacy and safety of ledipasvir (LDV)-SOF plus RBV in patients with genotype 1 hepatitis C virus (HCV)” PMID 25846014 ↗ Apr 2015
Known as ledipasvir-sofosbuvir “Ledipasvir-sofosbuvir plus ribavirin for patients with genotype 1 hepatitis C virus previously treated in clinical trials of sofosbuvir regimens.” PMID 25846014 ↗ Apr 2015
Known as Sofosbuvir/Ledipasvir “An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin” NCT01987453 ↗