Drugs / LDV/SOF
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT01965535 | Oct 2013 → Aug 2014 | hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
Among genotype 1-infected patients who had failed prior treatment with SOF plus RBV, 100 percent (19/19) achieved SVR12 following 12 weeks of LDV/SOF plus RBV. |
| 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, |
All press releases naming this drug 2 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LDV/SOF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01965535 ↗ |
| Known as | SOF/LDV | “SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks” NCT01965535 ↗ |
| Action | Inhibit | “the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir” PMID 25773757 ↗ Mar 2015 |
| Route | Oral | “LDV/SOF (90/400 mg) FDC tablet administered orally once daily” NCT01965535 ↗ |