Drugs / Ledipasvir/Sofosbuvir
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2014-02-10 | “Gilead filed the NDA for LDV/SOF on February 10, 2014” gilead.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02613871 | Dec 2015 → Jan 2017 | hepatitis C virus infection | Gilead Sciences | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2019-03-27 | Gilead Sciences | Results Gilead to Present New Data From Multiple Liver Disease Research and Development Programs at The International Liver Congress™ 2019 gilead.com ↗
High efficacy and improvement in CPT class with sofosbuvir/velpatasvir plus ribavirin for 12 weeks in patients with CPT C decompensated cirrhosis (poster #0138) |
| 2018-11-09 | Gilead Sciences | Results Gilead Presents Latest Data from Viral Hepatitis Research Programs at The Liver Meeting® 2018 gilead.com ↗
Data Demonstrate Sofosbuvir-Based Regimens Achieve High Cure Rates in Hepatitis C Patient Populations with Unmet Need |
| 2016-02-16 | Gilead Sciences | Regulatory U.S. FDA Approves Two Supplemental Indications for Harvoni® in Chronic Hepatitis C Patients With Advanced Liver Disease gilead.com ↗
Harvoni in combination with ribavirin (RBV) for 12 weeks was approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation. |
| 2015-07-03 | Gilead Sciences | Regulatory Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Harvoni®, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Harvoni ® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. |
| 2014-04-02 | Gilead Sciences | Results Gilead Announces Results From Phase 3 Study of Sofosbuvir Among Hepatitis C Patients in Japan gilead.com ↗
In the study, 97 percent (n=148/153) of genotype 2 HCV-infected patients receiving 12 weeks of an all-oral regimen of sofosbuvir plus RBV achieved a sustained virologic response 12 weeks after completing therapy (SVR12). |
All press releases naming this drug 17 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ledipasvir/Sofosbuvir | “Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment.” PMID 34864948 ↗ Aug 2022 |
| Known as | LDV/SOF | “The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults...” NCT02613871 ↗ |
| Action | Inhibit | “the HCV NS5A inhibitor ledipasvir with 400 mg of the NS5B nucleotide analogue inhibitor sofosbuvir” PMID 29174546 ↗ Nov 2017 |
| Route | Oral | “90/400 mg FDC tablet administered orally once daily” NCT02613871 ↗ |