Drugs / Elbasvir / Grazoprevir
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT03823911 | Nov 2018 → Dec 2022 | HIV infectious disease, cardiovascular disorder, hepatitis C virus infection | University of Maryland, Baltimore | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2017-10-21 | Merck Sharp & Dohme LLC | Results Real-World Study Shows ZEPATIER® (Elbasvir and Grazoprevir) Resulted in High Rates of Sustained Virologic Response in Patients with Chronic Hepatitis C Infection Who Have Chronic Kidney Disease merck.com ↗
The response rates in the real-world setting of the VA further supplement findings from controlled clinical studies of ZEPATIER. |
| 2017-04-21 | Merck Sharp & Dohme LLC | Results Real-World Observational Study in the U.S. Veterans Affairs System Evaluating Use of Merck’s ZEPATIER® (Elbasvir and Grazoprevir) Shows High Sustained Virologic Response Rates in Patients with Chronic Hepatitis C merck.com ↗
For the evaluable population (n=2,436), 95.6 percent of veterans treated with ZEPATIER achieved the primary outcome of sustained virologic response (SVR), defined as undetectable HCV RNA at least twelve weeks after the end of treatment. |
| 2017-04-05 | Merck Sharp & Dohme LLC | Results Merck to Present New Data on ZEPATIER® (elbasvir and grazoprevir) and Investigational Combination Therapy MK-3682B for the Treatment of Chronic Hepatitis C Infection at The International Liver Congress™ 2017 merck.com ↗
Elbasvir/Grazoprevir Plus Sofosbuvir in Treatment-Naive and Treatment-Experienced Cirrhotic Patients With Hepatitis C Virus Genotype 3 Infection Treated for 8, 12, or 16 weeks: Final Results of the C-ISLE Study |
| 2016-11-12 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of New Findings for ZEPATIER™ (Elbasvir and Grazoprevir) in Patients with Chronic Hepatitis C at The Liver Meeting® merck.com ↗
The analysis showed 97 percent of patients (1040/1070) achieved sustained virologic response 12 weeks after the completion of therapy (SVR12, considered virologic cure). |
| 2016-08-08 | Merck Sharp & Dohme LLC | Results Results from Merck’s Phase 3 Study Evaluating ZEPATIER™ (elbasvir and grazoprevir) in Patients with Chronic Hepatitis C Receiving Treatment for Opioid Dependence Published in Annals of Internal Medicine merck.com ↗
The published efficacy results from the randomized, double-blind, placebo-controlled C-EDGE CO-STAR trial showed 92 percent (184/201) of patients receiving ZEPATIER for 12 weeks in the study’s immediate treatment group achieved SVR12 |
| 2016-05-27 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union merck.com ↗
today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER ™ (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment of chronic hepatitis C virus (HCV) in adult patients. |
| 2016-05-05 | Merck Sharp & Dohme LLC | Regulatory Merck Announces First-Quarter 2016 Financial Results merck.com ↗
The FDA approved ZEPATIER (elbasvir and grazoprevir), a once-daily, fixed-dose combination tablet for the treatment of adult patients with chronic hepatitis C virus genotype (GT) 1 or GT4 infection, with or without ribavirin. |
| 2016-04-16 | Merck Sharp & Dohme LLC | Results Merck Announces Results From Phase 3 Studies of ZEPATIER™ (Elbasvir and Grazoprevir) in Chronic Hepatitis C Patient Populations at The International Liver Congress™ merck.com ↗
Findings from C-EDGE CO-STAR showed a high rate of SVR 24 weeks after completion of treatment (SVR24) for the baseline chronic HCV infection and provided insights into the incidence of reinfection in this high risk population (abstract #SAT-163). |
| 2016-04-13 | Merck Sharp & Dohme LLC | Results Merck’s ZEPATIER™ (Elbasvir and Grazoprevir) Showed Superiority on Efficacy and Safety Endpoints Compared to Sofosbuvir Plus Peginterferon and Ribavirin Treatment Regimen in Phase 3 Trial merck.com ↗
In this study, ZEPATIER demonstrated superiority on efficacy and safety endpoints compared to sofosbuvir plus pegIFN/RBV, based on pre-specified analyses. |
| 2016-01-28 | Merck Sharp & Dohme LLC | Regulatory Merck Receives FDA Approval of ZEPATIER™ (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review merck.com ↗ |
All press releases naming this drug 13 releases
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 | Elbasvir / Grazoprevir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03823911 ↗ |
| Known as | Zepatier | “Elbasvir / Grazoprevir Oral Tablet [Zepatier]” NCT03823911 ↗ |
| Route | Oral | “Elbasvir / Grazoprevir Oral Tablet [Zepatier]” NCT03823911 ↗ |