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Label indication ZEPATIER ® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations [see Dosage and Administration (2.2) ] . FDA label
Zepatier · 1 trial · 1 indication
The primary analysis will be based on a calculation of SVR rates (number of subjects with SVR; negative HCV RNA after completing Zepatier therapy) / (number of subjects treated with Zepatier post-heart transplantation)
| Arm | Type | Description |
|---|---|---|
| Zepatier (grazoprevir 100mg and elbasvir 50 mg) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Zepatier | DRUG | Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines. |
Inclusion Criteria: * New York Heart Association (NYHA) Class III or IV CHF refractory to maximal medical therapy (ACE inhibitor, B-blocker, digoxin and diuretics, resynchronization therapy or Implantable Cardioverter Defibrillator when applicable) and/or conventional surgery. * Inoperable coronary...
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Zepatier is being studied for use in heart failure, specifically in hepatitis C-negative patients who receive heart transplants from hepatitis C-positive donors. It is an investigational small molecule developed by Merck & Company, Inc. (MRK) and is in Phase 1 clinical development.
Zepatier is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is responsible for the clinical development of the drug.
Zepatier is in Phase 1 clinical development. It has not been approved by the FDA for any indication and remains an investigational therapy.
Zepatier has been studied in one clinical trial, NCT03146741, titled "Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors (HCV)." This Phase 1 trial enrolled 20 participants in the United States and is now completed.
Zepatier is the drug name used by Merck & Company, Inc. for its investigational small molecule. It is not known by any other alternative names in the context of this development program.