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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 patients who receive heart transplants from hepatitis C-positive donors. The drug is given to hepatitis C-negative patients after transplantation to treat potential HCV infection. It is an investigational small molecule being developed by Merck & Company, Inc. for this cardiovascular indication.
Zepatier targets the hepatitis C virus. It is a direct-acting antiviral that combines two mechanisms: grazoprevir, an NS3/4A protease inhibitor, and elbasvir, an NS5A inhibitor. These work together to block viral replication. In the heart transplant setting, it is used to prevent or treat HCV infection acquired from a positive donor.
Zepatier is developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this drug for use in heart transplant patients who are hepatitis C-negative but receive organs from HCV-positive donors. Merck is the sole developer of this asset.
Zepatier is in Phase 1 clinical development for the heart failure indication. A single Phase 1 trial has been completed, with no active trials currently ongoing. The drug remains investigational and is not yet approved for this use. It is being studied in a small, uncontrolled trial setting.
Zepatier has one completed 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 study enrolled 20 participants in the United States, with a minimum age of 18 years, and included both sexes. The trial was uncontrolled and not randomized or double-blinded.
Zepatier is the brand name for the fixed-dose combination of grazoprevir and elbasvir. It is a single tablet containing both direct-acting antiviral agents. In the context of the heart transplant study, Zepatier refers to this combination product used to treat hepatitis C in recipients of HCV-positive donor hearts.