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Epclusa · 1 trial · 1 indication
The primary analysis will be based on a calculation of SVR rates (number of subjects with SVR-12; negative HCV RNA 12 weeks after completing Epclusa therapy)/(number of subjects treated with Epclusa post-kidney transplantation)
| Arm | Type | Description |
|---|---|---|
| Epclusa (sofosbuvir/velpatasvir) | EXPERIMENTAL | Epclusa is taken by mouth for 12 weeks as per the FDA label. |
| Name | Type | Description |
|---|---|---|
| Epclusa | DRUG | All patients will receive 12 weeks of sofosbuvir/velpatasvir as per the FDA label. |
Inclusion Criteria: * Able to provide informed consent * Active waiting list status for isolated kidney transplant * 18 years of age or older * No living kidney donor * Panel reactive antibody (PRA) ≤97% (most recent cPRA at time of screening). Patients with a PRA of 98-100% at screening can be inc...
Epclusa is being studied for use in patients with End Stage Renal Disease who are receiving kidney transplants from donors with Hepatitis C. The drug is given to Hepatitis C-negative kidney recipients to treat the infection acquired from the transplanted organ.
Epclusa is a small molecule antiviral that targets the Hepatitis C virus. It combines two direct-acting antiviral agents that inhibit viral proteins essential for Hepatitis C replication, allowing the virus to be cleared from the body.
Epclusa is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead is responsible for the clinical development and manufacturing of the drug.
Epclusa is in Phase 2 clinical development for End Stage Renal Disease. The drug is investigational in this setting and has not yet been approved for this indication, though it is already approved for other Hepatitis C indications.
Epclusa is being evaluated in a completed Phase 2 clinical trial with the identifier NCT04075916. The trial enrolled 201 participants in the United States and studied the transplantation of Hepatitis C kidneys into Hepatitis C-negative recipients with End Stage Renal Disease.
Yes, Epclusa is the brand name for the combination of sofosbuvir and velpatasvir. This fixed-dose combination is used to treat Hepatitis C and is being investigated for use in kidney transplant recipients with End Stage Renal Disease.