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Label indication EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection [see Dosage and Administration (2.2 , 2.3 , 2.4) and Clinical Studies (14) ] : without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin. FDA label
Also known as Epclusa
Sofosbuvir-Velpatasvir Drug Combination · 2 trials · 2 indications
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)
Maximum concentration of Velpatasvir measured in maternal plasma samples. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation. At the 6-week visit, a single convenience blood sample was collected.
Maximum concentration of Sofosbuvir measured in maternal plasma samples. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation. At the 6-week visit, a single convenience blood sample was collected.
Maximum concentration of GS-331007, an inactive metabolite of Sofosbuvir, measured in maternal plasma samples. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation. At the 6-week visit, a single convenience blood sample was collected.
Area under the maternal plasma concentration of Velpatasvir versus time curve tau of the dosing interval. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation.
Area under the maternal plasma concentration of Sofosbuvir versus time curve tau of the dosing interval. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation.
Area under the maternal plasma concentration of GS-331007 versus time curve tau of the dosing interval; GS-331007 is an inactive metabolite of Sofosbuvir. Plasma samples were obtained pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 5-, 8-, and 12- and 24 hours post-dose at the 3- and 9-week visits after treatment initiation.
| Arm | Type | Description |
|---|---|---|
| Epclusa (sofosbuvir/velpatasvir) | EXPERIMENTAL | Epclusa is taken by mouth for 12 weeks as per the FDA label. |
| Sofosbuvir-Velpatasvir | EXPERIMENTAL | Sofosbuvir-Velpatasvir |
| Name | Type | Description |
|---|---|---|
| Epclusa | DRUG | All patients will receive 12 weeks of sofosbuvir/velpatasvir as per the FDA label. |
| Sofosbuvir-Velpatasvir Drug Combination | DRUG | One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks |
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...
The sofosbuvir-velpatasvir drug combination is an investigational small molecule therapy being developed by Gilead Sciences, Inc. (ticker: GILD) for the treatment of chronic hepatitis C. It is a fixed-dose combination of two direct-acting antiviral agents. The combination is in Phase 1 clinical development.
The sofosbuvir-velpatasvir drug combination is being studied for the treatment of chronic hepatitis C, a viral infection of the liver. The only registered trial of this combination enrolled patients with chronic hepatitis C. It is not yet approved for any indication and remains investigational.
Gilead Sciences, Inc. (ticker: GILD) is the developer of the sofosbuvir-velpatasvir drug combination. The company is responsible for the clinical development program, which includes a Phase 1 trial in chronic hepatitis C. No other developers or partners are listed for this asset.
The sofosbuvir-velpatasvir drug combination is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The combination is investigational and has not been approved by the FDA for any indication.
The sofosbuvir-velpatasvir drug combination has been evaluated in one completed Phase 1 trial, NCT04382404, titled "Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir." The trial enrolled 11 female participants aged 18 years and older in the United States. It was an uncontrolled study without randomization or blinding.