Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sofosbuvir-Velpatasvir Drug Combination · 1 trial · 1 indication
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 |
|---|---|---|
| Sofosbuvir-Velpatasvir | EXPERIMENTAL | Sofosbuvir-Velpatasvir |
| Name | Type | Description |
|---|---|---|
| Sofosbuvir-Velpatasvir Drug Combination | DRUG | One oral pill containing 400mg sofosbuvir and 100mg velpatasvir taken once daily for 12 weeks |
Inclusion Criteria: * Able and willing to provide written informed consent and take part in the study -procedures * Able and willing to provide adequate locator information * Chronic hepatitis C viral (HCV) infection, defined as a positive HCV test at least 6 months prior to screening * Detectable ...
Sofosbuvir-Velpatasvir is a small molecule drug combination used for the treatment of chronic Hepatitis C. It is being developed by Gilead Sciences, Inc. for this infectious disease indication. The drug is currently in Phase 1 clinical development.
Sofosbuvir-Velpatasvir is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug for the treatment of chronic Hepatitis C.
Sofosbuvir-Velpatasvir is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed to evaluate its use in treating chronic Hepatitis C.
Sofosbuvir-Velpatasvir has one completed clinical trial registered under NCT04382404, titled "Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir." This Phase 1 study enrolled 11 female participants aged 18 years and older in the United States.
Yes, Sofosbuvir-Velpatasvir is the same drug combination as Sofosbuvir/Velpatasvir. The clinical trial NCT04382404 uses the name Sofosbuvir/Velpatasvir to refer to the same drug combination being developed for chronic Hepatitis C.