Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VEL, Velpatasvir
GS-5816 · 3 trials · 3 indications
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
Cmax is defined as the maximum observed plasma concentration of drug.
The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.
Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing).
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose.
Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo.
| Arm | Type | Description |
|---|---|---|
| Participants with renal impairment | EXPERIMENTAL | Participants with severe renal impairment will receive a single dose of velpatasvir. |
| Participants with normal renal function | ACTIVE_COMPARATOR | Participants with normal renal function will receive a single dose of velpatasvir. |
| Cohort 1 | EXPERIMENTAL | (N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816. |
| Cohort 2 | EXPERIMENTAL | (N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816. |
| Velpatasvir 5 mg (GT 1a) | EXPERIMENTAL | Participants with genotype (GT) 1a HCV infection will receive velpatasvir 5 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 25 mg (GT 1a) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 50 mg (GT 1a) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 100 mg (GT 1a) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive velpatasvir 100 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 150 mg (GT 1a) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 150 mg (GT 1b) | EXPERIMENTAL | Participants with GT 1b HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 150 mg (GT 2) | EXPERIMENTAL | Participants with GT 2 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 25 mg (GT 3) | EXPERIMENTAL | Participants with GT 3 HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 50 mg (GT 3) | EXPERIMENTAL | Participants with GT 3 HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 150 mg (GT 3) | EXPERIMENTAL | Participants with GT 3 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir 150 mg (GT 4) | EXPERIMENTAL | Participants with GT 4 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
| Velpatasvir up to 400 mg (GT 2) | EXPERIMENTAL | Participants with GT 2 HCV infection will receive velpatasvir up to 400 mg or placebo once daily for 3 days under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| Velpatasvir | DRUG | Velpatasvir 100 mg (2 x 50 mg tablets) administered orally |
| GS-5816 | DRUG | - |
| Placebo | DRUG | Tablets administered orally |
Key Inclusion Criteria: * General good health with stable chronic kidney disease in Severe Renal Impairment Group * Screening labs within defined thresholds * Creatinine clearance must be \< 30 mL/min for Severe Renal Impairment group, and ≥ 90 mL/min for Normal Renal Function group Key Exclusion ...
GS-5816 is an investigational small molecule being developed for the treatment of chronic Hepatitis C. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
GS-5816 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD.
GS-5816 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval for the treatment of chronic Hepatitis C.
GS-5816 has one completed Phase 1 clinical trial, NCT01817985, which evaluated its pharmacokinetics in subjects with normal hepatic function and moderate or severe hepatic impairment. The trial enrolled 33 participants in the United States and Puerto Rico.
No, GS-5816 is a distinct investigational compound developed by Gilead Sciences. It is not the same as sofosbuvir, which is a different medication used for the treatment of Hepatitis C.