Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GS-9857
Voxilaprevir · 3 trials · 2 indications
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data presented are unadjusted geometric means and confidence intervals.
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data presented are unadjusted geometric means and confidence intervals.
Cmax is defined as the maximum observed plasma concentration of drug. Data presented are unadjusted geometric means and confidence intervals.
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant.
The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.
| Arm | Type | Description |
|---|---|---|
| Normal Renal Function | EXPERIMENTAL | Participants will receive a single dose of voxilaprevir on Day 1. |
| Severe Renal Impairment | EXPERIMENTAL | Participants will receive a single dose of voxilaprevir on Day 1. |
| Moderate Hepatic Impaired | EXPERIMENTAL | Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1. |
| Severe Hepatic Impaired | EXPERIMENTAL | Participants with severe hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1. |
| Placebo (GT 1a, Cohort 1) | PLACEBO_COMPARATOR | Participants with genotype (GT) 1a HCV infection will receive placebo once daily for 3 days under fasted conditions. |
| Voxilaprevir 50 mg (GT 1a, Cohort 1) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 100 mg (GT 1a, Cohort 1) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 300 mg (GT 1a, Cohort 1) | EXPERIMENTAL | Participants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
| Placebo (GT 3, Cohort 2) | PLACEBO_COMPARATOR | Participants with GT 3 HCV infection will receive placebo once daily for 3 days under fasted conditions. |
| Voxilaprevir 50 mg (GT 3, Cohort 2) | EXPERIMENTAL | Participants with GT 3 HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 100 mg (GT 3, Cohort 2) | EXPERIMENTAL | Participants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 300 mg (GT 3, Cohort 2) | EXPERIMENTAL | Participants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
| Placebo (GT 2, Cohort 3) | PLACEBO_COMPARATOR | Participants with GT 2 HCV infection will receive placebo once daily for 3 days under fasted conditions. |
| Voxilaprevir 100 mg (GT 2, Cohort 3) | EXPERIMENTAL | Participants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 100 mg (GT 4, Cohort 4) | EXPERIMENTAL | Participants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 100 mg (GT 1b, Cohort 5) | EXPERIMENTAL | Participants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| Voxilaprevir 100 mg Fed (GT 3a, Cohort 6) | EXPERIMENTAL | Participants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions. |
| Voxilaprevir 600 mg (Cohorts 7-9) | EXPERIMENTAL | Participants with genotypes 1a, 1b, 2, 3, or 4 HCV infection will receive voxilaprevir up to 600 mg under fasted or fed conditions for 3 days. |
| Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10) | EXPERIMENTAL | Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 after moderate fat meal and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal. |
| Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10) | EXPERIMENTAL | Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. |
| Name | Type | Description |
|---|---|---|
| Voxilaprevir | DRUG | 100 mg tablet administered orally |
| Placebo to match voxilaprevir | DRUG | Placebo to match voxilaprevir tablets administered orally once daily |
| SOF/VEL | DRUG | 400 mg/100 mg FDC tablet administered orally once daily |
Key Inclusion Criteria: * All individuals: * Screening laboratory values within defined thresholds for group * Use of two effective contraception methods if female of childbearing potential or sexually active male * For individuals with severe renal impairment: * Stable chronic kidney disea...
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| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
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Voxilaprevir is an investigational small molecule being studied for the treatment of Hepatitis C Virus (HCV) infection. It is in Phase 1 clinical development for this indication. The drug is being evaluated in adults with chronic HCV infection, including those with normal hepatic function and those with moderate or severe hepatic impairment.
Voxilaprevir is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. Gilead is conducting clinical trials to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of Voxilaprevir in adults with chronic Hepatitis C Virus infection.
Voxilaprevir is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with no active trials currently ongoing. The drug is being studied for the treatment of Hepatitis C Virus infection.
Voxilaprevir has been studied in two completed Phase 1 clinical trials. NCT02185794 evaluated safety, tolerability, pharmacokinetics, and antiviral activity in adults with chronic Hepatitis C Virus infection. NCT02397707 and NCT02402452 assessed pharmacokinetics in adults with hepatic or renal impairment, respectively. All trials are completed.
Voxilaprevir is a small molecule therapeutic being developed for Hepatitis C Virus infection. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its antiviral activity against HCV in clinical studies.