The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
101
Voxilaprevir tablets administered orally once daily
Placebo to match voxilaprevir tablets administered orally once daily
400 mg/100 mg FDC tablet administered orally once daily
Unnamed facility
Costa Mesa, California, United States
Unnamed facility
DeLand, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Kansas City, Missouri, United States
Percentage of Participants Experiencing Treatment Emergent Adverse Events
Time frame: First dose date up to Day 3 plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
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.
Time frame: First dose date up to Day 3 plus 30 days
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.
Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48
Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).
Time frame: Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Categorical declines from baseline were summarized by the number of participants with a \< 1, ≥ 1 to \<2, ≥ 2 to \<3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline to each postdose assessment up to Week 48 by treatment/cohort and placebo. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).
Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48
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Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Berlin, New Jersey, United States
Unnamed facility
Marlton, New Jersey, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Knoxville, Tennessee, United States
Unnamed facility
San Antonio, Texas, United States
...and 1 more locations
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 15 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).
Time frame: Days 4, 5, 6, 7, 8, 10, and Week 48