The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
103
Tablets administered orally
Tablets administered orally
West Coast Clinical Trials, LLC
Costa Mesa, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Percentage of Participants Experiencing Treatment Emergent Adverse Events
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).
Time frame: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
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.
Time frame: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)
Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline
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.
Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and 17
Absolute HCV RNA Level
Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and 17
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 by treatment (velpatasvir dose/HCV genotype) and placebo at each collection time point through Day 17.
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Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States
CRI Worldwide, LLC
Marlton, New Jersey, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
New Orleans Center for Clinical Research-Knoxville
Knoxville, Tennessee, United States
Alamo Medical Research
San Antonio, Texas, United States
Charles River Clinical Services Northwest, Inc.
Tacoma, Washington, United States
Fundacion De Investigacion De Diego
San Juan, Puerto Rico
Time frame: Baseline; Days 4, 5, 6, 7, 8, 10, and 17
Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected
The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 25 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay.
Time frame: Days 4, 5, 6, 7, and 8
Plasma HCV RNA Levels by Treatment and IL28B Genotype
Time frame: Days 4, 5, 6, 7, 8, 10, and 17
Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1
PK Parameter of Velpatasvir: AUCtau
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3
PK Parameter of Velpatasvir: Cmax
Cmax is defined as the maximum observed plasma concentration of drug.
Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose.
PK Parameter of Velpatasvir: CL/F
CL/F is defined as the apparent oral clearance following administration of the drug.
Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose
PK Parameter of Velpatasvir: Ctau
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Time frame: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3
Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints
The full-length NS5A coding region was analyzed pretreatment (baseline) by deep sequencing using MiSeq for all 70 participants who received velpatasvir and for 8 of 17 participants who received placebo prior to and up to 2 weeks (Day 17) after dosing with velpatasvir. Participants were categorized by velpatasvir dose/HCV genotype and presence or absence of NS5A RAVs.
Time frame: First dose date up to Day 17