Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection (NCT NCT02185794)
NCT ID: NCT02185794
Last Updated: 2020-09-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
101 participants
Primary outcome timeframe
First dose date up to Day 3 plus 30 days
Results posted on
2020-09-17
Participant Flow
Participants were enrolled at study sites in United States and Puerto Rico. The first participant was screened on 13 June 2014. The last study visit occurred on 28 September 2015.
Participants were enrolled in Cohorts 1, 2, 3, 4, 5, 6 and 10. Cohorts 7, 8, and 9 were not conducted.
Participant milestones
| Measure |
Placebo
Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2 and 3.
|
Voxilaprevir 50 mg
Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 300 mg
Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg Fed
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC) on Days 2 and 3 after moderate fat or light meal. This arm was part of cohort 10.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
20
|
33
|
16
|
7
|
16
|
|
Overall Study
COMPLETED
|
4
|
7
|
17
|
8
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
13
|
16
|
8
|
3
|
16
|
Reasons for withdrawal
| Measure |
Placebo
Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2 and 3.
|
Voxilaprevir 50 mg
Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 300 mg
Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg Fed
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC) on Days 2 and 3 after moderate fat or light meal. This arm was part of cohort 10.
|
|---|---|---|---|---|---|---|
|
Overall Study
Enrolled but Never Dosed
|
1
|
6
|
3
|
1
|
1
|
0
|
|
Overall Study
Investigator's Discretion
|
1
|
0
|
1
|
2
|
2
|
15
|
|
Overall Study
Withdrew Consent
|
2
|
5
|
10
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
2
|
3
|
0
|
1
|
Baseline Characteristics
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2 and 3.
|
Voxilaprevir 50 mg
n=14 Participants
Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg
n=30 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 300 mg
n=15 Participants
Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg Fed
n=6 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
n=16 Participants
Participants with 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. This arm was part of cohort 10.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
49 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
52 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
43 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
51 years
STANDARD_DEVIATION 6.2 • n=21 Participants
|
56 years
STANDARD_DEVIATION 5.2 • n=8 Participants
|
51 years
STANDARD_DEVIATION 8.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
67 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
44 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
|
HCV Genotype
1a
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
HCV Genotype
1b
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
HCV Genotype
2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
HCV Genotype
2a/2c
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
HCV Genotype
2b
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
HCV Genotype
3a
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
HCV Genotype
4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
HCV Genotype
4a/4c/4d
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
HCV RNA
|
6.6 log10 IU/mL
STANDARD_DEVIATION 0.39 • n=5 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.64 • n=7 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.53 • n=5 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.64 • n=4 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.87 • n=21 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.83 • n=8 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.65 • n=8 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
61 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: First dose date up to Day 3 plus 30 daysPopulation: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.
|
Voxilaprevir 50 mg
n=14 Participants
Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg
n=30 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 300 mg
n=15 Participants
Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg Fed
n=6 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
n=16 Participants
Participants with 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. This arm was part of cohort 10.
|
Voxilaprevir 100 mg (GT 3, Cohort 2)
Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 300 mg (GT 3, Cohort 2)
Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.
|
Placebo (GT 2, Cohort 3)
Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 2, Cohort 3)
Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 4, Cohort 4)
Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 1b, Cohort 5)
Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment Emergent Adverse Events
|
25.0 percentage of participants
|
14.3 percentage of participants
|
16.7 percentage of participants
|
13.3 percentage of participants
|
33.3 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First dose date up to Day 3 plus 30 daysPopulation: Participants in the Safety Analysis Set were analyzed. Data were summarized by dose.
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.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.
|
Voxilaprevir 50 mg
n=14 Participants
Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg
n=30 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 300 mg
n=15 Participants
Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg Fed
n=6 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
n=16 Participants
Participants with 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. This arm was part of cohort 10.
|
Voxilaprevir 100 mg (GT 3, Cohort 2)
Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 300 mg (GT 3, Cohort 2)
Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.
|
Placebo (GT 2, Cohort 3)
Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 2, Cohort 3)
Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 4, Cohort 4)
Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 1b, Cohort 5)
Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 1
|
37.5 percentage of participants
|
28.6 percentage of participants
|
26.7 percentage of participants
|
20.0 percentage of participants
|
50.0 percentage of participants
|
62.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 2
|
25.0 percentage of participants
|
28.6 percentage of participants
|
33.3 percentage of participants
|
13.3 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 3
|
0 percentage of participants
|
14.3 percentage of participants
|
10.0 percentage of participants
|
26.7 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48Population: The Efficacy Analysis Set included all enrolled participants with appropriate genotype who received at least one dose of the study drug (voxilaprevir or placebo) and with at least one on-treatment HCV RNA assessment. Participants in the Efficacy Analysis Set with available data were analyzed.
The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.
|
Voxilaprevir 50 mg
n=8 Participants
Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg
n=8 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 300 mg
n=8 Participants
Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg Fed
n=2 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
n=6 Participants
Participants with 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. This arm was part of cohort 10.
|
Voxilaprevir 100 mg (GT 3, Cohort 2)
n=6 Participants
Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 300 mg (GT 3, Cohort 2)
n=7 Participants
Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.
|
Placebo (GT 2, Cohort 3)
n=2 Participants
Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 2, Cohort 3)
n=6 Participants
Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 4, Cohort 4)
n=4 Participants
Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 1b, Cohort 5)
n=6 Participants
Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
n=6 Participants
Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
Change at Week 48
|
0.41 log10 IU/mL
Standard Deviation 0.873
|
0.08 log10 IU/mL
Standard Deviation 0.337
|
-0.80 log10 IU/mL
Standard Deviation 2.094
|
-0.73 log10 IU/mL
Standard Deviation 2.352
|
0.41 log10 IU/mL
|
-0.03 log10 IU/mL
Standard Deviation 0.221
|
0.54 log10 IU/mL
|
0.06 log10 IU/mL
Standard Deviation 0.370
|
-0.02 log10 IU/mL
|
-0.02 log10 IU/mL
|
0.18 log10 IU/mL
Standard Deviation 0.247
|
-0.57 log10 IU/mL
Standard Deviation 2.389
|
0.16 log10 IU/mL
Standard Deviation 0.044
|
|
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
Change at Day 10
|
-0.06 log10 IU/mL
Standard Deviation 0.091
|
-2.69 log10 IU/mL
Standard Deviation 1.116
|
-3.33 log10 IU/mL
Standard Deviation 0.756
|
-2.97 log10 IU/mL
Standard Deviation 0.918
|
-0.23 log10 IU/mL
Standard Deviation 0.180
|
-0.28 log10 IU/mL
Standard Deviation 0.330
|
-1.18 log10 IU/mL
Standard Deviation 1.055
|
-2.17 log10 IU/mL
Standard Deviation 1.394
|
-0.13 log10 IU/mL
Standard Deviation 0.022
|
-2.28 log10 IU/mL
Standard Deviation 0.469
|
-3.61 log10 IU/mL
Standard Deviation 0.674
|
-3.08 log10 IU/mL
Standard Deviation 0.740
|
-0.62 log10 IU/mL
Standard Deviation 1.085
|
|
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
Change at Day 7
|
0.01 log10 IU/mL
Standard Deviation 0.340
|
-3.15 log10 IU/mL
Standard Deviation 0.973
|
-3.88 log10 IU/mL
Standard Deviation 0.729
|
-3.48 log10 IU/mL
Standard Deviation 0.695
|
0.02 log10 IU/mL
Standard Deviation 0.089
|
-0.76 log10 IU/mL
Standard Deviation 0.352
|
-2.00 log10 IU/mL
Standard Deviation 0.378
|
-2.89 log10 IU/mL
Standard Deviation 0.763
|
-0.05 log10 IU/mL
Standard Deviation 0.058
|
-2.80 log10 IU/mL
Standard Deviation 0.494
|
-3.70 log10 IU/mL
Standard Deviation 0.877
|
-3.42 log10 IU/mL
Standard Deviation 0.710
|
-1.74 log10 IU/mL
Standard Deviation 0.885
|
|
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
Change at Day 4
|
-0.12 log10 IU/mL
Standard Deviation 0.136
|
-3.81 log10 IU/mL
Standard Deviation 0.516
|
-3.97 log10 IU/mL
Standard Deviation 0.608
|
-3.33 log10 IU/mL
Standard Deviation 0.902
|
-0.24 log10 IU/mL
Standard Deviation 0.813
|
-1.47 log10 IU/mL
Standard Deviation 0.416
|
-3.20 log10 IU/mL
Standard Deviation 0.364
|
-3.57 log10 IU/mL
Standard Deviation 0.483
|
0.00 log10 IU/mL
Standard Deviation 0.104
|
-3.41 log10 IU/mL
Standard Deviation 0.444
|
-3.50 log10 IU/mL
Standard Deviation 0.677
|
-3.57 log10 IU/mL
Standard Deviation 0.227
|
-3.06 log10 IU/mL
Standard Deviation 0.752
|
|
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
Change at Day 5
|
-0.20 log10 IU/mL
Standard Deviation 0.519
|
-3.58 log10 IU/mL
Standard Deviation 1.104
|
-4.03 log10 IU/mL
Standard Deviation 0.594
|
-3.37 log10 IU/mL
Standard Deviation 0.894
|
-0.17 log10 IU/mL
Standard Deviation 0.285
|
-1.43 log10 IU/mL
Standard Deviation 0.606
|
-3.00 log10 IU/mL
Standard Deviation 0.470
|
-3.28 log10 IU/mL
Standard Deviation 0.515
|
-0.12 log10 IU/mL
Standard Deviation 0.151
|
-3.37 log10 IU/mL
Standard Deviation 0.480
|
-3.61 log10 IU/mL
Standard Deviation 0.702
|
-3.60 log10 IU/mL
Standard Deviation 0.390
|
-2.45 log10 IU/mL
Standard Deviation 0.664
|
|
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
Change at Day 6
|
-0.21 log10 IU/mL
Standard Deviation 0.479
|
-3.45 log10 IU/mL
Standard Deviation 0.829
|
-3.78 log10 IU/mL
Standard Deviation 0.710
|
-3.47 log10 IU/mL
Standard Deviation 0.763
|
-0.06 log10 IU/mL
Standard Deviation 0.051
|
-1.06 log10 IU/mL
Standard Deviation 0.632
|
-2.52 log10 IU/mL
Standard Deviation 0.739
|
-3.13 log10 IU/mL
Standard Deviation 0.736
|
-0.04 log10 IU/mL
Standard Deviation 0.139
|
-3.22 log10 IU/mL
Standard Deviation 0.689
|
-3.69 log10 IU/mL
Standard Deviation 0.879
|
-3.61 log10 IU/mL
Standard Deviation 0.601
|
-2.04 log10 IU/mL
Standard Deviation 0.706
|
|
Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA
Change at Day 8
|
0.13 log10 IU/mL
Standard Deviation 0.260
|
-2.92 log10 IU/mL
Standard Deviation 1.069
|
-3.54 log10 IU/mL
Standard Deviation 0.663
|
-3.23 log10 IU/mL
Standard Deviation 0.726
|
-0.14 log10 IU/mL
Standard Deviation 0.158
|
-0.53 log10 IU/mL
Standard Deviation 0.379
|
-1.79 log10 IU/mL
Standard Deviation 0.627
|
-2.74 log10 IU/mL
Standard Deviation 0.916
|
-0.05 log10 IU/mL
Standard Deviation 0.090
|
-2.48 log10 IU/mL
Standard Deviation 0.355
|
-3.53 log10 IU/mL
Standard Deviation 0.637
|
-3.27 log10 IU/mL
Standard Deviation 0.627
|
-1.43 log10 IU/mL
Standard Deviation 0.987
|
SECONDARY outcome
Timeframe: Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48Population: Participants in the Efficacy Analysis Set with available data were analyzed. Data are summarized by treatment/cohort and placebo.
The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6).
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.
|
Voxilaprevir 50 mg
n=8 Participants
Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg
n=8 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 300 mg
n=8 Participants
Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg Fed
n=2 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
n=6 Participants
Participants with 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. This arm was part of cohort 10.
|
Voxilaprevir 100 mg (GT 3, Cohort 2)
n=6 Participants
Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 300 mg (GT 3, Cohort 2)
n=7 Participants
Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.
|
Placebo (GT 2, Cohort 3)
n=2 Participants
Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 2, Cohort 3)
n=6 Participants
Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 4, Cohort 4)
n=4 Participants
Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 1b, Cohort 5)
n=6 Participants
Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
n=6 Participants
Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
Day 10
|
6.68 log10 IU/mL
Standard Deviation 0.263
|
3.61 log10 IU/mL
Standard Deviation 1.041
|
3.03 log10 IU/mL
Standard Deviation 0.857
|
3.07 log10 IU/mL
Standard Deviation 0.887
|
5.88 log10 IU/mL
Standard Deviation 0.300
|
5.43 log10 IU/mL
Standard Deviation 0.803
|
5.56 log10 IU/mL
Standard Deviation 0.987
|
3.83 log10 IU/mL
Standard Deviation 1.417
|
6.58 log10 IU/mL
Standard Deviation 0.081
|
3.96 log10 IU/mL
Standard Deviation 0.555
|
2.54 log10 IU/mL
Standard Deviation 0.553
|
3.15 log10 IU/mL
Standard Deviation 1.210
|
5.40 log10 IU/mL
Standard Deviation 0.697
|
|
Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
Week 48
|
6.97 log10 IU/mL
Standard Deviation 0.488
|
6.29 log10 IU/mL
Standard Deviation 0.825
|
5.55 log10 IU/mL
Standard Deviation 2.007
|
5.20 log10 IU/mL
Standard Deviation 2.085
|
6.18 log10 IU/mL
|
5.13 log10 IU/mL
Standard Deviation 0.207
|
7.29 log10 IU/mL
|
6.38 log10 IU/mL
Standard Deviation 1.479
|
6.65 log10 IU/mL
|
6.13 log10 IU/mL
|
6.34 log10 IU/mL
Standard Deviation 0.696
|
5.65 log10 IU/mL
Standard Deviation 2.473
|
5.98 log10 IU/mL
Standard Deviation 0.891
|
|
Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
Day 8
|
6.86 log10 IU/mL
Standard Deviation 0.144
|
3.38 log10 IU/mL
Standard Deviation 1.019
|
2.81 log10 IU/mL
Standard Deviation 0.901
|
2.81 log10 IU/mL
Standard Deviation 0.671
|
5.97 log10 IU/mL
Standard Deviation 0.323
|
5.08 log10 IU/mL
Standard Deviation 0.655
|
4.96 log10 IU/mL
Standard Deviation 0.531
|
3.27 log10 IU/mL
Standard Deviation 1.100
|
6.66 log10 IU/mL
Standard Deviation 0.031
|
3.76 log10 IU/mL
Standard Deviation 0.497
|
2.62 log10 IU/mL
Standard Deviation 0.278
|
2.96 log10 IU/mL
Standard Deviation 1.111
|
4.59 log10 IU/mL
Standard Deviation 0.528
|
|
Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
Day 4
|
6.62 log10 IU/mL
Standard Deviation 0.378
|
2.56 log10 IU/mL
Standard Deviation 0.705
|
2.38 log10 IU/mL
Standard Deviation 0.759
|
2.72 log10 IU/mL
Standard Deviation 0.943
|
5.87 log10 IU/mL
Standard Deviation 0.332
|
4.22 log10 IU/mL
Standard Deviation 0.878
|
3.54 log10 IU/mL
Standard Deviation 0.455
|
2.44 log10 IU/mL
Standard Deviation 0.693
|
6.71 log10 IU/mL
Standard Deviation 0.164
|
2.83 log10 IU/mL
Standard Deviation 0.611
|
2.65 log10 IU/mL
Standard Deviation 0.533
|
2.67 log10 IU/mL
Standard Deviation 0.500
|
2.95 log10 IU/mL
Standard Deviation 0.505
|
|
Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
Pre Day 1 Dose
|
6.73 log10 IU/mL
Standard Deviation 0.307
|
6.30 log10 IU/mL
Standard Deviation 0.497
|
6.35 log10 IU/mL
Standard Deviation 0.526
|
6.05 log10 IU/mL
Standard Deviation 0.558
|
6.11 log10 IU/mL
Standard Deviation 0.480
|
5.61 log10 IU/mL
Standard Deviation 0.612
|
6.75 log10 IU/mL
Standard Deviation 0.346
|
6.01 log10 IU/mL
Standard Deviation 0.773
|
6.71 log10 IU/mL
Standard Deviation 0.059
|
6.24 log10 IU/mL
Standard Deviation 0.394
|
6.16 log10 IU/mL
Standard Deviation 0.730
|
6.23 log10 IU/mL
Standard Deviation 0.608
|
6.01 log10 IU/mL
Standard Deviation 0.866
|
|
Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
Day 5
|
6.53 log10 IU/mL
Standard Deviation 0.426
|
2.73 log10 IU/mL
Standard Deviation 1.203
|
2.33 log10 IU/mL
Standard Deviation 0.643
|
2.67 log10 IU/mL
Standard Deviation 0.947
|
5.94 log10 IU/mL
Standard Deviation 0.195
|
4.19 log10 IU/mL
Standard Deviation 1.104
|
3.75 log10 IU/mL
Standard Deviation 0.455
|
2.73 log10 IU/mL
Standard Deviation 0.780
|
6.59 log10 IU/mL
Standard Deviation 0.210
|
2.87 log10 IU/mL
Standard Deviation 0.603
|
2.55 log10 IU/mL
Standard Deviation 0.549
|
2.63 log10 IU/mL
Standard Deviation 0.764
|
3.56 log10 IU/mL
Standard Deviation 0.273
|
|
Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
Day 6
|
6.52 log10 IU/mL
Standard Deviation 0.320
|
2.85 log10 IU/mL
Standard Deviation 1.000
|
2.57 log10 IU/mL
Standard Deviation 1.028
|
2.57 log10 IU/mL
Standard Deviation 0.818
|
6.05 log10 IU/mL
Standard Deviation 0.532
|
4.55 log10 IU/mL
Standard Deviation 1.203
|
4.23 log10 IU/mL
Standard Deviation 0.604
|
2.88 log10 IU/mL
Standard Deviation 0.882
|
6.68 log10 IU/mL
Standard Deviation 0.199
|
3.02 log10 IU/mL
Standard Deviation 0.754
|
2.46 log10 IU/mL
Standard Deviation 0.300
|
2.85 log10 IU/mL
Standard Deviation 0.685
|
3.98 log10 IU/mL
Standard Deviation 0.413
|
|
Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48
Day 7
|
6.74 log10 IU/mL
Standard Deviation 0.059
|
3.15 log10 IU/mL
Standard Deviation 1.268
|
2.47 log10 IU/mL
Standard Deviation 0.821
|
2.56 log10 IU/mL
Standard Deviation 0.714
|
6.13 log10 IU/mL
Standard Deviation 0.569
|
4.85 log10 IU/mL
Standard Deviation 0.886
|
4.75 log10 IU/mL
Standard Deviation 0.268
|
3.12 log10 IU/mL
Standard Deviation 0.991
|
6.67 log10 IU/mL
Standard Deviation 0.001
|
3.44 log10 IU/mL
Standard Deviation 0.613
|
2.45 log10 IU/mL
Standard Deviation 0.359
|
2.82 log10 IU/mL
Standard Deviation 1.111
|
4.27 log10 IU/mL
Standard Deviation 0.485
|
SECONDARY outcome
Timeframe: Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48Population: Participants in the Efficacy Analysis Set were analyzed.
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).
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.
|
Voxilaprevir 50 mg
n=8 Participants
Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg
n=8 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 300 mg
n=8 Participants
Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg Fed
n=2 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
n=6 Participants
Participants with 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. This arm was part of cohort 10.
|
Voxilaprevir 100 mg (GT 3, Cohort 2)
n=6 Participants
Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 300 mg (GT 3, Cohort 2)
n=7 Participants
Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.
|
Placebo (GT 2, Cohort 3)
n=2 Participants
Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 2, Cohort 3)
n=6 Participants
Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 4, Cohort 4)
n=4 Participants
Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 1b, Cohort 5)
n=6 Participants
Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
n=6 Participants
Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 10 · < 1 log10 IU/mL decrease in HCV RNA
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 6 · Missing HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 8 · ≥2 and <3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 6 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 8 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 7 · Missing HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 7 · < 1 log10 IU/mL decrease in HCV RNA
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 7 · ≥1 and <2 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 7 · ≥2 and <3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 7 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 8 · Missing HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 8 · < 1 log10 IU/mL decrease in HCV RNA
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 8 · ≥1 and <2 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 10 · Missing HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 10 · ≥1 and <2 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 10 · ≥2 and <3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 10 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Week 48 · Missing HCV RNA
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Week 48 · < 1 log10 IU/mL decrease in HCV RNA
|
2 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Week 48 · ≥1 and <2 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Week 48 · ≥2 and <3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Week 48 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 4 · Missing HCV RNA
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 4 · < 1 log10 IU/mL decrease in HCV RNA
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 4 · ≥1 and <2 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 4 · ≥2 and <3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 4 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 5 · Missing HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 5 · < 1 log10 IU/mL decrease in HCV RNA
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 5 · ≥1 and <2 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 5 · ≥2 and <3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 5 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 6 · < 1 log10 IU/mL decrease in HCV RNA
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 6 · ≥1 and <2 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 6 · ≥2 and <3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 4, 5, 6, 7, 8, 10, and Week 48Population: Participants in the Efficacy Analysis Set were analyzed. Data are summarized by treatment/cohort and placebo.
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).
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.
|
Voxilaprevir 50 mg
n=8 Participants
Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg
n=8 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 300 mg
n=8 Participants
Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg Fed
n=2 Participants
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
n=6 Participants
Participants with 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. This arm was part of cohort 10.
|
Voxilaprevir 100 mg (GT 3, Cohort 2)
n=6 Participants
Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 300 mg (GT 3, Cohort 2)
n=7 Participants
Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.
|
Placebo (GT 2, Cohort 3)
n=2 Participants
Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 2, Cohort 3)
n=6 Participants
Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 4, Cohort 4)
n=4 Participants
Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg (GT 1b, Cohort 5)
n=6 Participants
Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions.
|
Voxilaprevir 100 mg Fed (GT 3a, Cohort 6)
n=6 Participants
Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
Day 7 < LLOQ detected
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
Day 4 < LLOQ detected
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
Day 5 < LLOQ detected
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
Day 6 < LLOQ TND
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
Day 8 < LLOQ detected
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
Day 10 < LLOQ TND
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND)
Week 48 < LLOQ TND
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Voxilaprevir 50 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Voxilaprevir 100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Voxilaprevir 300 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Voxilaprevir 100 mg Fed
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=8 participants at risk
Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.
|
Voxilaprevir 50 mg
n=14 participants at risk
Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg
n=30 participants at risk
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 300 mg
n=15 participants at risk
Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg Fed
n=6 participants at risk
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
n=16 participants at risk
Participants with 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. This arm was part of cohort 10.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/14 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/30 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
16.7%
1/6 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/16 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, and 3.
|
Voxilaprevir 50 mg
n=14 participants at risk
Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg
n=30 participants at risk
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 300 mg
n=15 participants at risk
Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2.
|
Voxilaprevir 100 mg Fed
n=6 participants at risk
Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6.
|
Voxilaprevir 100 mg + SOF/VEL 400/100 mg
n=16 participants at risk
Participants with 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. This arm was part of cohort 10.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
7.1%
1/14 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/30 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/6 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/16 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/14 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/30 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/6 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/16 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/14 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
6.7%
2/30 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
6.7%
1/15 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/6 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
6.2%
1/16 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
7.1%
1/14 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/30 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/6 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/16 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
7.1%
1/14 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/30 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/6 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/16 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/14 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/30 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
16.7%
1/6 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/16 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/14 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
3.3%
1/30 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
16.7%
1/6 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
6.2%
1/16 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/14 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/30 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
6.7%
1/15 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/6 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
0.00%
0/16 • Adverse Events: First dose date up to Day 3 plus 30 days; All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER