Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection (NCT NCT01740791)
NCT ID: NCT01740791
Last Updated: 2020-12-16
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
103 participants
Primary outcome timeframe
First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)
Results posted on
2020-12-16
Participant Flow
Participants were enrolled at study sites in United States. The first participant was screened on 06 November 2012. The last study visit occurred on 24 January 2014.
163 participants were screened. Participants were not enrolled in 'Velpatasvir up to 400 mg genotype (GT) 2' group.
Participant milestones
| Measure |
Placebo
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
7
|
17
|
14
|
9
|
34
|
|
Overall Study
COMPLETED
|
10
|
4
|
11
|
7
|
6
|
23
|
|
Overall Study
NOT COMPLETED
|
12
|
3
|
6
|
7
|
3
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Overall Study
Randomized but never treated
|
5
|
3
|
2
|
2
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
2
|
3
|
2
|
3
|
|
Overall Study
Withdrew Consent
|
4
|
0
|
1
|
2
|
0
|
3
|
|
Overall Study
Investigator's discretion
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection
Baseline characteristics by cohort
| Measure |
Placebo
n=17 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=4 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=15 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=12 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=8 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
n=31 Participants
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 15.65 • n=7 Participants
|
45.1 years
STANDARD_DEVIATION 11.56 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 10.13 • n=4 Participants
|
47.0 years
STANDARD_DEVIATION 8.40 • n=21 Participants
|
49.2 years
STANDARD_DEVIATION 9.12 • n=10 Participants
|
47.3 years
STANDARD_DEVIATION 10.26 • n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
68 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
59 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
59 Participants
n=115 Participants
|
|
HCV RNA (log10 IU/mL)
|
6.52 log10 IU/mL
STANDARD_DEVIATION 0.517 • n=5 Participants
|
6.64 log10 IU/mL
STANDARD_DEVIATION 0.312 • n=7 Participants
|
6.32 log10 IU/mL
STANDARD_DEVIATION 0.826 • n=5 Participants
|
6.39 log10 IU/mL
STANDARD_DEVIATION 0.558 • n=4 Participants
|
6.46 log10 IU/mL
STANDARD_DEVIATION 0.479 • n=21 Participants
|
6.41 log10 IU/mL
STANDARD_DEVIATION 0.603 • n=10 Participants
|
6.43 log10 IU/mL
STANDARD_DEVIATION 0.597 • n=115 Participants
|
|
HCV Genotype
1a
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
45 Participants
n=115 Participants
|
|
HCV Genotype
1b
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
HCV Genotype
2b
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
HCV Genotype
3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
HCV Genotype
3a
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
HCV Genotype
4
|
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=10 Participants
|
1 Participants
n=115 Participants
|
|
HCV Genotype
4a/4c/4d
|
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=10 Participants
|
1 Participants
n=115 Participants
|
|
IL28B Genotype
C/C
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
|
IL28B Genotype
C/T
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
|
IL28B Genotype
T/T
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)Population: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (velpatasvir or placebo). Data were summarized by velpatasvir or placebo.
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).
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=4 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=15 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=12 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=8 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
n=31 Participants
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment Emergent Adverse Events
|
17.6 percentage of participants
|
25.0 percentage of participants
|
26.7 percentage of participants
|
8.3 percentage of participants
|
37.5 percentage of participants
|
29.0 percentage of participants
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)Population: Participants in the Safety Analysis Set were analyzed. Data were summarized by dose.
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.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=4 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=15 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=12 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=8 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
n=31 Participants
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 1
|
41.2 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
58.3 percentage of participants
|
62.5 percentage of participants
|
33.3 percentage of participants
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 2
|
17.6 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
8.3 percentage of participants
|
25.0 percentage of participants
|
33.3 percentage of participants
|
—
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—
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—
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—
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—
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—
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—
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Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Grade 3
|
11.8 percentage of participants
|
0 percentage of participants
|
13.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
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—
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PRIMARY outcome
Timeframe: Baseline; Days 4, 5, 6, 7, 8, 10, and 17Population: Participants in the Efficacy Analysis Set (all randomized participants with appropriate genotype who received at least one dose of the study drug (velpatasvir or placebo) and with at least one on-treatment HCV RNA assessment) with available data were analyzed. Data were summarized by treatment (velpatasvir dose/HCV genotype) and placebo.
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.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=4 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=8 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=8 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=8 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
n=7 Participants
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
n=8 Participants
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
n=8 Participants
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
n=7 Participants
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
n=4 Participants
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
n=6 Participants
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
n=2 Participants
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline
Change at Day 5
|
-0.018 log10 IU/mL
Standard Deviation 0.2346
|
-1.998 log10 IU/mL
Standard Deviation 0.8305
|
-3.538 log10 IU/mL
Standard Deviation 0.7566
|
-3.123 log10 IU/mL
Standard Deviation 1.5009
|
-3.060 log10 IU/mL
Standard Deviation 1.1098
|
-3.636 log10 IU/mL
Standard Deviation 1.0023
|
-3.955 log10 IU/mL
Standard Deviation 0.3519
|
-4.148 log10 IU/mL
Standard Deviation 0.5841
|
-2.617 log10 IU/mL
Standard Deviation 1.3034
|
-2.130 log10 IU/mL
Standard Deviation 1.4385
|
-2.259 log10 IU/mL
Standard Deviation 1.1488
|
-2.827 log10 IU/mL
Standard Deviation 0.5506
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline
Change at Day 10
|
0.142 log10 IU/mL
Standard Deviation 0.3813
|
-0.679 log10 IU/mL
Standard Deviation 0.4352
|
-1.304 log10 IU/mL
Standard Deviation 1.0374
|
-1.472 log10 IU/mL
Standard Deviation 1.4315
|
-1.143 log10 IU/mL
Standard Deviation 1.2137
|
-2.032 log10 IU/mL
Standard Deviation 1.4388
|
-3.348 log10 IU/mL
Standard Deviation 0.6201
|
-2.918 log10 IU/mL
Standard Deviation 1.1566
|
-0.844 log10 IU/mL
Standard Deviation 0.6967
|
-1.051 log10 IU/mL
Standard Deviation 1.4338
|
-1.198 log10 IU/mL
Standard Deviation 1.0991
|
-0.494 log10 IU/mL
Standard Deviation 0.8933
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline
Change at Day 17
|
-0.025 log10 IU/mL
Standard Deviation 0.2719
|
-0.135 log10 IU/mL
Standard Deviation 0.3747
|
-0.223 log10 IU/mL
Standard Deviation 0.4236
|
-1.110 log10 IU/mL
Standard Deviation 1.3584
|
-0.801 log10 IU/mL
Standard Deviation 0.7679
|
-0.879 log10 IU/mL
Standard Deviation 0.9231
|
-1.532 log10 IU/mL
Standard Deviation 1.2059
|
-0.886 log10 IU/mL
Standard Deviation 1.3190
|
-0.672 log10 IU/mL
Standard Deviation 0.5003
|
-0.085 log10 IU/mL
Standard Deviation 0.6910
|
-0.225 log10 IU/mL
Standard Deviation 0.4210
|
-0.351 log10 IU/mL
Standard Deviation 0.5914
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline
Change at Day 4
|
-0.005 log10 IU/mL
Standard Deviation 0.3343
|
-3.104 log10 IU/mL
Standard Deviation 0.7348
|
-3.638 log10 IU/mL
Standard Deviation 0.4350
|
-3.338 log10 IU/mL
Standard Deviation 1.3088
|
-3.154 log10 IU/mL
Standard Deviation 1.0089
|
-3.648 log10 IU/mL
Standard Deviation 0.9270
|
-3.848 log10 IU/mL
Standard Deviation 0.4834
|
-4.044 log10 IU/mL
Standard Deviation 0.3671
|
-2.796 log10 IU/mL
Standard Deviation 1.4313
|
-2.382 log10 IU/mL
Standard Deviation 1.5028
|
-2.834 log10 IU/mL
Standard Deviation 0.7608
|
-3.269 log10 IU/mL
Standard Deviation 0.6080
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline
Change at Day 6
|
-0.037 log10 IU/mL
Standard Deviation 0.2119
|
-1.244 log10 IU/mL
Standard Deviation 0.6135
|
-3.140 log10 IU/mL
Standard Deviation 0.9786
|
-2.704 log10 IU/mL
Standard Deviation 1.5100
|
-2.713 log10 IU/mL
Standard Deviation 1.1206
|
-3.221 log10 IU/mL
Standard Deviation 1.2323
|
-4.021 log10 IU/mL
Standard Deviation 0.3681
|
-4.109 log10 IU/mL
Standard Deviation 0.6408
|
-2.193 log10 IU/mL
Standard Deviation 1.1060
|
-1.737 log10 IU/mL
Standard Deviation 1.3854
|
-1.869 log10 IU/mL
Standard Deviation 1.3270
|
-2.243 log10 IU/mL
Standard Deviation 0.5919
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline
Change at Day 7
|
-0.003 log10 IU/mL
Standard Deviation 0.1923
|
-1.031 log10 IU/mL
Standard Deviation 0.6112
|
-2.424 log10 IU/mL
Standard Deviation 0.7292
|
-2.184 log10 IU/mL
Standard Deviation 1.5527
|
-2.273 log10 IU/mL
Standard Deviation 1.1753
|
-2.481 log10 IU/mL
Standard Deviation 1.3542
|
-4.205 log10 IU/mL
Standard Deviation 0.4393
|
-3.850 log10 IU/mL
Standard Deviation 0.9630
|
-1.586 log10 IU/mL
Standard Deviation 1.0710
|
-1.742 log10 IU/mL
Standard Deviation 1.3842
|
-1.380 log10 IU/mL
Standard Deviation 1.6686
|
-1.892 log10 IU/mL
Standard Deviation 1.0143
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline
Change at Day 8
|
0.027 log10 IU/mL
Standard Deviation 0.2740
|
-0.941 log10 IU/mL
Standard Deviation 0.5345
|
-2.074 log10 IU/mL
Standard Deviation 0.7701
|
-1.702 log10 IU/mL
Standard Deviation 1.6152
|
-1.780 log10 IU/mL
Standard Deviation 0.9987
|
-2.544 log10 IU/mL
Standard Deviation 1.5460
|
-4.026 log10 IU/mL
Standard Deviation 0.3155
|
-3.559 log10 IU/mL
Standard Deviation 0.9866
|
-1.025 log10 IU/mL
Standard Deviation 1.1864
|
-1.542 log10 IU/mL
Standard Deviation 1.0593
|
-1.062 log10 IU/mL
Standard Deviation 1.5998
|
-1.478 log10 IU/mL
Standard Deviation 1.1542
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Days 4, 5, 6, 7, 8, 10, and 17Population: Participants in the Efficacy Analysis Set with available data were analyzed. Data were summarized by treatment (velpatasvir dose/HCV genotype) and placebo.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=4 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=8 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=8 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=8 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
n=7 Participants
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
n=8 Participants
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
n=8 Participants
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
n=7 Participants
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
n=4 Participants
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
n=6 Participants
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
n=2 Participants
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Absolute HCV RNA Level
Day 10
|
6.659 log10 IU/mL
Standard Deviation 0.4583
|
5.960 log10 IU/mL
Standard Deviation 0.6104
|
5.156 log10 IU/mL
Standard Deviation 1.3456
|
4.986 log10 IU/mL
Standard Deviation 1.7558
|
5.315 log10 IU/mL
Standard Deviation 1.5130
|
4.319 log10 IU/mL
Standard Deviation 1.6357
|
3.074 log10 IU/mL
Standard Deviation 0.8660
|
3.834 log10 IU/mL
Standard Deviation 1.1710
|
5.103 log10 IU/mL
Standard Deviation 1.1273
|
5.190 log10 IU/mL
Standard Deviation 2.0061
|
5.120 log10 IU/mL
Standard Deviation 0.6140
|
5.240 log10 IU/mL
Standard Deviation 1.1278
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute HCV RNA Level
Day 17
|
6.503 log10 IU/mL
Standard Deviation 0.5432
|
6.505 log10 IU/mL
Standard Deviation 0.5615
|
6.237 log10 IU/mL
Standard Deviation 0.6709
|
5.468 log10 IU/mL
Standard Deviation 1.6269
|
5.657 log10 IU/mL
Standard Deviation 1.0148
|
5.455 log10 IU/mL
Standard Deviation 1.2889
|
4.890 log10 IU/mL
Standard Deviation 1.5438
|
5.867 log10 IU/mL
Standard Deviation 1.5443
|
5.275 log10 IU/mL
Standard Deviation 1.1421
|
6.007 log10 IU/mL
Standard Deviation 0.9524
|
6.093 log10 IU/mL
Standard Deviation 0.6451
|
5.383 log10 IU/mL
Standard Deviation 0.8259
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute HCV RNA Level
Baseline
|
6.523 log10 IU/mL
Standard Deviation 0.5173
|
6.639 log10 IU/mL
Standard Deviation 0.3123
|
6.461 log10 IU/mL
Standard Deviation 0.6623
|
6.459 log10 IU/mL
Standard Deviation 0.5726
|
6.458 log10 IU/mL
Standard Deviation 0.4785
|
6.335 log10 IU/mL
Standard Deviation 0.5710
|
6.379 log10 IU/mL
Standard Deviation 0.4187
|
6.753 log10 IU/mL
Standard Deviation 0.5857
|
6.150 log10 IU/mL
Standard Deviation 1.0108
|
6.240 log10 IU/mL
Standard Deviation 0.5796
|
6.318 log10 IU/mL
Standard Deviation 0.8151
|
5.734 log10 IU/mL
Standard Deviation 0.2345
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute HCV RNA Level
Day 4
|
6.518 log10 IU/mL
Standard Deviation 0.4840
|
3.535 log10 IU/mL
Standard Deviation 0.7588
|
2.823 log10 IU/mL
Standard Deviation 0.7866
|
3.121 log10 IU/mL
Standard Deviation 1.6969
|
3.304 log10 IU/mL
Standard Deviation 1.2823
|
2.687 log10 IU/mL
Standard Deviation 0.8776
|
2.574 log10 IU/mL
Standard Deviation 0.3526
|
2.708 log10 IU/mL
Standard Deviation 0.5823
|
3.151 log10 IU/mL
Standard Deviation 2.0090
|
3.858 log10 IU/mL
Standard Deviation 1.9120
|
3.484 log10 IU/mL
Standard Deviation 0.6784
|
2.465 log10 IU/mL
Standard Deviation 0.8425
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute HCV RNA Level
Day 5
|
6.512 log10 IU/mL
Standard Deviation 0.5715
|
4.642 log10 IU/mL
Standard Deviation 0.9016
|
2.922 log10 IU/mL
Standard Deviation 1.0852
|
3.336 log10 IU/mL
Standard Deviation 1.8716
|
3.398 log10 IU/mL
Standard Deviation 1.3325
|
2.699 log10 IU/mL
Standard Deviation 1.0083
|
2.466 log10 IU/mL
Standard Deviation 0.3511
|
2.681 log10 IU/mL
Standard Deviation 0.3893
|
3.329 log10 IU/mL
Standard Deviation 1.8305
|
4.110 log10 IU/mL
Standard Deviation 1.8964
|
4.059 log10 IU/mL
Standard Deviation 1.0186
|
2.907 log10 IU/mL
Standard Deviation 0.7850
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute HCV RNA Level
Day 6
|
6.493 log10 IU/mL
Standard Deviation 0.5373
|
5.395 log10 IU/mL
Standard Deviation 0.6898
|
3.321 log10 IU/mL
Standard Deviation 1.3322
|
3.755 log10 IU/mL
Standard Deviation 1.9323
|
3.745 log10 IU/mL
Standard Deviation 1.3213
|
3.104 log10 IU/mL
Standard Deviation 1.2373
|
2.400 log10 IU/mL
Standard Deviation 0.3365
|
2.644 log10 IU/mL
Standard Deviation 0.6568
|
3.753 log10 IU/mL
Standard Deviation 1.6214
|
4.503 log10 IU/mL
Standard Deviation 1.9383
|
4.450 log10 IU/mL
Standard Deviation 1.1943
|
3.491 log10 IU/mL
Standard Deviation 0.8264
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute HCV RNA Level
Day 7
|
6.527 log10 IU/mL
Standard Deviation 0.6190
|
5.608 log10 IU/mL
Standard Deviation 0.6929
|
4.036 log10 IU/mL
Standard Deviation 1.1305
|
4.275 log10 IU/mL
Standard Deviation 1.9196
|
4.185 log10 IU/mL
Standard Deviation 1.4107
|
3.862 log10 IU/mL
Standard Deviation 1.4141
|
2.217 log10 IU/mL
Standard Deviation 0.5807
|
2.903 log10 IU/mL
Standard Deviation 0.7639
|
4.361 log10 IU/mL
Standard Deviation 1.4130
|
4.498 log10 IU/mL
Standard Deviation 1.9226
|
4.938 log10 IU/mL
Standard Deviation 1.4707
|
3.842 log10 IU/mL
Standard Deviation 1.2488
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Absolute HCV RNA Level
Day 8
|
6.555 log10 IU/mL
Standard Deviation 0.4880
|
5.699 log10 IU/mL
Standard Deviation 0.6305
|
4.387 log10 IU/mL
Standard Deviation 1.1089
|
4.756 log10 IU/mL
Standard Deviation 1.9494
|
4.678 log10 IU/mL
Standard Deviation 1.3233
|
3.791 log10 IU/mL
Standard Deviation 1.5984
|
2.396 log10 IU/mL
Standard Deviation 0.6092
|
3.194 log10 IU/mL
Standard Deviation 0.8402
|
4.922 log10 IU/mL
Standard Deviation 1.3395
|
4.698 log10 IU/mL
Standard Deviation 1.6047
|
5.256 log10 IU/mL
Standard Deviation 1.3141
|
4.256 log10 IU/mL
Standard Deviation 1.3887
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Days 4, 5, 6, 7, 8, 10, and 17Population: 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 by treatment (velpatasvir dose/HCV genotype) and placebo at each collection time point through Day 17.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=4 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=8 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=8 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=8 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
n=7 Participants
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
n=8 Participants
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
n=8 Participants
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
n=7 Participants
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
n=4 Participants
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
n=6 Participants
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
n=2 Participants
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 17 · < 1 log10 IU/mL decrease in HCV RNA
|
16 Participants
|
4 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 10 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 17 · Missing HCV RNA
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 7 · Missing HCV RNA
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 17 · ≥1 and <2 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 17 · ≥2 and <3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 4 · < 1 log10 IU/mL decrease in HCV RNA
|
17 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 6 · ≥1 and <2 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 6 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 7 · < 1 log10 IU/mL decrease in HCV RNA
|
15 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 8 · Missing HCV RNA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 8 · < 1 log10 IU/mL decrease in HCV RNA
|
16 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 17 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 5 · Missing HCV RNA
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 4 · Missing HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 4 · ≥2 and <3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 4 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 5 · < 1 log10 IU/mL decrease in HCV RNA
|
15 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 5 · ≥2 and <3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 5 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 6 · Missing HCV RNA
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 6 · < 1 log10 IU/mL decrease in HCV RNA
|
15 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 7 · ≥1 and <2 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
5 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 7 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 8 · ≥2 and <3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 8 · ≥3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 10 · Missing HCV RNA
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 10 · < 1 log10 IU/mL decrease in HCV RNA
|
15 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 10 · ≥1 and <2 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Achieving Reductions From Baseline in HCV RNA
Day 10 · ≥2 and <3 log10 IU/mL decrease in HCV RNA
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 4, 5, 6, 7, and 8Population: Participants in the Efficacy Analysis Set were analyzed. Data were summarized by treatment (velpatasvir dose/HCV genotype) and placebo.
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.
Outcome measures
| Measure |
Placebo
n=17 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=4 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=8 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=8 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=8 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
n=7 Participants
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
n=8 Participants
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
n=8 Participants
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
n=7 Participants
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
n=4 Participants
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
n=6 Participants
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
n=2 Participants
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected
Day 4 < LLOQ detected
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected
Day 5 < LLOQ detected
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected
Day 6 < LLOQ detected
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected
Day 7 < LLOQ detected
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected
Day 8 < LLOQ detected
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 4, 5, 6, 7, 8, 10, and 17Population: Participants in the Efficacy Analysis Set with available data were analyzed. Data are were summarized by treatment (velpatasvir dose/HCV genotype and placebo) and IL28B genotype (CC and non-CC). Due to the small number of participants in each treatment group, no conclusions can be made on the effect of IL28B genotype on HCV RNA decline.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=2 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=3 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=2 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=2 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
n=1 Participants
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
n=3 Participants
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
n=2 Participants
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
n=3 Participants
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
n=1 Participants
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
n=10 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
n=2 Participants
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
n=5 Participants
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
n=6 Participants
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
n=6 Participants
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
n=7 Participants
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
n=7 Participants
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
n=5 Participants
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
n=5 Participants
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
n=1 Participants
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
n=5 Participants
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
n=2 Participants
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma HCV RNA Levels by Treatment and IL28B Genotype
Day 4
|
6.473 log10 IU/mL
Standard Deviation 0.4869
|
3.410 log10 IU/mL
Standard Deviation 0.4007
|
2.603 log10 IU/mL
Standard Deviation 0.5255
|
1.762 log10 IU/mL
Standard Deviation 0.5394
|
2.891 log10 IU/mL
Standard Deviation 0.4237
|
—
|
2.539 log10 IU/mL
|
2.758 log10 IU/mL
Standard Deviation 0.3416
|
2.976 log10 IU/mL
|
4.304 log10 IU/mL
Standard Deviation 2.0716
|
3.590 log10 IU/mL
|
—
|
6.549 log10 IU/mL
Standard Deviation 0.5057
|
3.660 log10 IU/mL
Standard Deviation 1.2265
|
2.955 log10 IU/mL
Standard Deviation 0.9418
|
3.574 log10 IU/mL
Standard Deviation 1.7284
|
3.442 log10 IU/mL
Standard Deviation 1.4747
|
2.687 log10 IU/mL
Standard Deviation 0.8776
|
2.579 log10 IU/mL
Standard Deviation 0.3859
|
2.678 log10 IU/mL
Standard Deviation 0.7295
|
3.186 log10 IU/mL
Standard Deviation 2.2441
|
2.521 log10 IU/mL
|
3.463 log10 IU/mL
Standard Deviation 0.7562
|
2.465 log10 IU/mL
Standard Deviation 0.8425
|
|
Plasma HCV RNA Levels by Treatment and IL28B Genotype
Day 5
|
6.604 log10 IU/mL
Standard Deviation 0.4842
|
4.578 log10 IU/mL
Standard Deviation 0.6202
|
2.581 log10 IU/mL
Standard Deviation 1.0972
|
1.748 log10 IU/mL
Standard Deviation 0.0110
|
2.996 log10 IU/mL
Standard Deviation 0.4644
|
—
|
2.605 log10 IU/mL
|
2.689 log10 IU/mL
Standard Deviation 0.5473
|
3.117 log10 IU/mL
|
4.620 log10 IU/mL
Standard Deviation 1.9568
|
3.742 log10 IU/mL
|
—
|
6.450 log10 IU/mL
Standard Deviation 0.6437
|
4.705 log10 IU/mL
Standard Deviation 1.4275
|
3.127 log10 IU/mL
Standard Deviation 1.1484
|
3.865 log10 IU/mL
Standard Deviation 1.8868
|
3.532 log10 IU/mL
Standard Deviation 1.5350
|
2.699 log10 IU/mL
Standard Deviation 1.0083
|
2.443 log10 IU/mL
Standard Deviation 0.3787
|
2.673 log10 IU/mL
Standard Deviation 0.2813
|
3.372 log10 IU/mL
Standard Deviation 2.0433
|
2.577 log10 IU/mL
|
4.123 log10 IU/mL
Standard Deviation 1.1255
|
2.907 log10 IU/mL
Standard Deviation 0.7850
|
|
Plasma HCV RNA Levels by Treatment and IL28B Genotype
Day 6
|
6.595 log10 IU/mL
Standard Deviation 0.3266
|
5.388 log10 IU/mL
Standard Deviation 0.5909
|
2.740 log10 IU/mL
Standard Deviation 1.2380
|
2.134 log10 IU/mL
Standard Deviation 0.3192
|
3.138 log10 IU/mL
Standard Deviation 0.5754
|
—
|
2.801 log10 IU/mL
|
2.668 log10 IU/mL
Standard Deviation 0.7974
|
3.813 log10 IU/mL
|
5.035 log10 IU/mL
Standard Deviation 1.9842
|
3.653 log10 IU/mL
|
—
|
6.426 log10 IU/mL
Standard Deviation 0.6525
|
5.403 log10 IU/mL
Standard Deviation 1.0383
|
3.669 log10 IU/mL
Standard Deviation 1.3910
|
4.295 log10 IU/mL
Standard Deviation 1.9510
|
3.947 log10 IU/mL
Standard Deviation 1.4771
|
3.104 log10 IU/mL
Standard Deviation 1.2373
|
2.334 log10 IU/mL
Standard Deviation 0.3139
|
2.629 log10 IU/mL
Standard Deviation 0.6604
|
3.741 log10 IU/mL
Standard Deviation 1.8125
|
2.907 log10 IU/mL
|
4.609 log10 IU/mL
Standard Deviation 1.2620
|
3.491 log10 IU/mL
Standard Deviation 0.8264
|
|
Plasma HCV RNA Levels by Treatment and IL28B Genotype
Day 7
|
6.563 log10 IU/mL
Standard Deviation 0.3311
|
5.612 log10 IU/mL
Standard Deviation 0.4912
|
3.637 log10 IU/mL
Standard Deviation 0.7489
|
2.988 log10 IU/mL
Standard Deviation 0.7310
|
3.390 log10 IU/mL
Standard Deviation 0.1908
|
—
|
3.312 log10 IU/mL
|
2.684 log10 IU/mL
Standard Deviation 1.0300
|
4.196 log10 IU/mL
|
5.038 log10 IU/mL
Standard Deviation 1.9476
|
3.713 log10 IU/mL
|
—
|
6.504 log10 IU/mL
Standard Deviation 0.7748
|
5.604 log10 IU/mL
Standard Deviation 1.0949
|
4.276 log10 IU/mL
Standard Deviation 1.3284
|
4.704 log10 IU/mL
Standard Deviation 2.0419
|
4.449 log10 IU/mL
Standard Deviation 1.5628
|
3.862 log10 IU/mL
Standard Deviation 1.4141
|
2.034 log10 IU/mL
Standard Deviation 0.3534
|
3.034 log10 IU/mL
Standard Deviation 0.6583
|
4.394 log10 IU/mL
Standard Deviation 1.5772
|
2.877 log10 IU/mL
|
5.183 log10 IU/mL
Standard Deviation 1.5012
|
3.842 log10 IU/mL
Standard Deviation 1.2488
|
|
Plasma HCV RNA Levels by Treatment and IL28B Genotype
Day 8
|
6.643 log10 IU/mL
Standard Deviation 0.4611
|
5.744 log10 IU/mL
Standard Deviation 0.7194
|
3.875 log10 IU/mL
Standard Deviation 0.5026
|
3.053 log10 IU/mL
Standard Deviation 1.1852
|
3.867 log10 IU/mL
Standard Deviation 0.3347
|
—
|
3.441 log10 IU/mL
|
2.913 log10 IU/mL
Standard Deviation 1.0913
|
4.553 log10 IU/mL
|
5.123 log10 IU/mL
Standard Deviation 1.6669
|
4.114 log10 IU/mL
|
—
|
6.503 log10 IU/mL
Standard Deviation 0.5202
|
5.653 log10 IU/mL
Standard Deviation 0.8166
|
4.694 log10 IU/mL
Standard Deviation 1.3082
|
5.324 log10 IU/mL
Standard Deviation 1.8687
|
4.949 log10 IU/mL
Standard Deviation 1.4416
|
3.791 log10 IU/mL
Standard Deviation 1.5984
|
2.222 log10 IU/mL
Standard Deviation 0.4366
|
3.362 log10 IU/mL
Standard Deviation 0.7384
|
4.996 log10 IU/mL
Standard Deviation 1.4838
|
3.423 log10 IU/mL
|
5.485 log10 IU/mL
Standard Deviation 1.3293
|
4.256 log10 IU/mL
Standard Deviation 1.3887
|
|
Plasma HCV RNA Levels by Treatment and IL28B Genotype
Day 10
|
6.817 log10 IU/mL
Standard Deviation 0.3336
|
6.171 log10 IU/mL
Standard Deviation 0.8102
|
4.369 log10 IU/mL
Standard Deviation 0.3684
|
3.488 log10 IU/mL
Standard Deviation 1.1964
|
4.059 log10 IU/mL
Standard Deviation 0.0027
|
—
|
3.948 log10 IU/mL
|
3.438 log10 IU/mL
Standard Deviation 1.2872
|
5.061 log10 IU/mL
|
5.724 log10 IU/mL
Standard Deviation 2.0787
|
4.754 log10 IU/mL
|
—
|
6.580 log10 IU/mL
Standard Deviation 0.5065
|
5.750 log10 IU/mL
Standard Deviation 0.5333
|
5.629 log10 IU/mL
Standard Deviation 1.5354
|
5.485 log10 IU/mL
Standard Deviation 1.6832
|
5.733 log10 IU/mL
Standard Deviation 1.5375
|
4.319 log10 IU/mL
Standard Deviation 1.6357
|
2.928 log10 IU/mL
Standard Deviation 0.8495
|
4.073 log10 IU/mL
Standard Deviation 1.1757
|
5.111 log10 IU/mL
Standard Deviation 1.2601
|
3.585 log10 IU/mL
|
5.193 log10 IU/mL
Standard Deviation 0.6566
|
5.240 log10 IU/mL
Standard Deviation 1.1278
|
|
Plasma HCV RNA Levels by Treatment and IL28B Genotype
Day 17
|
6.601 log10 IU/mL
Standard Deviation 0.3466
|
6.713 log10 IU/mL
Standard Deviation 0.6714
|
6.147 log10 IU/mL
Standard Deviation 1.0166
|
2.949 log10 IU/mL
|
4.572 log10 IU/mL
Standard Deviation 0.1838
|
—
|
6.953 log10 IU/mL
|
5.127 log10 IU/mL
Standard Deviation 1.8225
|
6.744 log10 IU/mL
|
5.881 log10 IU/mL
Standard Deviation 1.3108
|
6.621 log10 IU/mL
|
—
|
6.444 log10 IU/mL
Standard Deviation 0.6440
|
6.297 log10 IU/mL
Standard Deviation 0.5676
|
6.292 log10 IU/mL
Standard Deviation 0.5110
|
5.888 log10 IU/mL
Standard Deviation 1.3019
|
6.019 log10 IU/mL
Standard Deviation 0.8985
|
5.455 log10 IU/mL
Standard Deviation 1.2889
|
4.546 log10 IU/mL
Standard Deviation 1.3663
|
6.311 log10 IU/mL
Standard Deviation 1.3623
|
4.981 log10 IU/mL
Standard Deviation 0.9912
|
6.260 log10 IU/mL
|
5.987 log10 IU/mL
Standard Deviation 0.6606
|
5.383 log10 IU/mL
Standard Deviation 0.8259
|
SECONDARY outcome
Timeframe: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1Population: The PK analysis set included all randomized and treated participants who have evaluable PK profiles for velpatasvir.
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=15 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=12 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=8 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=30 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf
|
113.8 h*ng/mL
Standard Deviation 71.61
|
857.9 h*ng/mL
Standard Deviation 612.23
|
2054.3 h*ng/mL
Standard Deviation 806.69
|
2727.3 h*ng/mL
Standard Deviation 1619.74
|
4546.6 h*ng/mL
Standard Deviation 1757.10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3Population: Participants in the PK Analysis Set were analyzed.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=15 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=12 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=8 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=30 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter of Velpatasvir: AUCtau
|
86.4 h*ng/mL
Standard Deviation 14.32
|
857.5 h*ng/mL
Standard Deviation 467.74
|
1950.5 h*ng/mL
Standard Deviation 486.87
|
2745.3 h*ng/mL
Standard Deviation 1480.47
|
5003.0 h*ng/mL
Standard Deviation 2371.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.Population: Participants in the PK Analysis Set were analyzed.
Cmax is defined as the maximum observed plasma concentration of drug.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=15 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=12 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=8 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=30 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter of Velpatasvir: Cmax
Day 1 (Single-Dose)
|
20.1 ng/mL
Standard Deviation 14.62
|
110.8 ng/mL
Standard Deviation 55.97
|
272.3 ng/mL
Standard Deviation 95.46
|
372.8 ng/mL
Standard Deviation 222.74
|
583.3 ng/mL
Standard Deviation 257.90
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK Parameter of Velpatasvir: Cmax
Day 3 (Multiple-Dose)
|
16.2 ng/mL
Standard Deviation 2.34
|
122.9 ng/mL
Standard Deviation 61.38
|
292.4 ng/mL
Standard Deviation 88.77
|
413.9 ng/mL
Standard Deviation 243.66
|
690.1 ng/mL
Standard Deviation 307.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 dosePopulation: Participants in the PK Analysis Set were analyzed.
CL/F is defined as the apparent oral clearance following administration of the drug.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=15 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=12 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=8 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=30 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter of Velpatasvir: CL/F
Day 1
|
61312.2 mL/hr
Standard Deviation 42726.76
|
37170.7 mL/hr
Standard Deviation 16570.51
|
27930.6 mL/hr
Standard Deviation 10689.18
|
49237.5 mL/hr
Standard Deviation 25550.98
|
38011.7 mL/hr
Standard Deviation 14392.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK Parameter of Velpatasvir: CL/F
Day 3
|
59173.6 mL/hr
Standard Deviation 10490.08
|
34,820.1 mL/hr
Standard Deviation 13217.45
|
27,263.0 mL/hr
Standard Deviation 7367.47
|
53,194.3 mL/hr
Standard Deviation 39618.97
|
37,362.8 mL/hr
Standard Deviation 18382.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3Population: Participants in the PK Analysis Set were analyzed.
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=15 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=12 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=8 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=30 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter of Velpatasvir: Ctau
|
0.6 ng/mL
Standard Deviation 0.70
|
10.8 ng/mL
Standard Deviation 8.50
|
22.4 ng/mL
Standard Deviation 4.66
|
30.8 ng/mL
Standard Deviation 15.03
|
60.6 ng/mL
Standard Deviation 33.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First dose date up to Day 17Population: Participants in the efficacy analysis set who were sequenced at pre-treatment or post baseline treatment were analyzed.
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.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=4 Participants
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=8 Participants
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=8 Participants
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=8 Participants
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
n=7 Participants
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b)
n=8 Participants
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2)
n=8 Participants
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3)
n=7 Participants
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3)
n=4 Participants
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3)
n=6 Participants
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4)
n=2 Participants
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Placebo (IL28B Genotype Non-CC)
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC)
Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC)
Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC)
Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC)
Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC)
Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints
Number of participants with RAVs at postbaseline
|
0 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints
Number of participants sequenced pretreatment
|
8 Participants
|
4 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints
Number of participants with RAVs at pretreatment
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints
Number of participants sequenced at postbaseline
|
2 Participants
|
4 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Velpatasvir 5 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Velpatasvir 25 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Velpatasvir 50 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Velpatasvir 100 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Velpatasvir 150 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=17 participants at risk
Participants with HCV infection received placebo once daily for 3 days under fasted conditions.
|
Velpatasvir 5 mg
n=4 participants at risk
Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 25 mg
n=15 participants at risk
Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 50 mg
n=12 participants at risk
Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 100 mg
n=8 participants at risk
Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions.
|
Velpatasvir 150 mg
n=31 participants at risk
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
6.7%
1/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Eye disorders
Eye irritation
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
6.7%
1/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
6.7%
1/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
6.7%
1/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
12.5%
1/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
6.7%
1/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
8.3%
1/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
6.7%
1/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
6.7%
1/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.9%
1/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
8.3%
1/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
6.5%
2/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
6.7%
1/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
8.3%
1/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
3.2%
1/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
12.5%
1/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
1/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
5.9%
1/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
25.0%
1/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
12.5%
1/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
12.9%
4/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
6.7%
1/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
12.5%
1/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
3.2%
1/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
6.7%
1/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
8.3%
1/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/4 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/15 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/12 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
0.00%
0/8 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
3.2%
1/31 • Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); 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 (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
|
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