Trial Outcomes & Findings for Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection (NCT NCT01858766)
NCT ID: NCT01858766
Last Updated: 2018-11-14
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
379 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-14
Participant Flow
Participants were enrolled at study sites in the United States. The first participant was screened on 22 April 2013. The last study visit occurred on 12 August 2014.
469 participants were screened.
Participant milestones
| Measure |
SOF+VEL 25 mg 12 Weeks (GT1)
Sofosbuvir (SOF) 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 1)
|
SOF+VEL 100 mg 12 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 100 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 25 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 100 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 25 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 100 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 25 mg 12 Weeks (GT5)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
|
SOF+VEL 25 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 100 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 25 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 100 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 25 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
SOF+VEL 100 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
11
|
10
|
27
|
28
|
7
|
7
|
1
|
4
|
5
|
30
|
30
|
29
|
31
|
26
|
25
|
27
|
26
|
|
Overall Study
COMPLETED
|
26
|
28
|
10
|
10
|
26
|
24
|
7
|
5
|
1
|
4
|
5
|
25
|
25
|
26
|
23
|
20
|
22
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
1
|
4
|
0
|
2
|
0
|
0
|
0
|
5
|
5
|
3
|
8
|
6
|
3
|
4
|
4
|
Reasons for withdrawal
| Measure |
SOF+VEL 25 mg 12 Weeks (GT1)
Sofosbuvir (SOF) 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 1)
|
SOF+VEL 100 mg 12 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 100 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 25 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 100 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 25 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 100 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 25 mg 12 Weeks (GT5)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
|
SOF+VEL 25 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 100 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 25 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 100 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 25 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
SOF+VEL 100 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Randomized but Never Treated
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
3
|
5
|
3
|
5
|
5
|
2
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
3
|
1
|
1
|
0
|
1
|
|
Overall Study
Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
Baseline characteristics by cohort
| Measure |
SOF+VEL 25 mg 12 Weeks (GT1)
n=27 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 100 mg 12 Weeks (GT1)
n=28 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg 12 Weeks (GT2)
n=11 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 100 mg 12 Weeks (GT2)
n=10 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 25 mg 12 Weeks (GT3)
n=27 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 100 mg 12 Weeks (GT3)
n=27 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 25 mg 12 Weeks (GT4)
n=7 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 100 mg 12 Weeks (GT4)
n=7 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 25 mg 12 Weeks (GT5)
n=1 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
|
SOF+VEL 25 mg 12 Weeks (GT6)
n=4 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 100 mg 12 Weeks (GT6)
n=5 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 25 mg 8 Weeks (GT1)
n=30 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
n=30 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 100 mg 8 Weeks (GT1)
n=29 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
n=31 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 25 mg 8 Weeks (GT2)
n=26 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
n=25 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
SOF+VEL 100 mg 8 Weeks (GT2)
n=26 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
n=26 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
Total
n=377 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
49 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
42 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
53 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
52 years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
50 years
STANDARD_DEVIATION 12.7 • n=8 Participants
|
51 years
STANDARD_DEVIATION 16.1 • n=8 Participants
|
56 years
STANDARD_DEVIATION 5.5 • n=24 Participants
|
53 years
STANDARD_DEVIATION NA • n=42 Participants
|
57 years
STANDARD_DEVIATION 4.8 • n=42 Participants
|
54 years
STANDARD_DEVIATION 9.3 • n=42 Participants
|
50 years
STANDARD_DEVIATION 10.7 • n=42 Participants
|
53 years
STANDARD_DEVIATION 8.5 • n=36 Participants
|
55 years
STANDARD_DEVIATION 9.6 • n=36 Participants
|
52 years
STANDARD_DEVIATION 13.8 • n=24 Participants
|
52 years
STANDARD_DEVIATION 10.8 • n=135 Participants
|
54 years
STANDARD_DEVIATION 11.5 • n=136 Participants
|
54 years
STANDARD_DEVIATION 10.8 • n=44 Participants
|
51 years
STANDARD_DEVIATION 9.4 • n=667 Participants
|
52 years
STANDARD_DEVIATION 11.3 • n=15 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
13 Participants
n=36 Participants
|
15 Participants
n=24 Participants
|
11 Participants
n=135 Participants
|
8 Participants
n=136 Participants
|
14 Participants
n=44 Participants
|
16 Participants
n=667 Participants
|
159 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
18 Participants
n=36 Participants
|
16 Participants
n=36 Participants
|
16 Participants
n=24 Participants
|
15 Participants
n=135 Participants
|
17 Participants
n=136 Participants
|
12 Participants
n=44 Participants
|
10 Participants
n=667 Participants
|
218 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
5 Participants
n=667 Participants
|
39 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
29 Participants
n=36 Participants
|
27 Participants
n=36 Participants
|
30 Participants
n=24 Participants
|
23 Participants
n=135 Participants
|
23 Participants
n=136 Participants
|
19 Participants
n=44 Participants
|
21 Participants
n=667 Participants
|
338 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
2 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
1 participants
n=667 Participants
|
6 participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
2 participants
n=42 Participants
|
4 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
7 participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
4 participants
n=42 Participants
|
3 participants
n=36 Participants
|
5 participants
n=36 Participants
|
5 participants
n=24 Participants
|
2 participants
n=135 Participants
|
2 participants
n=136 Participants
|
2 participants
n=44 Participants
|
0 participants
n=667 Participants
|
35 participants
n=15 Participants
|
|
Race/Ethnicity, Customized
White
|
23 participants
n=5 Participants
|
25 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
22 participants
n=21 Participants
|
26 participants
n=8 Participants
|
5 participants
n=8 Participants
|
5 participants
n=24 Participants
|
1 participants
n=42 Participants
|
2 participants
n=42 Participants
|
1 participants
n=42 Participants
|
26 participants
n=42 Participants
|
27 participants
n=36 Participants
|
24 participants
n=36 Participants
|
24 participants
n=24 Participants
|
22 participants
n=135 Participants
|
23 participants
n=136 Participants
|
24 participants
n=44 Participants
|
25 participants
n=667 Participants
|
326 participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
2 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
3 participants
n=15 Participants
|
|
HCV Genotype
Genotype 1a
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
25 participants
n=42 Participants
|
25 participants
n=36 Participants
|
24 participants
n=36 Participants
|
25 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
142 participants
n=15 Participants
|
|
HCV Genotype
Genotype 1b
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
5 participants
n=42 Participants
|
5 participants
n=36 Participants
|
5 participants
n=36 Participants
|
6 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
32 participants
n=15 Participants
|
|
HCV Genotype
Genotype 1g
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
1 participants
n=15 Participants
|
|
HCV Genotype
Genotype 2
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
26 participants
n=135 Participants
|
25 participants
n=136 Participants
|
26 participants
n=44 Participants
|
26 participants
n=667 Participants
|
124 participants
n=15 Participants
|
|
HCV Genotype
Genotype 3
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
27 participants
n=21 Participants
|
27 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
54 participants
n=15 Participants
|
|
HCV Genotype
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
|
0 participants
n=8 Participants
|
7 participants
n=8 Participants
|
7 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
14 participants
n=15 Participants
|
|
HCV Genotype
Genotype 5
|
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
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
1 participants
n=15 Participants
|
|
HCV Genotype
Genotype 6
|
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
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
4 participants
n=42 Participants
|
5 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
0 participants
n=667 Participants
|
9 participants
n=15 Participants
|
|
IL28b Status
CC
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
12 participants
n=21 Participants
|
13 participants
n=8 Participants
|
2 participants
n=8 Participants
|
2 participants
n=24 Participants
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
5 participants
n=42 Participants
|
9 participants
n=42 Participants
|
10 participants
n=36 Participants
|
13 participants
n=36 Participants
|
9 participants
n=24 Participants
|
9 participants
n=135 Participants
|
13 participants
n=136 Participants
|
9 participants
n=44 Participants
|
7 participants
n=667 Participants
|
135 participants
n=15 Participants
|
|
IL28b Status
CT
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
13 participants
n=21 Participants
|
12 participants
n=8 Participants
|
5 participants
n=8 Participants
|
2 participants
n=24 Participants
|
0 participants
n=42 Participants
|
3 participants
n=42 Participants
|
0 participants
n=42 Participants
|
14 participants
n=42 Participants
|
16 participants
n=36 Participants
|
13 participants
n=36 Participants
|
18 participants
n=24 Participants
|
14 participants
n=135 Participants
|
9 participants
n=136 Participants
|
14 participants
n=44 Participants
|
14 participants
n=667 Participants
|
196 participants
n=15 Participants
|
|
IL28b Status
TT
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
3 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
7 participants
n=42 Participants
|
4 participants
n=36 Participants
|
3 participants
n=36 Participants
|
4 participants
n=24 Participants
|
3 participants
n=135 Participants
|
3 participants
n=136 Participants
|
3 participants
n=44 Participants
|
3 participants
n=667 Participants
|
43 participants
n=15 Participants
|
|
IL28b Status
Missing
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=36 Participants
|
0 participants
n=36 Participants
|
0 participants
n=24 Participants
|
0 participants
n=135 Participants
|
0 participants
n=136 Participants
|
0 participants
n=44 Participants
|
2 participants
n=667 Participants
|
3 participants
n=15 Participants
|
|
HCV RNA
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.60 • n=5 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.74 • n=7 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.74 • n=5 Participants
|
6.7 log10 IU/mL
STANDARD_DEVIATION 0.78 • n=4 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 1.09 • n=21 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.74 • n=8 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.58 • n=8 Participants
|
5.8 log10 IU/mL
STANDARD_DEVIATION 0.55 • n=24 Participants
|
7.0 log10 IU/mL
STANDARD_DEVIATION NA • n=42 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.89 • n=42 Participants
|
6.7 log10 IU/mL
STANDARD_DEVIATION 0.88 • n=42 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.69 • n=42 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.63 • n=36 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.85 • n=36 Participants
|
6.6 log10 IU/mL
STANDARD_DEVIATION 0.55 • n=24 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.87 • n=135 Participants
|
6.6 log10 IU/mL
STANDARD_DEVIATION 0.80 • n=136 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.74 • n=44 Participants
|
6.7 log10 IU/mL
STANDARD_DEVIATION 0.57 • n=667 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.75 • n=15 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
9 participants
n=21 Participants
|
6 participants
n=8 Participants
|
2 participants
n=8 Participants
|
4 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
5 participants
n=42 Participants
|
5 participants
n=36 Participants
|
8 participants
n=36 Participants
|
3 participants
n=24 Participants
|
6 participants
n=135 Participants
|
4 participants
n=136 Participants
|
5 participants
n=44 Participants
|
2 participants
n=667 Participants
|
74 participants
n=15 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
18 participants
n=21 Participants
|
21 participants
n=8 Participants
|
5 participants
n=8 Participants
|
3 participants
n=24 Participants
|
1 participants
n=42 Participants
|
3 participants
n=42 Participants
|
4 participants
n=42 Participants
|
25 participants
n=42 Participants
|
25 participants
n=36 Participants
|
21 participants
n=36 Participants
|
28 participants
n=24 Participants
|
20 participants
n=135 Participants
|
21 participants
n=136 Participants
|
21 participants
n=44 Participants
|
24 participants
n=667 Participants
|
303 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF+VEL 25 mg 12 Weeks (GT1)
n=27 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 100 mg 12 Weeks (GT1)
n=28 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg 12 Weeks (GT2)
n=11 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 100 mg 12 Weeks (GT2)
n=10 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 25 mg 12 Weeks (GT3)
n=27 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 100 mg 12 Weeks (GT3)
n=27 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 25 mg 12 Weeks (GT4)
n=7 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 100 mg 12 Weeks (GT4)
n=7 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 25 mg 12 Weeks (GT5)
n=1 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
|
SOF+VEL 25 mg 12 Weeks (GT6)
n=4 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 100 mg 12 Weeks (GT6)
n=5 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 25 mg 8 Weeks (GT1)
n=30 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
n=30 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 100 mg 8 Weeks (GT1)
n=29 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
n=31 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 25 mg 8 Weeks (GT2)
n=26 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
n=25 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
SOF+VEL 100 mg 8 Weeks (GT2)
n=26 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
n=26 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
96.3 percentage of participants
Interval 81.0 to 99.9
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
90.9 percentage of participants
Interval 58.7 to 99.8
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
92.6 percentage of participants
Interval 75.7 to 99.1
|
92.6 percentage of participants
Interval 75.7 to 99.1
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
86.7 percentage of participants
Interval 69.3 to 96.2
|
83.3 percentage of participants
Interval 65.3 to 94.4
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
80.6 percentage of participants
Interval 62.5 to 92.5
|
76.9 percentage of participants
Interval 56.4 to 91.0
|
88.0 percentage of participants
Interval 68.8 to 97.5
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF+VEL 25 mg 12 Weeks (GT1)
n=77 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 100 mg 12 Weeks (GT1)
n=77 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg 12 Weeks (GT2)
n=56 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 100 mg 12 Weeks (GT2)
n=55 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 25 mg 12 Weeks (GT3)
n=55 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 100 mg 12 Weeks (GT3)
n=57 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 25 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 100 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 25 mg 12 Weeks (GT5)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
|
SOF+VEL 25 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 100 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 25 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 100 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 25 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
SOF+VEL 100 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Outcome measures
| Measure |
SOF+VEL 25 mg 12 Weeks (GT1)
n=27 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 100 mg 12 Weeks (GT1)
n=28 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg 12 Weeks (GT2)
n=11 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 100 mg 12 Weeks (GT2)
n=10 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 25 mg 12 Weeks (GT3)
n=27 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 100 mg 12 Weeks (GT3)
n=27 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 25 mg 12 Weeks (GT4)
n=7 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 100 mg 12 Weeks (GT4)
n=7 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 25 mg 12 Weeks (GT5)
n=1 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
|
SOF+VEL 25 mg 12 Weeks (GT6)
n=4 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 100 mg 12 Weeks (GT6)
n=5 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 25 mg 8 Weeks (GT1)
n=30 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
n=30 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 100 mg 8 Weeks (GT1)
n=29 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
n=31 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 25 mg 8 Weeks (GT2)
n=26 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
n=25 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
SOF+VEL 100 mg 8 Weeks (GT2)
n=26 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
n=26 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
92.6 percentage of participants
Interval 75.7 to 99.1
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
90.9 percentage of participants
Interval 58.7 to 99.8
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
92.6 percentage of participants
Interval 75.7 to 99.1
|
92.6 percentage of participants
Interval 75.7 to 99.1
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
86.7 percentage of participants
Interval 69.3 to 96.2
|
83.3 percentage of participants
Interval 65.3 to 94.4
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
80.6 percentage of participants
Interval 62.5 to 92.5
|
76.9 percentage of participants
Interval 56.4 to 91.0
|
88.0 percentage of participants
Interval 68.8 to 97.5
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
96.3 percentage of participants
Interval 81.0 to 99.9
|
100.0 percentage of participants
Interval 87.7 to 100.0
|
90.9 percentage of participants
Interval 58.7 to 99.8
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
92.6 percentage of participants
Interval 75.7 to 99.1
|
100.0 percentage of participants
Interval 87.2 to 100.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
86.7 percentage of participants
Interval 69.3 to 96.2
|
83.3 percentage of participants
Interval 65.3 to 94.4
|
93.1 percentage of participants
Interval 77.2 to 99.2
|
87.1 percentage of participants
Interval 70.2 to 96.4
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
88.0 percentage of participants
Interval 68.8 to 97.5
|
92.3 percentage of participants
Interval 74.9 to 99.1
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
SOF+VEL 25 mg 12 Weeks (GT1)
n=27 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 100 mg 12 Weeks (GT1)
n=28 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg 12 Weeks (GT2)
n=11 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 100 mg 12 Weeks (GT2)
n=10 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
|
SOF+VEL 25 mg 12 Weeks (GT3)
n=27 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 100 mg 12 Weeks (GT3)
n=27 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
|
SOF+VEL 25 mg 12 Weeks (GT4)
n=7 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 100 mg 12 Weeks (GT4)
n=7 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
|
SOF+VEL 25 mg 12 Weeks (GT5)
n=1 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
|
SOF+VEL 25 mg 12 Weeks (GT6)
n=4 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 100 mg 12 Weeks (GT6)
n=5 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
|
SOF+VEL 25 mg 8 Weeks (GT1)
n=30 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
n=30 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 100 mg 8 Weeks (GT1)
n=29 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
n=31 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
|
SOF+VEL 25 mg 8 Weeks (GT2)
n=26 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
n=25 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
SOF+VEL 100 mg 8 Weeks (GT2)
n=26 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
|
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
n=26 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure
|
3.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
7.4 percentage of participants
|
7.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
16.7 percentage of participants
|
10.3 percentage of participants
|
16.1 percentage of participants
|
23.1 percentage of participants
|
8.0 percentage of participants
|
11.5 percentage of participants
|
11.5 percentage of participants
|
Adverse Events
SOF+VEL 25 mg 8 Weeks
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
SOF+VEL 25 mg + RBV 8 Weeks
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
SOF+VEL 100 mg 8 Weeks
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
SOF+VEL 100 mg + RBV 8 Weeks
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
SOF+VEL 25 mg 12 Weeks
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
SOF+VEL 100 mg 12 Weeks
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF+VEL 25 mg 8 Weeks
n=56 participants at risk
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
|
SOF+VEL 25 mg + RBV 8 Weeks
n=55 participants at risk
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
|
SOF+VEL 100 mg 8 Weeks
n=55 participants at risk
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
|
SOF+VEL 100 mg + RBV 8 Weeks
n=57 participants at risk
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
|
SOF+VEL 25 mg 12 Weeks
n=77 participants at risk
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
|
SOF+VEL 100 mg 12 Weeks
n=77 participants at risk
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Appendicitis
|
1.8%
1/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Investigations
Electrocardiogram ST segment elevation
|
1.8%
1/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Major depression
|
1.8%
1/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF+VEL 25 mg 8 Weeks
n=56 participants at risk
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
|
SOF+VEL 25 mg + RBV 8 Weeks
n=55 participants at risk
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
|
SOF+VEL 100 mg 8 Weeks
n=55 participants at risk
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
|
SOF+VEL 100 mg + RBV 8 Weeks
n=57 participants at risk
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
|
SOF+VEL 25 mg 12 Weeks
n=77 participants at risk
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
|
SOF+VEL 100 mg 12 Weeks
n=77 participants at risk
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.3%
4/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.5%
2/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
1/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.2%
4/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.5%
3/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.5%
3/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
11.7%
9/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.8%
6/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
3/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.1%
5/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.6%
2/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
10.5%
6/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.5%
5/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.1%
7/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.3%
4/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.0%
4/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.2%
4/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.2%
4/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
7.1%
4/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
12.7%
7/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
12.7%
7/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
14.0%
8/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
13.0%
10/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
10.4%
8/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.0%
4/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.5%
5/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
12.5%
7/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
30.9%
17/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.6%
2/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
36.8%
21/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
24.7%
19/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
18.2%
14/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
5.4%
3/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Influenza
|
3.6%
2/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.6%
2/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.3%
3/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
10.7%
6/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.3%
4/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.3%
3/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.6%
2/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.5%
5/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Sinusitis
|
1.8%
1/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.5%
3/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.6%
2/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.5%
3/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.0%
4/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.9%
3/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
3/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.3%
4/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.9%
3/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.6%
2/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.6%
2/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.9%
3/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.2%
4/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
3.6%
2/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.6%
2/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.3%
3/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.6%
2/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.9%
3/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
12.5%
7/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
38.2%
21/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
16.4%
9/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
17.5%
10/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
20.8%
16/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
18.2%
14/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
3.6%
2/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.5%
2/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.8%
6/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
5.4%
3/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
16.4%
9/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
8.8%
5/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.9%
3/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.9%
3/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
1.8%
1/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.1%
5/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.5%
2/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.2%
4/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.2%
4/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.3%
4/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
1/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.5%
2/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.8%
1/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.5%
3/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.5%
2/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.6%
2/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.5%
3/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.6%
2/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.3%
3/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.3%
1/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.5%
5/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
2/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.5%
3/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
8.8%
5/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.6%
2/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.9%
3/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
1/56 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
12.7%
7/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/55 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.3%
3/57 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.2%
4/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.2%
4/77 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
Additional Information
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