Trial Outcomes & Findings for Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection (NCT NCT01909804)
NCT ID: NCT01909804
Last Updated: 2018-11-15
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
323 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-15
Participant Flow
Participants were enrolled at study sites in Australia, New Zealand, and the United States. The first participant was screened on 17 June 2013. The last study visit occurred on 22 August 2014.
416 participants were screened.
Participant milestones
| Measure |
SOF+VEL 25 mg (GT3 Non-Cirrhotic)
Sofosbuvir (SOF) 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
|
SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)
SOF 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 100 mg (GT3 Non-Cirrhotic)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 25 mg (GT3 Cirrhotic)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg + RBV (GT3 Cirrhotic)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg (GT3 Cirrhotic)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Cirrhotic)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
SOF+VEL 100 mg (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 100 mg + RBV (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
28
|
27
|
26
|
26
|
25
|
27
|
26
|
27
|
29
|
27
|
29
|
|
Overall Study
COMPLETED
|
22
|
27
|
27
|
26
|
18
|
21
|
25
|
25
|
27
|
28
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
0
|
0
|
8
|
4
|
2
|
1
|
0
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
SOF+VEL 25 mg (GT3 Non-Cirrhotic)
Sofosbuvir (SOF) 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
|
SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)
SOF 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 100 mg (GT3 Non-Cirrhotic)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 25 mg (GT3 Cirrhotic)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg + RBV (GT3 Cirrhotic)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg (GT3 Cirrhotic)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Cirrhotic)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
SOF+VEL 100 mg (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 100 mg + RBV (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Randomized but Never Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
4
|
1
|
0
|
0
|
7
|
3
|
1
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrew Consent
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
Baseline characteristics by cohort
| Measure |
SOF+VEL 25 mg (GT3 Non-Cirrhotic)
n=26 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
|
SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)
n=28 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 100 mg (GT3 Non-Cirrhotic)
n=27 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)
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 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 25 mg (GT3 Cirrhotic)
n=26 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg + RBV (GT3 Cirrhotic)
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 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg (GT3 Cirrhotic)
n=26 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Cirrhotic)
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 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg (GT1)
n=27 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV (GT1)
n=29 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
SOF+VEL 100 mg (GT1)
n=27 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 100 mg + RBV (GT1)
n=28 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
51 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
55 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
56 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
57 years
STANDARD_DEVIATION 7.0 • n=21 Participants
|
56 years
STANDARD_DEVIATION 5.6 • n=10 Participants
|
56 years
STANDARD_DEVIATION 5.7 • n=115 Participants
|
54 years
STANDARD_DEVIATION 4.7 • n=24 Participants
|
55 years
STANDARD_DEVIATION 8.1 • n=42 Participants
|
57 years
STANDARD_DEVIATION 5.8 • n=42 Participants
|
57 years
STANDARD_DEVIATION 6.4 • n=42 Participants
|
56 years
STANDARD_DEVIATION 6.0 • n=42 Participants
|
55 years
STANDARD_DEVIATION 7.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
100 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
20 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
221 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
20 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
26 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
301 Participants
n=36 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=10 Participants
|
0 Participants
n=115 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
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
4 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
2 participants
n=42 Participants
|
9 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
7 participants
n=42 Participants
|
2 participants
n=42 Participants
|
4 participants
n=42 Participants
|
4 participants
n=42 Participants
|
19 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
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=10 Participants
|
0 participants
n=115 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
|
1 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
25 participants
n=5 Participants
|
24 participants
n=4 Participants
|
25 participants
n=21 Participants
|
23 participants
n=10 Participants
|
25 participants
n=115 Participants
|
24 participants
n=24 Participants
|
20 participants
n=42 Participants
|
27 participants
n=42 Participants
|
23 participants
n=42 Participants
|
21 participants
n=42 Participants
|
288 participants
n=36 Participants
|
|
HCV Genotype
Genotype 1a
|
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=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
19 participants
n=42 Participants
|
22 participants
n=42 Participants
|
21 participants
n=42 Participants
|
22 participants
n=42 Participants
|
84 participants
n=36 Participants
|
|
HCV Genotype
Genotype 1b
|
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=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
7 participants
n=42 Participants
|
7 participants
n=42 Participants
|
6 participants
n=42 Participants
|
6 participants
n=42 Participants
|
26 participants
n=36 Participants
|
|
HCV Genotype
Genotype 1 (no confirmed subtype)
|
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=10 Participants
|
0 participants
n=115 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
|
1 participants
n=36 Participants
|
|
HCV Genotype
Genotype 3
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
27 participants
n=5 Participants
|
26 participants
n=4 Participants
|
26 participants
n=21 Participants
|
25 participants
n=10 Participants
|
26 participants
n=115 Participants
|
26 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
210 participants
n=36 Participants
|
|
IL28b Status
CC
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
11 participants
n=4 Participants
|
12 participants
n=21 Participants
|
5 participants
n=10 Participants
|
12 participants
n=115 Participants
|
13 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
2 participants
n=42 Participants
|
3 participants
n=42 Participants
|
85 participants
n=36 Participants
|
|
IL28b Status
CT
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
13 participants
n=5 Participants
|
12 participants
n=4 Participants
|
11 participants
n=21 Participants
|
14 participants
n=10 Participants
|
11 participants
n=115 Participants
|
10 participants
n=24 Participants
|
19 participants
n=42 Participants
|
21 participants
n=42 Participants
|
17 participants
n=42 Participants
|
19 participants
n=42 Participants
|
177 participants
n=36 Participants
|
|
IL28b Status
TT
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
6 participants
n=10 Participants
|
3 participants
n=115 Participants
|
3 participants
n=24 Participants
|
8 participants
n=42 Participants
|
7 participants
n=42 Participants
|
8 participants
n=42 Participants
|
6 participants
n=42 Participants
|
59 participants
n=36 Participants
|
|
Cirrhosis Status
Absent
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
27 participants
n=5 Participants
|
24 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
17 participants
n=42 Participants
|
19 participants
n=42 Participants
|
18 participants
n=42 Participants
|
18 participants
n=42 Participants
|
175 participants
n=36 Participants
|
|
Cirrhosis Status
Present
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
26 participants
n=21 Participants
|
25 participants
n=10 Participants
|
26 participants
n=115 Participants
|
26 participants
n=24 Participants
|
8 participants
n=42 Participants
|
10 participants
n=42 Participants
|
7 participants
n=42 Participants
|
10 participants
n=42 Participants
|
138 participants
n=36 Participants
|
|
Cirrhosis Status
Missing
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
2 participants
n=42 Participants
|
0 participants
n=42 Participants
|
2 participants
n=42 Participants
|
0 participants
n=42 Participants
|
8 participants
n=36 Participants
|
|
HCV RNA
|
6.7 log10 IU/mL
STANDARD_DEVIATION 0.76 • n=5 Participants
|
6.6 log10 IU/mL
STANDARD_DEVIATION 0.70 • n=7 Participants
|
6.6 log10 IU/mL
STANDARD_DEVIATION 0.59 • n=5 Participants
|
6.7 log10 IU/mL
STANDARD_DEVIATION 0.53 • n=4 Participants
|
6.6 log10 IU/mL
STANDARD_DEVIATION 0.46 • n=21 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.68 • n=10 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.76 • n=115 Participants
|
6.7 log10 IU/mL
STANDARD_DEVIATION 0.51 • n=24 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.59 • n=42 Participants
|
6.8 log10 IU/mL
STANDARD_DEVIATION 0.37 • n=42 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.53 • n=42 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.43 • n=42 Participants
|
6.6 log10 IU/mL
STANDARD_DEVIATION 0.60 • n=36 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
7 participants
n=10 Participants
|
7 participants
n=115 Participants
|
2 participants
n=24 Participants
|
6 participants
n=42 Participants
|
0 participants
n=42 Participants
|
3 participants
n=42 Participants
|
3 participants
n=42 Participants
|
46 participants
n=36 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
25 participants
n=5 Participants
|
24 participants
n=4 Participants
|
23 participants
n=21 Participants
|
18 participants
n=10 Participants
|
19 participants
n=115 Participants
|
24 participants
n=24 Participants
|
21 participants
n=42 Participants
|
29 participants
n=42 Participants
|
24 participants
n=42 Participants
|
25 participants
n=42 Participants
|
275 participants
n=36 Participants
|
|
Prior HCV Treatment
Non-responder
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
7 participants
n=5 Participants
|
5 participants
n=4 Participants
|
6 participants
n=21 Participants
|
9 participants
n=10 Participants
|
10 participants
n=115 Participants
|
3 participants
n=24 Participants
|
6 participants
n=42 Participants
|
13 participants
n=42 Participants
|
7 participants
n=42 Participants
|
8 participants
n=42 Participants
|
91 participants
n=36 Participants
|
|
Prior HCV Treatment
Relapse / Breakthrough
|
19 participants
n=5 Participants
|
18 participants
n=7 Participants
|
20 participants
n=5 Participants
|
21 participants
n=4 Participants
|
20 participants
n=21 Participants
|
16 participants
n=10 Participants
|
16 participants
n=115 Participants
|
23 participants
n=24 Participants
|
21 participants
n=42 Participants
|
16 participants
n=42 Participants
|
20 participants
n=42 Participants
|
20 participants
n=42 Participants
|
230 participants
n=36 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 100 mg (GT3 Non-Cirrhotic)
n=27 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 100 mg + RBV (GT1)
n=28 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
SOF+VEL 25 mg (GT3 Non-Cirrhotic)
n=26 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)
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 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 25 mg (GT3 Cirrhotic)
n=26 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg + RBV (GT3 Cirrhotic)
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 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg (GT3 Cirrhotic)
n=26 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Cirrhotic)
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 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg (GT1)
n=27 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV (GT1)
n=29 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
SOF+VEL 100 mg (GT1)
n=27 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)
n=28 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
100.0 percentage of participants
Interval 87.2 to 100.0
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
84.6 percentage of participants
Interval 65.1 to 95.6
|
100.0 percentage of participants
Interval 86.8 to 100.0
|
57.7 percentage of participants
Interval 36.9 to 76.6
|
84.0 percentage of participants
Interval 63.9 to 95.5
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
100.0 percentage of participants
Interval 87.2 to 100.0
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
100.0 percentage of participants
Interval 87.2 to 100.0
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF+VEL 100 mg (GT3 Non-Cirrhotic)
n=80 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 100 mg + RBV (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
SOF+VEL 25 mg (GT3 Non-Cirrhotic)
n=79 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)
n=80 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 25 mg (GT3 Cirrhotic)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg + RBV (GT3 Cirrhotic)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg (GT3 Cirrhotic)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Cirrhotic)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
SOF+VEL 100 mg (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)
n=82 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.2 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 100 mg (GT3 Non-Cirrhotic)
n=27 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 100 mg + RBV (GT1)
n=28 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
SOF+VEL 25 mg (GT3 Non-Cirrhotic)
n=26 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)
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 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 25 mg (GT3 Cirrhotic)
n=26 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg + RBV (GT3 Cirrhotic)
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 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg (GT3 Cirrhotic)
n=26 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Cirrhotic)
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 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg (GT1)
n=27 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV (GT1)
n=29 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
SOF+VEL 100 mg (GT1)
n=27 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)
n=28 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
100.0 percentage of participants
Interval 87.2 to 100.0
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
100.0 percentage of participants
Interval 86.8 to 100.0
|
61.5 percentage of participants
Interval 40.6 to 79.8
|
84.0 percentage of participants
Interval 63.9 to 95.5
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
100.0 percentage of participants
Interval 87.2 to 100.0
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
100.0 percentage of participants
Interval 87.2 to 100.0
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
100.0 percentage of participants
Interval 87.2 to 100.0
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
84.6 percentage of participants
Interval 65.1 to 95.6
|
100.0 percentage of participants
Interval 86.8 to 100.0
|
57.7 percentage of participants
Interval 36.9 to 76.6
|
84.0 percentage of participants
Interval 63.9 to 95.5
|
92.3 percentage of participants
Interval 74.9 to 99.1
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
100.0 percentage of participants
Interval 87.2 to 100.0
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
100.0 percentage of participants
Interval 87.2 to 100.0
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
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 100 mg (GT3 Non-Cirrhotic)
n=27 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 100 mg + RBV (GT1)
n=28 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
SOF+VEL 25 mg (GT3 Non-Cirrhotic)
n=26 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)
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 12 weeks (genotype 3 non-cirrhotic)
|
SOF+VEL 25 mg (GT3 Cirrhotic)
n=26 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg + RBV (GT3 Cirrhotic)
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 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg (GT3 Cirrhotic)
n=26 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 100 mg + RBV (GT3 Cirrhotic)
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 12 weeks (genotype 3 cirrhotic)
|
SOF+VEL 25 mg (GT1)
n=27 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV (GT1)
n=29 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
|
SOF+VEL 100 mg (GT1)
n=27 Participants
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
|
SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)
n=28 Participants
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure
|
0 percentage of participants
|
3.6 percentage of participants
|
15.4 percentage of participants
|
0 percentage of participants
|
42.3 percentage of participants
|
12.0 percentage of participants
|
11.5 percentage of participants
|
3.8 percentage of participants
|
0 percentage of participants
|
3.4 percentage of participants
|
0 percentage of participants
|
3.6 percentage of participants
|
Adverse Events
SOF+VEL 25 mg
Serious events: 1 serious events
Other events: 54 other events
Deaths: 0 deaths
SOF+VEL 25 mg + RBV
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
SOF+VEL 100 mg
Serious events: 4 serious events
Other events: 54 other events
Deaths: 0 deaths
SOF+VEL 100 mg + RBV
Serious events: 3 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF+VEL 25 mg
n=79 participants at risk
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
|
SOF+VEL 25 mg + RBV
n=82 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 12 weeks (genotypes 1 and 3)
|
SOF+VEL 100 mg
n=80 participants at risk
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
|
SOF+VEL 100 mg + RBV
n=80 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 12 weeks (genotypes 1 and 3)
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Thrombosis in device
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Viral infection
|
1.3%
1/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
May-Thurner syndrome
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF+VEL 25 mg
n=79 participants at risk
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
|
SOF+VEL 25 mg + RBV
n=82 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 12 weeks (genotypes 1 and 3)
|
SOF+VEL 100 mg
n=80 participants at risk
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
|
SOF+VEL 100 mg + RBV
n=80 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 12 weeks (genotypes 1 and 3)
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
4/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
4/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
5/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.3%
5/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
5/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.0%
4/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
8.8%
7/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.3%
6/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.2%
5/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.7%
3/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.2%
5/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
4.9%
4/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.2%
5/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
5.1%
4/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.7%
3/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.0%
4/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.5%
6/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
11.4%
9/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
4.9%
4/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
11.2%
9/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.0%
4/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
2/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.7%
3/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.0%
4/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.5%
6/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.1%
4/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.4%
2/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.0%
4/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
15.2%
12/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
22.0%
18/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
8.8%
7/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
22.5%
18/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
4.9%
4/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.0%
4/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
20.3%
16/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
32.9%
27/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
23.8%
19/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
33.8%
27/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Influenza like illness
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.0%
4/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.4%
2/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.5%
2/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.0%
4/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
7.6%
6/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
8.5%
7/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.2%
5/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.8%
3/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.4%
2/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.0%
4/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.1%
4/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.7%
3/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.5%
2/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
3/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
4.9%
4/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
8.8%
7/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.8%
3/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
3/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.3%
6/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.8%
3/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.5%
2/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
2/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.0%
4/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
1/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
4.9%
4/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.5%
6/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.0%
4/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
8.9%
7/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.8%
8/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.0%
4/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
29.1%
23/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
34.1%
28/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
22.5%
18/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
30.0%
24/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
15.2%
12/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
13.4%
11/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.5%
6/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
20.0%
16/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
7.6%
6/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.3%
6/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.8%
3/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
15.0%
12/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.3%
1/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.3%
6/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.2%
1/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
2/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
11.0%
9/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.5%
2/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
15.0%
12/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
4/79 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
5/82 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.5%
2/80 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
11.2%
9/80 • 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