Trial Outcomes & Findings for Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection (NCT NCT02378935)
NCT ID: NCT02378935
Last Updated: 2020-03-06
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
205 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2020-03-06
Participant Flow
Participants were enrolled at study sites in United States and New Zealand. The first participant was screened on 17 February 2015. The last study visit occurred on 12 April 2016.
255 participants were screened. Enrollment was sequential, with the longer treatment duration groups enrolled, treated, and evaluated for Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) prior to enrollment of the shorter treatment duration groups, which were not enrolled, at the discretion of the Sponsor.
Participant milestones
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
Voxilaprevir (VOX) 100 mg tablet + sofosbuvir/veltapasvir (Epclusa® ; SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in direct-acting antiviral (DAA) experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
36
|
33
|
31
|
31
|
32
|
8
|
|
Overall Study
COMPLETED
|
24
|
36
|
30
|
25
|
31
|
32
|
8
|
|
Overall Study
NOT COMPLETED
|
10
|
0
|
3
|
6
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
Voxilaprevir (VOX) 100 mg tablet + sofosbuvir/veltapasvir (Epclusa® ; SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in direct-acting antiviral (DAA) experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
10
|
0
|
2
|
6
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
Baseline characteristics by cohort
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=34 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
n=33 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
n=32 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
n=8 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
51 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
58 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
59 years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
57 years
STANDARD_DEVIATION 7.8 • n=21 Participants
|
59 years
STANDARD_DEVIATION 6.5 • n=10 Participants
|
5.7 years
STANDARD_DEVIATION 5.9 • n=115 Participants
|
56 years
STANDARD_DEVIATION 9.8 • n=6 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
71 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
134 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
29 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
175 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
42 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
163 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
198 Participants
n=6 Participants
|
|
Region of Enrollment
New Zealand
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
|
IL28b Status
CC
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
51 Participants
n=6 Participants
|
|
IL28b Status
CT
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
110 Participants
n=6 Participants
|
|
IL28b Status
TT
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
40 Participants
n=6 Participants
|
|
IL28b Status
Missing
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
|
HCV RNA
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.51 • n=5 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.55 • n=7 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.59 • n=5 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.47 • n=4 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.77 • n=21 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.61 • n=10 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.38 • n=115 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.60 • n=6 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
58 Participants
n=6 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
147 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set (FAS): participants who received at least 1 dose of study drug
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Outcome measures
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=34 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
n=33 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
n=32 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
n=8 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
70.6 percentage of participants
Interval 52.5 to 84.9
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
93.9 percentage of participants
Interval 79.8 to 99.3
|
80.6 percentage of participants
Interval 62.5 to 92.5
|
100 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 89.1 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
PRIMARY outcome
Timeframe: Up to 12 WeeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=34 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
n=33 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
n=32 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
n=8 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
|
|---|---|---|---|---|---|---|---|
|
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
|
6.5 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 SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Outcome measures
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=34 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
n=33 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
n=32 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
n=8 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
88.2 percentage of participants
Interval 72.5 to 96.7
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
93.9 percentage of participants
Interval 79.8 to 99.3
|
87.1 percentage of participants
Interval 70.2 to 96.4
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 89.1 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
70.6 percentage of participants
Interval 52.5 to 84.9
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
93.9 percentage of participants
Interval 79.8 to 99.3
|
80.6 percentage of participants
Interval 62.5 to 92.5
|
100.0 percentage of participants
Interval 88.0 to 100.0
|
100.0 percentage of participants
Interval 89.1 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
SECONDARY outcome
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)Population: Participants in the Full Analysis Set with available data were analyzed
Outcome measures
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=34 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
n=33 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
n=32 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
n=8 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 1
|
23.5 percentage of participants
Interval 10.7 to 41.2
|
38.9 percentage of participants
Interval 23.1 to 56.5
|
33.3 percentage of participants
Interval 18.0 to 51.8
|
16.1 percentage of participants
Interval 5.5 to 33.7
|
22.6 percentage of participants
Interval 9.6 to 41.1
|
28.1 percentage of participants
Interval 13.7 to 46.7
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 2
|
79.4 percentage of participants
Interval 62.1 to 91.3
|
75.0 percentage of participants
Interval 57.8 to 87.9
|
63.6 percentage of participants
Interval 45.1 to 79.6
|
54.8 percentage of participants
Interval 36.0 to 72.7
|
58.1 percentage of participants
Interval 39.1 to 75.5
|
62.5 percentage of participants
Interval 43.7 to 78.9
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 4
|
100.0 percentage of participants
Interval 89.7 to 100.0
|
94.4 percentage of participants
Interval 81.3 to 99.3
|
90.9 percentage of participants
Interval 75.7 to 98.1
|
96.8 percentage of participants
Interval 83.3 to 99.9
|
93.5 percentage of participants
Interval 78.6 to 99.2
|
96.9 percentage of participants
Interval 83.8 to 99.9
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 6
|
100.0 percentage of participants
Interval 89.7 to 100.0
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
97.0 percentage of participants
Interval 84.2 to 99.9
|
100.0 percentage of participants
Interval 88.4 to 100.0
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 89.1 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 8
|
—
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
100.0 percentage of participants
Interval 89.4 to 100.0
|
100.0 percentage of participants
Interval 88.4 to 100.0
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 89.1 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 10
|
—
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 89.1 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 12
|
—
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
100.0 percentage of participants
Interval 89.1 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
SECONDARY outcome
Timeframe: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)Population: Participants in the Full Analysis Set with available data were analyzed
Outcome measures
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=34 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
n=33 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
n=32 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
n=8 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
|
|---|---|---|---|---|---|---|---|
|
HCV RNA Change From Baseline
Change at Week 12
|
—
|
—
|
—
|
—
|
-5.24 log10 IU/mL
Standard Deviation 0.767
|
-4.84 log10 IU/mL
Standard Deviation 0.611
|
-5.35 log10 IU/mL
Standard Deviation 0.385
|
|
HCV RNA Change From Baseline
Change at Week 1
|
-4.64 log10 IU/mL
Standard Deviation 0.556
|
-4.60 log10 IU/mL
Standard Deviation 0.595
|
-4.15 log10 IU/mL
Standard Deviation 0.733
|
-4.31 log10 IU/mL
Standard Deviation 0.658
|
-4.40 log10 IU/mL
Standard Deviation 0.577
|
-4.19 log10 IU/mL
Standard Deviation 0.504
|
-4.71 log10 IU/mL
Standard Deviation 0.486
|
|
HCV RNA Change From Baseline
Change at Week 2
|
-5.00 log10 IU/mL
Standard Deviation 0.504
|
-4.98 log10 IU/mL
Standard Deviation 0.519
|
-4.57 log10 IU/mL
Standard Deviation 0.662
|
-4.85 log10 IU/mL
Standard Deviation 0.583
|
-4.97 log10 IU/mL
Standard Deviation 0.711
|
-4.66 log10 IU/mL
Standard Deviation 0.520
|
-5.27 log10 IU/mL
Standard Deviation 0.450
|
|
HCV RNA Change From Baseline
Change at Week 4
|
-5.07 log10 IU/mL
Standard Deviation 0.514
|
-5.06 log10 IU/mL
Standard Deviation 0.534
|
-4.81 log10 IU/mL
Standard Deviation 0.576
|
-5.17 log10 IU/mL
Standard Deviation 0.481
|
-5.22 log10 IU/mL
Standard Deviation 0.755
|
-4.84 log10 IU/mL
Standard Deviation 0.601
|
-5.35 log10 IU/mL
Standard Deviation 0.385
|
|
HCV RNA Change From Baseline
Change at Week 6
|
-5.07 log10 IU/mL
Standard Deviation 0.514
|
-5.08 log10 IU/mL
Standard Deviation 0.549
|
-4.84 log10 IU/mL
Standard Deviation 0.586
|
-5.16 log10 IU/mL
Standard Deviation 0.480
|
-5.24 log10 IU/mL
Standard Deviation 0.767
|
-4.84 log10 IU/mL
Standard Deviation 0.611
|
-5.35 log10 IU/mL
Standard Deviation 0.385
|
|
HCV RNA Change From Baseline
Change at Week 8
|
—
|
-5.08 log10 IU/mL
Standard Deviation 0.549
|
-4.85 log10 IU/mL
Standard Deviation 0.591
|
-5.16 log10 IU/mL
Standard Deviation 0.480
|
-5.24 log10 IU/mL
Standard Deviation 0.767
|
-4.84 log10 IU/mL
Standard Deviation 0.611
|
-5.35 log10 IU/mL
Standard Deviation 0.385
|
|
HCV RNA Change From Baseline
Change at Week 10
|
—
|
—
|
—
|
—
|
-5.24 log10 IU/mL
Standard Deviation 0.767
|
-4.84 log10 IU/mL
Standard Deviation 0.611
|
-5.35 log10 IU/mL
Standard Deviation 0.385
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
* 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 |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=34 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
n=33 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
n=31 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
n=32 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
n=8 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure
|
29.4 percentage of participants
|
0 percentage of participants
|
6.1 percentage of participants
|
19.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=34 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
n=36 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
n=33 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic
n=31 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
n=31 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
n=32 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
n=8 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.0%
1/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.0%
1/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=34 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic
n=36 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis
|
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
n=33 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic
n=31 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic
n=31 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic
n=32 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis
|
VOX+SOF/VEL 12 Weeks (GS-US-338-1121)
n=8 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
22.6%
7/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.6%
2/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
2/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
11.1%
4/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.1%
3/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.2%
1/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
11.8%
4/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
16.7%
6/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
2/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.7%
3/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.7%
3/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.4%
3/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
25.0%
2/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.2%
2/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.0%
1/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.2%
1/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.2%
2/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
27.8%
10/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
21.2%
7/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
29.0%
9/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.7%
3/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.4%
3/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.8%
1/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
2/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.2%
1/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
11.8%
4/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
19.4%
7/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.0%
1/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
32.3%
10/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
22.6%
7/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.4%
3/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
25.0%
2/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Malaise
|
5.9%
2/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Oedema peripheral
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
2/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.6%
2/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
1/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
8.3%
3/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.0%
1/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.5%
2/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Pneumonia
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.2%
1/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
1/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.8%
1/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.5%
2/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.2%
1/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
2/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
2/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.1%
1/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.2%
2/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
2/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.2%
1/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
2/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.2%
1/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
5.9%
2/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.6%
2/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.0%
1/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.2%
1/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dysgeusia
|
5.9%
2/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
32.4%
11/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
19.4%
7/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
21.2%
7/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
29.0%
9/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
12.9%
4/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
15.6%
5/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Paraesthesia
|
5.9%
2/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Sciatica
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.6%
2/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
5.9%
2/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.0%
1/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.2%
2/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
14.7%
5/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.8%
1/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.7%
3/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.5%
2/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
25.0%
2/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
8.3%
3/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.2%
1/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.1%
1/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.5%
2/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
0.00%
0/34 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.5%
2/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.2%
1/31 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.1%
1/32 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • 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