Trial Outcomes & Findings for Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection (NCT NCT02378961)
NCT ID: NCT02378961
Last Updated: 2020-03-03
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
128 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2020-03-03
Participant Flow
Participants were enrolled at study sites in United States and New Zealand. The first participant was screened on 16 February 2015. The last study visit occurred on 26 January 2016.
171 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, 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 12 Weeks, Treatment Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
30
|
36
|
29
|
|
Overall Study
COMPLETED
|
29
|
28
|
35
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
1
|
1
|
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, 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 12 Weeks, Treatment Experienced, Non Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
4
|
2
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
Baseline characteristics by cohort
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=33 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, Cirrhotic
n=30 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 12 Weeks, Treatment-Experienced, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic
n=29 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
56 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
57 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
58 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
56 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native India or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
111 Participants
n=21 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
26 participants
n=7 Participants
|
34 participants
n=5 Participants
|
29 participants
n=4 Participants
|
121 participants
n=21 Participants
|
|
IL28b Status
CC
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
IL28b Status
CT
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
IL28b Status
TT
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
HCV RNA
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.86 • n=5 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.66 • n=7 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.72 • n=5 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.57 • n=4 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.72 • n=21 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
84 Participants
n=21 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=33 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, Cirrhotic
n=30 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 12 Weeks, Treatment Experienced, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic
n=29 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
87.9 percentage of participants
Interval 71.8 to 96.6
|
93.3 percentage of participants
Interval 77.9 to 99.2
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
PRIMARY outcome
Timeframe: Up to 12 WeeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=33 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, Cirrhotic
n=30 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 12 Weeks, Treatment Experienced, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic
n=29 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
3.4 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 treatment, respectively.
Outcome measures
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=33 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, Cirrhotic
n=30 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 12 Weeks, Treatment Experienced, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic
n=29 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
90.9 percentage of participants
Interval 75.7 to 98.1
|
96.7 percentage of participants
Interval 82.8 to 99.9
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
100.0 percentage of participants
Interval 88.1 to 100.0
|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
87.9 percentage of participants
Interval 71.8 to 96.6
|
93.3 percentage of participants
Interval 77.9 to 99.2
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
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=33 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, Cirrhotic
n=30 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 12 Weeks, Treatment Experienced, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic
n=29 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 1
|
33.3 percentage of participants
Interval 18.0 to 51.8
|
20.0 percentage of participants
Interval 7.7 to 38.6
|
33.3 percentage of participants
Interval 18.6 to 51.0
|
10. percentage of participants
Interval 2.2 to 27.4
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 2
|
81.8 percentage of participants
Interval 64.5 to 93.0
|
73.3 percentage of participants
Interval 54.1 to 87.7
|
72.2 percentage of participants
Interval 54.8 to 85.8
|
58.6 percentage of participants
Interval 38.9 to 76.5
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 4
|
100.0 percentage of participants
Interval 89.4 to 100.0
|
100.0 percentage of participants
Interval 88.4 to 100.0
|
88.9 percentage of participants
Interval 73.9 to 96.9
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 6
|
100.0 percentage of participants
Interval 89.4 to 100.0
|
100.0 percentage of participants
Interval 88.4 to 100.0
|
97.2 percentage of participants
Interval 85.5 to 99.9
|
96.6 percentage of participants
Interval 82.2 to 99.9
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 8
|
—
|
100.0 percentage of participants
Interval 88.1 to 100.0
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
100.0 percentage of participants
Interval 88.1 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 10
|
—
|
—
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
100.0 percentage of participants
Interval 88.1 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 12
|
—
|
—
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
100.0 percentage of participants
Interval 87.7 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=33 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, Cirrhotic
n=30 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 12 Weeks, Treatment Experienced, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic
n=29 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
|
|---|---|---|---|---|
|
HCV RNA Change From Baseline
Change at Week 10
|
—
|
—
|
-5.19 log10 IU/mL
Standard Deviation 0.718
|
-5.30 log10 IU/mL
Standard Deviation 0.571
|
|
HCV RNA Change From Baseline
Change at Week 1
|
-4.51 log10 IU/mL
Standard Deviation 0.568
|
-4.28 log10 IU/mL
Standard Deviation 0.546
|
-4.51 log10 IU/mL
Standard Deviation 0.594
|
-4.24 log10 IU/mL
Standard Deviation 0.510
|
|
HCV RNA Change From Baseline
Change at Week 2
|
-4.91 log10 IU/mL
Standard Deviation 0.786
|
-4.84 log10 IU/mL
Standard Deviation 0.648
|
-4.95 log10 IU/mL
Standard Deviation 0.619
|
-4.96 log10 IU/mL
Standard Deviation 0.592
|
|
HCV RNA Change From Baseline
Change at Week 4
|
-5.01 log10 IU/mL
Standard Deviation 0.857
|
-4.99 log10 IU/mL
Standard Deviation 0.661
|
-5.14 log10 IU/mL
Standard Deviation 0.709
|
-5.25 log10 IU/mL
Standard Deviation 0.567
|
|
HCV RNA Change From Baseline
Change at Week 6
|
-5.01 log10 IU/mL
Standard Deviation 0.857
|
-4.99 log10 IU/mL
Standard Deviation 0.661
|
-5.19 log10 IU/mL
Standard Deviation 0.716
|
-5.29 log10 IU/mL
Standard Deviation 0.572
|
|
HCV RNA Change From Baseline
Change at Week 8
|
—
|
-4.98 log10 IU/mL
Standard Deviation 0.672
|
-5.19 log10 IU/mL
Standard Deviation 0.718
|
-5.30 log10 IU/mL
Standard Deviation 0.571
|
|
HCV RNA Change From Baseline
Change at Week 12
|
—
|
—
|
-5.19 log10 IU/mL
Standard Deviation 0.718
|
-5.32 log10 IU/mL
Standard Deviation 0.566
|
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=33 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, Cirrhotic
n=30 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 12 Weeks, Treatment Experienced, Non Cirrhotic
n=36 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic
n=29 Participants
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure
|
12.1 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
3.4 percentage of participants
|
Adverse Events
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=33 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, Cirrhotic
n=30 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 12 Weeks, Treatment Experienced, Non Cirrhotic
n=36 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic
n=29 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
|
|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic
n=33 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, Cirrhotic
n=30 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 12 Weeks, Treatment Experienced, Non Cirrhotic
n=36 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis
|
VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic
n=29 participants at risk
VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
2/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.3%
1/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.8%
1/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
3.0%
1/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.7%
2/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.6%
2/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
30.3%
10/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.3%
1/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
27.8%
10/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
27.6%
8/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dry mouth
|
6.1%
2/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.3%
1/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
10.3%
3/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.3%
1/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.6%
2/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
27.3%
9/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
10.0%
3/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
22.2%
8/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
13.8%
4/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
21.2%
7/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
10.0%
3/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
27.8%
10/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
20.7%
6/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
1/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.3%
1/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
10.3%
3/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
2/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.3%
1/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.8%
1/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Increased appetite
|
3.0%
1/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.3%
1/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.8%
1/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
9.1%
3/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
10.3%
3/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
30.3%
10/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
10.0%
3/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
30.6%
11/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
27.6%
8/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.6%
2/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.6%
2/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.7%
2/30 • 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%
0/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/30 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.8%
1/36 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
0.00%
0/33 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/30 • 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%
0/29 • 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