Trial Outcomes & Findings for Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy (NCT NCT02607735)
NCT ID: NCT02607735
Last Updated: 2019-03-05
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
416 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2019-03-05
Participant Flow
Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 11 November 2015. The last study visit occurred on 21 June 2017.
520 participants were screened.
Participant milestones
| Measure |
SOF/VEL/VOX (Primary Study)
Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
Placebo tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX (Deferred Treatment Substudy)
Participants who completed placebo treatment were eligible to enroll in to the open-label Deferred Treatment Substudy to receive SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks.
|
|---|---|---|---|
|
Primary Study
STARTED
|
264
|
152
|
0
|
|
Primary Study
COMPLETED
|
257
|
152
|
0
|
|
Primary Study
NOT COMPLETED
|
7
|
0
|
0
|
|
Deferred Treatment Substudy
STARTED
|
0
|
0
|
147
|
|
Deferred Treatment Substudy
COMPLETED
|
0
|
0
|
142
|
|
Deferred Treatment Substudy
NOT COMPLETED
|
0
|
0
|
5
|
Reasons for withdrawal
| Measure |
SOF/VEL/VOX (Primary Study)
Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
Placebo tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX (Deferred Treatment Substudy)
Participants who completed placebo treatment were eligible to enroll in to the open-label Deferred Treatment Substudy to receive SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks.
|
|---|---|---|---|
|
Primary Study
Randomized but Never Treated
|
1
|
0
|
0
|
|
Primary Study
Lost to Follow-up
|
4
|
0
|
0
|
|
Primary Study
Withdrew Consent
|
2
|
0
|
0
|
|
Deferred Treatment Substudy
Lost to Follow-up
|
0
|
0
|
4
|
|
Deferred Treatment Substudy
Withdrew Consent
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
Baseline characteristics by cohort
| Measure |
SOF/VEL/VOX (Primary Study)
n=263 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
n=152 Participants
Placebo tablet orally once daily with food for 12 weeks
|
Total
n=415 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
59 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
58 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
200 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
321 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
211 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
335 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
38 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
247 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
389 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
135 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
28 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
56 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
IL28b Status
CC
|
47 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
IL28b Status
CT
|
165 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
IL28b Status
TT
|
51 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
HCV RNA
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.68 • n=5 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.63 • n=7 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.66 • n=5 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
73 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
190 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Participants in the Full Analysis Set (all randomized/enrolled participants who took at least 1 dose of study drug) in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 12 visit.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL/VOX (Primary Study)
n=263 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
Placebo tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)
|
96.2 percentage of participants
Interval 93.1 to 98.8
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF/VEL/VOX (Primary Study)
n=263 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
n=152 Participants
Placebo tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study)
|
0.4 percentage of participants
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Full Analysis Set
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment, respectively.
Outcome measures
| Measure |
SOF/VEL/VOX (Primary Study)
n=263 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
n=152 Participants
Placebo tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)
|
97.7 percentage of participants
Interval 95.1 to 99.2
|
0 percentage of participants
Interval 0.0 to 2.4
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8 and 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL/VOX (Primary Study)
n=263 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
n=152 Participants
Placebo tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
Week 1
|
15.6 percentage of participants
Interval 11.4 to 20.5
|
0 percentage of participants
Interval 0.0 to 2.4
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
Week 2
|
56.7 percentage of participants
Interval 50.4 to 62.7
|
0 percentage of participants
Interval 0.0 to 2.4
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
Week 4
|
92.7 percentage of participants
Interval 88.9 to 95.6
|
0 percentage of participants
Interval 0.0 to 2.4
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
Week 8
|
100.0 percentage of participants
Interval 98.6 to 100.0
|
0 percentage of participants
Interval 0.0 to 2.4
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
Week 12
|
99.6 percentage of participants
Interval 97.9 to 100.0
|
0 percentage of participants
Interval 0.0 to 2.4
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 8 and 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL/VOX (Primary Study)
n=262 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
n=150 Participants
Placebo tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Change From Baseline in HCV RNA (Primary Study)
Week 1
|
-4.20 log10 IU/mL
Standard Deviation 0.733
|
0.02 log10 IU/mL
Standard Deviation 0.300
|
|
Change From Baseline in HCV RNA (Primary Study)
Week 2
|
-4.81 log10 IU/mL
Standard Deviation 0.704
|
0.02 log10 IU/mL
Standard Deviation 0.322
|
|
Change From Baseline in HCV RNA (Primary Study)
Week 4
|
-5.07 log10 IU/mL
Standard Deviation 0.677
|
-0.01 log10 IU/mL
Standard Deviation 0.441
|
|
Change From Baseline in HCV RNA (Primary Study)
Week 8
|
-5.11 log10 IU/mL
Standard Deviation 0.678
|
0.05 log10 IU/mL
Standard Deviation 0.434
|
|
Change From Baseline in HCV RNA (Primary Study)
Week 12
|
-5.10 log10 IU/mL
Standard Deviation 0.690
|
0.03 log10 IU/mL
Standard Deviation 0.430
|
SECONDARY outcome
Timeframe: Posttreatment Week 24Population: Participants in the Full Analysis Set in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 24 visit.
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL/VOX (Primary Study)
n=263 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
Placebo tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)
|
96.2 percentage of participants
Interval 93.1 to 98.2
|
—
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Participants in the Full Analysis Set in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 24 visit.
Virologic failure is 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/VOX (Primary Study)
n=263 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
Placebo tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Virologic Failure (Primary Study)
|
2.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)Population: Full Analysis Set
SVR4, SVR12 and SVR24 was defined as HCV RNA \< LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively.
Outcome measures
| Measure |
SOF/VEL/VOX (Primary Study)
n=147 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
Placebo tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)
SVR4
|
98.6 percentage of participants
Interval 95.2 to 99.8
|
—
|
|
Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)
SVR12
|
97.3 percentage of participants
Interval 93.2 to 99.3
|
—
|
|
Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)
SVR24
|
97.3 percentage of participants
Interval 93.2 to 99.3
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)Population: Full Analysis Set from the Deferred Treatment Sub study: all enrolled participants who took at least 1 dose of study drug
Outcome measures
| Measure |
SOF/VEL/VOX (Primary Study)
n=147 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
Placebo tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
Week 4
|
93.2 percentage of participants
Interval 87.8 to 96.7
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
Week 1
|
14.3 percentage of participants
Interval 9.1 to 21.0
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
Week 2
|
62.6 percentage of participants
Interval 54.2 to 70.4
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
Week 8
|
100.0 percentage of participants
Interval 97.5 to 100.0
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
Week 12
|
100.0 percentage of participants
Interval 97.5 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)Population: Participants with available data in the Full Analysis Set of the Deferred Treatment Substudy were analyzed.
Outcome measures
| Measure |
SOF/VEL/VOX (Primary Study)
n=147 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
Placebo tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Change From Baseline in HCV RNA (Deferred Treatment Substudy)
Week 1
|
-4.30 log10 IU/mL
Standard Deviation 0.626
|
—
|
|
Change From Baseline in HCV RNA (Deferred Treatment Substudy)
Week 2
|
-4.93 log10 IU/mL
Standard Deviation 0.602
|
—
|
|
Change From Baseline in HCV RNA (Deferred Treatment Substudy)
Week 4
|
-5.16 log10 IU/mL
Standard Deviation 0.512
|
—
|
|
Change From Baseline in HCV RNA (Deferred Treatment Substudy)
Week 8
|
-5.20 log10 IU/mL
Standard Deviation 0.532
|
—
|
|
Change From Baseline in HCV RNA (Deferred Treatment Substudy)
Week 12
|
-5.20 log10 IU/mL
Standard Deviation 0.532
|
—
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24 (Deferred Treatment Substudy)Population: Full Analysis Set in the Deferred Treatment Substudy
Virologic failure is 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/VOX (Primary Study)
n=147 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
Placebo tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)
|
2.7 percentage of participants
|
—
|
Adverse Events
SOF/VEL/VOX (Primary Study)
Serious events: 5 serious events
Other events: 147 other events
Deaths: 0 deaths
Placebo (Primary Study)
Serious events: 7 serious events
Other events: 80 other events
Deaths: 0 deaths
SOF/VEL/VOX (Deferred Treatment Substudy)
Serious events: 6 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL/VOX (Primary Study)
n=263 participants at risk
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
n=152 participants at risk
Placebo tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX (Deferred Treatment Substudy)
n=147 participants at risk
Participants who completed placebo treatment were eligible for open-label Deferred Treatment Substudy.
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.68%
1/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.68%
1/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.66%
1/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.66%
1/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.68%
1/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.66%
1/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Infections and infestations
Pneumonia
|
0.38%
1/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.66%
1/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Infections and infestations
Urosepsis
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.68%
1/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.66%
1/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.68%
1/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.38%
1/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.66%
1/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.38%
1/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.38%
1/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.68%
1/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Seizure
|
0.38%
1/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.66%
1/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.68%
1/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.38%
1/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Vascular disorders
Arteritis
|
0.38%
1/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
Other adverse events
| Measure |
SOF/VEL/VOX (Primary Study)
n=263 participants at risk
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
Placebo (Primary Study)
n=152 participants at risk
Placebo tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX (Deferred Treatment Substudy)
n=147 participants at risk
Participants who completed placebo treatment were eligible for open-label Deferred Treatment Substudy.
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
18.3%
48/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
12.5%
19/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
19.0%
28/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
14.1%
37/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
7.9%
12/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
14.3%
21/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
General disorders
Asthenia
|
7.6%
20/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
5.9%
9/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
2.0%
3/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
General disorders
Fatigue
|
21.3%
56/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
19.7%
30/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
21.1%
31/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
8/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
5.3%
8/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
6.1%
9/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
11/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
5.3%
8/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
4.8%
7/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Dizziness
|
4.2%
11/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
9.2%
14/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
4.8%
7/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
25.1%
66/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
17.1%
26/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
19.7%
29/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Psychiatric disorders
Insomnia
|
7.2%
19/263 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
5.3%
8/152 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
3.4%
5/147 • Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER