Trial Outcomes & Findings for Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor (NCT NCT02639247)
NCT ID: NCT02639247
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
333 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2019-03-05
Participant Flow
Participants were enrolled across 101 study sites in North America, Europe, and Asia Pacific. The first participant was screened on 23 December 2015. The last study visit occurred on 18 January 2017.
397 participants were screened.
Participant milestones
| Measure |
SOF/VEL/VOX 12 Weeks
Sofosbuvir/veltapasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet orally once daily with food for 12 weeks
|
SOF/VEL 12 Weeks
Sofosbuvir/Velpatasvir (Epclusa®; SOF/VEL) (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
182
|
151
|
|
Overall Study
COMPLETED
|
177
|
149
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
SOF/VEL/VOX 12 Weeks
Sofosbuvir/veltapasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet orally once daily with food for 12 weeks
|
SOF/VEL 12 Weeks
Sofosbuvir/Velpatasvir (Epclusa®; SOF/VEL) (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrew Consent
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
Baseline characteristics by cohort
| Measure |
SOF/VEL/VOX 12 Weeks
n=182 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL 12 Weeks
n=151 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
57 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
57 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
160 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
163 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=5 Participants
|
87 participants
n=7 Participants
|
188 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
France
|
26 participants
n=5 Participants
|
19 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
IL28b Status
CC
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
IL28b Status
CT
|
107 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
IL28b Status
TT
|
42 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
HCV RNA
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.56 • n=5 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.66 • n=7 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.61 • n=5 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
46 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
136 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: all randomized or enrolled participants who received at least 1 dose of study drug
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 12 Weeks
n=182 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL 12 Weeks
n=151 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
97.8 percentage of participants
Interval 94.5 to 99.4
|
90.1 percentage of participants
Interval 84.1 to 94.3
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF/VEL/VOX 12 Weeks
n=182 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL 12 Weeks
n=151 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
|
0 percentage of participants
|
0.7 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 after stopping study treatment, respectively.
Outcome measures
| Measure |
SOF/VEL/VOX 12 Weeks
n=182 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL 12 Weeks
n=151 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
98.4 percentage of participcants
Interval 95.3 to 99.7
|
91.4 percentage of participcants
Interval 85.7 to 95.3
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
97.8 percentage of participcants
Interval 94.5 to 99.4
|
90.1 percentage of participcants
Interval 84.1 to 94.3
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8 and 12Population: Full Analysis Set
Outcome measures
| Measure |
SOF/VEL/VOX 12 Weeks
n=182 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL 12 Weeks
n=151 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 1
|
15.9 percentage of participants
Interval 10.9 to 22.1
|
17.2 percentage of participants
Interval 11.6 to 24.2
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 4
|
88.5 percentage of participants
Interval 82.9 to 92.7
|
90.7 percentage of participants
Interval 84.9 to 94.8
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 2
|
62.6 percentage of participants
Interval 55.2 to 69.7
|
56.3 percentage of participants
Interval 48.0 to 64.3
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 8
|
100.0 percentage of participants
Interval 98.0 to 100.0
|
98.7 percentage of participants
Interval 95.3 to 99.8
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 12
|
98.9 percentage of participants
Interval 96.1 to 99.9
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
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 12 Weeks
n=182 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL 12 Weeks
n=151 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Change From Baseline in HCV RNA
Change at Week 1
|
-4.29 log10 IU/mL
Standard Deviation 0.627
|
-4.17 log10 IU/mL
Standard Deviation 0.651
|
|
Change From Baseline in HCV RNA
Change at Week 2
|
-4.93 log10 IU/mL
Standard Deviation 0.604
|
-4.78 log10 IU/mL
Standard Deviation 0.677
|
|
Change From Baseline in HCV RNA
Change at Week 4
|
-5.13 log10 IU/mL
Standard Deviation 0.561
|
-5.06 log10 IU/mL
Standard Deviation 0.660
|
|
Change From Baseline in HCV RNA
Change at Week 8
|
-5.17 log10 IU/mL
Standard Deviation 0.562
|
-5.08 log10 IU/mL
Standard Deviation 0.759
|
|
Change From Baseline in HCV RNA
Change at Week 12
|
-5.17 log10 IU/mL
Standard Deviation 0.559
|
-5.09 log10 IU/mL
Standard Deviation 0.727
|
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 |
SOF/VEL/VOX 12 Weeks
n=182 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL 12 Weeks
n=151 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Virologic Failure
|
0.5 percentage of participants
|
9.9 percentage of participants
|
Adverse Events
SOF/VEL/VOX 12 Weeks
Serious events: 4 serious events
Other events: 111 other events
Deaths: 0 deaths
SOF/VEL 12 Weeks
Serious events: 4 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL/VOX 12 Weeks
n=182 participants at risk
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL 12 Weeks
n=151 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.66%
1/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Cardiac disorders
Cardiac failure congestive
|
0.55%
1/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.55%
1/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.66%
1/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.55%
1/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.55%
1/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.00%
0/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.66%
1/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
0.66%
1/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
Other adverse events
| Measure |
SOF/VEL/VOX 12 Weeks
n=182 participants at risk
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL 12 Weeks
n=151 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
3/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
6.0%
9/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
19.8%
36/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
4.6%
7/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
12.1%
22/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
7.9%
12/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
General disorders
Asthenia
|
5.5%
10/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
6.0%
9/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
General disorders
Fatigue
|
23.6%
43/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
28.5%
43/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
12/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
5.3%
8/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
27.5%
50/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
28.5%
43/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Psychiatric disorders
Insomnia
|
6.6%
12/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
2.0%
3/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
|
Psychiatric disorders
Irritability
|
2.2%
4/182 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
5.3%
8/151 • Up to 12 weeks plus 30 days
Safety Analysis Set: all participants who received at least 1 dose of study drug
|
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