Trial Outcomes & Findings for Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis (NCT NCT02639338)
NCT ID: NCT02639338
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
220 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 23 December 2015. The last study visit occurred on 02 January 2017.
315 participants were screened.
Participant milestones
| Measure |
SOF/VEL/VOX 8 Weeks
Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 8 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
|
110
|
110
|
|
Overall Study
COMPLETED
|
106
|
105
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
SOF/VEL/VOX 8 Weeks
Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 8 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
|
2
|
|
Overall Study
Withdrew Consent
|
1
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Randomized but Not Treated
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
Baseline characteristics by cohort
| Measure |
SOF/VEL/VOX 8 Weeks
n=110 Participants
SOF/VEL/VOX (400/100/100 mg) tablet orally once daily with food for 8 weeks
|
SOF/VEL 12 Weeks
n=109 Participants
SOF/VEL (400/100 mg) tablet orally once daily without regard to food for 12 weeks
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
55 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
55 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
100 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 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
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
IL28b Status
CC
|
41 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
IL28b Status
CT
|
57 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
IL28b Status
TT
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
HCV RNA
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.80 • n=5 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.63 • n=7 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.73 • n=5 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
40 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
70 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of the 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 8 Weeks
n=110 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
|
SOF/VEL 12 Weeks
n=109 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)
|
96.4 percentage of participants
Interval 91.0 to 99.0
|
96.3 percentage of participants
Interval 90.9 to 99.0
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF/VEL/VOX 8 Weeks
n=110 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
|
SOF/VEL 12 Weeks
n=109 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
|
0.9 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 8 Weeks
n=110 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
|
SOF/VEL 12 Weeks
n=109 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
|
97.3 percentage of participants
Interval 92.2 to 99.4
|
97.2 percentage of participants
Interval 92.2 to 99.4
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
96.4 percentage of participants
Interval 91.0 to 99.0
|
96.3 percentage of participants
Interval 90.9 to 99.0
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8 and 12Population: Percentage of participants in Full Analysis Set with on-treatment data were analyzed.
Outcome measures
| Measure |
SOF/VEL/VOX 8 Weeks
n=110 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
|
SOF/VEL 12 Weeks
n=109 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
|
17.3 percentage of participants
Interval 10.7 to 25.7
|
10.1 percentage of participants
Interval 5.1 to 17.3
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 2
|
56.4 percentage of participants
Interval 46.6 to 65.8
|
50.9 percentage of participants
Interval 41.1 to 60.7
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 4
|
87.3 percentage of participants
Interval 79.6 to 92.9
|
85.2 percentage of participants
Interval 77.1 to 91.3
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 8
|
97.3 percentage of participants
Interval 92.2 to 99.4
|
99.1 percentage of participants
Interval 94.9 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 12
|
—
|
100.0 percentage of participants
Interval 96.6 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 8 Weeks
n=110 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
|
SOF/VEL 12 Weeks
n=109 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Change From Baseline in HCV RNA
Week 1
|
-4.06 log10 IU/mL
Standard Deviation 0.716
|
-4.09 log10 IU/mL
Standard Deviation 0.653
|
|
Change From Baseline in HCV RNA
Week 2
|
-4.60 log10 IU/mL
Standard Deviation 0.825
|
-4.73 log10 IU/mL
Standard Deviation 0.783
|
|
Change From Baseline in HCV RNA
Week 4
|
-4.84 log10 IU/mL
Standard Deviation 0.789
|
-5.00 log10 IU/mL
Standard Deviation 0.781
|
|
Change From Baseline in HCV RNA
Week 8
|
-4.90 log10 IU/mL
Standard Deviation 0.801
|
-5.09 log10 IU/mL
Standard Deviation 0.832
|
|
Change From Baseline in HCV RNA
Week 12
|
—
|
-5.14 log10 IU/mL
Standard Deviation 0.630
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or * 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 8 Weeks
n=110 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
|
SOF/VEL 12 Weeks
n=109 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Virologic Failure
|
1.8 percentage of participants
|
1.8 percentage of participants
|
Adverse Events
SOF/VEL/VOX 8 Weeks
Serious events: 2 serious events
Other events: 68 other events
Deaths: 0 deaths
SOF/VEL 12 Weeks
Serious events: 3 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL/VOX 8 Weeks
n=110 participants at risk
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
|
SOF/VEL 12 Weeks
n=109 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.91%
1/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.91%
1/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Transient ischaemic attack
|
0.91%
1/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Hypertensive crisis
|
0.91%
1/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF/VEL/VOX 8 Weeks
n=110 participants at risk
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
|
SOF/VEL 12 Weeks
n=109 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.2%
9/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
4.6%
5/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
2/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.4%
7/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
15.5%
17/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
4.6%
5/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
20.9%
23/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.2%
10/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
7/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
25.5%
28/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
28.4%
31/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.91%
1/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.5%
6/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.4%
7/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.8%
2/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.91%
1/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.5%
6/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
24.5%
27/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
29.4%
32/109 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
5.5%
6/110 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
4.6%
5/109 • 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