Trial Outcomes & Findings for Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen (NCT NCT02536313)
NCT ID: NCT02536313
Last Updated: 2019-02-25
Results Overview
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2019-02-25
Participant Flow
Participants were enrolled at 1 study site in the United States. The first participant was screened on 29 July 2015. The last study visit occurred on 28 June 2016.
Participant milestones
| Measure |
SOF/VEL/VOX
Sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX ) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX + RBV
SOF/VEL/VOX (400/100/100 mg) FDC tablet + Ribavirin (RBV) (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
SOF/VEL/VOX
Sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX ) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX + RBV
SOF/VEL/VOX (400/100/100 mg) FDC tablet + Ribavirin (RBV) (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
Baseline characteristics by cohort
| Measure |
SOF/VEL/VOX
n=24 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX + RBV
n=25 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 10.1 • n=99 Participants
|
54 years
STANDARD_DEVIATION 14.1 • n=107 Participants
|
54 years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
IL28b Status
CC
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
IL28b Status
CT
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
IL28b Status
TT
|
12 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
HCV RNA
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.42 • n=99 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.46 • n=107 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.44 • n=206 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of study drug.
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL/VOX
n=24 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX + RBV
n=25 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)
|
100.0 percentage of particpants
Interval 85.8 to 100.0
|
96.0 percentage of particpants
Interval 79.6 to 99.9
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set: participants who took at least 1 dose of study drug
Outcome measures
| Measure |
SOF/VEL/VOX
n=24 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX + RBV
n=25 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR 24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Outcome measures
| Measure |
SOF/VEL/VOX
n=24 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX + RBV
n=25 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8 and 12Population: Full Analysis Set
Outcome measures
| Measure |
SOF/VEL/VOX
n=24 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX + RBV
n=25 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 1
|
54.2 percentage of participants
Interval 32.8 to 74.4
|
40 percentage of participants
Interval 21.1 to 61.3
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 2
|
79.2 percentage of participants
Interval 57.8 to 92.9
|
60.0 percentage of participants
Interval 38.7 to 78.9
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 4
|
100 percentage of participants
Interval 85.8 to 100.0
|
92.0 percentage of participants
Interval 74.0 to 99.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 8
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 12
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
100.0 percentage of participants
Interval 86.3 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
n=24 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX + RBV
n=25 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
HCV RNA Change From Baseline/Day 1 Through Week 12
Change at Week 1
|
-4.63 log10 IU/mL
Standard Deviation 0.737
|
-4.53 log10 IU/mL
Standard Deviation 0.687
|
|
HCV RNA Change From Baseline/Day 1 Through Week 12
Change at Week 2
|
-4.97 log10 IU/mL
Standard Deviation 0.484
|
-4.95 log10 IU/mL
Standard Deviation 0.566
|
|
HCV RNA Change From Baseline/Day 1 Through Week 12
Change at Week 4
|
-5.10 log10 IU/mL
Standard Deviation 0.419
|
-5.14 log10 IU/mL
Standard Deviation 0.477
|
|
HCV RNA Change From Baseline/Day 1 Through Week 12
Change at Week 8
|
-5.10 log10 IU/mL
Standard Deviation 0.419
|
-5.18 log10 IU/mL
Standard Deviation 0.461
|
|
HCV RNA Change From Baseline/Day 1 Through Week 12
Change at Week 12
|
-5.10 log10 IU/mL
Standard Deviation 0.419
|
-5.18 log10 IU/mL
Standard Deviation 0.461
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
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
n=24 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
|
SOF/VEL/VOX + RBV
n=25 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily with food for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Virologic Failure
|
0 percentage of participants
|
4.0 percentage of participants
|
Adverse Events
SOF/VEL/VOX
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
SOF/VEL/VOX + RBV
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL/VOX
n=24 participants at risk
SOF/VEL/VOX (400/100/100 mg) tablet orally once daily for 12 weeks
|
SOF/VEL/VOX + RBV
n=25 participants at risk
SOF/VEL/VOX (400/100/100 mg) tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily for 12 weeks
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
4.2%
1/24 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
0.00%
0/25 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
Other adverse events
| Measure |
SOF/VEL/VOX
n=24 participants at risk
SOF/VEL/VOX (400/100/100 mg) tablet orally once daily for 12 weeks
|
SOF/VEL/VOX + RBV
n=25 participants at risk
SOF/VEL/VOX (400/100/100 mg) tablet + RBV (1000 or 1200 mg daily based on weight) tablet orally once daily for 12 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/24 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
16.0%
4/25 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
3/24 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
0.00%
0/25 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
8.0%
2/25 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
|
General disorders
Fatigue
|
0.00%
0/24 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
36.0%
9/25 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
|
Infections and infestations
Bronchitis
|
8.3%
2/24 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
0.00%
0/25 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
4.2%
1/24 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
8.0%
2/25 • Up to 12 weeks + 30 days
Safety Analysis Set: participants who took 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