Trial Outcomes & Findings for Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen (NCT NCT02822794)
NCT ID: NCT02822794
Last Updated: 2018-11-14
Results Overview
SVR12 was 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
PHASE3
Target enrollment
117 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-14
Participant Flow
Participants were enrolled at study sites in Japan. The first participant was screened on 25 July 2016. The last study visit occurred on 25 August 2017.
132 participants were screened.
Participant milestones
| Measure |
SOF/VEL FDC + RBV 12 Weeks
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily + ribavirin (RBV) capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
SOF/VEL FDC + RBV 24 Weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
60
|
|
Overall Study
COMPLETED
|
56
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
SOF/VEL FDC + RBV 12 Weeks
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily + ribavirin (RBV) capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
SOF/VEL FDC + RBV 24 Weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
Overall Study
Withdrew Consent
|
1
|
0
|
Baseline Characteristics
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
Baseline characteristics by cohort
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=47 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=10 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
n=48 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
n=12 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
59 years
STANDARD_DEVIATION 15.7 • n=7 Participants
|
64 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
61 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
63 years
STANDARD_DEVIATION 10.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
47 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
HCV genotype
Genotype 1a
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
HCV genotype
Genotype 1b
|
45 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
HCV genotype
Genotype 2a/2c
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
HCV genotype
Genotype 2b
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
HCV genotype
Genotype 2 (No Confirmed Subtype)
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
IL28b Status
CC
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
IL28b Status
CT
|
28 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
IL28b Status
TT
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
HCV RNA (log10 IU/mL)
|
6.2 log10 IU/mL
STANDARD_DEVIATION .47 • n=5 Participants
|
6.6 log10 IU/mL
STANDARD_DEVIATION .46 • n=7 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION .51 • n=5 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION .86 • n=4 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION .54 • n=21 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
37 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.
SVR12 was 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+RBV 12 Weeks (GT1)
n=47 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=10 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
n=48 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
n=12 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
85.1 percentage of participants
Interval 71.7 to 93.8
|
70.0 percentage of participants
Interval 34.8 to 93.3
|
97.9 percentage of participants
Interval 88.9 to 99.9
|
91.7 percentage of participants
Interval 61.5 to 99.8
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=57 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
1.8 percentage of participants
|
3.3 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.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=57 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
|
86.0 percentage of participants
Interval 74.2 to 93.7
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Week 24Population: Full Analysis Set
SVR 24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=57 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
|
82.5 percentage of participants
Interval 70.1 to 91.3
|
96.7 percentage of participants
Interval 88.5 to 99.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1Population: Full Analysis Set
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=57 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 1
|
21.1 percentage of participants
Interval 11.4 to 33.9
|
25.0 percentage of participants
Interval 14.7 to 37.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 2Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 2
|
64.3 percentage of participants
Interval 50.4 to 76.6
|
70.0 percentage of participants
Interval 56.8 to 81.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 3
|
91.1 percentage of participants
Interval 80.4 to 97.0
|
90.0 percentage of participants
Interval 79.5 to 96.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 4
|
98.2 percentage of participants
Interval 90.4 to 100.0
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 5Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 5
|
98.2 percentage of participants
Interval 90.4 to 100.0
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 6
|
100.0 percentage of participants
Interval 93.6 to 100.0
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 8
|
100.0 percentage of participants
Interval 93.6 to 100.0
|
100.0 percentage of participants
Interval 94.0 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 10
|
100.0 percentage of participants
Interval 93.6 to 100.0
|
100.0 percentage of participants
Interval 93.9 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 12
|
100.0 percentage of participants
Interval 93.6 to 100.0
|
100.0 percentage of participants
Interval 93.9 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=58 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 16
|
100.0 percentage of participants
Interval 93.8 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 20Population: Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=58 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 20
|
100.0 percentage of participants
Interval 93.8 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=58 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 24
|
100.0 percentage of participants
Interval 93.8 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 1Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=57 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 1
|
-4.40 log10 IU/mL
Standard Deviation 0.640
|
-4.36 log10 IU/mL
Standard Deviation 0.698
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 2Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 2
|
-4.91 log10 IU/mL
Standard Deviation 0.510
|
-4.89 log10 IU/mL
Standard Deviation 0.603
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 3Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 3
|
-5.07 log10 IU/mL
Standard Deviation 0.506
|
-5.02 log10 IU/mL
Standard Deviation 0.575
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 4
|
-5.12 log10 IU/mL
Standard Deviation 0.486
|
-5.04 log10 IU/mL
Standard Deviation 0.580
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 5Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 5
|
-5.13 log10 IU/mL
Standard Deviation 0.487
|
-5.05 log10 IU/mL
Standard Deviation 0.579
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 6
|
-5.13 log10 IU/mL
Standard Deviation 0.492
|
-5.05 log10 IU/mL
Standard Deviation 0.579
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 8
|
-5.13 log10 IU/mL
Standard Deviation 0.492
|
-5.06 log10 IU/mL
Standard Deviation 0.584
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 10Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 10
|
-5.13 log10 IU/mL
Standard Deviation 0.492
|
-5.06 log10 IU/mL
Standard Deviation 0.589
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=56 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 12
|
-5.13 log10 IU/mL
Standard Deviation 0.492
|
-5.06 log10 IU/mL
Standard Deviation 0.589
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 16Population: Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=58 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 16
|
-5.06 log10 IU/mL
Standard Deviation 0.594
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 20Population: Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=58 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 20
|
-5.06 log10 IU/mL
Standard Deviation 0.594
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV 12 Weeks (GT1)
n=58 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 24
|
-5.06 log10 IU/mL
Standard Deviation 0.594
|
—
|
—
|
—
|
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) * 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+RBV 12 Weeks (GT1)
n=57 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 12 Weeks (GT2)
n=60 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT1)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection
|
SOF/VEL+RBV 24 Weeks (GT2)
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With Overall Virologic Failure
|
15.8 percentage of participants
|
3.3 percentage of participants
|
—
|
—
|
Adverse Events
SOF/VEL+RBV 12 Weeks
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
SOF/VEL+RBV 24 Weeks
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL+RBV 12 Weeks
n=57 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection
|
SOF/VEL+RBV 24 Weeks
n=60 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
1.7%
1/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic angiosarcoma
|
0.00%
0/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
1.7%
1/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
3.3%
2/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
Other adverse events
| Measure |
SOF/VEL+RBV 12 Weeks
n=57 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection
|
SOF/VEL+RBV 24 Weeks
n=60 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.6%
14/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
21.7%
13/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
3/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
0.00%
0/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
8.8%
5/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
1.7%
1/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Stomatitis
|
8.8%
5/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
5.0%
3/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
General disorders
Malaise
|
1.8%
1/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
5.0%
3/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
6.7%
4/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Infections and infestations
Oral herpes
|
0.00%
0/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
5.0%
3/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Infections and infestations
Pharyngitis
|
5.3%
3/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
5.0%
3/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Infections and infestations
Viral upper respiratory tract infection
|
35.1%
20/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
21.7%
13/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
4/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
1.7%
1/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
19.3%
11/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
3.3%
2/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
5.0%
3/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
6.7%
4/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.0%
4/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
3.3%
2/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.5%
2/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
6.7%
4/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.5%
2/57 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: participants who received at least 1 dose of study drug
|
5.0%
3/60 • Adverse Events and Serious Adverse Events: Up to 24 weeks + 30 days. All-Cause Mortality: Up to Posttreatment Week 24.
Safety Analysis Set: 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