Trial Outcomes & Findings for Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection (NCT NCT02220998)
NCT ID: NCT02220998
Last Updated: 2018-11-15
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
269 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-15
Participant Flow
Participants were enrolled at study sites in the United States. The first participant was screened on 22 September 2014. The last study visit occurred on 03 September 2015.
317 participants were screened.
Participant milestones
| Measure |
SOF/VEL
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
|
SOF+RBV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
134
|
|
Overall Study
COMPLETED
|
128
|
123
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
| Measure |
SOF/VEL
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
|
SOF+RBV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
|---|---|---|
|
Overall Study
Randomized but Never Treated
|
1
|
2
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
5
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection
Baseline characteristics by cohort
| Measure |
SOF/VEL
n=134 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
SOF+RBV
n=132 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
57 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
57 years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
211 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=99 Participants
|
12 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
124 participants
n=99 Participants
|
111 participants
n=107 Participants
|
235 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
5 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Cirrhosis Status
Present
|
19 participants
n=99 Participants
|
19 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Cirrhosis Status
Absent
|
115 participants
n=99 Participants
|
112 participants
n=107 Participants
|
227 participants
n=206 Participants
|
|
Cirrhosis Status
Missing
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
IL28b Status
CC
|
55 participants
n=99 Participants
|
46 participants
n=107 Participants
|
101 participants
n=206 Participants
|
|
IL28b Status
CT
|
61 participants
n=99 Participants
|
64 participants
n=107 Participants
|
125 participants
n=206 Participants
|
|
IL28b Status
TT
|
18 participants
n=99 Participants
|
22 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
HCV RNA
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.78 • n=99 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.74 • n=107 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.76 • n=206 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
23 participants
n=99 Participants
|
31 participants
n=107 Participants
|
54 participants
n=206 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
111 participants
n=99 Participants
|
101 participants
n=107 Participants
|
212 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants randomized or enrolled into the study 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+RBV
n=132 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF/VEL
n=134 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
93.9 percentage of participants
Interval 88.4 to 97.3
|
99.3 percentage of participants
Interval 95.9 to 100.0
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF+RBV
n=132 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF/VEL
n=134 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any 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 SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Outcome measures
| Measure |
SOF+RBV
n=132 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF/VEL
n=134 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
96.2 percentage of participants
Interval 91.4 to 98.8
|
99.3 percentage of participants
Interval 95.9 to 100.0
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
93.9 percentage of participants
Interval 88.4 to 97.3
|
99.3 percentage of participants
Interval 95.9 to 100.0
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12Outcome measures
| Measure |
SOF+RBV
n=132 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF/VEL
n=134 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 1 (SOF/VEL: N = 133; SOF+RBV: N = 132)
|
22.7 percentage of participants
Interval 15.9 to 30.8
|
12.8 percentage of participants
Interval 7.6 to 19.7
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 2 (SOF/VEL: N = 133; SOF+RBV: N = 132)
|
59.8 percentage of participants
Interval 51.0 to 68.3
|
57.1 percentage of participants
Interval 48.3 to 65.7
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 4 (SOF/VEL: N = 133; SOF+RBV: N = 132)
|
90.2 percentage of participants
Interval 83.7 to 94.7
|
90.2 percentage of participants
Interval 83.9 to 94.7
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 6 (SOF/VEL: N = 133; SOF+RBV: N = 132)
|
99.2 percentage of participants
Interval 95.9 to 100.0
|
97.7 percentage of participants
Interval 93.5 to 99.5
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 8 (SOF/VEL: N = 133; SOF+RBV: N = 132)
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 12 (SOF/VEL: N = 133; SOF+RBV: N = 131)
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12
Week 10 (SOF/VEL: N = 133; SOF+RBV: N = 132)
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV
n=132 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF/VEL
n=134 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 1 (SOF/VEL: N= 132; SOF+RBV: N= 131)
|
-4.51 log10 IU/mL
Standard Deviation 0.553
|
-4.51 log10 IU/mL
Standard Deviation 0.666
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 2 (SOF/VEL: N= 132; SOF+RBV: N= 131)
|
-5.04 log10 IU/mL
Standard Deviation 0.701
|
-5.08 log10 IU/mL
Standard Deviation 0.761
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 4 (SOF/VEL: N= 132; SOF+RBV: N= 131)
|
-5.24 log10 IU/mL
Standard Deviation 0.755
|
-5.29 log10 IU/mL
Standard Deviation 0.781
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 6 (SOF/VEL: N= 133; SOF+RBV: N= 131)
|
-5.27 log10 IU/mL
Standard Deviation 0.741
|
-5.31 log10 IU/mL
Standard Deviation 0.781
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 8 (SOF/VEL: N= 133; SOF+RBV: N= 132)
|
-5.27 log10 IU/mL
Standard Deviation 0.739
|
-5.32 log10 IU/mL
Standard Deviation 0.782
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 10 (SOF/VEL: N= 133; SOF+RBV: N= 132)
|
-5.27 log10 IU/mL
Standard Deviation 0.739
|
-5.32 log10 IU/mL
Standard Deviation 0.782
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12
Change at Wk 12 (SOF/VEL: N= 133; SOF+RBV: N= 131)
|
-5.26 log10 IU/mL
Standard Deviation 0.737
|
-5.32 log10 IU/mL
Standard Deviation 0.782
|
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+RBV
n=132 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF/VEL
n=134 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Virologic Failure
|
4.5 percentage of participants
|
0 percentage of participants
|
Adverse Events
SOF/VEL
Serious events: 2 serious events
Other events: 69 other events
Deaths: 0 deaths
SOF+RBV
Serious events: 2 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL
n=134 participants at risk
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
SOF+RBV
n=132 participants at risk
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.75%
1/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Enteritis
|
0.75%
1/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Pneumonia
|
0.75%
1/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.76%
1/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
0.00%
0/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.76%
1/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF/VEL
n=134 participants at risk
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
SOF+RBV
n=132 participants at risk
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
8/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
5/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.3%
7/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
10.4%
14/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
15.2%
20/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
5/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
8/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
14.9%
20/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
35.6%
47/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
8/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.5%
2/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Sinusitis
|
5.2%
7/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.8%
5/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
8/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.8%
5/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
6/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
8/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
2/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.3%
7/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
2.2%
3/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
8/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
17.9%
24/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
22.0%
29/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
6.0%
8/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.1%
8/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
4.5%
6/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
14.4%
19/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
3.0%
4/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.8%
9/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
6/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.3%
7/132 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
2/134 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.3%
7/132 • 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