Trial Outcomes & Findings for Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection (NCT NCT02346721)
NCT ID: NCT02346721
Last Updated: 2018-11-16
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
111 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 23 February 2015. The last study visit occurred on 15 June 2016.
116 participants were screened.
Participant milestones
| Measure |
SOF/VEL 12 Weeks
Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily
|
|---|---|
|
Overall Study
STARTED
|
111
|
|
Overall Study
COMPLETED
|
107
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
SOF/VEL 12 Weeks
Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily
|
|---|---|
|
Overall Study
Withdrew Consent
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
Baseline characteristics by cohort
| Measure |
SOF/VEL 12 Weeks
n=111 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily
|
|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
85 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
106 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 Participants
n=5 Participants
|
|
IL28b Status
CC
|
36 Participants
n=5 Participants
|
|
IL28b Status
CT
|
50 Participants
n=5 Participants
|
|
IL28b Status
TT
|
25 Participants
n=5 Participants
|
|
HCV RNA
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.55 • n=5 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
30 Participants
n=5 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
81 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set (FAS) included all enrolled participants who took at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=111 Participants
SOF/VEL 400/100 mg FDC tablet orally once daily
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
97.3 percentage of participants
Interval 92.3 to 99.4
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=111 Participants
SOF/VEL 400/100 mg FDC tablet orally once daily
|
|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
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 following the last dose of study drug, respectively.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=111 Participants
SOF/VEL 400/100 mg FDC tablet orally once daily
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
98.2 percentage of participants
Interval 93.6 to 99.8
|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
97.3 percentage of participants
Interval 92.3 to 99.4
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=111 Participants
SOF/VEL 400/100 mg FDC tablet orally once daily
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 12
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 1
|
18.0 percentage of participants
Interval 11.4 to 26.4
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 2
|
55.0 percentage of participants
Interval 45.2 to 64.4
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 4
|
94.6 percentage of participants
Interval 88.6 to 98.0
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 6
|
99.1 percentage of participants
Interval 95.1 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 8
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 10
|
100.0 percentage of participants
Interval 96.7 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=111 Participants
SOF/VEL 400/100 mg FDC tablet orally once daily
|
|---|---|
|
HCV RNA Change From Baseline
Change at Week 1
|
-4.23 log10 IU/mL
Standard Deviation 0.592
|
|
HCV RNA Change From Baseline
Change at Week 2
|
-4.79 log10 IU/mL
Standard Deviation 0.627
|
|
HCV RNA Change From Baseline
Change at Week 4
|
-5.10 log10 IU/mL
Standard Deviation 0.546
|
|
HCV RNA Change From Baseline
Change at Week 6
|
-5.11 log10 IU/mL
Standard Deviation 0.552
|
|
HCV RNA Change From Baseline
Change at Week 8
|
-5.11 log10 IU/mL
Standard Deviation 0.554
|
|
HCV RNA Change From Baseline
Change at Week 10
|
-5.11 log10 IU/mL
Standard Deviation 0.554
|
|
HCV RNA Change From Baseline
Change at Week 12
|
-5.11 log10 IU/mL
Standard Deviation 0.556
|
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 12 Weeks
n=111 Participants
SOF/VEL 400/100 mg FDC tablet orally once daily
|
|---|---|
|
Percentage of Participants With Virologic Failure
|
0.9 percentage of participants
|
Adverse Events
SOF/VEL 12 Weeks
Serious events: 5 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL 12 Weeks
n=111 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily
|
|---|---|
|
Infections and infestations
Cellulitis
|
0.90%
1/111 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Lymphangitis
|
0.90%
1/111 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.90%
1/111 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.90%
1/111 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.90%
1/111 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.90%
1/111 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF/VEL 12 Weeks
n=111 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.3%
7/111 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
10.8%
12/111 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
16.2%
18/111 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
21.6%
24/111 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.3%
7/111 • 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