Trial Outcomes & Findings for Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study (NCT NCT02300103)
NCT ID: NCT02300103
Last Updated: 2018-11-16
Results Overview
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at 31 study sites in North America and Asia Pacific. The first participant was screened on 01 December 2014. The last study visit occurred on 15 September 2016.
74 participants were screened.
Participant milestones
| Measure |
SOF/VEL+RBV
Sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) (400/100mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 mg or 1200 mg) for 24 weeks
|
|---|---|
|
Overall Study
STARTED
|
69
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
SOF/VEL+RBV
Sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) (400/100mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 mg or 1200 mg) for 24 weeks
|
|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrew Consent
|
2
|
Baseline Characteristics
Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
Baseline characteristics by cohort
| Measure |
SOF/VEL+RBV
n=69 Participants
SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
|
|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 Participants
n=5 Participants
|
|
IL28b Status
CC
|
23 Participants
n=5 Participants
|
|
IL28b Status
CT
|
32 Participants
n=5 Participants
|
|
IL28b Status
TT
|
14 Participants
n=5 Participants
|
|
HCV RNA
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.67 • n=5 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
15 Participants
n=5 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
54 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: all enrolled participants who received at least one dose of study drug.
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Outcome measures
| Measure |
SOF/VEL+RBV
n=69 Participants
SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
91.3 percentage of participants
Interval 82.0 to 96.7
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF/VEL+RBV
n=69 Participants
SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
|
|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
5.8 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug.
Outcome measures
| Measure |
SOF/VEL+RBV
n=69 Participants
SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
92.8 percentage of participants
Interval 83.9 to 97.6
|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
89.9 percentage of participants
Interval 80.2 to 95.8
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV
n=69 Participants
SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ On-treatment
Week 1
|
15.9 percentage of participants
Interval 8.2 to 26.7
|
|
Percentage of Participants With HCV RNA < LLOQ On-treatment
Week 2
|
60.9 percentage of participants
Interval 48.4 to 72.4
|
|
Percentage of Participants With HCV RNA < LLOQ On-treatment
Week 4
|
91.3 percentage of participants
Interval 82.0 to 96.7
|
|
Percentage of Participants With HCV RNA < LLOQ On-treatment
Week 6
|
98.5 percentage of participants
Interval 92.1 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ On-treatment
Week 8
|
97.1 percentage of participants
Interval 89.8 to 99.6
|
|
Percentage of Participants With HCV RNA < LLOQ On-treatment
Week 12
|
98.5 percentage of participants
Interval 92.0 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ On-treatment
Week 16
|
100.0 percentage of participants
Interval 94.6 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ On-treatment
Week 20
|
100.0 percentage of participants
Interval 94.6 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ On-treatment
Week 24
|
100.0 percentage of participants
Interval 94.6 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+RBV
n=69 Participants
SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
|
|---|---|
|
HCV RNA Change From Baseline
Week 1
|
-4.45 log10 IU/mL
Standard Deviation 0.615
|
|
HCV RNA Change From Baseline
Week 2
|
-5.04 log10 IU/mL
Standard Deviation 0.685
|
|
HCV RNA Change From Baseline
Week 4
|
-5.18 log10 IU/mL
Standard Deviation 0.719
|
|
HCV RNA Change From Baseline
Week 6
|
-5.23 log10 IU/mL
Standard Deviation 0.669
|
|
HCV RNA Change From Baseline
Week 8
|
-5.23 log10 IU/mL
Standard Deviation 0.675
|
|
HCV RNA Change From Baseline
Week 12
|
-5.23 log10 IU/mL
Standard Deviation 0.679
|
|
HCV RNA Change From Baseline
Week 16
|
-5.23 log10 IU/mL
Standard Deviation 0.679
|
|
HCV RNA Change From Baseline
Week 20
|
-5.23 log10 IU/mL
Standard Deviation 0.679
|
|
HCV RNA Change From Baseline
Week 24
|
-5.23 log10 IU/mL
Standard Deviation 0.679
|
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
n=69 Participants
SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
|
|---|---|
|
Percentage of Participants With Virologic Failure
|
7.2 percentage of participants
|
Adverse Events
SOF/VEL+RBV
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL+RBV
n=69 participants at risk
SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
|
|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
1/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF/VEL+RBV
n=69 participants at risk
SOF/VEL (400/100mg) FDC tablet once daily + RBV tablets (1000 mg or 1200 mg) for 24 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
5.8%
4/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
4/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
21.7%
15/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
4/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
31.9%
22/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
13.0%
9/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.7%
6/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
17.4%
12/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
15.9%
11/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
13.0%
9/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.7%
6/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.5%
10/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.0%
9/69 • Treatment Phase: Up to 24 weeks with an onset date on or after the study drug start date 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