Trial Outcomes & Findings for Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study (NCT NCT03118843)
NCT ID: NCT03118843
Last Updated: 2019-04-03
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
31 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2019-04-03
Participant Flow
Participants were enrolled at study sites in North America, Europe, New Zealand, and Australia. The first participant was screened on 25 April 2017. The last study visit occurred on 19 March 2018.
38 participants were screened.
Participant milestones
| Measure |
SOF/VEL/VOX
Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Baseline characteristics by cohort
| Measure |
SOF/VEL/VOX
n=31 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
|
|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 7.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
25 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
5 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Not Disclosed
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
New Zealand
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=93 Participants
|
|
HCV Genotype
Genotype 1
|
19 Participants
n=93 Participants
|
|
HCV Genotype
Genotype 2
|
2 Participants
n=93 Participants
|
|
HCV Genotype
Genotype 3
|
8 Participants
n=93 Participants
|
|
HCV Genotype
Genotype 4
|
1 Participants
n=93 Participants
|
|
HCV Genotype
Genotype 5
|
1 Participants
n=93 Participants
|
|
IL28b Status
CC
|
3 Participants
n=93 Participants
|
|
IL28b Status
CT
|
21 Participants
n=93 Participants
|
|
IL28b Status
TT
|
7 Participants
n=93 Participants
|
|
Cirrhosis Status
Yes
|
15 Participants
n=93 Participants
|
|
Cirrhosis Status
No
|
16 Participants
n=93 Participants
|
|
HCV RNA (log10 IU/mL)
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.56 • n=93 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
6 Participants
n=93 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
25 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set 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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL/VOX
n=31 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Participants in the Safety Analysis Set were analyzed.
Outcome measures
| Measure |
SOF/VEL/VOX
n=31 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
|
|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Participants in the Full Analysis Set were analyzed.
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL/VOX
n=31 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
|
|---|---|
|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, and 12Population: Participants in the Full Analysis Set were analyzed.
Outcome measures
| Measure |
SOF/VEL/VOX
n=31 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 4
|
96.8 percentage of participants
Interval 83.3 to 99.9
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 8
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 12
|
100.0 percentage of participants
Interval 88.8 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 2
|
51.6 percentage of participants
Interval 33.1 to 69.8
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 12Population: Participants in the Full Analysis Set were analyzed.
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after 2 consecutive HCV RNA \< LLOQ), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit
Outcome measures
| Measure |
SOF/VEL/VOX
n=31 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
|
|---|---|
|
Percentage of Participants With Virologic Failure
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, and 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL/VOX
n=31 Participants
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
|
|---|---|
|
Change From Baseline in HCV RNA
Change at Week 2
|
-5.16 log10 IU/mL
Standard Deviation 0.560
|
|
Change From Baseline in HCV RNA
Change at Week 4
|
-5.34 log10 IU/mL
Standard Deviation 0.571
|
|
Change From Baseline in HCV RNA
Change at Week 8
|
-5.34 log10 IU/mL
Standard Deviation 0.563
|
|
Change From Baseline in HCV RNA
Change at Week 12
|
-5.34 log10 IU/mL
Standard Deviation 0.563
|
Adverse Events
SOF/VEL/VOX
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL/VOX
n=31 participants at risk
SOF/VEL/VOX (400/100/100 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.2%
1/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
3.2%
1/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
SOF/VEL/VOX
n=31 participants at risk
SOF/VEL/VOX (400/100/100 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.5%
2/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
2/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
2/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
2/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.1%
5/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
16.1%
5/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pain
|
6.5%
2/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.7%
3/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
12.9%
4/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
6.5%
2/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
6.5%
2/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
2/31 • Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took 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