Trial Outcomes & Findings for Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV (NCT NCT02671500)
NCT ID: NCT02671500
Last Updated: 2019-01-08
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
375 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2019-01-08
Participant Flow
Participants were enrolled at study sites in Asia. The first participant was screened on 19 April 2016. The last study visit occurred on 27 March 2018.
437 participants were screened.
Participant milestones
| Measure |
SOF/VEL
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks
|
|---|---|
|
Overall Study
STARTED
|
375
|
|
Overall Study
COMPLETED
|
361
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
SOF/VEL
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks
|
|---|---|
|
Overall Study
Lack of Efficacy
|
12
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
Baseline characteristics by cohort
| Measure |
SOF/VEL
n=375 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Age, Continuous
|
45 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
374 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
375 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Vietnam
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
264 Participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
41 Participants
n=5 Participants
|
|
HCV genotype
Genotype 1
|
129 Participants
n=5 Participants
|
|
HCV genotype
Genotype 2
|
64 Participants
n=5 Participants
|
|
HCV genotype
Genotype 3
|
84 Participants
n=5 Participants
|
|
HCV genotype
Genotype 6
|
98 Participants
n=5 Participants
|
|
IL28b Status
CC
|
320 Participants
n=5 Participants
|
|
IL28b Status
CT
|
53 Participants
n=5 Participants
|
|
IL28b Status
TT
|
2 Participants
n=5 Participants
|
|
HCV RNA (log10 international units per milliliter [IU/mL])
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.86 • n=5 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
116 Participants
n=5 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
259 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set included participants who were 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/VEL (Overall)
n=375 Participants
All participants received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (China - Region 1)
n=264 Participants
All participants in China received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (Southeast Asia - Region 2)
n=111 Participants
All participants in Southeast Asia (Malaysia, Singapore, Thailand, and Vietnam) received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
96.5 Percentage of participants
Interval 94.1 to 98.1
|
96.2 Percentage of participants
Interval 93.1 to 98.2
|
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 (Overall)
n=375 Participants
All participants received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (China - Region 1)
All participants in China received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (Southeast Asia - Region 2)
All participants in Southeast Asia (Malaysia, Singapore, Thailand, and Vietnam) received SOF/VEL (400/100 mg) FDC tablet orally 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: Full Analysis Set
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL (Overall)
n=375 Participants
All participants received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (China - Region 1)
All participants in China received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (Southeast Asia - Region 2)
All participants in Southeast Asia (Malaysia, Singapore, Thailand, and Vietnam) received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
|
97.1 Percentage of participants
Interval 94.8 to 98.5
|
—
|
—
|
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 (Overall)
n=375 Participants
All participants received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (China - Region 1)
All participants in China received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (Southeast Asia - Region 2)
All participants in Southeast Asia (Malaysia, Singapore, Thailand, and Vietnam) received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
|
96.5 percentage of participants
Interval 94.1 to 98.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 8, 10, and 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL (Overall)
n=375 Participants
All participants received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (China - Region 1)
All participants in China received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (Southeast Asia - Region 2)
All participants in Southeast Asia (Malaysia, Singapore, Thailand, and Vietnam) received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 1
|
27.7 Percentage of participants
Interval 23.3 to 32.6
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 2
|
73.8 Percentage of participants
Interval 69.0 to 78.2
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 4
|
95.5 Percentage of participants
Interval 92.8 to 97.3
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 6
|
99.7 Percentage of participants
Interval 98.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 8
|
100.0 Percentage of participants
Interval 99.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 10
|
100.0 Percentage of participants
Interval 99.0 to 100.0
|
—
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Week 12
|
100.0 Percentage of participants
Interval 99.0 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL (Overall)
n=374 Participants
All participants received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (China - Region 1)
All participants in China received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (Southeast Asia - Region 2)
All participants in Southeast Asia (Malaysia, Singapore, Thailand, and Vietnam) received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in HCV RNA
Change at Week 8
|
-5.03 log10 IU/mL
Standard Deviation 0.857
|
—
|
—
|
|
Change From Baseline in HCV RNA
Change at Week 10
|
-5.03 log10 IU/mL
Standard Deviation 0.857
|
—
|
—
|
|
Change From Baseline in HCV RNA
Change at Week 12
|
-5.03 log10 IU/mL
Standard Deviation 0.857
|
—
|
—
|
|
Change From Baseline in HCV RNA
Change at Week 1
|
-4.38 log10 IU/mL
Standard Deviation 0.705
|
—
|
—
|
|
Change From Baseline in HCV RNA
Change at Week 2
|
-4.89 log10 IU/mL
Standard Deviation 0.822
|
—
|
—
|
|
Change From Baseline in HCV RNA
Change at Week 4
|
-5.02 log10 IU/mL
Standard Deviation 0.849
|
—
|
—
|
|
Change From Baseline in HCV RNA
Change at Week 6
|
-5.03 log10 IU/mL
Standard Deviation 0.857
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as: (1) 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) or (2) 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 (Overall)
n=375 Participants
All participants received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (China - Region 1)
All participants in China received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
SOF/VEL (Southeast Asia - Region 2)
All participants in Southeast Asia (Malaysia, Singapore, Thailand, and Vietnam) received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Overall Virologic Failure
|
3.2 percentage of participants
|
—
|
—
|
Adverse Events
SOL/VEL
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOL/VEL
n=375 participants at risk
SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Infections and infestations
Diabetic foot infection
|
0.27%
1/375 • Up to 12 weeks plus 30 days
Safety Analysis Set included participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.27%
1/375 • Up to 12 weeks plus 30 days
Safety Analysis Set included participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.27%
1/375 • Up to 12 weeks plus 30 days
Safety Analysis Set included participants who were enrolled into the study and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
SOL/VEL
n=375 participants at risk
SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
9.6%
36/375 • Up to 12 weeks plus 30 days
Safety Analysis Set included participants who were enrolled into the study and 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