Trial Outcomes & Findings for Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection (NCT NCT02722837)
NCT ID: NCT02722837
Last Updated: 2018-11-16
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
119 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at study sites in the Russian Federation and Sweden. The first participant was screened on 04 April 2016 and the last study visit occurred on 13 September 2017.
122 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, with or without food
|
|---|---|
|
Overall Study
STARTED
|
119
|
|
Overall Study
COMPLETED
|
119
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection
Baseline characteristics by cohort
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
117 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
119 Participants
n=99 Participants
|
|
Region of Enrollment
Sweden
|
16 Participants
n=99 Participants
|
|
Region of Enrollment
Russia
|
103 Participants
n=99 Participants
|
|
IL28b Status
CC
|
29 Participants
n=99 Participants
|
|
IL28b Status
CT
|
72 Participants
n=99 Participants
|
|
IL28b Status
TT
|
18 Participants
n=99 Participants
|
|
HCV RNA
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.54 • n=99 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
38 Participants
n=99 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
81 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who received at least 1 dose of study drug
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
99.2 percentage of participants
Interval 95.4 to 100.0
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety analysis Set
Outcome measures
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Percentage of Participants Who Permanently Discontinued 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
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
|
100.0 percentage of participants
Interval 96.6 to 100.0
|
SECONDARY outcome
Timeframe: Posttreatment Week 24Population: Full Analysis Set
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
|
99.2 percentage of participants
Interval 95.4 to 100.0
|
SECONDARY outcome
Timeframe: Week 1Population: Full Analysis Set
Outcome measures
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1
|
21.0 percentage of participants
Interval 14.1 to 29.4
|
SECONDARY outcome
Timeframe: Week 2Population: Full Analysis Set
Outcome measures
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2
|
64.7 percentage of participants
Interval 55.4 to 73.2
|
SECONDARY outcome
Timeframe: Week 4Population: Full analysis set
Outcome measures
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4
|
96.6 percentage of participants
Interval 91.6 to 99.1
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis Set
Outcome measures
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8
|
100.0 percentage of participants
Interval 96.9 to 100.0
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set
Outcome measures
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12
|
100.0 percentage of participants
Interval 96.9 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Week 1Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL
n=118 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Change From Baseline in HCV RNA at Week 1
|
-4.17 log10 IU/mL
Standard Deviation 0.502
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Week 2Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL
n=117 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Change From Baseline in HCV RNA at Week 2
|
-4.70 log10 IU/mL
Standard Deviation 0.525
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Week 4Population: Full Analysis Set
Outcome measures
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Change From Baseline in HCV RNA at Week 4
|
-4.90 log10 IU/mL
Standard Deviation 0.540
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Week 8Population: Full Analysis Set
Outcome measures
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Change From Baseline in HCV RNA at Week 8
|
-4.93 log10 IU/mL
Standard Deviation 0.544
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Week 12Population: Full Analysis Set
Outcome measures
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Change From Baseline in HCV RNA at Week 12
|
-4.93 log10 IU/mL
Standard Deviation 0.544
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as: * 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 * Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)
Outcome measures
| Measure |
SOF/VEL
n=119 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Percentage of Participants With Virologic Failure
|
0.8 percentage of participants
|
Adverse Events
SOF/VEL
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL
n=119 participants at risk
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
Infections and infestations
Orchitis
|
0.84%
1/119 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.84%
1/119 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Nervous system disorders
Sciatica
|
0.84%
1/119 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Calculus urinary
|
0.84%
1/119 • Up to 12 weeks + 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF/VEL
n=119 participants at risk
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food
|
|---|---|
|
General disorders
Asthenia
|
5.9%
7/119 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
6.7%
8/119 • Up to 12 weeks + 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
16.0%
19/119 • Up to 12 weeks + 30 days
Safety Analysis Set
|
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