Trial Outcomes & Findings for Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis (NCT NCT02994056)
NCT ID: NCT02994056
Last Updated: 2020-03-02
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
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2020-03-02
Participant Flow
Participants were enrolled at study sites in the United States and France. The first participant was screened on 23 January 2017. The last study visit occurred on 12 December 2018.
73 participants were screened.
Participant milestones
| Measure |
SOF/VEL+ RBV
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
SOF/VEL+ RBV
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis
|
|---|---|
|
Overall Study
Death
|
8
|
|
Overall Study
Withdrew Consent
|
1
|
Baseline Characteristics
Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
Baseline characteristics by cohort
| Measure |
SOF/VEL+ RBV
n=32 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American Native
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
|
Region of Enrollment
France
|
6 participants
n=5 Participants
|
|
HCV RNA
|
5.2 log10 IU/mL
STANDARD_DEVIATION 1.19 • n=5 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
23 Participants
n=5 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
9 Participants
n=5 Participants
|
|
IL28B
CC
|
15 Participants
n=5 Participants
|
|
IL28B
CT
|
14 Participants
n=5 Participants
|
|
IL28B
TT
|
3 Participants
n=5 Participants
|
|
Child-Pugh-Turcotte Class
CPT B [7-9]
|
9 Participants
n=5 Participants
|
|
Child-Pugh-Turcotte Class
CPT C [10-15]
|
23 Participants
n=5 Participants
|
|
Model for End Stage Liver Disease (MELD) Score Category
10-15 MELD Score
|
13 Participants
n=5 Participants
|
|
Model for End Stage Liver Disease (MELD) Score Category
16-20 MELD Score
|
17 Participants
n=5 Participants
|
|
Model for End Stage Liver Disease (MELD) Score Category
21-25 MELD Score
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: The 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+ RBV (Total)
n=32 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-1)
n=18 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-2)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-3)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
78.1 percentage of participants
Interval 60.0 to 90.7
|
72.2 percentage of participants
Interval 46.5 to 90.3
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
PRIMARY outcome
Timeframe: First dose date up to Week 12Population: The Safety Analysis Set included all participants who took at least 1 dose of study drug.
Outcome measures
| Measure |
SOF/VEL+ RBV (Total)
n=32 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-1)
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-2)
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-3)
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event
Discontinuation of SOF/VEL
|
6.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event
Discontinuation of RBV
|
21.9 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Participants in the Full Analysis Set were analyzed.
SVR4 was defined as HCV RNA \< LLOQ 4 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL+ RBV (Total)
n=32 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-1)
n=18 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-2)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-3)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
|
87.5 percentage of participants
Interval 71.0 to 96.5
|
88.9 percentage of participants
Interval 65.3 to 98.6
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
SECONDARY outcome
Timeframe: Posttreatment Week 24Population: Participants in the Full Analysis Set were analyzed.
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL+ RBV (Total)
n=32 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-1)
n=18 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-2)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-3)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
|
75.0 percentage of participants
Interval 56.6 to 88.5
|
72.2 percentage of participants
Interval 46.5 to 90.3
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, and 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL+ RBV (Total)
n=32 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-1)
n=18 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-2)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-3)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ While on Study Treatment
Week 2
|
43.8 Percentage of participants
Interval 26.4 to 62.3
|
38.9 Percentage of participants
Interval 17.3 to 64.3
|
0 Percentage of participants
Interval 0.0 to 52.2
|
71.4 Percentage of participants
Interval 29.0 to 96.3
|
|
Percentage of Participants With HCV RNA < LLOQ While on Study Treatment
Week 4
|
96.6 Percentage of participants
Interval 82.2 to 99.9
|
100.0 Percentage of participants
Interval 79.4 to 100.0
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
100.0 Percentage of participants
Interval 59.0 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ While on Study Treatment
Week 8
|
100.0 Percentage of participants
Interval 88.1 to 100.0
|
100.0 Percentage of participants
Interval 79.4 to 100.0
|
100.0 Percentage of participants
Interval 39.8 to 100.0
|
100.0 Percentage of participants
Interval 59.0 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ While on Study Treatment
Week 12
|
100.0 Percentage of participants
Interval 88.1 to 100.0
|
100.0 Percentage of participants
Interval 79.4 to 100.0
|
100.0 Percentage of participants
Interval 39.8 to 100.0
|
100.0 Percentage of participants
Interval 59.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment Week 24Population: Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.
CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24.
Outcome measures
| Measure |
SOF/VEL+ RBV (Total)
n=19 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-1)
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-2)
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-3)
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class
Improved CPT Class
|
42.1 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class
Worsened CPT Class
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class
No Change CPT Class
|
57.9 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment Week 24Population: Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.
MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2.
Outcome measures
| Measure |
SOF/VEL+ RBV (Total)
n=19 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-1)
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-2)
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-3)
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
Decrease (Improvement)
|
52.6 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
No Change
|
21.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
Increase (Worsening)
|
26.3 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+ RBV (Total)
n=32 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-1)
n=18 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-2)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-3)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis
|
|---|---|---|---|---|
|
Absolute HCV RNA Level Through Week 12
Baseline
|
5.17 log10 IU/mL
Standard Deviation 1.187
|
5.46 log10 IU/mL
Standard Deviation 0.537
|
6.01 log10 IU/mL
Standard Deviation 0.502
|
4.84 log10 IU/mL
Standard Deviation 1.058
|
|
Absolute HCV RNA Level Through Week 12
Week 2
|
1.46 log10 IU/mL
Standard Deviation 0.392
|
1.47 log10 IU/mL
Standard Deviation 0.387
|
1.63 log10 IU/mL
Standard Deviation 0.150
|
1.43 log10 IU/mL
Standard Deviation 0.526
|
|
Absolute HCV RNA Level Through Week 12
Week 4
|
1.15 log10 IU/mL
Standard Deviation 0.00
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
Absolute HCV RNA Level Through Week 12
Week 8
|
1.15 log10 IU/mL
Standard Deviation 0.00
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
Absolute HCV RNA Level Through Week 12
Week 12
|
1.15 log10 IU/mL
Standard Deviation 0.00
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
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+ RBV (Total)
n=29 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-1)
n=16 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-2)
n=4 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-3)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA
Change at Week 2
|
-3.72 log10 IU/mL
Standard Deviation 1.092
|
-4.06 log10 IU/mL
Standard Deviation 0.531
|
-4.50 log10 IU/mL
Standard Deviation 0.366
|
-3.41 log10 IU/mL
Standard Deviation 0.665
|
|
Change From Baseline in HCV RNA
Change at Week 4
|
-3.99 log10 IU/mL
Standard Deviation 1.238
|
-4.39 log10 IU/mL
Standard Deviation 0.520
|
-4.88 log10 IU/mL
Standard Deviation 0.395
|
-3.70 log10 IU/mL
Standard Deviation 1.058
|
|
Change From Baseline in HCV RNA
Change at Week 8
|
-4.00 log10 IU/mL
Standard Deviation 1.217
|
-4.39 log10 IU/mL
Standard Deviation 0.520
|
-4.72 log10 IU/mL
Standard Deviation 0.445
|
-3.70 log10 IU/mL
Standard Deviation 1.058
|
|
Change From Baseline in HCV RNA
Change at Week 12
|
-4.00 log10 IU/mL
Standard Deviation 1.217
|
-4.39 log10 IU/mL
Standard Deviation 0.520
|
-4.72 log10 IU/mL
Standard Deviation 0.445
|
-3.70 log10 IU/mL
Standard Deviation 1.058
|
SECONDARY outcome
Timeframe: Baseline up to Posttreatment Week 24Population: Participants in the Full Analysis Set were analyzed.
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 (Total)
n=18 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-1)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-2)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis
|
SOF/VEL+ RBV (GT-3)
n=32 Participants
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis
|
|---|---|---|---|---|
|
Number of Participants With Virologic Failure
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
SOF/VEL+ RBV
Serious events: 17 serious events
Other events: 27 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
SOF/VEL+ RBV
n=32 participants at risk
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Dermo-hypodermitis
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Erysipelas
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia sepsis
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
6.2%
2/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
6.2%
2/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mixed hepatocellular cholangiocarcinoma
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hepatic hydrothorax
|
6.2%
2/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.1%
1/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
SOF/VEL+ RBV
n=32 participants at risk
SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
8/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
2/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
9.4%
3/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
9.4%
3/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
3/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
8/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
15.6%
5/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
18.8%
6/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
6.2%
2/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
6.2%
2/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
2/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
2/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.4%
3/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
9.4%
3/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
2/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
6.2%
2/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hepatic hydrothorax
|
6.2%
2/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
2/32 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The 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