Trial Outcomes & Findings for Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection (NCT NCT02738333)
NCT ID: NCT02738333
Last Updated: 2018-11-16
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
239 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at study sites in Japan. The first participant was screened on 12 April 2016. The last study visit occurred on 11 May 2017.
266 participants were screened.
Participant milestones
| Measure |
LDV/SOF (Cohort 1)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
|
SOF+RBV (Cohort 1)
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
106
|
108
|
25
|
|
Overall Study
COMPLETED
|
104
|
108
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
LDV/SOF (Cohort 1)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
|
SOF+RBV (Cohort 1)
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection
Baseline characteristics by cohort
| Measure |
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
SOF+RBV (Cohort 1)
n=108 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
60 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
74 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
61 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
106 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
239 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
106 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
239 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
IL28b Status
CC
|
88 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
|
IL28b Status
CT
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
IL28b Status
TT
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
HCV RNA (log10 IU/mL)
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.79 • n=5 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.79 • n=7 Participants
|
5.9 log10 IU/mL
STANDARD_DEVIATION 0.72 • n=5 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.78 • n=4 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
76 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who were randomized and 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+RBV (Cohort 1)
n=108 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
95.4 percentage of participants
Interval 89.5 to 98.5
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
96.2 percentage of participants
Interval 90.6 to 99.0
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=108 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
1.9 percentage of participants
|
0 percentage of participants
|
0.9 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+RBV (Cohort 1)
n=108 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
|
98.1 percentage of participants
Interval 93.5 to 99.8
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
97.2 percentage of participants
Interval 92.0 to 99.4
|
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+RBV (Cohort 1)
n=108 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
|
95.4 percentage of participants
Interval 89.5 to 98.5
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
96.2 percentage of participants
Interval 90.6 to 99.0
|
SECONDARY outcome
Timeframe: Week 1Population: Full Analysis Set
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=108 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 1
|
31.5 percentage of participants
Interval 22.9 to 41.1
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
24.5 percentage of participants
Interval 16.7 to 33.8
|
SECONDARY outcome
Timeframe: Week 2Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 2
|
76.6 percentage of participants
Interval 67.5 to 84.3
|
76.0 percentage of participants
Interval 54.9 to 90.6
|
73.6 percentage of participants
Interval 64.1 to 81.7
|
SECONDARY outcome
Timeframe: Week 3Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 3
|
90.7 percentage of participants
Interval 83.5 to 95.4
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
90.6 percentage of participants
Interval 83.3 to 95.4
|
SECONDARY outcome
Timeframe: Week 4Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 4
|
96.3 percentage of participants
Interval 90.7 to 99.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
98.1 percentage of participants
Interval 93.4 to 99.8
|
SECONDARY outcome
Timeframe: Week 5Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 5
|
99.1 percentage of participants
Interval 94.9 to 100.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
98.1 percentage of participants
Interval 93.3 to 99.8
|
SECONDARY outcome
Timeframe: Week 6Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 6
|
99.1 percentage of participants
Interval 94.9 to 100.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
99.0 percentage of participants
Interval 94.8 to 100.0
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 8
|
100.0 percentage of participants
Interval 96.6 to 100.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
100.0 percentage of participants
Interval 96.5 to 100.0
|
SECONDARY outcome
Timeframe: Week 10Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 10
|
100.0 percentage of participants
Interval 96.6 to 100.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
100.0 percentage of participants
Interval 96.5 to 100.0
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=106 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 12
|
100.0 percentage of participants
Interval 96.6 to 100.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
100.0 percentage of participants
Interval 96.5 to 100.0
|
SECONDARY outcome
Timeframe: Baseline; Week 1Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 1
|
-4.34 log10 IU/mL
Standard Deviation 0.602
|
-4.24 log10 IU/mL
Standard Deviation 0.550
|
-4.18 log10 IU/mL
Standard Deviation 0.540
|
SECONDARY outcome
Timeframe: Baseline; Week 2Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 2
|
-4.81 log10 IU/mL
Standard Deviation 0.772
|
-4.64 log10 IU/mL
Standard Deviation 0.719
|
-4.76 log10 IU/mL
Standard Deviation 0.759
|
SECONDARY outcome
Timeframe: Baseline; Week 3Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 3
|
-4.89 log10 IU/mL
Standard Deviation 0.790
|
-4.75 log10 IU/mL
Standard Deviation 0.714
|
-4.87 log10 IU/mL
Standard Deviation 0.780
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 4
|
-4.91 log10 IU/mL
Standard Deviation 0.794
|
-4.76 log10 IU/mL
Standard Deviation 0.719
|
-4.89 log10 IU/mL
Standard Deviation 0.782
|
SECONDARY outcome
Timeframe: Baseline; Week 5Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 5
|
-4.92 log10 IU/mL
Standard Deviation 0.794
|
-4.76 log10 IU/mL
Standard Deviation 0.719
|
-4.91 log10 IU/mL
Standard Deviation 0.781
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 6
|
-4.92 log10 IU/mL
Standard Deviation 0.793
|
-4.76 log10 IU/mL
Standard Deviation 0.719
|
-4.91 log10 IU/mL
Standard Deviation 0.781
|
SECONDARY outcome
Timeframe: Baseline; Week 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 8
|
-4.93 log10 IU/mL
Standard Deviation 0.794
|
-4.76 log10 IU/mL
Standard Deviation 0.719
|
-4.92 log10 IU/mL
Standard Deviation 0.785
|
SECONDARY outcome
Timeframe: Baseline; Week 10Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=107 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 10
|
-4.93 log10 IU/mL
Standard Deviation 0.794
|
-4.76 log10 IU/mL
Standard Deviation 0.719
|
-4.92 log10 IU/mL
Standard Deviation 0.785
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV (Cohort 1)
n=106 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 12
|
-4.92 log10 IU/mL
Standard Deviation 0.794
|
-4.76 log10 IU/mL
Standard Deviation 0.719
|
-4.92 log10 IU/mL
Standard Deviation 0.785
|
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+RBV (Cohort 1)
n=108 Participants
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
LDV/SOF (Cohort 1)
n=106 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With Overall Virologic Failure
|
3.7 percentage of participants
|
4.0 percentage of participants
|
2.8 percentage of participants
|
Adverse Events
LDV/SOF (Cohort 1)
Serious events: 1 serious events
Other events: 25 other events
Deaths: 1 deaths
SOF+RBV (Cohort 1)
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
LDV/SOF (Cohort 2)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF (Cohort 1)
n=106 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
SOF+RBV (Cohort 1)
n=108 participants at risk
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
|---|---|---|---|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.94%
1/106 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
0.00%
0/108 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
0.00%
0/25 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/106 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
0.93%
1/108 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
0.00%
0/25 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/106 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
0.00%
0/108 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
4.0%
1/25 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
Other adverse events
| Measure |
LDV/SOF (Cohort 1)
n=106 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
SOF+RBV (Cohort 1)
n=108 participants at risk
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
|
LDV/SOF (Cohort 2)
n=25 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/106 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
23.1%
25/108 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
0.00%
0/25 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
|
Gastrointestinal disorders
Stomatitis
|
3.8%
4/106 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
1.9%
2/108 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
8.0%
2/25 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
|
General disorders
Pyrexia
|
0.00%
0/106 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
0.00%
0/108 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
8.0%
2/25 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
|
Infections and infestations
Viral upper respiratory tract infection
|
11.3%
12/106 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
21.3%
23/108 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
4.0%
1/25 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
9.4%
10/106 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
8.3%
9/108 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug
|
8.0%
2/25 • Up to 12 weeks plus 30 days
Safety Analysis Set: 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