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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

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

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

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=99 Participants
60 years
STANDARD_DEVIATION 12.3 • n=107 Participants
74 years
STANDARD_DEVIATION 7.1 • n=206 Participants
61 years
STANDARD_DEVIATION 11.9 • n=7 Participants
Sex: Female, Male
Female
54 Participants
n=99 Participants
71 Participants
n=107 Participants
19 Participants
n=206 Participants
144 Participants
n=7 Participants
Sex: Female, Male
Male
52 Participants
n=99 Participants
37 Participants
n=107 Participants
6 Participants
n=206 Participants
95 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
106 Participants
n=99 Participants
108 Participants
n=107 Participants
25 Participants
n=206 Participants
239 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Asian
106 Participants
n=99 Participants
108 Participants
n=107 Participants
25 Participants
n=206 Participants
239 Participants
n=7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
IL28b Status
CC
88 Participants
n=99 Participants
86 Participants
n=107 Participants
15 Participants
n=206 Participants
189 Participants
n=7 Participants
IL28b Status
CT
17 Participants
n=99 Participants
19 Participants
n=107 Participants
10 Participants
n=206 Participants
46 Participants
n=7 Participants
IL28b Status
TT
1 Participants
n=99 Participants
3 Participants
n=107 Participants
0 Participants
n=206 Participants
4 Participants
n=7 Participants
HCV RNA (log10 IU/mL)
6.1 log10 IU/mL
STANDARD_DEVIATION 0.79 • n=99 Participants
6.1 log10 IU/mL
STANDARD_DEVIATION 0.79 • n=107 Participants
5.9 log10 IU/mL
STANDARD_DEVIATION 0.72 • n=206 Participants
6.0 log10 IU/mL
STANDARD_DEVIATION 0.78 • n=7 Participants
HCV RNA Category
< 800,000 IU/mL
30 Participants
n=99 Participants
36 Participants
n=107 Participants
10 Participants
n=206 Participants
76 Participants
n=7 Participants
HCV RNA Category
≥ 800,000 IU/mL
76 Participants
n=99 Participants
72 Participants
n=107 Participants
15 Participants
n=206 Participants
163 Participants
n=7 Participants

PRIMARY outcome

Timeframe: Posttreatment Week 12

Population: 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

Outcome measures
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
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
96.2 percentage of participants
Interval 90.6 to 99.0
95.4 percentage of participants
Interval 89.5 to 98.5
96.0 percentage of participants
Interval 79.6 to 99.9

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Safety Analysis Set

Outcome measures

Outcome measures
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
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
0.9 percentage of participants
1.9 percentage of participants
0 percentage of participants

SECONDARY outcome

Timeframe: Posttreatment Week 4

Population: Full Analysis Set

SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.

Outcome measures

Outcome measures
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
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
97.2 percentage of participants
Interval 92.0 to 99.4
98.1 percentage of participants
Interval 93.5 to 99.8
96.0 percentage of participants
Interval 79.6 to 99.9

SECONDARY outcome

Timeframe: Posttreatment Week 24

Population: Full Analysis Set

SVR 24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.

Outcome measures

Outcome measures
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
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
96.2 percentage of participants
Interval 90.6 to 99.0
95.4 percentage of participants
Interval 89.5 to 98.5
96.0 percentage of participants
Interval 79.6 to 99.9

SECONDARY outcome

Timeframe: Week 1

Population: Full Analysis Set

Outcome measures

Outcome measures
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
Percentage of Participants With HCV RNA < LLOQ at Week 1
24.5 percentage of participants
Interval 16.7 to 33.8
31.5 percentage of participants
Interval 22.9 to 41.1
32.0 percentage of participants
Interval 14.9 to 53.5

SECONDARY outcome

Timeframe: Week 2

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
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=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
Percentage of Participants With HCV RNA < LLOQ at Week 2
73.6 percentage of participants
Interval 64.1 to 81.7
76.6 percentage of participants
Interval 67.5 to 84.3
76.0 percentage of participants
Interval 54.9 to 90.6

SECONDARY outcome

Timeframe: Week 3

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
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=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
Percentage of Participants With HCV RNA < LLOQ at Week 3
90.6 percentage of participants
Interval 83.3 to 95.4
90.7 percentage of participants
Interval 83.5 to 95.4
96.0 percentage of participants
Interval 79.6 to 99.9

SECONDARY outcome

Timeframe: Week 4

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
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=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
Percentage of Participants With HCV RNA < LLOQ at Week 4
98.1 percentage of participants
Interval 93.4 to 99.8
96.3 percentage of participants
Interval 90.7 to 99.0
100.0 percentage of participants
Interval 86.3 to 100.0

SECONDARY outcome

Timeframe: Week 5

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
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
Percentage of Participants With HCV RNA < LLOQ at Week 5
98.1 percentage of participants
Interval 93.3 to 99.8
99.1 percentage of participants
Interval 94.9 to 100.0
100.0 percentage of participants
Interval 86.3 to 100.0

SECONDARY outcome

Timeframe: Week 6

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
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
Percentage of Participants With HCV RNA < LLOQ at Week 6
99.0 percentage of participants
Interval 94.8 to 100.0
99.1 percentage of participants
Interval 94.9 to 100.0
100.0 percentage of participants
Interval 86.3 to 100.0

SECONDARY outcome

Timeframe: Week 8

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
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
Percentage of Participants With HCV RNA < LLOQ at Week 8
100.0 percentage of participants
Interval 96.5 to 100.0
100.0 percentage of participants
Interval 96.6 to 100.0
100.0 percentage of participants
Interval 86.3 to 100.0

SECONDARY outcome

Timeframe: Week 10

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
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
Percentage of Participants With HCV RNA < LLOQ at Week 10
100.0 percentage of participants
Interval 96.5 to 100.0
100.0 percentage of participants
Interval 96.6 to 100.0
100.0 percentage of participants
Interval 86.3 to 100.0

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
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
Percentage of Participants With HCV RNA < LLOQ at Week 12
100.0 percentage of participants
Interval 96.5 to 100.0
100.0 percentage of participants
Interval 96.6 to 100.0
100.0 percentage of participants
Interval 86.3 to 100.0

SECONDARY outcome

Timeframe: Baseline; Week 1

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
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=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
Change From Baseline in HCV RNA at Week 1
-4.18 log10 IU/mL
Standard Deviation 0.540
-4.34 log10 IU/mL
Standard Deviation 0.602
-4.24 log10 IU/mL
Standard Deviation 0.550

SECONDARY outcome

Timeframe: Baseline; Week 2

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
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=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
Change From Baseline in HCV RNA at Week 2
-4.76 log10 IU/mL
Standard Deviation 0.759
-4.81 log10 IU/mL
Standard Deviation 0.772
-4.64 log10 IU/mL
Standard Deviation 0.719

SECONDARY outcome

Timeframe: Baseline; Week 3

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
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=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
Change From Baseline in HCV RNA at Week 3
-4.87 log10 IU/mL
Standard Deviation 0.780
-4.89 log10 IU/mL
Standard Deviation 0.790
-4.75 log10 IU/mL
Standard Deviation 0.714

SECONDARY outcome

Timeframe: Baseline; Week 4

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
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=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
Change From Baseline in HCV RNA at Week 4
-4.89 log10 IU/mL
Standard Deviation 0.782
-4.91 log10 IU/mL
Standard Deviation 0.794
-4.76 log10 IU/mL
Standard Deviation 0.719

SECONDARY outcome

Timeframe: Baseline; Week 5

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
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
Change From Baseline in HCV RNA at Week 5
-4.91 log10 IU/mL
Standard Deviation 0.781
-4.92 log10 IU/mL
Standard Deviation 0.794
-4.76 log10 IU/mL
Standard Deviation 0.719

SECONDARY outcome

Timeframe: Baseline; Week 6

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
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
Change From Baseline in HCV RNA at Week 6
-4.91 log10 IU/mL
Standard Deviation 0.781
-4.92 log10 IU/mL
Standard Deviation 0.793
-4.76 log10 IU/mL
Standard Deviation 0.719

SECONDARY outcome

Timeframe: Baseline; Week 8

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
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
Change From Baseline in HCV RNA at Week 8
-4.92 log10 IU/mL
Standard Deviation 0.785
-4.93 log10 IU/mL
Standard Deviation 0.794
-4.76 log10 IU/mL
Standard Deviation 0.719

SECONDARY outcome

Timeframe: Baseline; Week 10

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
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
Change From Baseline in HCV RNA at Week 10
-4.92 log10 IU/mL
Standard Deviation 0.785
-4.93 log10 IU/mL
Standard Deviation 0.794
-4.76 log10 IU/mL
Standard Deviation 0.719

SECONDARY outcome

Timeframe: Baseline; Week 12

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure
LDV/SOF (Cohort 1)
n=105 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
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
Change From Baseline in HCV RNA at Week 12
-4.92 log10 IU/mL
Standard Deviation 0.785
-4.92 log10 IU/mL
Standard Deviation 0.794
-4.76 log10 IU/mL
Standard Deviation 0.719

SECONDARY outcome

Timeframe: Up to Posttreatment Week 24

Population: 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

Outcome measures
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
Percentage of Participants With Overall Virologic Failure
2.8 percentage of participants
3.7 percentage of participants
4.0 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

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

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)

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