Trial Outcomes & Findings for Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection (NCT NCT01768286)
NCT ID: NCT01768286
Last Updated: 2018-11-16
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
441 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at a total of 64 study sites in the United States. The first participant was screened on 03 January 2013. The last participant observation occurred on 20 February 2014.
551 participants were screened.
Participant milestones
| Measure |
LDV/SOF 12 Weeks
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
109
|
111
|
110
|
111
|
|
Overall Study
COMPLETED
|
102
|
107
|
108
|
110
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
2
|
1
|
Reasons for withdrawal
| Measure |
LDV/SOF 12 Weeks
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Overall Study
Randomized But Not Treated
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
7
|
4
|
0
|
1
|
|
Overall Study
Withdrew Consent
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
Baseline characteristics by cohort
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
Total
n=440 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
57 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
56 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
55 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
56 years
STANDARD_DEVIATION 7.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
153 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
287 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
24 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
20 participants
n=4 Participants
|
77 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
84 participants
n=5 Participants
|
94 participants
n=7 Participants
|
91 participants
n=5 Participants
|
89 participants
n=4 Participants
|
358 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hawaiian or Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
7 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
41 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
100 participants
n=5 Participants
|
99 participants
n=7 Participants
|
98 participants
n=5 Participants
|
99 participants
n=4 Participants
|
396 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
HCV RNA
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.44 • n=5 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.54 • n=7 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.57 • n=5 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.60 • n=4 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.54 • n=21 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
6 participants
n=5 Participants
|
13 participants
n=7 Participants
|
16 participants
n=5 Participants
|
15 participants
n=4 Participants
|
50 participants
n=21 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
103 participants
n=5 Participants
|
98 participants
n=7 Participants
|
93 participants
n=5 Participants
|
96 participants
n=4 Participants
|
390 participants
n=21 Participants
|
|
HCV Genotype
Genotype 1a
|
86 participants
n=5 Participants
|
88 participants
n=7 Participants
|
85 participants
n=5 Participants
|
88 participants
n=4 Participants
|
347 participants
n=21 Participants
|
|
HCV Genotype
Genotype 1b
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
24 participants
n=5 Participants
|
23 participants
n=4 Participants
|
93 participants
n=21 Participants
|
|
IL28b Status
CC
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
16 participants
n=5 Participants
|
18 participants
n=4 Participants
|
55 participants
n=21 Participants
|
|
IL28b Status
CT
|
70 participants
n=5 Participants
|
77 participants
n=7 Participants
|
68 participants
n=5 Participants
|
68 participants
n=4 Participants
|
283 participants
n=21 Participants
|
|
IL28b Status
TT
|
29 participants
n=5 Participants
|
23 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
102 participants
n=21 Participants
|
|
Prior HCV Treatment
PEG-IFN-alfa-2a or PEG-IFN-alfa-2b+RBV
|
43 participants
n=5 Participants
|
47 participants
n=7 Participants
|
58 participants
n=5 Participants
|
59 participants
n=4 Participants
|
207 participants
n=21 Participants
|
|
Prior HCV Treatment
PI+PEG-IFN-alfa-2a or PEG-IFN-alfa-2b+RBV
|
66 participants
n=5 Participants
|
64 participants
n=7 Participants
|
50 participants
n=5 Participants
|
51 participants
n=4 Participants
|
231 participants
n=21 Participants
|
|
Prior HCV Treatment
IFN-alfa-2b+RBV
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who were randomized and received at least one dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
93.6 percentage of participants
|
96.4 percentage of participants
|
99.1 percentage of participants
|
99.1 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set
The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
93.6 percentage of participants
|
96.4 percentage of participants
|
99.1 percentage of participants
|
99.1 percentage of participants
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
94.5 percentage of participants
|
96.4 percentage of participants
|
100.0 percentage of participants
|
99.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 1Population: Full Analysis Set
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 1
|
26.6 percentage of participants
|
33.3 percentage of participants
|
20.2 percentage of participants
|
29.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2Population: Full Analysis Set
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 2
|
81.7 percentage of participants
|
82.9 percentage of participants
|
81.7 percentage of participants
|
83.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: Full Analysis Set
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 4
|
100.0 percentage of participants
|
99.1 percentage of participants
|
99.1 percentage of participants
|
99.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=110 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 8
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=110 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 12
|
99.1 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set with available data were analyzed. Participants in the LDV/SOF 12 Weeks and LDV/SOF+RBV 12 Weeks groups did not continue treatment past Week 12 and are not included in the analysis.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=107 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=110 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 24
|
—
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 1Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=108 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=110 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 1
|
-4.57 log10 IU/mL
Standard Deviation 0.501
|
-4.50 log10 IU/mL
Standard Deviation 0.540
|
-4.47 log10 IU/mL
Standard Deviation 0.569
|
-4.50 log10 IU/mL
Standard Deviation 0.575
|
SECONDARY outcome
Timeframe: Baseline; Week 2Population: Full Analysis Set
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 2
|
-5.08 log10 IU/mL
Standard Deviation 0.443
|
-4.94 log10 IU/mL
Standard Deviation 0.520
|
-4.99 log10 IU/mL
Standard Deviation 0.571
|
-4.99 log10 IU/mL
Standard Deviation 0.617
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Full Analysis Set
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 4
|
-5.16 log10 IU/mL
Standard Deviation 0.439
|
-5.02 log10 IU/mL
Standard Deviation 0.543
|
-5.06 log10 IU/mL
Standard Deviation 0.571
|
-5.04 log10 IU/mL
Standard Deviation 0.779
|
SECONDARY outcome
Timeframe: Baseline; Week 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=110 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 8
|
-5.16 log10 IU/mL
Standard Deviation 0.439
|
-5.02 log10 IU/mL
Standard Deviation 0.544
|
-5.06 log10 IU/mL
Standard Deviation 0.571
|
-5.08 log10 IU/mL
Standard Deviation 0.605
|
SECONDARY outcome
Timeframe: Baseline to posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as on-treatment virologic failure or virologic relapse. * On-Treatment Virologic Failure was defined as * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=111 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure
On-Treatment Virologic Failure
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Virologic Failure
Virologic relapse
|
6.5 percentage of participants
|
3.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
LDV/SOF 12 Weeks
Serious events: 0 serious events
Other events: 73 other events
Deaths: 0 deaths
LDV/SOF+RBV 12 Weeks
Serious events: 0 serious events
Other events: 96 other events
Deaths: 0 deaths
LDV/SOF 24 Weeks
Serious events: 6 serious events
Other events: 87 other events
Deaths: 0 deaths
LDV/SOF+RBV 24 Weeks
Serious events: 3 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF 12 Weeks
n=109 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=111 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.90%
1/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Wound infection
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.90%
1/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Convulsion
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.90%
1/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
LDV/SOF 12 Weeks
n=109 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=111 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks
n=109 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=111 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.1%
9/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.8%
12/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
11.9%
13/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
18.0%
20/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.4%
7/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
22.5%
25/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
7/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.5%
5/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.3%
9/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
15.3%
17/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
1.8%
2/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.6%
4/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.5%
6/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.7%
3/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
2/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.7%
3/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.1%
9/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
6/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.8%
2/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.5%
5/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
21.1%
23/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
40.5%
45/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
23.9%
26/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
45.0%
50/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Irritability
|
1.8%
2/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.7%
13/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.7%
4/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.8%
12/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
4/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.4%
6/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.4%
7/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.9%
11/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
1.8%
2/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.7%
3/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.7%
4/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.2%
8/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
3/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.5%
5/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.8%
3/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.4%
6/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Sinusitis
|
0.92%
1/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.4%
6/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.8%
3/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.3%
7/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
7/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.7%
13/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.4%
7/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
15.3%
17/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.6%
5/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.4%
6/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.3%
8/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.0%
10/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.92%
1/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.2%
8/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.8%
2/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.8%
12/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
3/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.7%
3/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.7%
4/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.0%
10/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
25.7%
28/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
23.4%
26/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
22.9%
25/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
31.5%
35/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
2.8%
3/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.2%
8/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.4%
7/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.8%
12/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
9.2%
10/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.2%
18/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.7%
4/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
17.1%
19/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
1.8%
2/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.3%
7/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.7%
4/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.7%
3/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
5/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
14.4%
16/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.6%
5/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
14.4%
16/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
14.4%
16/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.8%
3/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.1%
9/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.5%
6/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.7%
3/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.92%
1/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.7%
3/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.5%
5/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.4%
6/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.92%
1/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.7%
3/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.4%
6/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
2/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.9%
11/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.5%
6/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
14.4%
16/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.6%
5/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.0%
10/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.8%
2/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.0%
10/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.7%
3/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.8%
3/109 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.9%
11/111 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Additional Information
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