Trial Outcomes & Findings for Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects (NCT NCT01726517)
NCT ID: NCT01726517
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 after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at 1 study site in the United States. The first participant was screened on 22 October 2012. The last participant observation was on 13 January 2014.
116 participants were screened.
Participant milestones
| Measure |
LDV/SOF 8 Weeks (TN)
Treatment-naive (TN) participants were randomized to receive ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg for 8 weeks.
|
LDV/SOF+RBV 8 Weeks (TN)
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based ribavirin (RBV) (1000-1200 mg) for 8 weeks.
|
LDV/SOF 12 Weeks (TN)
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF 12 Weeks (TE)
Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor \[PI\]+pegylated interferon \[PEG\]+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF+RBV 12 Weeks (TE)
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
19
|
19
|
21
|
|
Overall Study
COMPLETED
|
20
|
21
|
18
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
LDV/SOF 8 Weeks (TN)
Treatment-naive (TN) participants were randomized to receive ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg for 8 weeks.
|
LDV/SOF+RBV 8 Weeks (TN)
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based ribavirin (RBV) (1000-1200 mg) for 8 weeks.
|
LDV/SOF 12 Weeks (TN)
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF 12 Weeks (TE)
Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor \[PI\]+pegylated interferon \[PEG\]+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF+RBV 12 Weeks (TE)
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
Baseline characteristics by cohort
| Measure |
LDV/SOF 8 Weeks (TN)
n=20 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
|
LDV/SOF+RBV 8 Weeks (TN)
n=21 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
|
LDV/SOF 12 Weeks (TN)
n=19 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF 12 Weeks (TE)
n=19 Participants
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF+RBV 12 Weeks (TE)
n=21 Participants
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
50 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
46 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
54 years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
52 years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
50 years
STANDARD_DEVIATION 10.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
66 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
60 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
88 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Hepatitis C Virus (HCV) Genotype
1a
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
17 participants
n=5 Participants
|
18 participants
n=4 Participants
|
16 participants
n=21 Participants
|
87 participants
n=8 Participants
|
|
Hepatitis C Virus (HCV) Genotype
1b
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
13 participants
n=8 Participants
|
|
IL28b Status
CC
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
15 participants
n=8 Participants
|
|
IL28b Status
CT
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
14 participants
n=5 Participants
|
13 participants
n=4 Participants
|
11 participants
n=21 Participants
|
61 participants
n=8 Participants
|
|
IL28b Status
TT
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
9 participants
n=21 Participants
|
24 participants
n=8 Participants
|
|
HCV RNA (log10 IU/mL)
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.82 • n=5 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.84 • n=7 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.79 • n=5 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.49 • n=4 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.42 • n=21 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.69 • n=8 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
4 participants
n=4 Participants
|
5 participants
n=21 Participants
|
32 participants
n=8 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
12 participants
n=5 Participants
|
15 participants
n=4 Participants
|
16 participants
n=21 Participants
|
68 participants
n=8 Participants
|
|
Prior HCV Treatment and Response
Non-responder to PI boceprevir
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
18 participants
n=8 Participants
|
|
Prior HCV Treatment and Response
Relapse/Breakthrough to PI boceprevir
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
4 participants
n=8 Participants
|
|
Prior HCV Treatment and Response
Non-responder to PI telaprevir
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
9 participants
n=8 Participants
|
|
Prior HCV Treatment and Response
Relapse/Breakthrough to PI telaprevir
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
4 participants
n=21 Participants
|
9 participants
n=8 Participants
|
|
Cirrhosis
No
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
19 participants
n=5 Participants
|
8 participants
n=4 Participants
|
10 participants
n=21 Participants
|
78 participants
n=8 Participants
|
|
Cirrhosis
Yes
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
11 participants
n=4 Participants
|
11 participants
n=21 Participants
|
22 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants were randomized and received at least 1 dose of study drug
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.
Outcome measures
| Measure |
LDV/SOF 8 Weeks (TN)
n=20 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
|
LDV/SOF+RBV 8 Weeks (TN)
n=21 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
|
LDV/SOF 12 Weeks (TN)
n=19 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF 12 Weeks (TE)
n=19 Participants
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF+RBV 12 Weeks (TE)
n=21 Participants
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
|
95.0 percentage of participants
|
100.0 percentage of participants
|
94.7 percentage of participants
|
94.7 percentage of participants
|
100.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Safety Analysis Set
The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.
Outcome measures
| Measure |
LDV/SOF 8 Weeks (TN)
n=20 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
|
LDV/SOF+RBV 8 Weeks (TN)
n=21 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
|
LDV/SOF 12 Weeks (TN)
n=19 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF 12 Weeks (TE)
n=19 Participants
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF+RBV 12 Weeks (TE)
n=21 Participants
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
|
|---|---|---|---|---|---|
|
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 2, 4, 8, and 24Population: Full Analysis Set
SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA \< LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.
Outcome measures
| Measure |
LDV/SOF 8 Weeks (TN)
n=20 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
|
LDV/SOF+RBV 8 Weeks (TN)
n=21 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
|
LDV/SOF 12 Weeks (TN)
n=19 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF 12 Weeks (TE)
n=19 Participants
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF+RBV 12 Weeks (TE)
n=21 Participants
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)
SVR2
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
94.7 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)
SVR4
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
94.7 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)
SVR8
|
95.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
94.7 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)
SVR24
|
95.0 percentage of participants
|
100.0 percentage of participants
|
94.7 percentage of participants
|
94.7 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment Week 24* Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values. * Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
Outcome measures
| Measure |
LDV/SOF 8 Weeks (TN)
n=20 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
|
LDV/SOF+RBV 8 Weeks (TN)
n=21 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
|
LDV/SOF 12 Weeks (TN)
n=19 Participants
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF 12 Weeks (TE)
n=19 Participants
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF+RBV 12 Weeks (TE)
n=21 Participants
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Viral breakthrough
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Viral relapse
|
5.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.3 percentage of participants
|
0 percentage of participants
|
Adverse Events
LDV/SOF 8 Weeks (TN)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
LDV/SOF+RBV 8 Weeks (TN)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
LDV/SOF 12 Weeks (TN)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
LDV/SOF 12 Weeks (TE)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
LDV/SOF+RBV 12 Weeks (TE)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF 8 Weeks (TN)
n=20 participants at risk
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
|
LDV/SOF+RBV 8 Weeks (TN)
n=21 participants at risk
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
|
LDV/SOF 12 Weeks (TN)
n=19 participants at risk
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF 12 Weeks (TE)
n=19 participants at risk
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF+RBV 12 Weeks (TE)
n=21 participants at risk
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
4.8%
1/21 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Psychiatric disorders
Delirium
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
4.8%
1/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
4.8%
1/21 • Baseline to Week 12 plus 30 days
|
Other adverse events
| Measure |
LDV/SOF 8 Weeks (TN)
n=20 participants at risk
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
|
LDV/SOF+RBV 8 Weeks (TN)
n=21 participants at risk
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
|
LDV/SOF 12 Weeks (TN)
n=19 participants at risk
Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF 12 Weeks (TE)
n=19 participants at risk
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
|
LDV/SOF+RBV 12 Weeks (TE)
n=21 participants at risk
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
9.5%
2/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
28.6%
6/21 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Baseline to Week 12 plus 30 days
|
9.5%
2/21 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
19.0%
4/21 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Baseline to Week 12 plus 30 days
|
4.8%
1/21 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
4.8%
1/21 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
2/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
9.5%
2/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
5.0%
1/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
General disorders
Fatigue
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
4.8%
1/21 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
2/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
19.0%
4/21 • Baseline to Week 12 plus 30 days
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • Baseline to Week 12 plus 30 days
|
4.8%
1/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
4.8%
1/21 • Baseline to Week 12 plus 30 days
|
|
Infections and infestations
Influenza
|
10.0%
2/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
9.5%
2/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Investigations
Blood pressure increased
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
9.5%
2/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Baseline to Week 12 plus 30 days
|
4.8%
1/21 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
1/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
9.5%
2/21 • Baseline to Week 12 plus 30 days
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Baseline to Week 12 plus 30 days
|
14.3%
3/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
4.8%
1/21 • Baseline to Week 12 plus 30 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
9.5%
2/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
9.5%
2/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
1/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
9.5%
2/21 • Baseline to Week 12 plus 30 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
0.00%
0/19 • Baseline to Week 12 plus 30 days
|
5.3%
1/19 • Baseline to Week 12 plus 30 days
|
0.00%
0/21 • Baseline to Week 12 plus 30 days
|
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