Trial Outcomes & Findings for Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies (NCT NCT02600351)
NCT ID: NCT02600351
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
TERMINATED
Study phase
PHASE3
Target enrollment
87 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at study sites in the United States (including a site in Puerto Rico), and Canada. The first participant was screened on 11 November 2015. The last study visit occurred on 29 May 2017.
120 participants were screened.
Participant milestones
| Measure |
LDV/SOF 12 Weeks, Without Cirrhosis
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, Without Cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis
LDV/SOF (90 mg/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
|
LDV/SOF 24 Weeks, With Compensated Cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
26
|
27
|
|
Overall Study
COMPLETED
|
12
|
17
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
6
|
5
|
Reasons for withdrawal
| Measure |
LDV/SOF 12 Weeks, Without Cirrhosis
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, Without Cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis
LDV/SOF (90 mg/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
|
LDV/SOF 24 Weeks, With Compensated Cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Randomized but Not Treated
|
1
|
0
|
1
|
3
|
Baseline Characteristics
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
Baseline characteristics by cohort
| Measure |
LDV/SOF 12 Weeks, Without Cirrhosis
n=16 Participants
LDV/SOF (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, Without Cirrhosis
n=17 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis
n=25 Participants
LDV/SOF FDC (90 mg/400 mg) tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
|
LDV/SOF 24 Weeks, With Compensated Cirrhosis
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
57 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
58 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
60 years
STANDARD_DEVIATION 4.5 • n=4 Participants
|
59 years
STANDARD_DEVIATION 6.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
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
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
20 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
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
23 participants
n=5 Participants
|
16 participants
n=4 Participants
|
67 participants
n=21 Participants
|
|
IL28b Status
CC
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
IL28b Status
CT
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
IL28b Status
TT
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
HCV RNA
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.45 • n=5 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.48 • n=7 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.59 • n=5 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.89 • n=4 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.67 • n=21 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set by Actual Treatment: participants were grouped according to their cirrhotic status and the treatment/duration they actually received.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
LDV/SOF 12 Weeks, Without Cirrhosis
n=16 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, Without Cirrhosis
n=17 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
|
LDV/SOF 24 Weeks, With Compensated Cirrhosis
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Cessation of Therapy (SVR12)
|
81.3 percentage of participants
Interval 54.4 to 96.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
80.0 percentage of participants
Interval 59.3 to 93.2
|
91.7 percentage of participants
Interval 73.0 to 99.0
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
LDV/SOF 12 Weeks, Without Cirrhosis
n=16 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, Without Cirrhosis
n=17 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
|
LDV/SOF 24 Weeks, With Compensated Cirrhosis
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants Who Discontinued From Study Treatment for an Adverse Event
|
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 by Actual Treatment
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, Without Cirrhosis
n=16 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, Without Cirrhosis
n=17 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
|
LDV/SOF 24 Weeks, With Compensated Cirrhosis
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < the Lower Limit of Quantitation (LLOQ) at 4 and 24 Weeks Posttreatment
SVR4
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
88.0 percentage of participants
Interval 68.8 to 97.5
|
95.8 percentage of participants
Interval 78.9 to 99.9
|
|
Percentage of Participants With HCV RNA < the Lower Limit of Quantitation (LLOQ) at 4 and 24 Weeks Posttreatment
SVR24
|
81.3 percentage of participants
Interval 54.4 to 96.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
80.0 percentage of participants
Interval 59.3 to 93.2
|
91.7 percentage of participants
Interval 73.0 to 99.0
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Full Analysis Set by Actual Treatment
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment.
Outcome measures
| Measure |
LDV/SOF 12 Weeks, Without Cirrhosis
n=16 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, Without Cirrhosis
n=17 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
|
LDV/SOF 24 Weeks, With Compensated Cirrhosis
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With Viral Breakthrough
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set by Actual Treatment
Viral 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, Without Cirrhosis
n=16 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, Without Cirrhosis
n=17 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
|
LDV/SOF 24 Weeks, With Compensated Cirrhosis
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
|
|---|---|---|---|---|
|
Percentage of Participants With Viral Relapse
|
18.8 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set by Actual Treatment who have pre-existing NS5B, NS5A, and NS3/4A resistance-associated variants (RAVs) at baseline and who experienced virologic failure were analyzed. There were no participants with pre-existing RAVs who experienced virologic failure in the LDV/SOF+RBV 12 weeks, without cirrhosis group.
The full-length NS3, NS5A, and NS5B coding regions were deep sequenced at pretreatment (baseline) for all participants included in the Full Analysis Set, and at posttreatment for all participants who relapsed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks, Without Cirrhosis
n=3 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, Without Cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
|
LDV/SOF 24 Weeks, With Compensated Cirrhosis
n=2 Participants
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
|
|---|---|---|---|---|
|
Number of Participants With Emerging Resistance
|
3 Participants
|
—
|
5 Participants
|
2 Participants
|
Adverse Events
LDV/SOF 12 Weeks, Without Cirrhosis
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
LDV/SOF + RBV 12 Weeks, Without Cirrhosis
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
LDV/SOF 24 Weeks, With Compensated Cirrhosis
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF 12 Weeks, Without Cirrhosis
n=16 participants at risk
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, Without Cirrhosis
n=17 participants at risk
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis
n=25 participants at risk
LDV/SOF FDC (90 mg/400 mg) tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
|
LDV/SOF 24 Weeks, With Compensated Cirrhosis
n=24 participants at risk
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
LDV/SOF 12 Weeks, Without Cirrhosis
n=16 participants at risk
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, Without Cirrhosis
n=17 participants at risk
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
|
LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis
n=25 participants at risk
LDV/SOF FDC (90 mg/400 mg) tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
|
LDV/SOF 24 Weeks, With Compensated Cirrhosis
n=24 participants at risk
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
|
|---|---|---|---|---|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
29.4%
5/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.0%
3/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
3/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.3%
2/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
17.6%
3/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.8%
2/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.0%
5/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.3%
2/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Eye disorders
Dry eye
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.3%
2/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.3%
2/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.8%
2/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.0%
3/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
3/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Chills
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.8%
2/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.3%
2/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
12.5%
2/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
35.3%
6/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
28.0%
7/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
4/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Candida infection
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Hordeolum
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.8%
2/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Gout
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.0%
4/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.2%
1/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.0%
1/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
1/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.0%
2/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
31.2%
5/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.8%
2/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
36.0%
9/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
29.2%
7/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.8%
2/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Migraine
|
6.2%
1/16 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/17 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/25 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/24 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER