Trial Outcomes & Findings for Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders (NCT NCT02120300)
NCT ID: NCT02120300
Last Updated: 2016-12-06
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2016-12-06
Participant Flow
Participants were enrolled at study sites in the United States. The first participant was screened on 10 April 2014. The last study visit occurred on 17 August 2015.
147 participants were screened.
Participant milestones
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
101
|
5
|
10
|
6
|
|
Overall Study
COMPLETED
|
98
|
5
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Overall Study
Enrolled but Never Treated
|
2
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
Baseline characteristics by cohort
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
n=99 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
n=10 Participants
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
49 Years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
48 Years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
47 Years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
45 Years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
115 Participants
n=21 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
|
|
Race/Ethnicity, Customized
Black or African American
|
18 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
75 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
5 participants
n=4 Participants
|
92 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Cirrhosis Status
No
|
71 participants
n=5 Participants
|
0 participants
n=7 Participants
|
8 participants
n=5 Participants
|
4 participants
n=4 Participants
|
83 participants
n=21 Participants
|
|
Cirrhosis Status
Yes
|
28 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
37 participants
n=21 Participants
|
|
HCV Genotype
Genotype 1
|
98 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
103 participants
n=21 Participants
|
|
HCV Genotype
Genotype 2
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
10 participants
n=5 Participants
|
0 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
HCV Genotype
Genotype 3
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
HCV Genotype
Genotype 4
|
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
|
|
HCV RNA
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.67 • n=5 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.85 • n=7 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 1.00 • n=5 Participants
|
6.6 log10 IU/mL
STANDARD_DEVIATION 0.80 • n=4 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.71 • n=21 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
23 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
28 participants
n=21 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
76 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
5 participants
n=4 Participants
|
92 participants
n=21 Participants
|
|
IL28b Status
CC
|
22 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
5 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
IL28b Status
CT
|
60 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
65 participants
n=21 Participants
|
|
IL28b Status
TT
|
17 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
HIV Status
Negative
|
80 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
94 participants
n=21 Participants
|
|
HIV Status
Positive
|
19 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
26 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants enrolled into the study and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
n=99 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
n=10 Participants
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
99.0 percentage of participants
Interval 94.5 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
n=99 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
n=10 Participants
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Full Analysis Set
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Outcome measures
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
n=99 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
n=10 Participants
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
|
99.0 percentage of participants
Interval 94.5 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
100.0 percentage of participants
Interval 69.2 to 100.0
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
n=99 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
n=10 Participants
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 1
|
28.3 percentage of participants
|
20.0 percentage of participants
|
20.0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 2
|
68.7 percentage of participants
|
40.0 percentage of participants
|
70.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 4
|
94.9 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 8
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 12
|
99.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 16
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
100.0 percentage of participants
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 20
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
100.0 percentage of participants
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 24
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
100.0 percentage of participants
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16, 20, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
n=99 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
n=10 Participants
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 12 (LDV/SOF 12 Weeks: n= 98)
|
-5.06 log10 IU/mL
Standard Deviation 0.675
|
-4.87 log10 IU/mL
Standard Deviation 0.847
|
-5.05 log10 IU/mL
Standard Deviation 1.002
|
-5.45 log10 IU/mL
Standard Deviation 0.803
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 16
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was only 12 weeks.
|
-4.87 log10 IU/mL
Standard Deviation 0.847
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was only 12 weeks.
|
-5.45 log10 IU/mL
Standard Deviation 0.803
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Baseline
|
6.21 log10 IU/mL
Standard Deviation 0.673
|
6.02 log10 IU/mL
Standard Deviation 0.847
|
6.20 log10 IU/mL
Standard Deviation 1.002
|
6.6 log10 IU/mL
Standard Deviation 0.803
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 1 (LDV/SOF 12 Weeks: n= 98)
|
-4.41 log10 IU/mL
Standard Deviation 0.580
|
-4.32 log10 IU/mL
Standard Deviation 0.815
|
-4.39 log10 IU/mL
Standard Deviation 0.633
|
-3.95 log10 IU/mL
Standard Deviation 0.473
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 2 (LDV/SOF 24 Week: n=4)
|
-4.87 log10 IU/mL
Standard Deviation 0.642
|
-4.65 log10 IU/mL
Standard Deviation 0.967
|
-5.01 log10 IU/mL
Standard Deviation 0.965
|
-4.76 log10 IU/mL
Standard Deviation 0.797
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 4
|
-5.05 log10 IU/mL
Standard Deviation 0.662
|
-4.87 log10 IU/mL
Standard Deviation 0.847
|
-5.05 log10 IU/mL
Standard Deviation 1.002
|
-5.26 log10 IU/mL
Standard Deviation 0.786
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 8
|
-5.06 log10 IU/mL
Standard Deviation 0.673
|
-4.87 log10 IU/mL
Standard Deviation 0.847
|
-5.05 log10 IU/mL
Standard Deviation 1.002
|
-5.45 log10 IU/mL
Standard Deviation 0.803
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 20
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was only 12 weeks.
|
-4.87 log10 IU/mL
Standard Deviation 0.847
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was only 12 weeks.
|
-5.45 log10 IU/mL
Standard Deviation 0.803
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 24
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was only 12 weeks.
|
-4.87 log10 IU/mL
Standard Deviation 0.847
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was only 12 weeks.
|
-5.45 log10 IU/mL
Standard Deviation 0.803
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
n=99 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
n=5 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
n=10 Participants
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: Only the participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
n=19 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
n=4 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
n=3 Participants
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)
Week 4
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
|
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)
Week 8
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
|
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)
Week 12
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
|
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)
Week 16
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
100 percentage of participants
|
—
|
|
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)
Week 20
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
100 percentage of participants
|
—
|
|
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)
Week 24
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
66.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline; Weeks 12, 24, and Posttreatment Week 12Population: Participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
n=19 Participants
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
n=4 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
n=3 Participants
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)
Baseline
|
0.94 mg/dL
Standard Deviation 0.197
|
1.01 mg/dL
Standard Deviation 0.118
|
0.94 mg/dL
Standard Deviation 0.086
|
—
|
|
Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)
Week 12
|
0.04 mg/dL
Standard Deviation 0.079
|
-0.03 mg/dL
Standard Deviation 0.095
|
-0.03 mg/dL
Standard Deviation 0.093
|
—
|
|
Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)
Week 24
|
NA mg/dL
Standard Deviation NA
Treatment for this group was only 12 weeks.
|
NA mg/dL
Standard Deviation NA
Treatment for this group was only 12 weeks.
|
-0.08 mg/dL
Standard Deviation 0.069
|
—
|
|
Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)
Posttreatment Week12
|
-0.01 mg/dL
Standard Deviation 0.113
|
-0.08 mg/dL
Standard Deviation 0.015
|
-0.02 mg/dL
Standard Deviation 0.081
|
—
|
Adverse Events
LDV/SOF 12 Weeks GT1 or GT4
Serious events: 5 serious events
Other events: 54 other events
Deaths: 0 deaths
LDV/SOF 24 Weeks GT1 (TE)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SOF+RBV 12 Weeks GT2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SOF+RBV 24 Weeks GT3
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
n=99 participants at risk
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
n=5 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
n=10 participants at risk
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
n=6 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
2.0%
2/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Suicidal ideation
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Social circumstances
Miscarriage of partner
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Haematoma
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
LDV/SOF 12 Weeks GT1 or GT4
n=99 participants at risk
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
|
LDV/SOF 24 Weeks GT1 (TE)
n=5 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced \[TE\] participants with genotype 1 HCV infection and cirrhosis)
|
SOF+RBV 12 Weeks GT2
n=10 participants at risk
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
|
SOF+RBV 24 Weeks GT3
n=6 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
40.0%
2/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
7/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
50.0%
3/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
2/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.0%
1/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
8.1%
8/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Chills
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
29.3%
29/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.0%
1/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
30.0%
3/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
33.3%
2/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Influenza like illness
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.0%
1/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Folliculitis
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Influenza
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.0%
1/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
2/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
3/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
8.1%
8/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
5.1%
5/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
3/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Osteorrhagia
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Disturbance in attention
|
6.1%
6/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
14.1%
14/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
30.0%
3/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
5.1%
5/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
6.1%
6/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
50.0%
3/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
2.0%
2/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
2/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
33.3%
2/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
1/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.7%
1/6 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/99 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.0%
1/5 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/10 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/6 • 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