Trial Outcomes & Findings for Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults (NCT NCT01667731)
NCT ID: NCT01667731
Last Updated: 2014-11-21
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
224 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2014-11-21
Participant Flow
Participants were enrolled at a total of 34 study sites in the United States. The first participant was screened on 20 July 2012. The last participant observation occurred on 10 February 2014.
330 participants were screened.
Participant milestones
| Measure |
SOF+RBV 12 Wk GT 2 TN
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN), genotype (GT) 2)
|
SOF+RBV 12 Wk GT 3 TN
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced (TE), genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
42
|
24
|
17
|
115
|
|
Overall Study
COMPLETED
|
21
|
26
|
22
|
15
|
87
|
|
Overall Study
NOT COMPLETED
|
5
|
16
|
2
|
2
|
28
|
Reasons for withdrawal
| Measure |
SOF+RBV 12 Wk GT 2 TN
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN), genotype (GT) 2)
|
SOF+RBV 12 Wk GT 3 TN
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced (TE), genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|---|---|
|
Overall Study
Enrolled but not treated
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Efficacy Failure
|
1
|
12
|
0
|
1
|
24
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
1
|
1
|
2
|
|
Overall Study
Subject Withdrew Consent
|
2
|
0
|
1
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
Baseline characteristics by cohort
| Measure |
SOF+RBV 12 Wk GT 2 TN
n=26 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
|
SOF+RBV 12 Wk GT 3 TN
n=42 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
n=24 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
n=114 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
48 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
54 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
54 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
48 years
STANDARD_DEVIATION 8.4 • n=21 Participants
|
49 years
STANDARD_DEVIATION 8.7 • n=10 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
185 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
54 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
169 Participants
n=10 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=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
1 participants
n=4 Participants
|
37 participants
n=21 Participants
|
52 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
18 participants
n=5 Participants
|
36 participants
n=7 Participants
|
17 participants
n=5 Participants
|
15 participants
n=4 Participants
|
70 participants
n=21 Participants
|
156 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native/First Nations
|
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=10 Participants
|
|
Race/Ethnicity, Customized
Hawaiian or Other Pacific Islander
|
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
|
2 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
9 participants
n=10 Participants
|
|
HCV Genotype
Genotype 1
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
114 participants
n=21 Participants
|
114 participants
n=10 Participants
|
|
HCV Genotype
Genotype 2
|
26 participants
n=5 Participants
|
0 participants
n=7 Participants
|
24 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
50 participants
n=10 Participants
|
|
HCV Genotype
Genotype 3
|
0 participants
n=5 Participants
|
42 participants
n=7 Participants
|
0 participants
n=5 Participants
|
17 participants
n=4 Participants
|
0 participants
n=21 Participants
|
59 participants
n=10 Participants
|
|
Liver Cirrhosis
No
|
25 participants
n=5 Participants
|
36 participants
n=7 Participants
|
20 participants
n=5 Participants
|
11 participants
n=4 Participants
|
109 participants
n=21 Participants
|
201 participants
n=10 Participants
|
|
Liver Cirrhosis
Yes
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
5 participants
n=21 Participants
|
22 participants
n=10 Participants
|
|
IL28b Status
CC
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
30 participants
n=21 Participants
|
75 participants
n=10 Participants
|
|
IL28b Status
CT
|
15 participants
n=5 Participants
|
22 participants
n=7 Participants
|
10 participants
n=5 Participants
|
7 participants
n=4 Participants
|
57 participants
n=21 Participants
|
111 participants
n=10 Participants
|
|
IL28b Status
TT
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
0 participants
n=4 Participants
|
26 participants
n=21 Participants
|
36 participants
n=10 Participants
|
|
IL28b Status
Missing
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
HCV RNA (log10 IU/mL)
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.59 • n=5 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.59 • n=7 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.82 • n=5 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.47 • n=4 Participants
|
6.6 log10 IU/mL
STANDARD_DEVIATION 0.83 • n=21 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.75 • n=10 Participants
|
|
HCV RNA Category
< 6 log10 IU/mL
|
6 participants
n=5 Participants
|
15 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
22 participants
n=21 Participants
|
50 participants
n=10 Participants
|
|
HCV RNA Category
≥ 6 log10 IU/mL
|
20 participants
n=5 Participants
|
27 participants
n=7 Participants
|
19 participants
n=5 Participants
|
15 participants
n=4 Participants
|
92 participants
n=21 Participants
|
173 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who were enrolled 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) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF+RBV 12 Wk GT 2 TN
n=26 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
|
SOF+RBV 12 Wk GT 3 TN
n=42 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
n=24 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
n=114 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
|
88.5 percentage of participants
|
66.7 percentage of participants
|
91.7 percentage of participants
|
94.1 percentage of participants
|
76.3 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug
The percentage of participants discontinuing any study drug due to an adverse event was summarized.
Outcome measures
| Measure |
SOF+RBV 12 Wk GT 2 TN
n=68 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
|
SOF+RBV 12 Wk GT 3 TN
n=41 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
n=114 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|---|---|
|
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
|
4.4 percentage of participants
|
2.4 percentage of participants
|
2.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Outcome measures
| Measure |
SOF+RBV 12 Wk GT 2 TN
n=26 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
|
SOF+RBV 12 Wk GT 3 TN
n=42 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
n=24 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
n=114 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
88.5 percentage of participants
|
71.4 percentage of participants
|
95.8 percentage of participants
|
94.1 percentage of participants
|
80.7 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
88.5 percentage of participants
|
66.7 percentage of participants
|
91.7 percentage of participants
|
88.2 percentage of participants
|
75.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 1Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV 12 Wk GT 2 TN
n=25 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
|
SOF+RBV 12 Wk GT 3 TN
n=40 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
n=24 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
n=16 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
n=108 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 1
|
-4.69 log10 IU/mL
Standard Deviation 0.471
|
-4.52 log10 IU/mL
Standard Deviation 0.464
|
-4.63 log10 IU/mL
Standard Deviation 0.680
|
-4.78 log10 IU/mL
Standard Deviation 0.354
|
-4.42 log10 IU/mL
Standard Deviation 0.958
|
SECONDARY outcome
Timeframe: Baseline; Week 2Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV 12 Wk GT 2 TN
n=26 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
|
SOF+RBV 12 Wk GT 3 TN
n=41 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
n=24 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
n=112 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 2
|
-5.11 log10 IU/mL
Standard Deviation 0.574
|
-4.84 log10 IU/mL
Standard Deviation 0.579
|
-5.15 log10 IU/mL
Standard Deviation 0.813
|
-5.06 log10 IU/mL
Standard Deviation 0.467
|
-5.00 log10 IU/mL
Standard Deviation 0.829
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV 12 Wk GT 2 TN
n=26 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
|
SOF+RBV 12 Wk GT 3 TN
n=41 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
n=24 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
n=114 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 4
|
-5.04 log10 IU/mL
Standard Deviation 0.710
|
-4.86 log10 IU/mL
Standard Deviation 0.602
|
-5.16 log10 IU/mL
Standard Deviation 0.820
|
-5.06 log10 IU/mL
Standard Deviation 0.467
|
-5.12 log10 IU/mL
Standard Deviation 0.957
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV 12 Wk GT 2 TN
n=26 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
|
SOF+RBV 12 Wk GT 3 TN
n=41 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
n=24 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
n=110 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 6
|
-5.13 log10 IU/mL
Standard Deviation 0.593
|
-4.86 log10 IU/mL
Standard Deviation 0.602
|
-5.16 log10 IU/mL
Standard Deviation 0.820
|
-5.06 log10 IU/mL
Standard Deviation 0.467
|
-5.20 log10 IU/mL
Standard Deviation 0.785
|
SECONDARY outcome
Timeframe: Baseline; Week 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV 12 Wk GT 2 TN
n=26 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
|
SOF+RBV 12 Wk GT 3 TN
n=40 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
n=24 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
n=111 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 8
|
-5.13 log10 IU/mL
Standard Deviation 0.593
|
-4.83 log10 IU/mL
Standard Deviation 0.589
|
-5.16 log10 IU/mL
Standard Deviation 0.820
|
-5.06 log10 IU/mL
Standard Deviation 0.467
|
-5.20 log10 IU/mL
Standard Deviation 0.785
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Full Analysis Set
On-treatment virologic failure was defined as: 1. Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 2. Viral rebound: \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 3. Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
Outcome measures
| Measure |
SOF+RBV 12 Wk GT 2 TN
n=26 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
|
SOF+RBV 12 Wk GT 3 TN
n=42 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
n=24 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
n=114 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing On-treatment Virologic Failure
|
3.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR.
Outcome measures
| Measure |
SOF+RBV 12 Wk GT 2 TN
n=25 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
|
SOF+RBV 12 Wk GT 3 TN
n=42 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
|
SOF+RBV 24 Wk GT 2 TE
n=24 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
|
SOF+RBV 24 Wk GT 3 TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
|
SOF+RBV 24 Wk GT 1 TN
n=113 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Viral Relapse
|
0 percentage of participants
|
28.6 percentage of participants
|
4.2 percentage of participants
|
5.9 percentage of participants
|
22.1 percentage of participants
|
Adverse Events
SOF+RBV 12 Wk GT 2/3 TN
Serious events: 5 serious events
Other events: 57 other events
Deaths: 0 deaths
SOF+RBV 24 Wk GT 2/3 TE
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
SOF+RBV 24 Wk GT 1 TN
Serious events: 8 serious events
Other events: 106 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF+RBV 12 Wk GT 2/3 TN
n=68 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
|
SOF+RBV 24 Wk GT 2/3 TE
n=41 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
|
SOF+RBV 24 Wk GT 1 TN
n=114 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Chest pain
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Cellulitis
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.8%
2/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Pneumonia
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Incision site infection
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Septic shock
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Fracture
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Encephalopathy
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Completed suicide
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Drug abuse
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Suicide attempt
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Renal failure acute
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.8%
2/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF+RBV 12 Wk GT 2/3 TN
n=68 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
|
SOF+RBV 24 Wk GT 2/3 TE
n=41 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
|
SOF+RBV 24 Wk GT 1 TN
n=114 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
|
|---|---|---|---|
|
General disorders
Irritability
|
10.3%
7/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.9%
2/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.3%
14/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Pyrexia
|
2.9%
2/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.3%
3/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.1%
7/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Anaemia
|
8.8%
6/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.3%
3/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.5%
12/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
17.6%
12/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
14.6%
6/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
15.8%
18/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
6/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.2%
5/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.5%
12/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
4/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.8%
4/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.6%
11/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.9%
2/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.3%
6/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.3%
6/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.9%
2/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.3%
3/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.8%
2/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.3%
6/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
35.3%
24/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
46.3%
19/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
36.0%
41/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
11.8%
8/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.2%
5/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.4%
13/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.8%
4/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.6%
11/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
3/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.8%
10/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Oral herpes
|
2.9%
2/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.3%
3/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.4%
5/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Herpes simplex
|
5.9%
4/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.4%
3/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.9%
2/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.1%
7/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.9%
2/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.3%
6/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.1%
7/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
13.2%
9/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.2%
5/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
14.0%
16/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.8%
4/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.1%
7/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
20.6%
14/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
19.5%
8/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
13.2%
15/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
8.8%
6/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.0%
8/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
2.9%
2/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.0%
8/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
4/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.8%
4/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.3%
14/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.9%
2/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.9%
9/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.9%
2/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.0%
8/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.3%
3/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.5%
1/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.3%
3/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.4%
3/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.8%
4/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.1%
7/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.8%
6/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.9%
2/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.3%
6/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
2/68 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.3%
6/114 • 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