Trial Outcomes & Findings for A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults (NCT NCT01783678)
NCT ID: NCT01783678
Last Updated: 2015-04-30
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
275 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2015-04-30
Participant Flow
Participants were enrolled at a total of 39 study sites in Australia and Europe. The first participant was screened on 18 January 2013. The last study visit occurred on 10 July 2014.
346 participants were screened.
Participant milestones
| Measure |
Genotype 2 Treatment-naive
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 1 Treatment-naive
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
|
Genotype 2 Treatment-experienced
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 3 Treatment-naive
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 3 Treatment-experienced
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 4 Treatment-naive
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
112
|
6
|
58
|
49
|
31
|
|
Overall Study
COMPLETED
|
17
|
94
|
5
|
50
|
42
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
18
|
1
|
8
|
7
|
5
|
Reasons for withdrawal
| Measure |
Genotype 2 Treatment-naive
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 1 Treatment-naive
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
|
Genotype 2 Treatment-experienced
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 3 Treatment-naive
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 3 Treatment-experienced
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 4 Treatment-naive
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
|
|---|---|---|---|---|---|---|
|
Overall Study
Randomized but Not Treated
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
13
|
1
|
3
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
0
|
2
|
1
|
0
|
|
Overall Study
Withdrew Consent
|
1
|
1
|
0
|
2
|
0
|
0
|
Baseline Characteristics
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
Baseline characteristics by cohort
| Measure |
Genotype 2 Treatment-naive
n=19 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 1 Treatment-naive
n=112 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
|
Genotype 2 Treatment-experienced
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 3 Treatment-naive
n=57 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 3 Treatment-experienced
n=49 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 4 Treatment-naive
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
|
Total
n=274 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 8.2 • n=93 Participants
|
45 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
55 years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
47 years
STANDARD_DEVIATION 5.4 • n=483 Participants
|
49 years
STANDARD_DEVIATION 6.2 • n=36 Participants
|
47 years
STANDARD_DEVIATION 5.9 • n=10 Participants
|
47 years
STANDARD_DEVIATION 7.4 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
53 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
100 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
38 Participants
n=36 Participants
|
24 Participants
n=10 Participants
|
221 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
1 participants
n=10 Participants
|
3 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
18 participants
n=93 Participants
|
104 participants
n=4 Participants
|
5 participants
n=27 Participants
|
54 participants
n=483 Participants
|
49 participants
n=36 Participants
|
29 participants
n=10 Participants
|
259 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=93 Participants
|
5 participants
n=4 Participants
|
0 participants
n=27 Participants
|
2 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
7 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native/First Nations
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
1 participants
n=10 Participants
|
3 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 participants
n=93 Participants
|
4 participants
n=4 Participants
|
0 participants
n=27 Participants
|
3 participants
n=483 Participants
|
5 participants
n=36 Participants
|
1 participants
n=10 Participants
|
16 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
16 participants
n=93 Participants
|
106 participants
n=4 Participants
|
6 participants
n=27 Participants
|
54 participants
n=483 Participants
|
44 participants
n=36 Participants
|
29 participants
n=10 Participants
|
255 participants
n=115 Participants
|
|
Cirrhosis Status
No
|
18 participants
n=93 Participants
|
95 participants
n=4 Participants
|
4 participants
n=27 Participants
|
54 participants
n=483 Participants
|
26 participants
n=36 Participants
|
23 participants
n=10 Participants
|
220 participants
n=115 Participants
|
|
Cirrhosis Status
Yes
|
1 participants
n=93 Participants
|
17 participants
n=4 Participants
|
2 participants
n=27 Participants
|
3 participants
n=483 Participants
|
23 participants
n=36 Participants
|
8 participants
n=10 Participants
|
54 participants
n=115 Participants
|
|
IL28b Status
CC
|
12 participants
n=93 Participants
|
48 participants
n=4 Participants
|
3 participants
n=27 Participants
|
30 participants
n=483 Participants
|
25 participants
n=36 Participants
|
9 participants
n=10 Participants
|
127 participants
n=115 Participants
|
|
IL28b Status
CT
|
5 participants
n=93 Participants
|
45 participants
n=4 Participants
|
1 participants
n=27 Participants
|
21 participants
n=483 Participants
|
20 participants
n=36 Participants
|
14 participants
n=10 Participants
|
106 participants
n=115 Participants
|
|
IL28b Status
TT
|
2 participants
n=93 Participants
|
18 participants
n=4 Participants
|
2 participants
n=27 Participants
|
6 participants
n=483 Participants
|
4 participants
n=36 Participants
|
8 participants
n=10 Participants
|
40 participants
n=115 Participants
|
|
IL28b Status
Missing
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Hepatitis C Virus (HCV) RNA
|
6.7 log10 IU/mL
STANDARD_DEVIATION 0.66 • n=93 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.72 • n=4 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.62 • n=27 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.71 • n=483 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.77 • n=36 Participants
|
5.9 log10 IU/mL
STANDARD_DEVIATION 0.85 • n=10 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.75 • n=115 Participants
|
|
HCV RNA Category
< 6 log10 IU/mL
|
2 participants
n=93 Participants
|
33 participants
n=4 Participants
|
1 participants
n=27 Participants
|
21 participants
n=483 Participants
|
12 participants
n=36 Participants
|
12 participants
n=10 Participants
|
81 participants
n=115 Participants
|
|
HCV RNA Category
≥ 6 log10 IU/mL
|
17 participants
n=93 Participants
|
79 participants
n=4 Participants
|
5 participants
n=27 Participants
|
36 participants
n=483 Participants
|
37 participants
n=36 Participants
|
19 participants
n=10 Participants
|
193 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. 1 participant with genotype 1 HCV infection did not have subtype information available.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.
Outcome measures
| Measure |
Genotype 3 Treatment-naive
n=57 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 3 Treatment-experienced
n=49 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 4 Treatment-naive
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
|
Genotype 2 Treatment-naive
n=19 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 2/3 Treatment-experienced
n=112 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
|
Genotype 1/3/4 Treatment-naive
n=100 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
|
Genotype 1b Treatment-naive
n=11 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
|
Genotype 2 Treatment-experienced
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
|
91.2 percentage of participants
|
85.7 percentage of participants
|
83.9 percentage of participants
|
89.5 percentage of participants
|
84.8 percentage of participants
|
84.0 percentage of participants
|
90.9 percentage of participants
|
83.3 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Outcome measures
| Measure |
Genotype 3 Treatment-naive
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 3 Treatment-experienced
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 4 Treatment-naive
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
|
Genotype 2 Treatment-naive
n=19 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 2/3 Treatment-experienced
n=55 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
|
Genotype 1/3/4 Treatment-naive
n=200 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
|
Genotype 1b Treatment-naive
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
|
Genotype 2 Treatment-experienced
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
|
|---|---|---|---|---|---|---|---|---|
|
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
|
—
|
—
|
—
|
0 percentage of participants
|
1.8 percentage of participants
|
3.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available.
SVR4 and SVR24 were defined as HCV RNA \< the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.
Outcome measures
| Measure |
Genotype 3 Treatment-naive
n=57 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 3 Treatment-experienced
n=48 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 4 Treatment-naive
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
|
Genotype 2 Treatment-naive
n=19 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 2/3 Treatment-experienced
n=112 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
|
Genotype 1/3/4 Treatment-naive
n=100 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
|
Genotype 1b Treatment-naive
n=11 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
|
Genotype 2 Treatment-experienced
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
91.2 percentage of participants
|
87.8 percentage of participants
|
90.3 percentage of participants
|
89.5 percentage of participants
|
87.5 percentage of participants
|
87.0 percentage of participants
|
90.9 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
91.2 percentage of participants
|
83.7 percentage of participants
|
80.6 percentage of participants
|
89.5 percentage of participants
|
83.0 percentage of participants
|
82.0 percentage of participants
|
90.9 percentage of participants
|
83.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 1Population: Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.
Outcome measures
| Measure |
Genotype 3 Treatment-naive
n=54 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 3 Treatment-experienced
n=48 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 4 Treatment-naive
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
|
Genotype 2 Treatment-naive
n=19 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 2/3 Treatment-experienced
n=112 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
|
Genotype 1/3/4 Treatment-naive
n=100 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
|
Genotype 1b Treatment-naive
n=11 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
|
Genotype 2 Treatment-experienced
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
|
|---|---|---|---|---|---|---|---|---|
|
HCV RNA Change From Baseline at Week 1
|
-4.41 log10 IU/mL
Standard Deviation 0.498
|
-4.33 log10 IU/mL
Standard Deviation 0.667
|
-4.21 log10 IU/mL
Standard Deviation 0.665
|
-4.72 log10 IU/mL
Standard Deviation 0.573
|
-4.54 log10 IU/mL
Standard Deviation 0.776
|
-4.57 log10 IU/mL
Standard Deviation 0.777
|
-4.35 log10 IU/mL
Standard Deviation 0.752
|
-4.34 log10 IU/mL
Standard Deviation 0.575
|
SECONDARY outcome
Timeframe: Baseline; Week 2Population: Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.
Outcome measures
| Measure |
Genotype 3 Treatment-naive
n=55 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 3 Treatment-experienced
n=47 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 4 Treatment-naive
n=30 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
|
Genotype 2 Treatment-naive
n=19 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 2/3 Treatment-experienced
n=111 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
|
Genotype 1/3/4 Treatment-naive
n=99 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
|
Genotype 1b Treatment-naive
n=11 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
|
Genotype 2 Treatment-experienced
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
|
|---|---|---|---|---|---|---|---|---|
|
HCV RNA Change From Baseline at Week 2
|
-4.86 log10 IU/mL
Standard Deviation 0.677
|
-4.89 log10 IU/mL
Standard Deviation 0.776
|
-4.52 log10 IU/mL
Standard Deviation 0.843
|
-5.29 log10 IU/mL
Standard Deviation 0.681
|
-4.92 log10 IU/mL
Standard Deviation 0.717
|
-4.97 log10 IU/mL
Standard Deviation 0.674
|
-4.55 log10 IU/mL
Standard Deviation 0.928
|
-4.98 log10 IU/mL
Standard Deviation 0.633
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.
Outcome measures
| Measure |
Genotype 3 Treatment-naive
n=57 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 3 Treatment-experienced
n=49 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 4 Treatment-naive
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
|
Genotype 2 Treatment-naive
n=19 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 2/3 Treatment-experienced
n=109 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
|
Genotype 1/3/4 Treatment-naive
n=97 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
|
Genotype 1b Treatment-naive
n=11 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
|
Genotype 2 Treatment-experienced
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
|
|---|---|---|---|---|---|---|---|---|
|
HCV RNA Change From Baseline at Week 4
|
-4.89 log10 IU/mL
Standard Deviation 0.708
|
-4.84 log10 IU/mL
Standard Deviation 0.895
|
-4.57 log10 IU/mL
Standard Deviation 0.846
|
-5.33 log10 IU/mL
Standard Deviation 0.655
|
-4.95 log10 IU/mL
Standard Deviation 0.720
|
-5.01 log10 IU/mL
Standard Deviation 0.674
|
-4.55 log10 IU/mL
Standard Deviation 0.928
|
-5.05 log10 IU/mL
Standard Deviation 0.618
|
SECONDARY outcome
Timeframe: Baseline; Week 6Population: Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.
Outcome measures
| Measure |
Genotype 3 Treatment-naive
n=57 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 3 Treatment-experienced
n=49 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 4 Treatment-naive
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
|
Genotype 2 Treatment-naive
n=19 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 2/3 Treatment-experienced
n=109 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
|
Genotype 1/3/4 Treatment-naive
n=97 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
|
Genotype 1b Treatment-naive
n=11 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
|
Genotype 2 Treatment-experienced
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
|
|---|---|---|---|---|---|---|---|---|
|
HCV RNA Change From Baseline at Week 6
|
-4.89 log10 IU/mL
Standard Deviation 0.710
|
-4.91 log10 IU/mL
Standard Deviation 0.789
|
-4.57 log10 IU/mL
Standard Deviation 0.846
|
-5.33 log10 IU/mL
Standard Deviation 0.655
|
-4.95 log10 IU/mL
Standard Deviation 0.718
|
-5.01 log10 IU/mL
Standard Deviation 0.672
|
-4.55 log10 IU/mL
Standard Deviation 0.928
|
-5.05 log10 IU/mL
Standard Deviation 0.618
|
SECONDARY outcome
Timeframe: Baseline; Week 8Population: Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.
Outcome measures
| Measure |
Genotype 3 Treatment-naive
n=56 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 3 Treatment-experienced
n=49 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 4 Treatment-naive
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
|
Genotype 2 Treatment-naive
n=19 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 2/3 Treatment-experienced
n=109 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
|
Genotype 1/3/4 Treatment-naive
n=97 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
|
Genotype 1b Treatment-naive
n=11 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
|
Genotype 2 Treatment-experienced
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
|
|---|---|---|---|---|---|---|---|---|
|
HCV RNA Change From Baseline at Week 8
|
-4.88 log10 IU/mL
Standard Deviation 0.708
|
-4.86 log10 IU/mL
Standard Deviation 0.876
|
-4.57 log10 IU/mL
Standard Deviation 0.846
|
-5.33 log10 IU/mL
Standard Deviation 0.655
|
-4.95 log10 IU/mL
Standard Deviation 0.722
|
-5.01 log10 IU/mL
Standard Deviation 0.676
|
-4.55 log10 IU/mL
Standard Deviation 0.928
|
-5.05 log10 IU/mL
Standard Deviation 0.618
|
SECONDARY outcome
Timeframe: Baseline up to Posttreatment Week 24Population: Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available.
On-treatment virologic failure was defined as either: * Virologic 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 * Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment). Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA \< LLOQ at last on-treatment visit."
Outcome measures
| Measure |
Genotype 3 Treatment-naive
n=57 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 3 Treatment-experienced
n=49 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
|
Genotype 4 Treatment-naive
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
|
Genotype 2 Treatment-naive
n=19 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 2/3 Treatment-experienced
n=112 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
|
Genotype 1/3/4 Treatment-naive
n=100 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
|
Genotype 1b Treatment-naive
n=11 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
|
Genotype 2 Treatment-experienced
n=6 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Virologic Failure
On-Treatment Virologic Failure
|
0 percentage of participants
|
2.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Virologic Failure
Virologic Relapse
|
7.0 percentage of participants
|
12.5 percentage of participants
|
16.1 percentage of participants
|
5.3 percentage of participants
|
12.5 percentage of participants
|
13.0 percentage of participants
|
9.1 percentage of participants
|
16.7 percentage of participants
|
Adverse Events
Genotype 2 Treatment-naive
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Genotype 2/3 Treatment-experienced
Serious events: 5 serious events
Other events: 45 other events
Deaths: 0 deaths
Genotype 1/3/4 Treatment-naive
Serious events: 10 serious events
Other events: 166 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Genotype 2 Treatment-naive
n=19 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 2/3 Treatment-experienced
n=55 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
|
Genotype 1/3/4 Treatment-naive
n=200 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
General disorders
Pyrexia
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Mania
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
Other adverse events
| Measure |
Genotype 2 Treatment-naive
n=19 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
|
Genotype 2/3 Treatment-experienced
n=55 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
|
Genotype 1/3/4 Treatment-naive
n=200 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
3/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
8.0%
16/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Cardiac disorders
Tachycardia
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
3.6%
2/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Ear and labyrinth disorders
Ear discomfort
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
15.8%
3/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
7.3%
4/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
16.0%
32/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
9.1%
5/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
12.0%
24/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
6.5%
13/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
3/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
4.5%
9/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.8%
3/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
4.5%
9/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.0%
10/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.0%
10/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal tenderness
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Tongue ulceration
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
General disorders
Fatigue
|
26.3%
5/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
20.0%
11/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
20.0%
40/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
General disorders
Asthenia
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
20.0%
11/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
16.0%
32/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
General disorders
Pyrexia
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
3/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
2.5%
5/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
General disorders
Influenza like illness
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
2.0%
4/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
General disorders
Malaise
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.0%
2/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Hepatobiliary disorders
Jaundice
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
2.5%
5/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.0%
2/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
15.8%
3/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
9.1%
5/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
11/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
3.6%
2/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
6.5%
13/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Rhinitis
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
4.0%
8/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
3.5%
7/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
3.5%
7/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
3/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
2.0%
4/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Pharyngitis
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.5%
3/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Ear infection
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Localised infection
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Otitis media
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Subcutaneous abscess
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Urethritis gonococcal
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Investigations
Haemoglobin decreased
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.5%
3/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
3.6%
2/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
8.5%
17/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
3/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
10.9%
6/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
11/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
3.6%
2/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
6.5%
13/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
3.6%
2/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
11/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.0%
2/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.0%
2/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
12.7%
7/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
17.5%
35/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Nervous system disorders
Lethargy
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
7.5%
15/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
9.1%
5/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
4.5%
9/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Insomnia
|
15.8%
3/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
9.1%
5/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
18.0%
36/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Irritability
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
10.9%
6/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
10.0%
20/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
3/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
7.5%
15/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Sleep disorder
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
6.5%
13/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
9.1%
5/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
4.5%
9/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Depressed mood
|
10.5%
2/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
2.0%
4/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Mood swings
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.0%
2/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Stress
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Abnormal dreams
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Claustrophobia
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
3/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
10.9%
6/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
8.5%
17/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
2/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
14.5%
8/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.0%
10/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.5%
2/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
9.1%
5/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
11/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
9.1%
5/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
8.0%
16/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.5%
2/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
3/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
7.5%
15/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
3.6%
2/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
4.5%
9/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.5%
3/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
2.5%
5/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.5%
2/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.8%
1/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
2.0%
4/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.0%
2/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
5.3%
1/19 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/55 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
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