Trial Outcomes & Findings for Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection (NCT NCT02021643)
NCT ID: NCT02021643
Last Updated: 2018-02-20
Results Overview
SVR12 is defined as HCV RNA \< the lower limit of quantification (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
687 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-02-20
Participant Flow
Participants were enrolled at 61 study sites in Asia. The first participant was screened on 10 December 2013. The last study visit occurred on 03 November 2016.
815 participants were screened.
Participant milestones
| Measure |
SOF+PEG+RBV 12 Weeks
Participants with genotype 1 or 6 received Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + Pegylated interferon alfa-2a (PEG) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 12 Weeks
Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 16 Weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
156
|
290
|
11
|
230
|
|
Overall Study
COMPLETED
|
147
|
280
|
11
|
218
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
0
|
12
|
Reasons for withdrawal
| Measure |
SOF+PEG+RBV 12 Weeks
Participants with genotype 1 or 6 received Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + Pegylated interferon alfa-2a (PEG) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 12 Weeks
Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 16 Weeks
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Overall Study
Enrolled but Never Treated
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Investigator's Discretion
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
7
|
6
|
0
|
12
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrew Consent
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection
Baseline characteristics by cohort
| Measure |
SOF+PEG+RBV 12 Weeks (GT 1 and GT6)
n=155 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 12 Weeks (GT1 and GT6)
n=10 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 16 Weeks (GT1 and GT6)
n=11 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks (GT1 and GT6)
n=104 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV 12 Weeks (GT2)
n=280 Participants
Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks (GT3)
n=126 Participants
Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
Total
n=686 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
43 years
STANDARD_DEVIATION 17.2 • n=107 Participants
|
43 years
STANDARD_DEVIATION 17.6 • n=206 Participants
|
49 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
53 years
STANDARD_DEVIATION 12.3 • n=31 Participants
|
40 years
STANDARD_DEVIATION 8.1 • n=30 Participants
|
47 years
STANDARD_DEVIATION 13.3 • n=3 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
61 Participants
n=7 Participants
|
160 Participants
n=31 Participants
|
56 Participants
n=30 Participants
|
351 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
120 Participants
n=31 Participants
|
70 Participants
n=30 Participants
|
335 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Asian
|
155 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
104 Participants
n=7 Participants
|
280 Participants
n=31 Participants
|
126 Participants
n=30 Participants
|
686 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
151 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
98 Participants
n=7 Participants
|
280 Participants
n=31 Participants
|
126 Participants
n=30 Participants
|
676 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
|
Region of Enrollment
China
|
130 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
69 participants
n=7 Participants
|
64 participants
n=31 Participants
|
126 participants
n=30 Participants
|
389 participants
n=3 Participants
|
|
Region of Enrollment
Hong Kong
|
0 participants
n=99 Participants
|
10 participants
n=107 Participants
|
11 participants
n=206 Participants
|
10 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
31 participants
n=3 Participants
|
|
Region of Enrollment
South Korea
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
129 participants
n=31 Participants
|
0 participants
n=30 Participants
|
129 participants
n=3 Participants
|
|
Region of Enrollment
Taiwan
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
87 participants
n=31 Participants
|
0 participants
n=30 Participants
|
87 participants
n=3 Participants
|
|
Region of Enrollment
Vietnam
|
25 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
25 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
50 participants
n=3 Participants
|
|
HCV Genotype
Genotype 1
|
108 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
81 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
203 Participants
n=3 Participants
|
|
HCV Genotype
Genotype 2
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
280 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
280 Participants
n=3 Participants
|
|
HCV Genotype
Genotype 3
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
126 Participants
n=30 Participants
|
126 Participants
n=3 Participants
|
|
HCV Genotype
Genotype 6
|
47 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
77 Participants
n=3 Participants
|
|
IL28b Status
CC
|
114 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
74 Participants
n=7 Participants
|
237 Participants
n=31 Participants
|
102 Participants
n=30 Participants
|
546 Participants
n=3 Participants
|
|
IL28b Status
CT
|
40 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
23 Participants
n=30 Participants
|
136 Participants
n=3 Participants
|
|
IL28b Status
TT
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
HCV RNA
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.74 • n=99 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.49 • n=107 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.88 • n=206 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.71 • n=7 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.96 • n=31 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.71 • n=30 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.84 • n=3 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
21 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
87 Participants
n=31 Participants
|
32 Participants
n=30 Participants
|
170 Participants
n=3 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
134 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
82 Participants
n=7 Participants
|
193 Participants
n=31 Participants
|
94 Participants
n=30 Participants
|
516 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who enrolled in the study and received at least one dose of study drug.
SVR12 is defined as HCV RNA \< the lower limit of quantification (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.
Outcome measures
| Measure |
SOF+PEG+RBV 12 Weeks (GT 1 and GT6)
n=155 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 12 Weeks (GT1 and GT6)
n=10 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 16 Weeks (GT1 and GT6)
n=11 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks (GT1 and GT6)
n=104 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV 12 Weeks (GT2)
n=280 Participants
Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks (GT3)
n=126 Participants
Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
95.5 percentage of participants
Interval 90.9 to 98.2
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 71.5 to 100.0
|
94.2 percentage of participants
Interval 87.9 to 97.9
|
96.8 percentage of participants
Interval 94.0 to 98.5
|
95.2 percentage of participants
Interval 89.9 to 98.2
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF+PEG+RBV 12 Weeks (GT 1 and GT6)
n=155 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 12 Weeks (GT1 and GT6)
n=290 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 16 Weeks (GT1 and GT6)
n=11 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks (GT1 and GT6)
n=230 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV 12 Weeks (GT2)
Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks (GT3)
Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Outcome measures
| Measure |
SOF+PEG+RBV 12 Weeks (GT 1 and GT6)
n=155 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 12 Weeks (GT1 and GT6)
n=10 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 16 Weeks (GT1 and GT6)
n=11 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks (GT1 and GT6)
n=104 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV 12 Weeks (GT2)
n=280 Participants
Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks (GT3)
n=126 Participants
Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
96.8 percentage of participants
Interval 92.6 to 98.9
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 71.5 to 100.0
|
94.2 percentage of participants
Interval 87.9 to 97.9
|
97.5 percentage of participants
Interval 94.9 to 99.0
|
97.6 percentage of participants
Interval 93.2 to 99.5
|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
95.5 percentage of participants
Interval 90.9 to 98.2
|
100 percentage of participants
Interval 69.2 to 100.0
|
90.9 percentage of participants
Interval 58.7 to 99.8
|
94.2 percentage of participants
Interval 87.9 to 97.9
|
96.8 percentage of participants
Interval 94.0 to 98.5
|
95.2 percentage of participants
Interval 89.9 to 98.2
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Full Analysis Set
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment.
Outcome measures
| Measure |
SOF+PEG+RBV 12 Weeks (GT 1 and GT6)
n=155 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 12 Weeks (GT1 and GT6)
n=10 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 16 Weeks (GT1 and GT6)
n=11 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks (GT1 and GT6)
n=104 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV 12 Weeks (GT2)
n=280 Participants
Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks (GT3)
n=126 Participants
Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With On-Treatment Virologic Failure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
Outcome measures
| Measure |
SOF+PEG+RBV 12 Weeks (GT 1 and GT6)
n=155 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 12 Weeks (GT1 and GT6)
n=10 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 16 Weeks (GT1 and GT6)
n=11 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks (GT1 and GT6)
n=104 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV 12 Weeks (GT2)
n=280 Participants
Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks (GT3)
n=126 Participants
Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Viral Relapse
|
7 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Participants in the Full Analysis Set with available data were analyzed
Outcome measures
| Measure |
SOF+PEG+RBV 12 Weeks (GT 1 and GT6)
n=155 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 12 Weeks (GT1 and GT6)
n=10 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 16 Weeks (GT1 and GT6)
n=11 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks (GT1 and GT6)
n=104 Participants
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV 12 Weeks (GT2)
n=280 Participants
Participants with genotype 2 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks (GT3)
n=126 Participants
Participants with genotype 3 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Change at Week 1
|
-4.81 log10 IU/mL
Standard Deviation 0.653
|
-4.59 log10 IU/mL
Standard Deviation 0.359
|
-4.36 log10 IU/mL
Standard Deviation 0.560
|
-4.61 log10 IU/mL
Standard Deviation 0.607
|
-4.46 log10 IU/mL
Standard Deviation 0.815
|
-4.52 log10 IU/mL
Standard Deviation 0.695
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Change at Week 2
|
-5.11 log10 IU/mL
Standard Deviation 0.734
|
-4.89 log10 IU/mL
Standard Deviation 0.488
|
-4.79 log10 IU/mL
Standard Deviation 0.858
|
-5.04 log10 IU/mL
Standard Deviation 0.682
|
-4.78 log10 IU/mL
Standard Deviation 1.008
|
-4.86 log10 IU/mL
Standard Deviation 0.706
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Change at Week 4
|
-5.12 log10 IU/mL
Standard Deviation 0.738
|
-4.89 log10 IU/mL
Standard Deviation 0.488
|
-4.82 log10 IU/mL
Standard Deviation 0.880
|
-5.12 log10 IU/mL
Standard Deviation 0.710
|
-4.81 log10 IU/mL
Standard Deviation 1.025
|
-4.87 log10 IU/mL
Standard Deviation 0.713
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Change at Week 6
|
-5.12 log10 IU/mL
Standard Deviation 0.738
|
-4.89 log10 IU/mL
Standard Deviation 0.488
|
-4.82 log10 IU/mL
Standard Deviation 0.880
|
-5.12 log10 IU/mL
Standard Deviation 0.710
|
-4.80 log10 IU/mL
Standard Deviation 1.038
|
-4.87 log10 IU/mL
Standard Deviation 0.713
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Change at Week 8
|
-5.12 log10 IU/mL
Standard Deviation 0.738
|
-4.89 log10 IU/mL
Standard Deviation 0.488
|
-4.82 log10 IU/mL
Standard Deviation 0.880
|
-5.12 log10 IU/mL
Standard Deviation 0.708
|
-4.83 log10 IU/mL
Standard Deviation 0.966
|
-4.87 log10 IU/mL
Standard Deviation 0.713
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Change at Week 10
|
-5.12 log10 IU/mL
Standard Deviation 0.738
|
-4.89 log10 IU/mL
Standard Deviation 0.488
|
-4.82 log10 IU/mL
Standard Deviation 0.880
|
-5.12 log10 IU/mL
Standard Deviation 0.708
|
-4.83 log10 IU/mL
Standard Deviation 0.966
|
-4.87 log10 IU/mL
Standard Deviation 0.713
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Change at Week 12
|
-5.12 log10 IU/mL
Standard Deviation 0.739
|
-4.89 log10 IU/mL
Standard Deviation 0.488
|
-4.82 log10 IU/mL
Standard Deviation 0.880
|
-5.12 log10 IU/mL
Standard Deviation 0.708
|
-4.83 log10 IU/mL
Standard Deviation 0.966
|
-4.84 log10 IU/mL
Standard Deviation 0.779
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Change at Week 16
|
—
|
—
|
-4.82 log10 IU/mL
Standard Deviation 0.880
|
-5.12 log10 IU/mL
Standard Deviation 0.708
|
—
|
-4.87 log10 IU/mL
Standard Deviation 0.713
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Change at Week 20
|
—
|
—
|
—
|
-5.14 log10 IU/mL
Standard Deviation 0.701
|
—
|
-4.87 log10 IU/mL
Standard Deviation 0.713
|
|
Change From Baseline in HCV RNA (log10 IU/mL)
Change at Week 24
|
—
|
—
|
—
|
-5.14 log10 IU/mL
Standard Deviation 0.701
|
—
|
-4.87 log10 IU/mL
Standard Deviation 0.713
|
Adverse Events
SOF+PEG+RBV 12 Weeks
Serious events: 5 serious events
Other events: 145 other events
Deaths: 0 deaths
SOF+RBV 12 Weeks
Serious events: 7 serious events
Other events: 215 other events
Deaths: 0 deaths
SOF+RBV 16 Weeks
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SOF+RBV 24 Weeks
Serious events: 4 serious events
Other events: 177 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF+PEG+RBV 12 Weeks
n=155 participants at risk
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 12 Weeks
n=290 participants at risk
Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 16 Weeks
n=11 participants at risk
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks
n=230 participants at risk
Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Eye disorders
Angle closure glaucoma
|
0.65%
1/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Gastritis
|
0.65%
1/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.43%
1/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.43%
1/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.43%
1/230 • Up to 24 Weeks Plus 30 Days
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.43%
1/230 • Up to 24 Weeks Plus 30 Days
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.43%
1/230 • Up to 24 Weeks Plus 30 Days
|
|
Infections and infestations
Bronchitis
|
0.65%
1/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.65%
1/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.43%
1/230 • Up to 24 Weeks Plus 30 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Nervous system disorders
Cerebral infarction
|
0.65%
1/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
Other adverse events
| Measure |
SOF+PEG+RBV 12 Weeks
n=155 participants at risk
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + PEG 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 12 Weeks
n=290 participants at risk
Participants with genotype 1, 2 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 16 Weeks
n=11 participants at risk
Participants with genotype 1 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks
n=230 participants at risk
Participants with genotype 1, 3 or 6 received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.4%
30/155 • Up to 24 Weeks Plus 30 Days
|
7.6%
22/290 • Up to 24 Weeks Plus 30 Days
|
9.1%
1/11 • Up to 24 Weeks Plus 30 Days
|
11.7%
27/230 • Up to 24 Weeks Plus 30 Days
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.4%
30/155 • Up to 24 Weeks Plus 30 Days
|
0.69%
2/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
2.6%
6/230 • Up to 24 Weeks Plus 30 Days
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.4%
27/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
1.3%
3/230 • Up to 24 Weeks Plus 30 Days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.9%
20/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
1.3%
3/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.65%
1/155 • Up to 24 Weeks Plus 30 Days
|
1.7%
5/290 • Up to 24 Weeks Plus 30 Days
|
9.1%
1/11 • Up to 24 Weeks Plus 30 Days
|
1.7%
4/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Constipation
|
0.65%
1/155 • Up to 24 Weeks Plus 30 Days
|
0.69%
2/290 • Up to 24 Weeks Plus 30 Days
|
9.1%
1/11 • Up to 24 Weeks Plus 30 Days
|
3.0%
7/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
3/155 • Up to 24 Weeks Plus 30 Days
|
2.4%
7/290 • Up to 24 Weeks Plus 30 Days
|
9.1%
1/11 • Up to 24 Weeks Plus 30 Days
|
1.3%
3/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.65%
1/155 • Up to 24 Weeks Plus 30 Days
|
2.8%
8/290 • Up to 24 Weeks Plus 30 Days
|
9.1%
1/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.65%
1/155 • Up to 24 Weeks Plus 30 Days
|
1.4%
4/290 • Up to 24 Weeks Plus 30 Days
|
9.1%
1/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
9.1%
1/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Nausea
|
6.5%
10/155 • Up to 24 Weeks Plus 30 Days
|
4.8%
14/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.87%
2/230 • Up to 24 Weeks Plus 30 Days
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
6/155 • Up to 24 Weeks Plus 30 Days
|
2.8%
8/290 • Up to 24 Weeks Plus 30 Days
|
9.1%
1/11 • Up to 24 Weeks Plus 30 Days
|
0.43%
1/230 • Up to 24 Weeks Plus 30 Days
|
|
General disorders
Asthenia
|
13.5%
21/155 • Up to 24 Weeks Plus 30 Days
|
2.8%
8/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
3.9%
9/230 • Up to 24 Weeks Plus 30 Days
|
|
General disorders
Fatigue
|
15.5%
24/155 • Up to 24 Weeks Plus 30 Days
|
7.2%
21/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
8.7%
20/230 • Up to 24 Weeks Plus 30 Days
|
|
General disorders
Malaise
|
0.00%
0/155 • Up to 24 Weeks Plus 30 Days
|
1.0%
3/290 • Up to 24 Weeks Plus 30 Days
|
18.2%
2/11 • Up to 24 Weeks Plus 30 Days
|
0.43%
1/230 • Up to 24 Weeks Plus 30 Days
|
|
General disorders
Non-cardiac chest pain
|
5.2%
8/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
1.7%
4/230 • Up to 24 Weeks Plus 30 Days
|
|
General disorders
Pain
|
5.8%
9/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
2.2%
5/230 • Up to 24 Weeks Plus 30 Days
|
|
General disorders
Pyrexia
|
36.1%
56/155 • Up to 24 Weeks Plus 30 Days
|
1.4%
4/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
4.3%
10/230 • Up to 24 Weeks Plus 30 Days
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
6/155 • Up to 24 Weeks Plus 30 Days
|
7.2%
21/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
2.6%
6/230 • Up to 24 Weeks Plus 30 Days
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
11/155 • Up to 24 Weeks Plus 30 Days
|
10.3%
30/290 • Up to 24 Weeks Plus 30 Days
|
18.2%
2/11 • Up to 24 Weeks Plus 30 Days
|
11.7%
27/230 • Up to 24 Weeks Plus 30 Days
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
10/155 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
2.6%
6/230 • Up to 24 Weeks Plus 30 Days
|
|
Investigations
Blood bilirubin increased
|
4.5%
7/155 • Up to 24 Weeks Plus 30 Days
|
2.4%
7/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
14.8%
34/230 • Up to 24 Weeks Plus 30 Days
|
|
Investigations
Haemoglobin decreased
|
14.8%
23/155 • Up to 24 Weeks Plus 30 Days
|
3.1%
9/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
8.7%
20/230 • Up to 24 Weeks Plus 30 Days
|
|
Investigations
Neutrophil count decreased
|
24.5%
38/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.43%
1/230 • Up to 24 Weeks Plus 30 Days
|
|
Investigations
Platelet count decreased
|
23.9%
37/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.87%
2/230 • Up to 24 Weeks Plus 30 Days
|
|
Investigations
Red blood cell count decreased
|
7.1%
11/155 • Up to 24 Weeks Plus 30 Days
|
2.1%
6/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
7.0%
16/230 • Up to 24 Weeks Plus 30 Days
|
|
Investigations
Reticulocyte count increased
|
8.4%
13/155 • Up to 24 Weeks Plus 30 Days
|
5.2%
15/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
15.2%
35/230 • Up to 24 Weeks Plus 30 Days
|
|
Investigations
White blood cell count decreased
|
21.3%
33/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/230 • Up to 24 Weeks Plus 30 Days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.8%
9/155 • Up to 24 Weeks Plus 30 Days
|
1.4%
4/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
3.0%
7/230 • Up to 24 Weeks Plus 30 Days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.9%
20/155 • Up to 24 Weeks Plus 30 Days
|
4.8%
14/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
0.43%
1/230 • Up to 24 Weeks Plus 30 Days
|
|
Nervous system disorders
Dizziness
|
9.0%
14/155 • Up to 24 Weeks Plus 30 Days
|
5.9%
17/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
4.8%
11/230 • Up to 24 Weeks Plus 30 Days
|
|
Nervous system disorders
Headache
|
15.5%
24/155 • Up to 24 Weeks Plus 30 Days
|
11.7%
34/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
6.1%
14/230 • Up to 24 Weeks Plus 30 Days
|
|
Psychiatric disorders
Insomnia
|
3.9%
6/155 • Up to 24 Weeks Plus 30 Days
|
10.0%
29/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
11.3%
26/230 • Up to 24 Weeks Plus 30 Days
|
|
Psychiatric disorders
Irritability
|
0.65%
1/155 • Up to 24 Weeks Plus 30 Days
|
0.34%
1/290 • Up to 24 Weeks Plus 30 Days
|
9.1%
1/11 • Up to 24 Weeks Plus 30 Days
|
0.43%
1/230 • Up to 24 Weeks Plus 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
16/155 • Up to 24 Weeks Plus 30 Days
|
6.2%
18/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
6.1%
14/230 • Up to 24 Weeks Plus 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.8%
9/155 • Up to 24 Weeks Plus 30 Days
|
2.4%
7/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
3.0%
7/230 • Up to 24 Weeks Plus 30 Days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
2/155 • Up to 24 Weeks Plus 30 Days
|
11.4%
33/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
3.5%
8/230 • Up to 24 Weeks Plus 30 Days
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
11/155 • Up to 24 Weeks Plus 30 Days
|
6.2%
18/290 • Up to 24 Weeks Plus 30 Days
|
0.00%
0/11 • Up to 24 Weeks Plus 30 Days
|
4.3%
10/230 • Up to 24 Weeks Plus 30 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER