Trial Outcomes & Findings for Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection (NCT NCT02201953)
NCT ID: NCT02201953
Last Updated: 2018-11-16
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
558 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at study sites in Australia, North America, Europe, and New Zealand. The first participant was screened on 14 July 2014. The last study visit occurred on 15 December 2015.
652 participants were screened.
Participant milestones
| Measure |
SOF/VEL 12 Weeks
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
|
SOF+RBV 24 Weeks
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
278
|
280
|
|
Overall Study
COMPLETED
|
258
|
224
|
|
Overall Study
NOT COMPLETED
|
20
|
56
|
Reasons for withdrawal
| Measure |
SOF/VEL 12 Weeks
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
|
SOF+RBV 24 Weeks
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
|
|---|---|---|
|
Overall Study
Randomized but Never Treated
|
1
|
5
|
|
Overall Study
Lack of Efficacy
|
9
|
30
|
|
Overall Study
Lost to Follow-up
|
8
|
8
|
|
Overall Study
Withdrew Consent
|
2
|
5
|
|
Overall Study
Adverse Event
|
0
|
5
|
|
Overall Study
Death
|
0
|
3
|
Baseline Characteristics
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection
Baseline characteristics by cohort
| Measure |
SOF/VEL 12 Weeks
n=277 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
SOF+RBV 24 Weeks
n=275 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
|
Total
n=552 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
50 years
STANDARD_DEVIATION 10.0 • n=107 Participants
|
50 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
208 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
170 Participants
n=99 Participants
|
174 Participants
n=107 Participants
|
344 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
266 Participants
n=99 Participants
|
263 Participants
n=107 Participants
|
529 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
250 participants
n=99 Participants
|
239 participants
n=107 Participants
|
489 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
23 participants
n=99 Participants
|
29 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
9 participants
n=99 Participants
|
8 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=99 Participants
|
18 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=99 Participants
|
60 participants
n=107 Participants
|
120 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
7 participants
n=99 Participants
|
11 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
58 participants
n=99 Participants
|
47 participants
n=107 Participants
|
105 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
49 participants
n=99 Participants
|
44 participants
n=107 Participants
|
93 participants
n=206 Participants
|
|
Region of Enrollment
France
|
48 participants
n=99 Participants
|
52 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
31 participants
n=99 Participants
|
35 participants
n=107 Participants
|
66 participants
n=206 Participants
|
|
HCV Genotype
Genotype 3 (No Confirmed Subtype)
|
9 participants
n=99 Participants
|
18 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
HCV Genotype
Genotype 3a
|
265 participants
n=99 Participants
|
250 participants
n=107 Participants
|
515 participants
n=206 Participants
|
|
HCV Genotype
Genotype 3b
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
HCV Genotype
Genotype 3h
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
HCV Genotype
Genotype 3k
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Cirrhosis Status
Yes
|
80 participants
n=99 Participants
|
83 participants
n=107 Participants
|
163 participants
n=206 Participants
|
|
Cirrhosis Status
No
|
197 participants
n=99 Participants
|
187 participants
n=107 Participants
|
384 participants
n=206 Participants
|
|
Cirrhosis Status
Missing
|
0 participants
n=99 Participants
|
5 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
IL28b Status
CC
|
105 participants
n=99 Participants
|
111 participants
n=107 Participants
|
216 participants
n=206 Participants
|
|
IL28b Status
CT
|
148 participants
n=99 Participants
|
133 participants
n=107 Participants
|
281 participants
n=206 Participants
|
|
IL28b Status
TT
|
24 participants
n=99 Participants
|
31 participants
n=107 Participants
|
55 participants
n=206 Participants
|
|
HCV RNA
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.72 • n=99 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.71 • n=107 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.72 • n=206 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
86 participants
n=99 Participants
|
81 participants
n=107 Participants
|
167 participants
n=206 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
191 participants
n=99 Participants
|
194 participants
n=107 Participants
|
385 participants
n=206 Participants
|
|
Prior HCV Treatment Experience
Treatment-Naive
|
206 participants
n=99 Participants
|
204 participants
n=107 Participants
|
410 participants
n=206 Participants
|
|
Prior HCV Treatment Experience
Treatment-Experienced
|
71 participants
n=99 Participants
|
71 participants
n=107 Participants
|
142 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=277 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
SOF+RBV 24 Weeks
n=275 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
95.3 percentage of participants
Interval 92.1 to 97.5
|
80.7 percentage of participants
Interval 75.6 to 85.2
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=277 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
SOF+RBV 24 Weeks
n=275 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
|
|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0 percentage of participants
|
3.3 percentage of 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.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=277 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
SOF+RBV 24 Weeks
n=275 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
|
|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
96.8 percentage of participants
Interval 93.9 to 98.5
|
82.2 percentage of participants
Interval 77.1 to 86.5
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
95.3 percentage of participants
Interval 92.1 to 97.5
|
80.7 percentage of participants
Interval 75.6 to 85.2
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=277 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
SOF+RBV 24 Weeks
n=275 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
|
|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Week 1 (SOF/VEL: N = 277; SOF+RBV: N = 275)
|
18.4 percentage of participants
Interval 14.0 to 23.5
|
17.5 percentage of participants
Interval 13.2 to 22.5
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Week 2 (SOF/VEL: N = 276; SOF+RBV: N = 274)
|
62.0 percentage of participants
Interval 55.9 to 67.7
|
50.0 percentage of participants
Interval 43.9 to 56.1
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Week 4 (SOF/VEL: N = 276; SOF+RBV: N = 272)
|
91.7 percentage of participants
Interval 87.8 to 94.6
|
88.2 percentage of participants
Interval 83.8 to 91.8
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Week 6 (SOF/VEL: N = 276; SOF+RBV: N = 269)
|
96.7 percentage of participants
Interval 93.9 to 98.5
|
98.9 percentage of participants
Interval 96.8 to 99.8
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Week 8 (SOF/VEL: N = 276; SOF+RBV: N = 269)
|
99.6 percentage of participants
Interval 98.0 to 100.0
|
99.3 percentage of participants
Interval 97.3 to 99.9
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Week 10 (SOF/VEL: N = 276; SOF+RBV: N = 268)
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
99.3 percentage of participants
Interval 97.3 to 99.9
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Week 12 (SOF/VEL: N = 275; SOF+RBV: N = 265)
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
99.6 percentage of participants
Interval 97.9 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Week 16 (SOF/VEL: N = 0; SOF+RBV: N = 262)
|
NA percentage of participants
Participants in the SOF/VEL group were only treated for 12 weeks.
|
98.9 percentage of participants
Interval 96.7 to 99.8
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Week 20 (SOF/VEL: N = 0; SOF+RBV: N = 260)
|
NA percentage of participants
Participants in the SOF/VEL group were only treated for 12 weeks.
|
99.6 percentage of participants
Interval 97.9 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Week 24 (SOF/VEL: N = 0; SOF+RBV: N = 255)
|
NA percentage of participants
Participants in the SOF/VEL group were only treated for 12 weeks.
|
100.0 percentage of participants
Interval 98.6 to 100.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=277 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
SOF+RBV 24 Weeks
n=275 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
|
|---|---|---|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Change at Wk 20 (SOF/VEL: N = 0; SOF+RBV: N = 259)
|
NA log10 IU/mL
Standard Deviation NA
Participants in the SOF/VEL group were only treated for 12 weeks.
|
-5.14 log10 IU/mL
Standard Deviation 0.715
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Change at Wk 24 (SOF/VEL: N = 0; SOF+RBV: N = 255)
|
NA log10 IU/mL
Standard Deviation NA
Participants in the SOF/VEL group were only treated for 12 weeks.
|
-5.14 log10 IU/mL
Standard Deviation 0.715
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Change at Wk 1 (SOF/VEL: N =272; SOF+RBV: N =268)
|
-4.26 log10 IU/mL
Standard Deviation 0.644
|
-4.16 log10 IU/mL
Standard Deviation 0.640
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Change at Wk 2 (SOF/VEL: N =274; SOF+RBV: N =272)
|
-4.82 log10 IU/mL
Standard Deviation 0.769
|
-4.79 log10 IU/mL
Standard Deviation 0.702
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Change at Wk 4 (SOF/VEL: N =276; SOF+RBV: N =270)
|
-5.02 log10 IU/mL
Standard Deviation 0.776
|
-5.09 log10 IU/mL
Standard Deviation 0.699
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Change at Wk 6 (SOF/VEL: N =275; SOF+RBV: N =269)
|
-5.06 log10 IU/mL
Standard Deviation 0.718
|
-5.13 log10 IU/mL
Standard Deviation 0.712
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Change at Wk 8 (SOF/VEL: N =276; SOF+RBV: N =269)
|
-5.07 log10 IU/mL
Standard Deviation 0.728
|
-5.13 log10 IU/mL
Standard Deviation 0.712
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Change at Wk 10 (SOF/VEL: N =276; SOF+RBV: N =267)
|
-5.07 log10 IU/mL
Standard Deviation 0.723
|
-5.14 log10 IU/mL
Standard Deviation 0.710
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Change at Wk 12 (SOF/VEL: N =275; SOF+RBV: N =264)
|
-5.08 log10 IU/mL
Standard Deviation 0.721
|
-5.14 log10 IU/mL
Standard Deviation 0.711
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Change at Wk 16 (SOF/VEL: N = 0; SOF+RBV: N = 262)
|
NA log10 IU/mL
Standard Deviation NA
Participants in the SOF/VEL group were only treated for 12 weeks.
|
-5.11 log10 IU/mL
Standard Deviation 0.765
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
SOF/VEL 12 Weeks
n=277 Participants
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
SOF+RBV 24 Weeks
n=275 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
|
|---|---|---|
|
Percentage of Participants With Virologic Failure
|
4.0 percentage of participants
|
14.2 percentage of participants
|
Adverse Events
SOF/VEL 12 Weeks
Serious events: 6 serious events
Other events: 216 other events
Deaths: 0 deaths
SOF+RBV 24 Weeks
Serious events: 15 serious events
Other events: 243 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL 12 Weeks
n=277 participants at risk
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
SOF+RBV 24 Weeks
n=275 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.36%
1/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Food poisoning
|
0.36%
1/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Haematochezia
|
0.36%
1/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Death
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.36%
1/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Cellulitis
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Lung infection
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Propionibacterium infection
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Intracranial aneurysm
|
0.36%
1/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.36%
1/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.36%
1/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF/VEL 12 Weeks
n=277 participants at risk
SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
|
SOF+RBV 24 Weeks
n=275 participants at risk
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
|
0.36%
1/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.1%
25/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
10/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
19/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
4.7%
13/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.6%
21/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
7.2%
20/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.6%
21/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
9/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.9%
30/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
17.0%
47/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
21.1%
58/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
8/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.3%
20/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Asthenia
|
5.8%
16/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.5%
26/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
25.6%
71/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
38.2%
105/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Pyrexia
|
1.4%
4/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.1%
14/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
2.2%
6/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.1%
14/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
12.3%
34/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.0%
33/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.9%
8/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.1%
14/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
10/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.0%
22/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.0%
25/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.3%
20/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.7%
13/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.2%
17/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
10/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.5%
15/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Disturbance in attention
|
2.5%
7/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.1%
14/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
5.4%
15/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.6%
21/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
32.5%
90/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
32.7%
90/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
2.5%
7/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.6%
21/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
11.6%
32/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
26.9%
74/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
8.3%
23/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
14.5%
40/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Sleep disorder
|
3.2%
9/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.5%
15/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
14/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.7%
35/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
8/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.0%
22/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.1%
3/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.3%
20/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.72%
2/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.1%
25/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
8/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.7%
35/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
15/277 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.1%
14/275 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER