Trial Outcomes & Findings for Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies (NCT NCT01625338)
NCT ID: NCT01625338
Last Updated: 2015-11-09
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
534 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2015-11-09
Participant Flow
Participants were enrolled at a total of 152 study sites from their prior Gilead study in North America, Europe, Australia, and New Zealand. The first participant was screened on 22 June 2012. The last study visit occurred on 22 December 2014.
585 participants were screened.
Participant milestones
| Measure |
SOF+RBV 12 Weeks
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks in participants
|
|---|---|---|---|
|
Overall Study
STARTED
|
114
|
200
|
220
|
|
Overall Study
COMPLETED
|
82
|
156
|
181
|
|
Overall Study
NOT COMPLETED
|
32
|
44
|
39
|
Reasons for withdrawal
| Measure |
SOF+RBV 12 Weeks
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks in participants
|
|---|---|---|---|
|
Overall Study
Enrolled but not Treated
|
0
|
0
|
1
|
|
Overall Study
Efficacy Failure
|
27
|
39
|
31
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
2
|
|
Overall Study
Investigator Decision
|
0
|
2
|
1
|
|
Overall Study
Subject Withdrew Consent
|
1
|
0
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
|
Overall Study
Study Discontinued by Sponsor
|
0
|
0
|
1
|
Baseline Characteristics
Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
Baseline characteristics by cohort
| Measure |
SOF+RBV 12 Weeks
n=114 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks
n=200 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=219 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
|
Total
n=533 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Cirrhosis Status
Yes
|
25 participants
n=5 Participants
|
62 participants
n=7 Participants
|
36 participants
n=5 Participants
|
123 participants
n=4 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
52 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
53 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
53 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
369 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
105 participants
n=5 Participants
|
184 participants
n=7 Participants
|
187 participants
n=5 Participants
|
476 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
20 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian Or Alaska Native
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian Or Other Pacific Islander
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
19 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
95 participants
n=5 Participants
|
187 participants
n=7 Participants
|
197 participants
n=5 Participants
|
479 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=5 Participants
|
82 participants
n=7 Participants
|
121 participants
n=5 Participants
|
280 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
8 participants
n=7 Participants
|
2 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
New Zealand
|
4 participants
n=5 Participants
|
30 participants
n=7 Participants
|
6 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
10 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
9 participants
n=5 Participants
|
14 participants
n=7 Participants
|
19 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
12 participants
n=7 Participants
|
18 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Region of Enrollment
Estonia
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
HCV Genotype
Genotype 1
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
134 participants
n=5 Participants
|
136 participants
n=4 Participants
|
|
HCV Genotype
Genotype 2
|
62 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
80 participants
n=4 Participants
|
|
HCV Genotype
Genotype 3
|
52 participants
n=5 Participants
|
180 participants
n=7 Participants
|
74 participants
n=5 Participants
|
306 participants
n=4 Participants
|
|
HCV Genotype
Genotype 4
|
0 participants
n=5 Participants
|
7 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
HCV Genotype
Indeterminate
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Cirrhosis Status
No
|
89 participants
n=5 Participants
|
138 participants
n=7 Participants
|
183 participants
n=5 Participants
|
410 participants
n=4 Participants
|
|
IL28b Status
CC
|
38 participants
n=5 Participants
|
59 participants
n=7 Participants
|
47 participants
n=5 Participants
|
144 participants
n=4 Participants
|
|
IL28b Status
CT
|
61 participants
n=5 Participants
|
103 participants
n=7 Participants
|
127 participants
n=5 Participants
|
291 participants
n=4 Participants
|
|
IL28b Status
TT
|
13 participants
n=5 Participants
|
35 participants
n=7 Participants
|
40 participants
n=5 Participants
|
88 participants
n=4 Participants
|
|
IL28b Status
Missing
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
HCV RNA
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.87 • n=5 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.70 • n=7 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.64 • n=5 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.72 • n=4 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
30 participants
n=5 Participants
|
44 participants
n=7 Participants
|
36 participants
n=5 Participants
|
110 participants
n=4 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
84 participants
n=5 Participants
|
156 participants
n=7 Participants
|
183 participants
n=5 Participants
|
423 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF+RBV 12 Weeks
n=114 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks
n=200 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=219 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
71.9 percentage of participants
|
77.5 percentage of participants
|
82.6 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
Outcome measures
| Measure |
SOF+RBV 12 Weeks
n=114 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks
n=200 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=219 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
|
|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0.9 percentage of participants
|
1.0 percentage of participants
|
3.7 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Outcome measures
| Measure |
SOF+RBV 12 Weeks
n=114 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks
n=200 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=219 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
|
|---|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
71.9 percentage of participants
|
76.0 percentage of participants
|
82.6 percentage of participants
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
73.7 percentage of participants
|
81.5 percentage of participants
|
87.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Full Analysis Set
On-treatment virologic failure was defined as * 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)
Outcome measures
| Measure |
SOF+RBV 12 Weeks
n=114 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks
n=200 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=219 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
|
|---|---|---|---|
|
Percentage of Participants With On-treatment Virologic Failure
|
0.9 percentage of participants
|
0.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
Outcome measures
| Measure |
SOF+RBV 12 Weeks
n=113 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks
n=199 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=219 Participants
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
|
|---|---|---|---|
|
Percentage of Participants With Viral Relapse
|
25.7 percentage of participants
|
20.6 percentage of participants
|
16.4 percentage of participants
|
Adverse Events
SOF+RBV 12 Weeks
Serious events: 4 serious events
Other events: 92 other events
Deaths: 0 deaths
SOF+RBV 24 Weeks
Serious events: 11 serious events
Other events: 167 other events
Deaths: 0 deaths
SOF+RBV+Peg-IFN 12 Weeks
Serious events: 4 serious events
Other events: 194 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF+RBV 12 Weeks
n=114 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks
n=200 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=219 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Myelitis transverse
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Presyncope
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Mania
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Suicide attempt
|
0.88%
1/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Social circumstances
Social stay hospitalisation
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF+RBV 12 Weeks
n=114 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Weeks
n=200 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=219 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.4%
13/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.0%
12/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.9%
26/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.0%
11/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
17.4%
38/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
6/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.5%
7/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.3%
5/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
7/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.0%
14/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.8%
28/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
19.3%
22/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
13.5%
27/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
23.7%
52/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
7/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.5%
7/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.1%
9/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Asthenia
|
4.4%
5/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.5%
9/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.7%
19/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Chills
|
1.8%
2/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.5%
3/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.7%
19/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
28.9%
33/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
33.0%
66/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
44.3%
97/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Influenza like illness
|
5.3%
6/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.5%
5/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.5%
45/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Pain
|
1.8%
2/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.0%
4/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.8%
17/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Pyrexia
|
4.4%
5/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.50%
1/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.3%
27/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
9/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.0%
22/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.8%
4/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
7/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.5%
9/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.91%
2/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.6%
3/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.0%
8/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
14.6%
32/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.4%
13/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.5%
21/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.9%
37/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
9/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.5%
11/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
13/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.1%
7/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.5%
17/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.0%
11/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
8/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.5%
9/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.5%
45/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
3.5%
4/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.5%
13/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.5%
23/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dysgeusia
|
2.6%
3/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.5%
12/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
13.2%
15/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
28.5%
57/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
32.4%
71/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
5.3%
6/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.5%
11/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.4%
14/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
6.1%
7/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.5%
21/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.4%
14/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
15.8%
18/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
17.0%
34/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.9%
37/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
4.4%
5/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
13.5%
27/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
17.4%
38/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
11/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.5%
11/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
15.1%
33/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
6/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.0%
12/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.0%
11/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.4%
5/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.5%
7/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.9%
13/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
3/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.0%
4/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.5%
12/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
6/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.0%
14/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.8%
17/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.2%
15/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.5%
23/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
18.3%
40/219 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.4%
13/114 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.5%
19/200 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
16.0%
35/219 • 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