Trial Outcomes & Findings for Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (NCT NCT01682720)
NCT ID: NCT01682720
Last Updated: 2014-10-09
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
421 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2014-10-09
Participant Flow
Participants were enrolled at a total of 77 study sites in Europe. The first participant was screened on 19 September 2012. The last participant observation occurred on 08 January 2014.
* 475 participants were screened and 421 were randomized. * 419 participants were randomized and received at least 1 dose of study drug (Safety Analysis Set). * 334 participants with genotype 2 or 3 hepatitis C virus (HCV) infection were randomized and received at least 1 dose of sofosbuvir (Full Analysis Set).
Participant milestones
| Measure |
Placebo 12 Weeks (GT2/3)
Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT)2 or 3 HCV infection.
|
SOF 12 Weeks (GT2)
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
|
SOF 12 Weeks (GT3)
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
|
SOF 24 Weeks (GT3)
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
85
|
74
|
12
|
250
|
|
Overall Study
Included in Full Analysis Set
|
0
|
73
|
11
|
250
|
|
Overall Study
COMPLETED
|
0
|
69
|
5
|
211
|
|
Overall Study
NOT COMPLETED
|
85
|
5
|
7
|
39
|
Reasons for withdrawal
| Measure |
Placebo 12 Weeks (GT2/3)
Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT)2 or 3 HCV infection.
|
SOF 12 Weeks (GT2)
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
|
SOF 12 Weeks (GT3)
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
|
SOF 24 Weeks (GT3)
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
|
|---|---|---|---|---|
|
Overall Study
Randomized but Not Treated
|
0
|
1
|
1
|
0
|
|
Overall Study
Terminated by Sponsor
|
83
|
0
|
0
|
0
|
|
Overall Study
Efficacy Failure
|
0
|
3
|
3
|
30
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
6
|
|
Overall Study
Subject Withdrew Consent
|
0
|
0
|
2
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
Baseline characteristics by cohort
| Measure |
Placebo 12 Weeks (GT2/3)
n=85 Participants
Placebo to match SOF + placebo to match RBV for 12 weeks in participants with genotype 2 or 3 HCV infection.
|
SOF 12 Weeks (GT2)
n=73 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
|
SOF 12 Weeks (GT3)
n=11 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
|
SOF 24 Weeks (GT3)
n=250 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
|
Total
n=419 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
58 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
46 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
48 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
50 years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
169 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
250 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
1 participants
n=5 Participants
|
36 participants
n=4 Participants
|
53 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
71 participants
n=5 Participants
|
65 participants
n=7 Participants
|
10 participants
n=5 Participants
|
203 participants
n=4 Participants
|
349 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
11 participants
n=4 Participants
|
17 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
81 participants
n=5 Participants
|
65 participants
n=7 Participants
|
11 participants
n=5 Participants
|
236 participants
n=4 Participants
|
393 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
9 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not permitted
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Region of Enrollment
France
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
0 participants
n=5 Participants
|
53 participants
n=4 Participants
|
81 participants
n=21 Participants
|
|
Region of Enrollment
Estonia
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
11 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
31 participants
n=4 Participants
|
48 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
18 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
12 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
0 participants
n=5 Participants
|
14 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants
|
8 participants
n=7 Participants
|
1 participants
n=5 Participants
|
46 participants
n=4 Participants
|
69 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
17 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
31 participants
n=4 Participants
|
55 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
25 participants
n=7 Participants
|
1 participants
n=5 Participants
|
27 participants
n=4 Participants
|
62 participants
n=21 Participants
|
|
Region of Enrollment
Sweden
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
0 participants
n=5 Participants
|
12 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
HCV Genotype
Genotype 2
|
18 participants
n=5 Participants
|
73 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
91 participants
n=21 Participants
|
|
HCV Genotype
Genotype 3
|
67 participants
n=5 Participants
|
0 participants
n=7 Participants
|
11 participants
n=5 Participants
|
250 participants
n=4 Participants
|
328 participants
n=21 Participants
|
|
Liver Cirrhosis
No
|
68 participants
n=5 Participants
|
62 participants
n=7 Participants
|
9 participants
n=5 Participants
|
190 participants
n=4 Participants
|
329 participants
n=21 Participants
|
|
Liver Cirrhosis
Yes
|
17 participants
n=5 Participants
|
11 participants
n=7 Participants
|
2 participants
n=5 Participants
|
60 participants
n=4 Participants
|
90 participants
n=21 Participants
|
|
IL28b Status
CC
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
4 participants
n=5 Participants
|
86 participants
n=4 Participants
|
136 participants
n=21 Participants
|
|
IL28b Status
CT
|
49 participants
n=5 Participants
|
41 participants
n=7 Participants
|
4 participants
n=5 Participants
|
131 participants
n=4 Participants
|
225 participants
n=21 Participants
|
|
IL28b Status
TT
|
14 participants
n=5 Participants
|
8 participants
n=7 Participants
|
3 participants
n=5 Participants
|
33 participants
n=4 Participants
|
58 participants
n=21 Participants
|
|
HCV RNA
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.69 • n=5 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.70 • n=7 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.77 • n=5 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.74 • n=4 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.72 • n=21 Participants
|
|
HCV RNA Category
< 6 log10 IU/mL
|
21 participants
n=5 Participants
|
16 participants
n=7 Participants
|
4 participants
n=5 Participants
|
72 participants
n=4 Participants
|
113 participants
n=21 Participants
|
|
HCV RNA Category
≥ 6 log10 IU/mL
|
64 participants
n=5 Participants
|
57 participants
n=7 Participants
|
7 participants
n=5 Participants
|
178 participants
n=4 Participants
|
306 participants
n=21 Participants
|
|
Prior HCV Treatment Experience
Experienced
|
50 participants
n=5 Participants
|
41 participants
n=7 Participants
|
9 participants
n=5 Participants
|
145 participants
n=4 Participants
|
245 participants
n=21 Participants
|
|
Prior HCV Treatment Experience
Naive
|
35 participants
n=5 Participants
|
32 participants
n=7 Participants
|
2 participants
n=5 Participants
|
105 participants
n=4 Participants
|
174 participants
n=21 Participants
|
|
Response to prior HCV treatment
Interferon intolerant
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
10 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Response to prior HCV treatment
Nonresponse
|
18 participants
n=5 Participants
|
10 participants
n=7 Participants
|
4 participants
n=5 Participants
|
41 participants
n=4 Participants
|
73 participants
n=21 Participants
|
|
Response to prior HCV treatment
Relapse/Breakthrough
|
32 participants
n=5 Participants
|
28 participants
n=7 Participants
|
5 participants
n=5 Participants
|
94 participants
n=4 Participants
|
159 participants
n=21 Participants
|
|
Interferon Eligibility
Interferon eligible
|
30 participants
n=5 Participants
|
27 participants
n=7 Participants
|
2 participants
n=5 Participants
|
94 participants
n=4 Participants
|
153 participants
n=21 Participants
|
|
Interferon Eligibility
Interferon ineligible
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
11 participants
n=4 Participants
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
Outcome measures
| Measure |
SOF 12 Weeks (GT2)
n=73 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
|
SOF 12 Weeks (GT3)
n=11 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
|
SOF 24 Weeks (GT3)
n=250 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
93.2 percentage of participants
|
27.3 percentage of participants
|
85.2 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.
Outcome measures
| Measure |
SOF 12 Weeks (GT2)
n=85 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
|
SOF 12 Weeks (GT3)
n=84 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
|
SOF 24 Weeks (GT3)
n=250 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
|
|---|---|---|---|
|
Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
|
1.2 percentage of participants
|
1.2 percentage of participants
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.
SVR4 and SVR24 was defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
Outcome measures
| Measure |
SOF 12 Weeks (GT2)
n=73 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
|
SOF 12 Weeks (GT3)
n=11 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
|
SOF 24 Weeks (GT3)
n=250 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
93.2 percentage of participants
|
45.5 percentage of participants
|
87.2 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
93.2 percentage of participants
|
27.3 percentage of participants
|
84.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.
Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA \> LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA \< LLOQ) while on treatment. Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
Outcome measures
| Measure |
SOF 12 Weeks (GT2)
n=73 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
|
SOF 12 Weeks (GT3)
n=11 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
|
SOF 24 Weeks (GT3)
n=250 Participants
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
|
|---|---|---|---|
|
Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Viral breakthrough
|
0 percentage of participants
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Viral relapse
|
6.8 percentage of participants
|
54.5 percentage of participants
|
14.0 percentage of participants
|
Adverse Events
Placebo 12 Weeks (GT2/3)
Serious events: 2 serious events
Other events: 60 other events
Deaths: 0 deaths
SOF 12 Weeks (GT2/3)
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
SOF 24 Weeks (GT3)
Serious events: 10 serious events
Other events: 229 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo 12 Weeks (GT2/3)
n=85 participants at risk
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
|
SOF 12 Weeks (GT2/3)
n=84 participants at risk
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
|
SOF 24 Weeks (GT3)
n=250 participants at risk
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
|
|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.40%
1/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Adenocarcinoma of colon
|
1.2%
1/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.40%
1/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.40%
1/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.40%
1/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Investigations
Amylase increased
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.40%
1/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.40%
1/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.40%
1/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.40%
1/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.40%
1/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.40%
1/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.40%
1/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo 12 Weeks (GT2/3)
n=85 participants at risk
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
|
SOF 12 Weeks (GT2/3)
n=84 participants at risk
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
|
SOF 24 Weeks (GT3)
n=250 participants at risk
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
7.1%
6/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.8%
17/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.6%
9/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
31.0%
26/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
13.2%
33/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
4/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.8%
4/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
12.0%
30/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
6/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
8.3%
7/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.0%
15/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
4/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
1.2%
1/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
8.4%
21/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
3.6%
3/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.0%
15/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
2.4%
2/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.2%
13/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
18.8%
16/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
22.6%
19/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
30.0%
75/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
4.7%
4/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
25.0%
21/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
21.2%
53/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Irritability
|
3.5%
3/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.8%
4/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
10.4%
26/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
5.9%
5/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
1.2%
1/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.4%
16/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
2.4%
2/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
8.3%
7/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
3.6%
9/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.0%
5/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
2.0%
5/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
10.6%
9/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.8%
4/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
14.4%
36/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
7.1%
6/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.8%
12/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.7%
4/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.0%
5/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.4%
16/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
6/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
3.6%
3/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
10.0%
25/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
1/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.8%
4/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
8.8%
22/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
5/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.0%
5/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.0%
15/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.2%
13/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
27.1%
23/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
28.6%
24/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
29.6%
74/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
2.4%
2/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.0%
5/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
7.6%
19/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
2.4%
2/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
1.2%
1/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.0%
15/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
2.4%
2/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
10.7%
9/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
16.4%
41/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
4.7%
4/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.8%
4/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
9.2%
23/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
2.4%
2/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
1.2%
1/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.2%
13/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depressed mood
|
2.4%
2/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
1.2%
1/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.2%
13/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
14.3%
12/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
10.8%
27/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
4/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
9.5%
8/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
10.8%
27/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
7.1%
6/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
3.6%
9/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.4%
8/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
23.8%
20/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
26.8%
67/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
5/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
9.5%
8/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
12.4%
31/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
2/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
1.2%
1/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
9.6%
24/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/85 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
3.6%
3/84 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.6%
14/250 • Baseline up to Week 24 plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER