Trial Outcomes & Findings for SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection (NCT NCT01962441)
NCT ID: NCT01962441
Last Updated: 2017-06-20
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
601 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2017-06-20
Participant Flow
Participants were enrolled at study sites in Europe, North America, Australia, and New Zealand. The first participant was screened on 24 September 2013. The last study visit occurred on 07 July 2016.
776 participants were screened.
Participant milestones
| Measure |
SOF+RBV 16 Weeks, Then Retreatment
Randomized Period: Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks.
|
SOF+RBV 24 Weeks, Then Retreatment
Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks.
|
SOF+RBV+Peg-IFN 12 Weeks
Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks
Participants in this group were not eligible to enroll into the Retreatment Period.
|
|---|---|---|---|
|
Randomized Period
STARTED
|
200
|
201
|
200
|
|
Randomized Period
COMPLETED
|
190
|
190
|
189
|
|
Randomized Period
NOT COMPLETED
|
10
|
11
|
11
|
|
Retreatment Substudy
STARTED
|
20
|
10
|
0
|
|
Retreatment Substudy
COMPLETED
|
18
|
10
|
0
|
|
Retreatment Substudy
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
SOF+RBV 16 Weeks, Then Retreatment
Randomized Period: Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks.
|
SOF+RBV 24 Weeks, Then Retreatment
Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
Retreatment Period: Participants who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF+Peg-IFN+RBV for 12 weeks.
|
SOF+RBV+Peg-IFN 12 Weeks
Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks
Participants in this group were not eligible to enroll into the Retreatment Period.
|
|---|---|---|---|
|
Randomized Period
Randomized but Never Treated
|
4
|
2
|
3
|
|
Randomized Period
Lost to Follow-up
|
2
|
4
|
4
|
|
Randomized Period
Withdrew Consent
|
3
|
3
|
2
|
|
Randomized Period
Adverse Event
|
1
|
1
|
0
|
|
Randomized Period
Death
|
0
|
0
|
2
|
|
Randomized Period
Protocol Violation
|
0
|
1
|
0
|
|
Retreatment Substudy
Lack of Efficacy
|
1
|
0
|
0
|
|
Retreatment Substudy
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
Baseline characteristics by cohort
| Measure |
SOF+RBV 16 Weeks
n=196 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
n=199 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=197 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
|
Total
n=592 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
49 years
STANDARD_DEVIATION 9.8 • n=107 Participants
|
50 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
50 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
197 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
395 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
2 participants
n=206 Participants
|
12 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
188 participants
n=99 Participants
|
188 participants
n=107 Participants
|
191 participants
n=206 Participants
|
567 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
162 participants
n=99 Participants
|
168 participants
n=107 Participants
|
165 participants
n=206 Participants
|
495 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
29 participants
n=99 Participants
|
26 participants
n=107 Participants
|
25 participants
n=206 Participants
|
80 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian/ Alaska Native/ First Nations
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hawaiian or Pacific Islander
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
New Zealand
|
15 participants
n=99 Participants
|
12 participants
n=107 Participants
|
13 participants
n=206 Participants
|
40 participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
21 participants
n=99 Participants
|
33 participants
n=107 Participants
|
29 participants
n=206 Participants
|
83 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
33 participants
n=107 Participants
|
31 participants
n=206 Participants
|
93 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
86 participants
n=99 Participants
|
82 participants
n=107 Participants
|
80 participants
n=206 Participants
|
248 participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
45 participants
n=99 Participants
|
39 participants
n=107 Participants
|
44 participants
n=206 Participants
|
128 participants
n=7 Participants
|
|
HCV Genotype
Genotype 2
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
16 participants
n=206 Participants
|
48 participants
n=7 Participants
|
|
HCV Genotype
Genotype 3
|
181 participants
n=99 Participants
|
182 participants
n=107 Participants
|
181 participants
n=206 Participants
|
544 participants
n=7 Participants
|
|
IL28b Status
CC
|
75 participants
n=99 Participants
|
73 participants
n=107 Participants
|
78 participants
n=206 Participants
|
226 participants
n=7 Participants
|
|
IL28b Status
CT
|
94 participants
n=99 Participants
|
95 participants
n=107 Participants
|
98 participants
n=206 Participants
|
287 participants
n=7 Participants
|
|
IL28b Status
TT
|
27 participants
n=99 Participants
|
31 participants
n=107 Participants
|
21 participants
n=206 Participants
|
79 participants
n=7 Participants
|
|
HCV RNA
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.68 • n=99 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.71 • n=107 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.69 • n=206 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.69 • n=7 Participants
|
|
HCV RNA Category
< 6 log10 IU/mL
|
60 participants
n=99 Participants
|
72 participants
n=107 Participants
|
60 participants
n=206 Participants
|
192 participants
n=7 Participants
|
|
HCV RNA Category
≥ 6 log10 IU/mL
|
136 participants
n=99 Participants
|
127 participants
n=107 Participants
|
137 participants
n=206 Participants
|
400 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized 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+RBV 16 Weeks
n=196 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
n=199 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=197 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
71.9 percentage of participants
|
85.4 percentage of participants
|
92.9 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.
Outcome measures
| Measure |
SOF+RBV 16 Weeks
n=196 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
n=199 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=197 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
1.5 percentage of participants
|
1.5 percentage of participants
|
1.5 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 16 Weeks
n=196 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
n=199 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=197 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
73.0 percentage of participants
|
85.9 percentage of participants
|
95.9 percentage of participants
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
71.9 percentage of participants
|
84.4 percentage of participants
|
93.4 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV 16 Weeks
n=196 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
n=199 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=197 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 1
|
14.8 percentage of participants
|
20.1 percentage of participants
|
25.9 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 2
|
53.3 percentage of participants
|
53.5 percentage of participants
|
67.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 4
|
86.6 percentage of participants
|
91.9 percentage of participants
|
97.4 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 8
|
99.5 percentage of participants
|
99.5 percentage of participants
|
99.5 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 12
|
100.0 percentage of participants
|
98.5 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 16
|
99.0 percentage of participants
|
99.5 percentage of participants
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 20
|
—
|
99.5 percentage of participants
|
—
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Week 24
|
—
|
100.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV 16 Weeks
n=194 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
n=198 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=195 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
|
|---|---|---|---|
|
HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 1
|
2.13 log10 IU/mL
Standard Deviation 0.658
|
2.08 log10 IU/mL
Standard Deviation 0.749
|
1.81 log10 IU/mL
Standard Deviation 0.576
|
|
HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 2
|
1.44 log10 IU/mL
Standard Deviation 0.436
|
1.45 log10 IU/mL
Standard Deviation 0.487
|
1.32 log10 IU/mL
Standard Deviation 0.342
|
|
HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 4
|
1.19 log10 IU/mL
Standard Deviation 0.156
|
1.21 log10 IU/mL
Standard Deviation 0.287
|
1.16 log10 IU/mL
Standard Deviation 0.085
|
|
HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 8
|
1.15 log10 IU/mL
Standard Deviation 0.021
|
1.15 log10 IU/mL
Standard Deviation 0.100
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
|
HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 12
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
1.17 log10 IU/mL
Standard Deviation 0.318
|
1.15 log10 IU/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV 16 Weeks
n=194 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
n=198 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=195 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 1
|
-4.18 log10 IU/mL
Standard Deviation 0.559
|
-4.15 log10 IU/mL
Standard Deviation 0.664
|
-4.46 log10 IU/mL
Standard Deviation 0.556
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 2
|
-4.86 log10 IU/mL
Standard Deviation 0.661
|
-4.78 log10 IU/mL
Standard Deviation 0.714
|
-4.96 log10 IU/mL
Standard Deviation 0.661
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 4
|
-5.11 log10 IU/mL
Standard Deviation 0.671
|
-5.02 log10 IU/mL
Standard Deviation 0.735
|
-5.12 log10 IU/mL
Standard Deviation 0.699
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 8
|
-5.16 log10 IU/mL
Standard Deviation 0.684
|
-5.08 log10 IU/mL
Standard Deviation 0.708
|
-5.12 log10 IU/mL
Standard Deviation 0.691
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 12
|
-5.15 log10 IU/mL
Standard Deviation 0.686
|
-5.05 log10 IU/mL
Standard Deviation 0.788
|
-5.12 log10 IU/mL
Standard Deviation 0.691
|
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 16 Weeks
n=196 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
n=199 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=197 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants Experiencing On-Treatment Virologic Failure
|
0 percentage of participants
|
1.5 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 is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
Outcome measures
| Measure |
SOF+RBV 16 Weeks
n=195 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
n=195 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
|
SOF+RBV+Peg-IFN 12 Weeks
n=195 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants Experiencing Viral Relapse
|
26.7 percentage of participants
|
12.3 percentage of participants
|
4.6 percentage of participants
|
Adverse Events
Randomized Period: SOF+RBV 16 Weeks
Serious events: 8 serious events
Other events: 173 other events
Deaths: 0 deaths
Randomized Period: SOF+RBV 24 Weeks
Serious events: 10 serious events
Other events: 176 other events
Deaths: 0 deaths
Randomized Period: SOF+RBV+Peg-IFN 12 Weeks
Serious events: 12 serious events
Other events: 192 other events
Deaths: 0 deaths
Retreatment Period: SOF+RBV+Peg-IFN 12 Weeks
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized Period: SOF+RBV 16 Weeks
n=196 participants at risk
Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
|
Randomized Period: SOF+RBV 24 Weeks
n=199 participants at risk
Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
|
Randomized Period: SOF+RBV+Peg-IFN 12 Weeks
n=197 participants at risk
Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
|
Retreatment Period: SOF+RBV+Peg-IFN 12 Weeks
n=30 participants at risk
Retreatment Period: Participants from the SOF+RBV 16 Weeks or 24 Weeks groups who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.51%
1/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Pancreatitis
|
0.51%
1/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
General disorders
Chest pain
|
0.51%
1/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Infections and infestations
Cellulitis
|
0.51%
1/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Infections and infestations
Pneumonia
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.51%
1/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.3%
1/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.51%
1/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Nervous system disorders
Syncope
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Depression
|
0.51%
1/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Suicidal ideation
|
0.51%
1/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Social circumstances
Miscarriage of partner
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Vascular disorders
Orthostatic hypotension
|
0.51%
1/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
Other adverse events
| Measure |
Randomized Period: SOF+RBV 16 Weeks
n=196 participants at risk
Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
|
Randomized Period: SOF+RBV 24 Weeks
n=199 participants at risk
Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
|
Randomized Period: SOF+RBV+Peg-IFN 12 Weeks
n=197 participants at risk
Randomized Period: SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
|
Retreatment Period: SOF+RBV+Peg-IFN 12 Weeks
n=30 participants at risk
Retreatment Period: Participants from the SOF+RBV 16 Weeks or 24 Weeks groups who experienced virologic failure during treatment or relapsed at or before Posttreatment Week 24 during the Randomized Period were eligible to enroll into the Retreatment Period to receive SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
4/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.5%
7/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.1%
12/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.6%
11/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Eye disorders
Dry eye
|
1.5%
3/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
2.5%
5/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
2.5%
5/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Abdominal pain
|
4.1%
8/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
4.0%
8/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.6%
11/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.3%
1/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
7/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.0%
10/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
4.6%
9/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Diarrhoea
|
10.7%
21/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
9.0%
18/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
13.7%
27/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
10.0%
3/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Dry mouth
|
1.5%
3/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.5%
7/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.1%
12/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
10/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.0%
12/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.6%
11/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.3%
1/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
4/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
4.0%
8/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
1.5%
3/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.6%
5/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
1.5%
3/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
2.5%
5/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Nausea
|
16.3%
32/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
17.1%
34/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
25.4%
50/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
23.3%
7/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
10/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
10.6%
21/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
9.6%
19/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
General disorders
Asthenia
|
1.0%
2/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
1.5%
3/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.1%
10/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
General disorders
Chills
|
1.5%
3/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
2.0%
4/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
10.7%
21/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.3%
1/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
General disorders
Fatigue
|
37.8%
74/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
41.7%
83/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
46.7%
92/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
60.0%
18/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
General disorders
Influenza like illness
|
3.6%
7/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
4.0%
8/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
19.8%
39/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
20.0%
6/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
General disorders
Injection site rash
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
2.5%
5/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
General disorders
Pyrexia
|
2.6%
5/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.5%
7/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
14.7%
29/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
20.0%
6/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
12/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
7.0%
14/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.6%
7/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.3%
1/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
8/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.0%
10/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
1.5%
3/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Investigations
Platelet count decreased
|
0.00%
0/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
1.5%
3/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.6%
13/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
8.0%
16/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
17.8%
35/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
10.0%
3/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
10/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
7.5%
15/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
12.7%
25/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
10.0%
3/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
10/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
7.0%
14/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
7.6%
15/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.6%
9/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
11.1%
22/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.6%
11/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.3%
1/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
12/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
9.5%
19/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
16.8%
33/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
23.3%
7/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.0%
2/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
1.0%
2/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.51%
1/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Nervous system disorders
Dizziness
|
5.6%
11/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
8.0%
16/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.6%
13/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Nervous system disorders
Dizziness postural
|
1.5%
3/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.50%
1/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.1%
10/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Nervous system disorders
Dysgeusia
|
3.1%
6/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
2.0%
4/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.1%
10/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.3%
1/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Nervous system disorders
Headache
|
31.1%
61/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
36.2%
72/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
35.5%
70/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
40.0%
12/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Nervous system disorders
Lethargy
|
4.6%
9/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
4.0%
8/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.1%
10/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.3%
1/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Nervous system disorders
Memory impairment
|
5.1%
10/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
1.5%
3/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
2.5%
5/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.3%
1/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Anxiety
|
6.1%
12/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
8.0%
16/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
8.6%
17/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.3%
1/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Depressed mood
|
4.1%
8/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.5%
11/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
8.6%
17/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Depression
|
0.51%
1/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
4.0%
8/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.1%
10/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
10.0%
3/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Insomnia
|
24.0%
47/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
28.1%
56/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
25.4%
50/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Irritability
|
8.7%
17/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
12.6%
25/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
10.7%
21/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
10.0%
3/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Mood swings
|
1.5%
3/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.5%
7/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
2.5%
5/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
10.0%
3/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Psychiatric disorders
Sleep disorder
|
7.7%
15/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.5%
7/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
5.6%
11/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
10/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
9.5%
19/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
14.2%
28/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
3/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
1.5%
3/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
2.5%
5/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.7%
2/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
11.2%
22/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
11.1%
22/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
15.2%
30/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
3.3%
1/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.6%
7/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
1.0%
2/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
6.1%
12/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.1%
6/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
4.5%
9/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
8.1%
16/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
15/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
11.1%
22/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
12.7%
25/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
10.0%
3/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.7%
21/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
12.1%
24/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
11.2%
22/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
20.0%
6/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
4.6%
9/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
8.0%
16/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
7.6%
15/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
0.00%
0/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.2%
24/196 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
13.6%
27/199 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
19.8%
39/197 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
20.0%
6/30 • Up to 24 weeks plus 30 days (Randomized Period) Up to 12 additional weeks plus 30 days (Retreatment Period)
Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. MedDRA version 18.0 = Randomized Period; MedDRA version 19.0 = Retreatment Period
|
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