Trial Outcomes & Findings for Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV (NCT NCT01701401)
NCT ID: NCT01701401
Last Updated: 2018-11-16
Results Overview
SVR12 was defined as HCV RNA level \< the lower limit of quantification (LLOQ, ie, \< 25 copies/mL) 12 weeks after last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
870 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at a total of 100 study sites in the United States and Europe. The first participant was screened on 26 September 2012. The last study visit occurred on 30 April 2014.
1015 participants were screened.
Participant milestones
| Measure |
LDV/SOF 12 Weeks
Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
LDV/SOF 90/400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
217
|
218
|
217
|
218
|
|
Overall Study
COMPLETED
|
207
|
209
|
212
|
212
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
5
|
6
|
Reasons for withdrawal
| Measure |
LDV/SOF 12 Weeks
Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
LDV/SOF 90/400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Overall Study
Randomized But Not Treated
|
3
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
1
|
3
|
|
Overall Study
Withdrew Consent
|
0
|
3
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
Baseline characteristics by cohort
| Measure |
LDV/SOF 12 Weeks
n=214 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
Total
n=865 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
52 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
53 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
53 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
52 years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
352 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
513 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
32 participants
n=5 Participants
|
26 participants
n=4 Participants
|
108 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
187 participants
n=5 Participants
|
188 participants
n=7 Participants
|
177 participants
n=5 Participants
|
183 participants
n=4 Participants
|
735 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hawaiian or Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
26 participants
n=5 Participants
|
20 participants
n=7 Participants
|
29 participants
n=5 Participants
|
26 participants
n=4 Participants
|
101 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
187 participants
n=5 Participants
|
197 participants
n=7 Participants
|
188 participants
n=5 Participants
|
190 participants
n=4 Participants
|
762 participants
n=21 Participants
|
|
Region of Enrollment
France
|
11 participants
n=5 Participants
|
24 participants
n=7 Participants
|
18 participants
n=5 Participants
|
10 participants
n=4 Participants
|
63 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=5 Participants
|
118 participants
n=7 Participants
|
132 participants
n=5 Participants
|
137 participants
n=4 Participants
|
512 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
12 participants
n=5 Participants
|
14 participants
n=4 Participants
|
55 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
24 participants
n=5 Participants
|
20 participants
n=7 Participants
|
22 participants
n=5 Participants
|
18 participants
n=4 Participants
|
84 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
13 participants
n=5 Participants
|
17 participants
n=7 Participants
|
10 participants
n=5 Participants
|
15 participants
n=4 Participants
|
55 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
27 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
23 participants
n=4 Participants
|
96 participants
n=21 Participants
|
|
Hepatitis C Virus (HCV) RNA
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.69 • n=5 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.64 • n=7 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.68 • n=5 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.65 • n=4 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.66 • n=21 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
45 participants
n=5 Participants
|
44 participants
n=7 Participants
|
49 participants
n=5 Participants
|
44 participants
n=4 Participants
|
182 participants
n=21 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
169 participants
n=5 Participants
|
173 participants
n=7 Participants
|
168 participants
n=5 Participants
|
173 participants
n=4 Participants
|
683 participants
n=21 Participants
|
|
HCV Genotype
Genotype 1a
|
144 participants
n=5 Participants
|
148 participants
n=7 Participants
|
146 participants
n=5 Participants
|
143 participants
n=4 Participants
|
581 participants
n=21 Participants
|
|
HCV Genotype
Genotype 1b
|
66 participants
n=5 Participants
|
68 participants
n=7 Participants
|
68 participants
n=5 Participants
|
71 participants
n=4 Participants
|
273 participants
n=21 Participants
|
|
HCV Genotype
Genotype 1 (no confirmed subtype)
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
HCV Genotype
Genotype 4
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
HCV Genotype
Missing
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
IL28b Status
CC
|
55 participants
n=5 Participants
|
76 participants
n=7 Participants
|
52 participants
n=5 Participants
|
73 participants
n=4 Participants
|
256 participants
n=21 Participants
|
|
IL28b Status
CT
|
113 participants
n=5 Participants
|
107 participants
n=7 Participants
|
119 participants
n=5 Participants
|
112 participants
n=4 Participants
|
451 participants
n=21 Participants
|
|
IL28b Status
TT
|
46 participants
n=5 Participants
|
34 participants
n=7 Participants
|
46 participants
n=5 Participants
|
32 participants
n=4 Participants
|
158 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants were randomized and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA level \< the lower limit of quantification (LLOQ, ie, \< 25 copies/mL) 12 weeks after last dose of study drug.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=214 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)
|
98.6 percentage of participants
|
97.2 percentage of participants
|
98.2 percentage of participants
|
99.1 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=214 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
|
0 percentage of participants
|
0.5 percentage of participants
|
1.8 percentage of participants
|
3.7 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR24 were defined as HCV RNA level \< LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=214 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug
SVR4
|
98.6 percentage of participants
|
98.2 percentage of participants
|
99.1 percentage of participants
|
99.1 percentage of participants
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug
SVR24
|
98.6 percentage of participants
|
97.2 percentage of participants
|
98.2 percentage of participants
|
99.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=213 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=216 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 2
|
82.2 percentage of participants
|
83.4 percentage of participants
|
82.9 percentage of participants
|
82.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=213 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=216 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 4
|
100 percentage of participants
|
99.1 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=213 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=215 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=215 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 8
|
99.5 percentage of participants
|
100 percentage of participants
|
99.5 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 2Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=213 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=216 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=216 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 2
|
-4.90 log10 IU/mL
Standard Deviation 0.657
|
-4.94 log10 IU/mL
Standard Deviation 0.633
|
-4.86 log10 IU/mL
Standard Deviation 0.670
|
-4.89 log10 IU/mL
Standard Deviation 0.648
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=213 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=216 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=216 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 4
|
-4.99 log10 IU/mL
Standard Deviation 0.697
|
-5.02 log10 IU/mL
Standard Deviation 0.623
|
-4.93 log10 IU/mL
Standard Deviation 0.678
|
-4.96 log10 IU/mL
Standard Deviation 0.651
|
SECONDARY outcome
Timeframe: Baseline; Week 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=213 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=215 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=216 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 8
|
-4.99 log10 IU/mL
Standard Deviation 0.696
|
-5.02 log10 IU/mL
Standard Deviation 0.625
|
-4.91 log10 IU/mL
Standard Deviation 0.702
|
-4.96 log10 IU/mL
Standard Deviation 0.651
|
SECONDARY outcome
Timeframe: Baseline to posttreatment Week 24Population: Full Analysis Set
On-treatment virologic failure was defined as: * Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR * Rebound: \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR * Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment Virologic relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=214 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=217 Participants
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure
On-treatment virologic failure
|
0 percentage of participants
|
0 percentage of participants
|
0.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Failure
Virologic relapse
|
0.5 percentage of participants
|
0 percentage of participants
|
0.5 percentage of participants
|
0 percentage of participants
|
Adverse Events
LDV/SOF 12 Weeks
Serious events: 1 serious events
Other events: 140 other events
Deaths: 0 deaths
LDV/SOF+RBV 12 Weeks
Serious events: 7 serious events
Other events: 168 other events
Deaths: 0 deaths
LDV/SOF 24 Weeks
Serious events: 18 serious events
Other events: 149 other events
Deaths: 0 deaths
LDV/SOF+RBV 24 Weeks
Serious events: 7 serious events
Other events: 189 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF 12 Weeks
n=214 participants at risk
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=217 participants at risk
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=217 participants at risk
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=217 participants at risk
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Factor VIII inhibition
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.47%
1/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.92%
2/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Salpingitis
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.92%
2/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.46%
1/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
LDV/SOF 12 Weeks
n=214 participants at risk
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF+RBV 12 Weeks
n=217 participants at risk
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
|
LDV/SOF 24 Weeks
n=217 participants at risk
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
LDV/SOF+RBV 24 Weeks
n=217 participants at risk
LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
11.5%
25/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.00%
0/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
10.1%
22/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
11.2%
24/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
17.1%
37/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
13.4%
29/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
14.7%
32/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.2%
24/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
8.3%
18/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
11.1%
24/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.5%
14/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
6.1%
13/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.5%
12/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.9%
15/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.6%
10/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
7/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.1%
11/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.5%
14/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.5%
12/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
12/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.1%
9/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
3.2%
7/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
3.7%
8/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
7/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.1%
9/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
2.8%
6/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.5%
12/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
5/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.1%
11/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
3.2%
7/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.1%
9/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.9%
4/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
3.2%
7/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
1.4%
3/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.1%
11/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
21.5%
46/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
36.4%
79/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
24.4%
53/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
38.7%
84/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
6.5%
14/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
10.6%
23/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
9.2%
20/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
12.0%
26/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
General disorders
Irritability
|
5.1%
11/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
7.8%
17/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
7.8%
17/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
11.1%
24/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
14/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.1%
9/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.0%
13/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
8.8%
19/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.7%
10/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.5%
12/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
3.7%
8/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.1%
9/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
9/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.5%
14/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
9.7%
21/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.0%
13/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
9/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.0%
13/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.5%
12/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.5%
12/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
12/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
2.3%
5/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.5%
12/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.5%
14/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.3%
7/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.5%
14/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.1%
9/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.5%
12/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
25.2%
54/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
23.0%
50/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
24.9%
54/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
30.4%
66/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.1%
11/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.6%
10/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.5%
14/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
8.3%
18/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
7.9%
17/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
20.7%
45/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
12.0%
26/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
21.2%
46/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
3.3%
7/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.1%
9/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.5%
12/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
8.8%
19/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
2.3%
5/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
2.8%
6/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
2.3%
5/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.1%
11/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
6/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
10.1%
22/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
7.4%
16/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
11.5%
25/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
3/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
8.3%
18/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
2.3%
5/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.9%
15/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.4%
3/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
4.1%
9/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
0.92%
2/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
5.1%
11/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.5%
16/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
9.7%
21/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
7.4%
16/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
12.0%
26/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
11/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
10.1%
22/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
3.7%
8/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
9.2%
20/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.93%
2/214 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.5%
14/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
1.4%
3/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
6.0%
13/217 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER