Trial Outcomes & Findings for Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection (NCT NCT02249182)
NCT ID: NCT02249182
Last Updated: 2020-03-02
Results Overview
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
226 participants
Primary outcome timeframe
Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to < 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10
Results posted on
2020-03-02
Participant Flow
Participants were enrolled at study sites in the United States, United Kingdom, Australia, and New Zealand. The first participant was screened on 05 November 2014. The last study visit occurred on 24 August 2018.
240 participants were screened.
Participant milestones
| Measure |
12 to < 18 Years Old - LDV/SOF 12 Weeks
Participants 12 to \< 18 years of age with hepatitis C virus (HCV) genotype 1 treatment-naive (TN) with or without cirrhosis or treatment-experienced (TE) without cirrhosis received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
6 to < 12 Years Old - LDV/SOF 12 Weeks
Participants 6 to \< 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
6 to < 12 Years Old - LDV/SOF 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin (RBV) capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
|---|---|---|---|---|---|
|
PK Lead-In Phase
STARTED
|
10
|
12
|
0
|
0
|
17
|
|
PK Lead-In Phase
COMPLETED
|
10
|
12
|
0
|
0
|
17
|
|
PK Lead-In Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Phase
STARTED
|
100
|
89
|
1
|
2
|
34
|
|
Treatment Phase
COMPLETED
|
96
|
89
|
1
|
2
|
34
|
|
Treatment Phase
NOT COMPLETED
|
4
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
12 to < 18 Years Old - LDV/SOF 12 Weeks
Participants 12 to \< 18 years of age with hepatitis C virus (HCV) genotype 1 treatment-naive (TN) with or without cirrhosis or treatment-experienced (TE) without cirrhosis received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
6 to < 12 Years Old - LDV/SOF 12 Weeks
Participants 6 to \< 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
6 to < 12 Years Old - LDV/SOF 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin (RBV) capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.
|
|---|---|---|---|---|---|
|
Treatment Phase
Lost to Follow-up
|
4
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
Baseline characteristics by cohort
| Measure |
12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 Participants
Participants 12 to \< 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 Participants
Participants 6 to \< 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF 24 Weeks
n=1 Participants
Participants 6 to \< 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 Participants
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
15 years
STANDARD_DEVIATION 1.7 • n=99 Participants
|
9 years
STANDARD_DEVIATION 1.6 • n=107 Participants
|
11 years
STANDARD_DEVIATION NA • n=206 Participants
|
9 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
4 years
STANDARD_DEVIATION 0.7 • n=31 Participants
|
11 years
STANDARD_DEVIATION 4.1 • n=30 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
125 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
101 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White
|
91 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
191 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
28 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
85 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
191 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
|
Region of Enrollment
New Zealand
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
91 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
190 Participants
n=30 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
|
Region of Enrollment
Australia
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
17 Participants
n=30 Participants
|
|
HCV Genotype
Genotype 1
|
100 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
221 Participants
n=30 Participants
|
|
HCV Genotype
Genotype 3
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
HCV Genotype
Genotype 4
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Cirrhosis Status
Yes
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Cirrhosis Status
No
|
43 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
92 Participants
n=30 Participants
|
|
Cirrhosis Status
Unknown
|
56 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
131 Participants
n=30 Participants
|
|
IL28b Status
CC
|
24 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
57 Participants
n=30 Participants
|
|
IL28b Status
CT
|
53 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
124 Participants
n=30 Participants
|
|
IL28b Status
TT
|
23 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
42 Participants
n=30 Participants
|
|
IL28b Status
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
45 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
98 Participants
n=30 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
55 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
128 Participants
n=30 Participants
|
|
Prior Treatment Experience
Treatment-Naive
|
80 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
186 Participants
n=30 Participants
|
|
Prior Treatment Experience
Treatment-Experienced
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
40 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to < 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10Population: Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=10 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=10 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=13 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF
GS-331007 (metabolite of SOF)
|
12682.5 h*ng/mL
Standard Deviation 1732.66
|
8210.3 h*ng/mL
Standard Deviation 2542.42
|
11688.9 h*ng/mL
Standard Deviation 3400.79
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF
LDV
|
10202.4 h*ng/mL
Standard Deviation 5196.49
|
7288.3 h*ng/mL
Standard Deviation 4547.33
|
9316.3 h*ng/mL
Standard Deviation 3280.51
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF
SOF
|
2175.7 h*ng/mL
Standard Deviation 578.92
|
1754.4 h*ng/mL
Standard Deviation 419.18
|
2495.2 h*ng/mL
Standard Deviation 412.64
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=1 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 Participants
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12Population: Participants who were enrolled in the PK lead-in phase with available data were analyzed.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=10 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=12 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=17 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 1
|
-4.34 log10 IU/mL
Standard Deviation 0.621
|
-4.29 log10 IU/mL
Standard Deviation 0.518
|
-4.32 log10 IU/mL
Standard Deviation 0.616
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 2
|
-4.71 log10 IU/mL
Standard Deviation 0.651
|
-4.55 log10 IU/mL
Standard Deviation 0.636
|
-4.87 log10 IU/mL
Standard Deviation 0.724
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 4
|
-4.73 log10 IU/mL
Standard Deviation 0.667
|
-4.75 log10 IU/mL
Standard Deviation 0.702
|
-4.92 log10 IU/mL
Standard Deviation 0.715
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 8
|
-4.73 log10 IU/mL
Standard Deviation 0.667
|
-4.76 log10 IU/mL
Standard Deviation 0.710
|
-4.92 log10 IU/mL
Standard Deviation 0.715
|
—
|
—
|
|
For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA
Change at Week 12
|
-4.73 log10 IU/mL
Standard Deviation 0.667
|
-4.76 log10 IU/mL
Standard Deviation 0.710
|
-4.92 log10 IU/mL
Standard Deviation 0.715
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 10Population: Participants who were enrolled in the PK lead-in phase were analyzed.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=10 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=12 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=17 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase
|
0 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
SVR4 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=1 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 Participants
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)
|
98.0 percentage of participants
Interval 93.0 to 99.8
|
98.9 percentage of participants
Interval 93.9 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
97.1 percentage of participants
Interval 84.7 to 99.9
|
SECONDARY outcome
Timeframe: Posttreatment Week 12Population: Participants in the Full Analysis Set were analyzed.
SVR12 was defined as HCV RNA \< LLOQ at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=1 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 Participants
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)
|
98.0 percentage of participants
Interval 93.0 to 99.8
|
98.9 percentage of participants
Interval 93.9 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
97.1 percentage of participants
Interval 84.7 to 99.9
|
SECONDARY outcome
Timeframe: Posttreatment Week 24Population: Participants in the Full Analysis Set were analyzed.
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=1 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 Participants
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
|
98.0 percentage of participants
Interval 93.0 to 99.8
|
98.9 percentage of participants
Interval 93.9 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
97.1 percentage of participants
Interval 84.7 to 99.9
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Participants in the Full Analysis Set were analyzed.
Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=1 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 Participants
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Participants in the Full Analysis Set were analyzed.
Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=1 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 Participants
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse
|
0 percentage of participants
|
1.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)Population: Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=1 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 Participants
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 1
|
-4.34 log10 IU/mL
Standard Deviation 0.634
|
-4.27 log10 IU/mL
Standard Deviation 0.592
|
-4.30 log10 IU/mL
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
-4.54 log10 IU/mL
Standard Deviation 0.308
|
-4.25 log10 IU/mL
Standard Deviation 0.505
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 2
|
-4.74 log10 IU/mL
Standard Deviation 0.585
|
-4.73 log10 IU/mL
Standard Deviation 0.544
|
-5.09 log10 IU/mL
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
-4.54 log10 IU/mL
Standard Deviation 0.308
|
-4.80 log10 IU/mL
Standard Deviation 0.628
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 4
|
-4.84 log10 IU/mL
Standard Deviation 0.557
|
-4.87 log10 IU/mL
Standard Deviation 0.592
|
-5.09 log10 IU/mL
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
-4.54 log10 IU/mL
Standard Deviation 0.308
|
-4.85 log10 IU/mL
Standard Deviation 0.628
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 8
|
-4.85 log10 IU/mL
Standard Deviation 0.556
|
-4.89 log10 IU/mL
Standard Deviation 0.597
|
-5.09 log10 IU/mL
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
-4.54 log10 IU/mL
Standard Deviation 0.308
|
-4.86 log10 IU/mL
Standard Deviation 0.633
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 12
|
-4.85 log10 IU/mL
Standard Deviation 0.556
|
-4.89 log10 IU/mL
Standard Deviation 0.597
|
-5.09 log10 IU/mL
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
-4.54 log10 IU/mL
Standard Deviation 0.308
|
-4.86 log10 IU/mL
Standard Deviation 0.633
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 16
|
—
|
—
|
-5.09 log10 IU/mL
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
-4.54 log10 IU/mL
Standard Deviation 0.308
|
—
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 20
|
—
|
—
|
-5.09 log10 IU/mL
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
-4.54 log10 IU/mL
Standard Deviation 0.308
|
—
|
|
For the Treatment Phase, Change From Baseline in HCV RNA
Change at Week 24
|
—
|
—
|
-5.09 log10 IU/mL
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
-4.54 log10 IU/mL
Standard Deviation 0.308
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)Population: Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=1 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 Participants
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 1
|
40.0 percentage of participants
Interval 30.3 to 50.3
|
30.3 percentage of participants
Interval 21.0 to 41.0
|
0 percentage of participants
Interval 0.0 to 97.5
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
29.4 percentage of participants
Interval 15.1 to 47.5
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 2
|
75.0 percentage of participants
Interval 65.3 to 83.1
|
71.9 percentage of participants
Interval 61.4 to 80.9
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
78.8 percentage of participants
Interval 61.1 to 91.0
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 4
|
97.0 percentage of participants
Interval 91.5 to 99.4
|
96.6 percentage of participants
Interval 90.5 to 99.3
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
97.0 percentage of participants
Interval 84.2 to 99.9
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 8
|
100.0 percentage of participants
Interval 96.3 to 100.0
|
100.0 percentage of participants
Interval 95.9 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 89.4 to 100.0
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 12
|
100.0 percentage of participants
Interval 96.3 to 100.0
|
100.0 percentage of participants
Interval 95.9 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 89.4 to 100.0
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 16
|
—
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 20
|
—
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
|
For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment
Week 24
|
—
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4Population: Participants in the Full Analysis Set with ALT \> ULN at Baseline with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.
ALT normalization was defined as ALT \> the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=49 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=72 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=1 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=27 Participants
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 1
|
72.3 percentage of participants
|
75.7 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
63.0 percentage of participants
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 2
|
89.8 percentage of participants
|
84.8 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
84.0 percentage of participants
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 4
|
93.8 percentage of participants
|
93.1 percentage of participants
|
0 percentage of participants
|
100.0 percentage of participants
|
96.0 percentage of participants
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 8
|
91.3 percentage of participants
|
90.1 percentage of participants
|
0 percentage of participants
|
100.0 percentage of participants
|
92.0 percentage of participants
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 12
|
93.3 percentage of participants
|
95.5 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
91.7 percentage of participants
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 16
|
—
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 20
|
—
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Week 24
|
—
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
|
For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization
Posttreatment Week 4
|
90.2 percentage of participants
|
98.4 percentage of participants
|
—
|
100.0 percentage of participants
|
91.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24Population: Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=1 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 Participants
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 1
|
0.1 centimeters
Standard Deviation 0.68
|
0.1 centimeters
Standard Deviation 0.83
|
0.3 centimeters
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
0.7 centimeters
Standard Deviation 1.13
|
0.2 centimeters
Standard Deviation 1.24
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 2
|
0.0 centimeters
Standard Deviation 0.70
|
0.3 centimeters
Standard Deviation 0.73
|
0.5 centimeters
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
0.5 centimeters
Standard Deviation 0.85
|
0.3 centimeters
Standard Deviation 0.72
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 4
|
0.1 centimeters
Standard Deviation 0.84
|
0.5 centimeters
Standard Deviation 0.79
|
1.2 centimeters
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
0.6 centimeters
Standard Deviation 0.92
|
0.7 centimeters
Standard Deviation 0.79
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 8
|
0.4 centimeters
Standard Deviation 1.04
|
0.8 centimeters
Standard Deviation 0.79
|
1.3 centimeters
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
0.8 centimeters
Standard Deviation 0.92
|
1.0 centimeters
Standard Deviation 0.82
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 12
|
0.5 centimeters
Standard Deviation 1.10
|
1.3 centimeters
Standard Deviation 0.83
|
2.1 centimeters
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
1.1 centimeters
Standard Deviation 1.41
|
1.6 centimeters
Standard Deviation 0.98
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 16
|
—
|
—
|
3.2 centimeters
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
1.4 centimeters
Standard Deviation 1.06
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 20
|
—
|
—
|
4.3 centimeters
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
1.6 centimeters
Standard Deviation 0.85
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Week 24
|
—
|
—
|
4.3 centimeters
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
2.5 centimeters
Standard Deviation 1.48
|
—
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Posttreatment Week 4
|
0.8 centimeters
Standard Deviation 1.46
|
1.8 centimeters
Standard Deviation 1.04
|
4.3 centimeters
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
2.4 centimeters
Standard Deviation 1.27
|
2.1 centimeters
Standard Deviation 1.13
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Posttreatment Week 12
|
1.2 centimeters
Standard Deviation 1.82
|
2.7 centimeters
Standard Deviation 0.97
|
5.0 centimeters
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
3.4 centimeters
Standard Deviation 1.56
|
3.3 centimeters
Standard Deviation 1.18
|
|
For the Treatment Phase, Change From Baseline in Height
Change at Posttreatment Week 24
|
1.8 centimeters
Standard Deviation 2.31
|
4.1 centimeters
Standard Deviation 1.39
|
7.6 centimeters
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
5.6 centimeters
Standard Deviation 0.85
|
4.7 centimeters
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24Population: Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=1 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 Participants
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 Participants
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 1
|
0.1 kilograms
Standard Deviation 1.00
|
0.3 kilograms
Standard Deviation 0.51
|
-0.5 kilograms
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
0.3 kilograms
Standard Deviation 1.34
|
0.1 kilograms
Standard Deviation 0.39
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 2
|
0.3 kilograms
Standard Deviation 1.11
|
0.4 kilograms
Standard Deviation 0.54
|
0.0 kilograms
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
0.3 kilograms
Standard Deviation 1.77
|
0.2 kilograms
Standard Deviation 0.44
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 4
|
0.4 kilograms
Standard Deviation 1.44
|
0.5 kilograms
Standard Deviation 0.64
|
0.5 kilograms
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
0.7 kilograms
Standard Deviation 1.91
|
0.3 kilograms
Standard Deviation 0.64
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 8
|
0.5 kilograms
Standard Deviation 1.90
|
0.8 kilograms
Standard Deviation 0.84
|
1.3 kilograms
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
0.6 kilograms
Standard Deviation 2.33
|
0.5 kilograms
Standard Deviation 0.66
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 12
|
0.6 kilograms
Standard Deviation 2.32
|
1.1 kilograms
Standard Deviation 1.27
|
2.1 kilograms
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
0.9 kilograms
Standard Deviation 2.90
|
0.6 kilograms
Standard Deviation 0.70
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 16
|
—
|
—
|
1.6 kilograms
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
1.2 kilograms
Standard Deviation 3.68
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 20
|
—
|
—
|
2.2 kilograms
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
1.8 kilograms
Standard Deviation 3.96
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Week 24
|
—
|
—
|
3.1 kilograms
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
2.4 kilograms
Standard Deviation 3.68
|
—
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Posttreatment Week 4
|
0.9 kilograms
Standard Deviation 2.70
|
1.4 kilograms
Standard Deviation 1.48
|
1.8 kilograms
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
2.2 kilograms
Standard Deviation 3.68
|
1.1 kilograms
Standard Deviation 1.09
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Posttreatment Week 12
|
1.6 kilograms
Standard Deviation 3.48
|
2.1 kilograms
Standard Deviation 1.87
|
3.1 kilograms
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
3.7 kilograms
Standard Deviation 2.90
|
1.2 kilograms
Standard Deviation 0.93
|
|
For the Treatment Phase, Change From Baseline in Weight
Change at Posttreatment Week 24
|
3.2 kilograms
Standard Deviation 4.38
|
3.5 kilograms
Standard Deviation 2.75
|
4.5 kilograms
Standard Deviation NA
Standard deviation of a single sample is undefined.
|
5.7 kilograms
Standard Deviation 1.41
|
2.0 kilograms
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24Population: Male participants in the Safety Analysis Set with available data were analyzed.
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=37 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=54 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=10 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
End of Treatment · No Change
|
35 Participants
|
52 Participants
|
10 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
End of Treatment · Increase
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
End of Treatment · Decrease
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 12 · No Change
|
32 Participants
|
51 Participants
|
9 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 12 · Increase
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 12 · Decrease
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 24 · No Change
|
28 Participants
|
48 Participants
|
9 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 24 · Increase
|
7 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 24 · Decrease
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24Population: Male participants in the Safety Analysis Set with available data were analyzed.
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=37 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=54 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=10 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
End of Treatment · No Change
|
34 Participants
|
52 Participants
|
10 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
End of Treatment · Increase
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
End of Treatment · Decrease
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Posttreatment Week 12 · No Change
|
33 Participants
|
50 Participants
|
9 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Posttreatment Week 12 · Increase
|
2 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Posttreatment Week 12 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Posttreatment Week 24 · No Change
|
29 Participants
|
47 Participants
|
10 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Posttreatment Week 24 · Increase
|
6 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development
Posttreatment Week 24 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24Population: Female participants in the Safety Analysis Set with available data were analyzed.
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=63 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=38 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=24 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
End of Treatment · No Change
|
52 Participants
|
34 Participants
|
21 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
End of Treatment · Increase
|
9 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
End of Treatment · Decrease
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 12 · No Change
|
45 Participants
|
31 Participants
|
22 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 12 · Increase
|
15 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 12 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 24 · No Change
|
40 Participants
|
27 Participants
|
22 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 24 · Increase
|
21 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair
Posttreatment Week 24 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24Population: Female participants in the Safety Analysis Set with available data were analyzed.
Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=63 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=38 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
n=24 Participants
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Posttreatment Week 12 · Decrease
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Posttreatment Week 24 · No Change
|
43 Participants
|
21 Participants
|
21 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Posttreatment Week 24 · Increase
|
18 Participants
|
14 Participants
|
1 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Posttreatment Week 12 · Increase
|
11 Participants
|
8 Participants
|
1 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
End of Treatment · No Change
|
53 Participants
|
31 Participants
|
21 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
End of Treatment · Increase
|
8 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
End of Treatment · Decrease
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Posttreatment Week 12 · No Change
|
49 Participants
|
25 Participants
|
21 Participants
|
—
|
—
|
|
For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development
Posttreatment Week 24 · Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants between 6 to \<18 years old in the Safety Analysis Set who performed the swallowability assessment were analyzed.
Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to \< 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to \< 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
n=92 Participants
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1
Able to Swallow 90/400 mg Placebo Tablet
|
89.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
|
Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1
Unable to Swallow 90/400 mg Placebo Tablet
|
11.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1
Able to Swallow 22.5/100 mg Placebo Tablet
|
72.7 percentage of participants
|
98.8 percentage of participants
|
—
|
—
|
—
|
|
Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1
Unable to Swallow 22.5/100 mg Placebo Tablet
|
27.3 percentage of participants
|
1.2 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants between 3 to \<6 years old in the Safety Analysis Set who performed the palatability test were analyzed.
Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score \> 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to \< 40.
Outcome measures
| Measure |
PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks
n=17 Participants
Participants 12 to \< 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks
Participants 6 to \< 12 years of age weighing ≥ 17 kg and \< 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1
Did not taste the study drug
|
41.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1
Tasted drug with score > 60 to 100
|
17.6 percentage of participants
|
—
|
—
|
—
|
—
|
|
Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1
Tasted drug with score 40 to 60
|
11.8 percentage of participants
|
—
|
—
|
—
|
—
|
|
Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1
Tasted drug with score of 0 to < 40
|
29.4 percentage of participants
|
—
|
—
|
—
|
—
|
Adverse Events
12 to < 18 Years Old - LDV/SOF 12 Weeks
Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths
6 to < 12 Years Old - LDV/SOF 12 Weeks
Serious events: 1 serious events
Other events: 54 other events
Deaths: 0 deaths
6 to < 12 Years Old - LDV/SOF 24 Weeks
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
3 to < 6 Years Old - LDV/SOF 12 Weeks
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 participants at risk
Participants 12 to \< 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 participants at risk
Participants 6 to \< 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF 24 Weeks
n=1 participants at risk
Participants 6 to \< 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 participants at risk
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 participants at risk
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
12 to < 18 Years Old - LDV/SOF 12 Weeks
n=100 participants at risk
Participants 12 to \< 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF 12 Weeks
n=89 participants at risk
Participants 6 to \< 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks.
|
6 to < 12 Years Old - LDV/SOF 24 Weeks
n=1 participants at risk
Participants 6 to \< 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks.
|
6 to < 12 Years Old - LDV/SOF+RBV 24 Weeks
n=2 participants at risk
Participants 6 to \< 12 years of age with HCV genotype 3 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily + ribavirin capsules or oral solution (dose depending on weight) for 24 weeks.
|
3 to < 6 Years Old - LDV/SOF 12 Weeks
n=34 participants at risk
Participants 3 to \< 6 years of age with HCV genotypes 1 or 4 TN without cirrhosis received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight \< 17 kg: 33.75/150 mg granules) once daily for 12 weeks.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
10/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
11.2%
10/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
2.9%
1/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
2/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
3.4%
3/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
100.0%
1/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
17.6%
6/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
4.0%
4/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.9%
2/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.0%
2/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.9%
2/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
9.0%
8/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
8.8%
3/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
2.2%
2/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
7/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
15.7%
14/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.9%
2/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.0%
7/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
3.4%
3/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.9%
2/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
13/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
12.4%
11/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
2.2%
2/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
2.9%
1/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
11.0%
11/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
10.1%
9/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
2.9%
1/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
12/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
13.5%
12/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
23.5%
8/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
13.0%
13/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
14.6%
13/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.9%
2/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
2.0%
2/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
16.9%
15/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
20.6%
7/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.9%
2/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.9%
2/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
7/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
2.2%
2/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
2.9%
1/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
3.4%
3/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
11.8%
4/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
5/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
7.9%
7/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
8.8%
3/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.0%
1/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.9%
2/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
5/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
3.4%
3/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
2.0%
2/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.6%
5/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
2.9%
1/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
26.0%
26/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
18.0%
16/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
8.8%
3/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Product Issues
Product taste abnormal
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
8.8%
3/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
1.0%
1/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
1.1%
1/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.9%
2/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.0%
5/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
10/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
12.4%
11/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
100.0%
1/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
20.6%
7/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
2/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
2.2%
2/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
100.0%
1/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.9%
2/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.0%
6/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.6%
5/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
100.0%
1/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
5.9%
2/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/100 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/89 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/1 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
50.0%
1/2 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
0.00%
0/34 • Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
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