Trial Outcomes & Findings for Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection (NCT NCT02219685)
NCT ID: NCT02219685
Last Updated: 2018-11-16
Results Overview
MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal N-acetylaspartate (NAA) + N-acetylaspartylglutamate (NAAG) was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.
COMPLETED
PHASE2
40 participants
Baseline; Posttreatment Week 4
2018-11-16
Participant Flow
Participants were enrolled at 1 study site in the United States. The first participant was screened on 25 August 2014. The last study visit occurred on 07 April 2016.
54 participants were screened.
Participant milestones
| Measure |
LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
|
Placebo, Followed by Open-Label LDV/SOF
LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|
|
Blinded Treatment Phase
STARTED
|
26
|
14
|
|
Blinded Treatment Phase
COMPLETED
|
24
|
14
|
|
Blinded Treatment Phase
NOT COMPLETED
|
2
|
0
|
|
Open-Label (After Posttreatment Week 4)
STARTED
|
0
|
14
|
|
Open-Label (After Posttreatment Week 4)
COMPLETED
|
0
|
14
|
|
Open-Label (After Posttreatment Week 4)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
|
Placebo, Followed by Open-Label LDV/SOF
LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
|---|---|---|
|
Blinded Treatment Phase
Lost to Follow-up
|
1
|
0
|
|
Blinded Treatment Phase
Withdrew Consent
|
1
|
0
|
Baseline Characteristics
Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection
Baseline characteristics by cohort
| Measure |
LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
47 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
45 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
23 participants
n=5 Participants
|
13 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Prior HCV Treatment Experience
Treatment-Naive
|
15 participants
n=5 Participants
|
8 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Prior HCV Treatment Experience
Treatment-Experienced
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
HCV Genotype
Genotype 1a
|
23 participants
n=5 Participants
|
12 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
HCV Genotype
Genotype 1b
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
IL28B Status
CC
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
IL28B Status
CT
|
19 participants
n=5 Participants
|
8 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
IL28B Status
TT
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
HCV RNA
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.57 • n=5 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.62 • n=7 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.58 • n=5 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
17 participants
n=5 Participants
|
11 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; Posttreatment Week 4Population: Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.
MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal N-acetylaspartate (NAA) + N-acetylaspartylglutamate (NAAG) was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: NAA + NAAG
Basal Ganglia
|
-0.03 ratio
Standard Deviation 0.085
|
-0.01 ratio
Standard Deviation 0.147
|
|
Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: NAA + NAAG
Frontal Cortex
|
-0.03 ratio
Standard Deviation 0.201
|
-0.09 ratio
Standard Deviation 0.279
|
|
Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: NAA + NAAG
Dorsolateral Prefrontal Cortex
|
0.00 ratio
Standard Deviation 0.154
|
-0.01 ratio
Standard Deviation 0.142
|
PRIMARY outcome
Timeframe: Baseline; Posttreatment Week 4Population: Full Analysis Set
MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal choline was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Choline
Basal Ganglia
|
-0.01 ratio
Standard Deviation 0.020
|
0.00 ratio
Standard Deviation 0.029
|
|
Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Choline
Frontal Cortex
|
0.01 ratio
Standard Deviation 0.033
|
0.00 ratio
Standard Deviation 0.055
|
|
Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Choline
Dorsolateral Prefrontal Cortex
|
0.00 ratio
Standard Deviation 0.029
|
0.01 ratio
Standard Deviation 0.023
|
PRIMARY outcome
Timeframe: Baseline; Posttreatment Week 4Population: Full Analysis Set
MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal myoinositol was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Myoinositol
Basal Ganglia
|
0.02 ratio
Standard Deviation 0.110
|
0.00 ratio
Standard Deviation 0.157
|
|
Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Myoinositol
Frontal Cortex
|
-0.01 ratio
Standard Deviation 0.207
|
0.08 ratio
Standard Deviation 0.156
|
|
Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Myoinositol
Dorsolateral Prefrontal Cortex
|
-0.02 ratio
Standard Deviation 0.112
|
0.00 ratio
Standard Deviation 0.104
|
PRIMARY outcome
Timeframe: Baseline; Posttreatment Week 4Population: Full Analysis Set
Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS). For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Memory T Score
|
-3.88 units on a scale
Standard Deviation 19.15
|
7.93 units on a scale
Standard Deviation 23.63
|
PRIMARY outcome
Timeframe: Baseline; Posttreatment Week 4Population: Full Analysis Set
Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS). For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Attention Scaled Score
|
0.73 units on a scale
Standard Deviation 4.29
|
1.43 units on a scale
Standard Deviation 3.34
|
PRIMARY outcome
Timeframe: Baseline; Posttreatment Week 4Population: Full Analysis Set
Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS). For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed
|
1.96 units on a scale
Standard Deviation 5.71
|
4.00 units on a scale
Standard Deviation 7.27
|
PRIMARY outcome
Timeframe: Baseline; Posttreatment Week 4Population: Full Analysis Set
Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age \& education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4). For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation
|
-13.04 units on a scale
Standard Deviation 21.03
|
-12.43 units on a scale
Standard Deviation 15.38
|
PRIMARY outcome
Timeframe: Baseline; Posttreatment Week 4Population: Full Analysis Set
Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot). For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Motor
|
-10.00 units on a scale
Standard Deviation 17.47
|
-6.00 units on a scale
Standard Deviation 17.16
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4, 12, and 24Population: Full Analysis Set
SVR4, SVR12, and SVR24 were defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4, 12, and 24 weeks after stopping study treatment with LDV/SOF, respectively.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)
SVR4
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
100.0 percentage of participants
Interval 76.8 to 100.0
|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)
SVR12
|
92.3 percentage of participants
Interval 74.9 to 99.1
|
100.0 percentage of participants
Interval 76.8 to 100.0
|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)
SVR24
|
92.3 percentage of participants
Interval 74.9 to 99.1
|
100.0 percentage of participants
Interval 76.8 to 100.0
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed. Data for the "Open-Label Phase: LDV/SOF" group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4.
Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS). For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Memory T Score
|
-17.42 units on a scale
Standard Deviation 31.57
|
—
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed. Data for the "Open-Label Phase: LDV/SOF" group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4.
Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS). For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Attention Scaled Score
|
1.42 units on a scale
Standard Deviation 0.36
|
—
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed. Data for the "Open-Label Phase: LDV/SOF" group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4.
Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS). For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed
|
4.00 units on a scale
Standard Deviation 7.95
|
—
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed. Data for the "Open-Label Phase: LDV/SOF" group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4.
Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age \& education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4). For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation
|
-16.67 units on a scale
Standard Deviation 35.12
|
—
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed. Data for the "Open-Label Phase: LDV/SOF" group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4.
Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot). For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Motor
|
-9.21 units on a scale
Standard Deviation 17.74
|
—
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment Weeks 4 and 24Population: Participants in the Full Analysis Set with available data were analyzed.
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower scores representing more disability and higher scores representing less disability.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Short Form 36 (SF-36) Health Survey Scale - Physical Component Score
Change at PT Wk 4 (LDV/SOF: N =25; Placebo: N =14)
|
1.1 units on a scale
Standard Deviation 3.73
|
-0.1 units on a scale
Standard Deviation 4.48
|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Short Form 36 (SF-36) Health Survey Scale - Physical Component Score
Change at PT Wk 24 (LDV/SOF: N =23; Placebo: NA)
|
1.5 units on a scale
Standard Deviation 4.13
|
NA units on a scale
Standard Deviation NA
Participants in the Placebo group did not have a Posttreatment Week 24 visit because they were enrolled into the Open-Label Phase after Posttreatment Week 4.
|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Short Form 36 (SF-36) Health Survey Scale - Physical Component Score
Baseline (LDV/SOF: N =25; Placebo: N =14)
|
53.8 units on a scale
Standard Deviation 5.51
|
56.2 units on a scale
Standard Deviation 4.42
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment (PT) Weeks 4 and 24Population: Participants in the Full Analysis Set with available data were analyzed.
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower score representing more disability and higher scores representing less disability.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by SF-36 Health Survey Scale - Mental Component Score
Baseline (LDV/SOF: N = 25; Placebo: N = 14)
|
52.5 units on a scale
Standard Deviation 6.25
|
50.9 units on a scale
Standard Deviation 10.26
|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by SF-36 Health Survey Scale - Mental Component Score
Change at PT Wk 4 (LDV/SOF: N =25; Placebo: N =14)
|
1.9 units on a scale
Standard Deviation 4.86
|
-2.9 units on a scale
Standard Deviation 9.31
|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by SF-36 Health Survey Scale - Mental Component Score
Change at PT Wk 24 (LDV/SOF: N =23; Placebo: NA)
|
4.7 units on a scale
Standard Deviation 5.77
|
NA units on a scale
Standard Deviation NA
Participants in the Placebo group did not have a Posttreatment Week 24 visit because they were enrolled into the Open-Label Phase after Posttreatment Week 4.
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment Weeks 4 and 24Population: Participants in the Full Analysis Set with available data were analyzed.
The CLDQ-HCV is a disease-specific questionnaire measuring health-related quality of life. CLDQ-HCV scores are calculated using participant responses to 29 questions divided into 4 domains: Activity/Energy, Emotion, Worry, and Systemic. An overall CLDQ-HCV score is calculated by taking the mean of all domain scores. Overall CLDQ-HCV scores range between 1 and 7, with higher scores representing better quality of life.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Chronic Liver Disease Questionnaire - HCV (CLDQ-HCV)
Baseline (LVD/SOF: N =26; Placebo: N =14)
|
5.8 units on a scale
Standard Deviation 0.89
|
6.0 units on a scale
Standard Deviation 0.78
|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Chronic Liver Disease Questionnaire - HCV (CLDQ-HCV)
Change at PT Wk 4 (LVD/SOF: N =26; Placebo: N =14)
|
0.4 units on a scale
Standard Deviation 0.61
|
-0.1 units on a scale
Standard Deviation 0.50
|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Chronic Liver Disease Questionnaire - HCV (CLDQ-HCV)
Change at PT Wk 24 (LVD/SOF: N =24; Placebo: NA)
|
0.7 units on a scale
Standard Deviation 0.77
|
NA units on a scale
Standard Deviation NA
Participants in the Placebo group did not have a Posttreatment Week 24 visit because they were enrolled into the Open-Label Phase after Posttreatment Week 4.
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment Weeks 4 and 24Population: Participants in the Full Analysis Set with available data were analyzed.
The FACIT-Fatigue score was measured using a 40-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale from 0 (Not at all) to 4 (Very much). The FACIT-F total score was calculated by taking the sum of all 40 individual scores and ranged from 0-160, with higher scores indicating better quality of life.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Baseline (LDV/SOF: N =26; Placebo: N =14)
|
94.7 units on a scale
Standard Deviation 12.12
|
97.0 units on a scale
Standard Deviation 8.72
|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Change at PT Wk 4 (LDV/SOF: N =26; Placebo: N =14)
|
3.1 units on a scale
Standard Deviation 8.43
|
-4.4 units on a scale
Standard Deviation 9.87
|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Change at PT Wk 24 (LDV/SOF: N =24; Placebo: NA)
|
5.9 units on a scale
Standard Deviation 9.04
|
NA units on a scale
Standard Deviation NA
Participants in the Placebo group did not have a Posttreatment Week 24 visit because they were enrolled into the Open-Label Phase after Posttreatment Week 4.
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment Weeks 4 and 24Population: Participants in the Full Analysis Set with available data were analyzed.
Impairment in overall work productivity was measured using the WPAI: Hepatitis C questionnaire completed by participants during study visits throughout the study. This questionnaire measured the effect of hepatitis C on the ability to work and perform regular activities. Overall work impairment is expressed as a percentage and ranges from 0% (no effect) to 100% (completely prevented from working).
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Work Productivity and Activity Impairment Questionnaire, Hepatitis C (WPAI: Hepatitis C) - Overall Work Impairment
Baseline (LDV/SOF: N =24; Placebo: N =10)
|
12.6 units on a scale
Standard Deviation 28.16
|
4.0 units on a scale
Standard Deviation 9.66
|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Work Productivity and Activity Impairment Questionnaire, Hepatitis C (WPAI: Hepatitis C) - Overall Work Impairment
Change at PT Wk 4 (LDV/SOF: N =21; Placebo: N =10)
|
-11.5 units on a scale
Standard Deviation 27.31
|
13.0 units on a scale
Standard Deviation 22.63
|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Work Productivity and Activity Impairment Questionnaire, Hepatitis C (WPAI: Hepatitis C) - Overall Work Impairment
Change at PT Wk 24 (LDV/SOF: N =20; Placebo: NA)
|
-3.6 units on a scale
Standard Deviation 34.01
|
NA units on a scale
Standard Deviation NA
Participants in the Placebo group did not have a Posttreatment Week 24 visit because they were enrolled into the Open-Label Phase after Posttreatment Week 4.
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment Weeks 4 and 24Population: Participants in the Full Analysis Set with available data were analyzed.
Activity impairment was measured using the WPAI: Hepatitis C questionnaire completed by participants during study visits throughout the study. This questionnaire measured the effect of hepatitis C on the ability to work and perform regular activities. Overall activity impairment is expressed as a percentage and ranges from 0% (no effect) to 100% (completely prevented from performing regular activities).
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by WPAI: Hepatitis C - Activity Impairment
Baseline (LDV/SOF: N =26; Placebo: N =13)
|
10.0 units on a scale
Standard Deviation 24.17
|
2.3 units on a scale
Standard Deviation 8.32
|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by WPAI: Hepatitis C - Activity Impairment
Change at PT Wk 4 (LDV/SOF: N =26; Placebo: N =13)
|
-6.9 units on a scale
Standard Deviation 23.28
|
6.9 units on a scale
Standard Deviation 11.82
|
|
Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by WPAI: Hepatitis C - Activity Impairment
Change at PT Wk 24 (LDV/SOF: N =20; Placebo: NA)
|
-6.1 units on a scale
Standard Deviation 19.48
|
NA units on a scale
Standard Deviation NA
Participants in the Placebo group did not have a Posttreatment Week 24 visit because they were enrolled into the Open-Label Phase after Posttreatment Week 4.
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment Weeks 4 and 24Population: Participants in the Full Analysis Set with available data were analyzed.
The BDI-II is a 21-item self-report instrument for measuring the severity of depression. Each item is rated on a 4-point scale ranging from 0 to 3. The item scores are summed to yield a derived total score that can range from 0 to 63 with lower values indicating less depression.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=25 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Depression Inventory-II (BDI-II)
Baseline
|
4.20 units on a scale
Standard Deviation 4.73
|
4.29 units on a scale
Standard Deviation 5.98
|
|
Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Depression Inventory-II (BDI-II)
Change at Posttreatment Week 4
|
-2.40 units on a scale
Standard Deviation 3.77
|
0.29 units on a scale
Standard Deviation 5.04
|
|
Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Depression Inventory-II (BDI-II)
Change at Posttreatment Week 24
|
-2.74 units on a scale
Standard Deviation 3.95
|
NA units on a scale
Standard Deviation NA
Participants in the Placebo group did not have a Posttreatment Week 24 visit because they were enrolled into the Open-Label Phase after Posttreatment Week 4.
|
SECONDARY outcome
Timeframe: Baseline; Posttreatment Weeks 4 and 24Population: Full Analysis Set
The BHS is a 20-item scale for measuring the extent of negative attitudes about the future (pessimism) as perceived by adolescents and adults. The BHS consists of 20 true-false statements. Each of the 20 statements is scored 1 or 0. Of the 20 true-false statements, 9 are keyed FALSE, and 11 are keyed TRUE to indicate endorsement of pessimism about the future. The item scores are summed to yield a total score that can range from 0 to 20 with higher scores indicating greater hopelessness.
Outcome measures
| Measure |
Blinded Phase: LDV/SOF
n=26 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
|
Blinded Phase: Placebo
n=14 Participants
LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
|
|---|---|---|
|
Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Hopelessness Scale (BHS)
Change at Posttreatment Week 4
|
-0.04 units on a scale
Standard Deviation 1.43
|
0.14 units on a scale
Standard Deviation 1.56
|
|
Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Hopelessness Scale (BHS)
Change at Posttreatment Week 24
|
-0.04 units on a scale
Standard Deviation 0.91
|
NA units on a scale
Standard Deviation NA
Participants in the Placebo group did not have a Posttreatment Week 24 visit because they were enrolled into the Open-Label Phase after Posttreatment Week 4.
|
|
Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Hopelessness Scale (BHS)
Baseline
|
1.27 units on a scale
Standard Deviation 1.40
|
1.36 units on a scale
Standard Deviation 1.55
|
Adverse Events
LDV/SOF (Blinded Phase)
Placebo (Blinded Phase)
LDV/SOF (Open-Label Phase), Following Placebo in Blinded Phase
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LDV/SOF (Blinded Phase)
n=26 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
|
Placebo (Blinded Phase)
n=14 participants at risk
LDV/SOF placebo tablet once daily for 12 weeks
|
LDV/SOF (Open-Label Phase), Following Placebo in Blinded Phase
n=14 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Open-Label Treatment Phase
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
2/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
21.4%
3/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
14.3%
2/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
19.2%
5/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
14.3%
2/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
21.4%
3/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
2/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
14.3%
2/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
21.4%
3/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
19.2%
5/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Chills
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
19.2%
5/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
42.9%
6/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Laryngitis
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
23.1%
6/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
21.4%
3/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
14.3%
2/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Investigations
Blood pressure increased
|
7.7%
2/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
2/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
14.3%
2/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Reproductive system and breast disorders
Orchitis noninfective
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
2/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
7.7%
2/26 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.1%
1/14 • Blinded Treatment Phase: Up to 12 weeks plus 30 days; Open-Label Treatment Phase: Up to 12 weeks plus 30 days
Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER