Trial Outcomes & Findings for Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease (NCT NCT02301936)
NCT ID: NCT02301936
Last Updated: 2018-11-19
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-19
Participant Flow
Participants were enrolled at 1 study site in the United States. The first participant was screened on 02 March 2015. The last study visit occurred on 18 April 2016.
Participant milestones
| Measure |
LDV/SOF 12 Weeks
Treatment-naive or treatment-experienced participants without cirrhosis received ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) 90/400 mg fixed dose combination (FDC) tablet once daily for 12 weeks
|
LDV/SOF 24 Weeks
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
1
|
|
Overall Study
COMPLETED
|
8
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
LDV/SOF 12 Weeks
Treatment-naive or treatment-experienced participants without cirrhosis received ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) 90/400 mg fixed dose combination (FDC) tablet once daily for 12 weeks
|
LDV/SOF 24 Weeks
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease
Baseline characteristics by cohort
| Measure |
LDV/SOF 12 Weeks
n=9 Participants
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
|
LDV/SOF 24 Weeks
n=1 Participants
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 Years
STANDARD_DEVIATION 14.9 • n=93 Participants
|
44 Years
STANDARD_DEVIATION NA • n=4 Participants
|
43 Years
STANDARD_DEVIATION 14.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
IL28b Status
CC
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
IL28b Status
CT
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
IL28b Status
TT
|
6 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
HCV RNA
|
5.8 log10 IU/mL
STANDARD_DEVIATION 0.74 • n=93 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION NA • n=4 Participants
|
5.8 log10 IU/mL
STANDARD_DEVIATION 0.71 • n=27 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
6 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
HCV genotype
Genotype 1a
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
HCV genotype
Genotype 1b
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
HCV genotype
Genotype 4a/4c/4d
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
HCV genotype
Genotype 4f
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
HCV genotype
Genotype 4h
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Cirrhosis status
Absence
|
9 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Cirrhosis status
Presence
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Prior HCV Treatment Experience With Cirrhosis
Treatment-Naive (Non-cirrhosis)
|
7 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Prior HCV Treatment Experience With Cirrhosis
Treatment-Experienced (Non-cirrhosis)
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Prior HCV Treatment Experience With Cirrhosis
Treatment-Experienced (Cirrhosis)
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who took at least 1 dose of study drug
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=9 Participants
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
|
LDV/SOF 24 Weeks
n=1 Participants
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
88.9 percentage of participants
|
100.0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=9 Participants
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
|
LDV/SOF 24 Weeks
n=1 Participants
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Full Analysis Set
SVR4 was defined as HCV RNA \< the LLOQ 4 weeks following the last dose of study drug.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=9 Participants
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
|
LDV/SOF 24 Weeks
n=1 Participants
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
|
88.9 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8,12, 16, 20, and 24Population: Full Analysis Set
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=9 Participants
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
|
LDV/SOF 24 Weeks
n=1 Participants
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 1
|
33.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 2
|
66.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 4
|
88.9 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 8
|
88.9 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 12
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 16
|
—
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 20
|
—
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 24
|
—
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=9 Participants
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
|
LDV/SOF 24 Weeks
n=1 Participants
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
HCV RNA Change From Baseline
Change at Week 16
|
—
|
-5.05 log10 IU/mL
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
HCV RNA Change From Baseline
Change at Week 1
|
-4.20 log10 IU/mL
Standard Deviation 0.543
|
-3.86 log10 IU/mL
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
HCV RNA Change From Baseline
Change at Week 2
|
-3.86 log10 IU/mL
Standard Deviation 1.644
|
-4.63 log10 IU/mL
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
HCV RNA Change From Baseline
Change at Week 4
|
-3.98 log10 IU/mL
Standard Deviation 1.694
|
-5.05 log10 IU/mL
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
HCV RNA Change From Baseline
Change at Week 8
|
-4.47 log10 IU/mL
Standard Deviation 0.662
|
-5.05 log10 IU/mL
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
HCV RNA Change From Baseline
Change at Week 12
|
-4.61 log10 IU/mL
Standard Deviation 0.737
|
-5.05 log10 IU/mL
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
HCV RNA Change From Baseline
Change at Week 20
|
—
|
-5.05 log10 IU/mL
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
HCV RNA Change From Baseline
Change at Week 24
|
—
|
-5.05 log10 IU/mL
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 12Population: Full Analysis Set
Virologic failure was defined as * On-treatment virologic failure * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment, * \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse) * Relapse * HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
Outcome measures
| Measure |
LDV/SOF 12 Weeks
n=9 Participants
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
|
LDV/SOF 24 Weeks
n=1 Participants
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Virologic Failure
|
11.1 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4,12, 24, Posttreatment Weeks 4 and 12Population: 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 |
LDV/SOF 12 Weeks
n=9 Participants
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
|
LDV/SOF 24 Weeks
n=1 Participants
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score
Week 4
|
1.2 units on a scale
Standard Deviation 6.66
|
8.5 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score
Week 12
|
2.7 units on a scale
Standard Deviation 7.20
|
5.8 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score
Week 24
|
—
|
2.3 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score
Posttreatment Week 4
|
3.5 units on a scale
Standard Deviation 8.26
|
0.1 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score
Posttreatment Week 12
|
0.7 units on a scale
Standard Deviation 12.46
|
5.5 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
SECONDARY outcome
Timeframe: Weeks 4,12, 24, Posttreatment Weeks 4 and 12Population: 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 |
LDV/SOF 12 Weeks
n=9 Participants
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
|
LDV/SOF 24 Weeks
n=1 Participants
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score
Week 4
|
2.2 units on a scale
Standard Deviation 8.88
|
-4.7 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score
Week 12
|
3.2 units on a scale
Standard Deviation 8.14
|
-3.3 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score
Week 24
|
—
|
-3.9 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score
Posttreatment Week 4
|
2.2 units on a scale
Standard Deviation 9.69
|
-4.6 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score
Posttreatment Week 12
|
2.4 units on a scale
Standard Deviation 6.53
|
-5.0 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
SECONDARY outcome
Timeframe: Weeks 4,12, 24, Posttreatment Weeks 4 and 12Population: 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 |
LDV/SOF 12 Weeks
n=9 Participants
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
|
LDV/SOF 24 Weeks
n=1 Participants
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Week 4
|
4.6 units on a scale
Standard Deviation 13.86
|
-0.2 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Week 12
|
9.8 units on a scale
Standard Deviation 17.15
|
14.5 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Week 24
|
—
|
11.7 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Posttreatment Week 4
|
13.0 units on a scale
Standard Deviation 17.20
|
13.2 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
|
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Posttreatment Week 24
|
8.5 units on a scale
Standard Deviation 6.32
|
5.0 units on a scale
Standard Deviation NA
This group had only 1 participant so SD is not applicable.
|
Adverse Events
LDV/SOF 12 Weeks
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
LDV/SOF 24 Weeks
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF 12 Weeks
n=9 participants at risk
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
|
LDV/SOF 24 Weeks
n=1 participants at risk
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
11.1%
1/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
LDV/SOF 12 Weeks
n=9 participants at risk
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
|
LDV/SOF 24 Weeks
n=1 participants at risk
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
11.1%
1/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Eye disorders
Eye discharge
|
0.00%
0/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
100.0%
1/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
11.1%
1/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
100.0%
1/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Atypical pneumonia
|
11.1%
1/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
100.0%
1/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
11.1%
1/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
100.0%
1/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
66.7%
6/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
100.0%
1/1 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/1 • Up to 24 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