Trial Outcomes & Findings for Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection (NCT NCT01713283)
NCT ID: NCT01713283
Last Updated: 2014-11-25
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2014-11-25
Participant Flow
Participants were enrolled at one study site in the United States. The first participant was screened on 01 October 2012. The last participant observation occurred on 12 February 2014.
76 participants were screened.
Participant milestones
| Measure |
SOF+RBV 12 Wk
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Wk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
20
|
26
|
|
Overall Study
NOT COMPLETED
|
11
|
3
|
Reasons for withdrawal
| Measure |
SOF+RBV 12 Wk
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Wk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
10
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
Baseline characteristics by cohort
| Measure |
SOF+RBV 12 Wk TN
n=14 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN))
|
SOF+RBV 12 Wk TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE))
|
SOF+RBV 24 Wk TN
n=14 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
|
SOF+RBV 24 Wk TE
n=15 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
54 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
52 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
57 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
54 years
STANDARD_DEVIATION 12.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
14 participants
n=5 Participants
|
15 participants
n=4 Participants
|
60 participants
n=21 Participants
|
|
Liver Cirrhosis
No
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
46 participants
n=21 Participants
|
|
Liver Cirrhosis
Yes
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
IL28b Status
CC
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
0 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
IL28b Status
CT
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
7 participants
n=5 Participants
|
12 participants
n=4 Participants
|
39 participants
n=21 Participants
|
|
IL28b Status
TT
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
HCV RNA (log10 IU/mL)
|
5.7 log10 IU/mL
STANDARD_DEVIATION 0.59 • n=5 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.58 • n=7 Participants
|
5.9 log10 IU/mL
STANDARD_DEVIATION 0.74 • n=5 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.45 • n=4 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.61 • n=21 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
7 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
34 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants with genotype 4 HCV infection who were randomized into the study and received at least 1 dose of study drug
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF+RBV 12 Wk TN
n=14 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
|
SOF+RBV 12 Wk TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
|
SOF+RBV 24 Wk TN
n=14 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
|
SOF+RBV 24 Wk TE
n=15 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
|
78.6 percentage of participants
|
58.8 percentage of participants
|
100.0 percentage of participants
|
86.7 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
The percentage of participants discontinuing any study drug due to an adverse event was summarized.
Outcome measures
| Measure |
SOF+RBV 12 Wk TN
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
|
SOF+RBV 12 Wk TE
n=29 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
|
SOF+RBV 24 Wk TN
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
|
SOF+RBV 24 Wk TE
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
|
|---|---|---|---|---|
|
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
|
0 percentage of participants
|
3.4 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Outcome measures
| Measure |
SOF+RBV 12 Wk TN
n=14 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
|
SOF+RBV 12 Wk TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
|
SOF+RBV 24 Wk TN
n=14 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
|
SOF+RBV 24 Wk TE
n=15 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
78.6 percentage of participants
|
58.8 percentage of participants
|
100.0 percentage of participants
|
93.3 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
78.6 percentage of participants
|
58.8 percentage of participants
|
100.0 percentage of participants
|
86.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Full Analysis Set
On-treatment virologic failure was defined as: 1. Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 2. Viral rebound: \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or 3. Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment
Outcome measures
| Measure |
SOF+RBV 12 Wk TN
n=14 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
|
SOF+RBV 12 Wk TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
|
SOF+RBV 24 Wk TN
n=14 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
|
SOF+RBV 24 Wk TE
n=15 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing On-treatment Virologic Failure
|
7.1 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 with available data were analyzed.
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR.
Outcome measures
| Measure |
SOF+RBV 12 Wk TN
n=13 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
|
SOF+RBV 12 Wk TE
n=17 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
|
SOF+RBV 24 Wk TN
n=14 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
|
SOF+RBV 24 Wk TE
n=15 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing Viral Relapse
|
15.4 percentage of participants
|
41.2 percentage of participants
|
0 percentage of participants
|
13.3 percentage of participants
|
Adverse Events
SOF+RBV 12 Wk
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
SOF+RBV 24 Wk
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF+RBV 12 Wk
n=31 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Wk
n=29 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF+RBV 12 Wk
n=31 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
|
SOF+RBV 24 Wk
n=29 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.3%
3/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Palpitations
|
6.5%
2/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.7%
6/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal distension
|
12.9%
4/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.7%
6/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
6.5%
2/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.7%
6/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
1/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.7%
6/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
2/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
13.8%
4/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.7%
3/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.3%
3/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
2/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
13.8%
4/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
13.8%
4/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Fatigue
|
45.2%
14/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
51.7%
15/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Irritability
|
19.4%
6/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
34.5%
10/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Pain
|
12.9%
4/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.7%
6/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Pyrexia
|
3.2%
1/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
17.2%
5/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Malaise
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Bronchitis
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
13.8%
4/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.7%
3/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.5%
2/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
2/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.7%
6/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
17.2%
5/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
17.2%
5/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.3%
3/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.5%
2/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
58.1%
18/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
65.5%
19/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
16.1%
5/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
31.0%
9/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Memory impairment
|
6.5%
2/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.3%
3/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
51.6%
16/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
48.3%
14/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
9.7%
3/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Anxiety
|
6.5%
2/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.4%
1/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
13.8%
4/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
6/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
44.8%
13/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.1%
5/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
27.6%
8/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.1%
5/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
24.1%
7/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.7%
3/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
17.2%
5/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.6%
7/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
24.1%
7/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
1/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
31.0%
9/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.2%
1/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/31 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
2/29 • 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