Trial Outcomes & Findings for Phase 3 Study of Sofosbuvir and Ribavirin (NCT NCT01497366)
NCT ID: NCT01497366
Last Updated: 2014-04-02
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; \< 25 IU/mL) 12 weeks after study drug cessation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
527 participants
Primary outcome timeframe
Post-treatment Week 12
Results posted on
2014-04-02
Participant Flow
Subjects were enrolled in a total of 90 study sites in the United States, Australia, New Zealand, Canada, Sweden, Italy, and the Netherlands. The first participant was screened on 19 December 2011. The last participant observation was on 08 April 2013.
666 participants were screened and 527 were randomized; 499 participants received at least 1 dose of study drug, and comprise the Safety Analysis Set. The 496 participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug comprise the Full Analysis Set.
Participant milestones
| Measure |
Sofosbuvir+RBV
Participants were randomized to receive sofosbuvir+ribavirin (RBV) for 12 weeks.
|
PEG+RBV
Participants were randomized to receive PEG+RBV for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
263
|
264
|
|
Overall Study
Randomized But Not Treated
|
7
|
21
|
|
Overall Study
COMPLETED
|
224
|
176
|
|
Overall Study
NOT COMPLETED
|
39
|
88
|
Reasons for withdrawal
| Measure |
Sofosbuvir+RBV
Participants were randomized to receive sofosbuvir+ribavirin (RBV) for 12 weeks.
|
PEG+RBV
Participants were randomized to receive PEG+RBV for 24 weeks.
|
|---|---|---|
|
Overall Study
Virologic failure
|
2
|
50
|
|
Overall Study
Lost to Follow-up
|
11
|
10
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Initiated Non-protocol HCV Treatment
|
7
|
0
|
|
Overall Study
Other
|
5
|
0
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Randomized but not treated
|
7
|
21
|
Baseline Characteristics
Phase 3 Study of Sofosbuvir and Ribavirin
Baseline characteristics by cohort
| Measure |
Sofosbuvir+RBV
n=256 Participants
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
|
PEG+RBV
n=243 Participants
Participants were randomized to receive PEG+RBV for 24 weeks.
|
Total
n=499 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
48 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
48 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
327 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
215 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
427 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
|
12 participants
n=5 Participants
|
5 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
223 participants
n=5 Participants
|
212 participants
n=7 Participants
|
435 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native/First Nations
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hawaiian or Pacific Islander
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black and White
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
165 participants
n=5 Participants
|
151 participants
n=7 Participants
|
316 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=5 Participants
|
24 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
32 participants
n=5 Participants
|
29 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Hepatitis C Virus (HCV) genotype
Genotype 1
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Hepatitis C Virus (HCV) genotype
Genotype 2
|
70 participants
n=5 Participants
|
67 participants
n=7 Participants
|
137 participants
n=5 Participants
|
|
Hepatitis C Virus (HCV) genotype
Genotype 3
|
183 participants
n=5 Participants
|
176 participants
n=7 Participants
|
359 participants
n=5 Participants
|
|
Baseline HCV RNA
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.82 • n=5 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.78 • n=7 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.80 • n=5 Participants
|
|
Baseline HCV RNA Category
< 6 log10 IU/mL
|
108 participants
n=5 Participants
|
106 participants
n=7 Participants
|
214 participants
n=5 Participants
|
|
Baseline HCV RNA Category
≥ 6 log10 IU/mL
|
148 participants
n=5 Participants
|
137 participants
n=7 Participants
|
285 participants
n=5 Participants
|
|
IL28b genotype
CC
|
108 participants
n=5 Participants
|
106 participants
n=7 Participants
|
214 participants
n=5 Participants
|
|
IL28b genotype
CT
|
121 participants
n=5 Participants
|
98 participants
n=7 Participants
|
219 participants
n=5 Participants
|
|
IL28b genotype
TT
|
25 participants
n=5 Participants
|
38 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
IL28b genotype
Missing
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Cirrhosis
No
|
205 participants
n=5 Participants
|
189 participants
n=7 Participants
|
394 participants
n=5 Participants
|
|
Cirrhosis
Yes
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Cirrhosis
Missing
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-treatment Week 12Population: Full Analysis Set
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; \< 25 IU/mL) 12 weeks after study drug cessation.
Outcome measures
| Measure |
Sofosbuvir+RBV
n=253 Participants
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
|
PEG+RBV
n=243 Participants
Participants were randomized to receive PEG+RBV for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)
|
67 percentage of participants
Interval 61.0 to 72.9
|
67 percentage of participants
Interval 60.4 to 72.6
|
SECONDARY outcome
Timeframe: Up to 24 weeks plus 30 days following the last dose of study drugPopulation: Safety Analysis Set
Outcome measures
| Measure |
Sofosbuvir+RBV
n=256 Participants
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
|
PEG+RBV
n=243 Participants
Participants were randomized to receive PEG+RBV for 24 weeks.
|
|---|---|---|
|
Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
AEs leading to discontinuation of any study drug
|
3 participants
|
29 participants
|
|
Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
Serious AEs
|
7 participants
|
3 participants
|
|
Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
Grade 3 laboratory abnormalities
|
33 participants
|
80 participants
|
|
Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
Grade 4 laboratory abnormalities
|
3 participants
|
21 participants
|
|
Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
Deaths
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Post-treatment Week 24Population: Full Analysis Set
SVR24 was defined as HCV RNA \< LLOQ 24 weeks after study drug cessation.
Outcome measures
| Measure |
Sofosbuvir+RBV
n=253 Participants
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
|
PEG+RBV
n=243 Participants
Participants were randomized to receive PEG+RBV for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)
|
66.8 percentage of participants
Interval 60.6 to 72.6
|
65.4 percentage of participants
Interval 59.1 to 71.4
|
SECONDARY outcome
Timeframe: Up to 12 WeeksPopulation: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Sofosbuvir+RBV
n=253 Participants
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
|
PEG+RBV
n=243 Participants
Participants were randomized to receive PEG+RBV for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 1 (SOF+RBV, n = 252; PEG+RBV, n = 243)
|
43.7 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 2 (SOF+RBV, n = 251; PEG+RBV, n = 241)
|
92.0 percentage of participants
|
31.5 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 4 (SOF+RBV, n = 250; PEG+RBV, n = 236)
|
99.6 percentage of participants
|
66.9 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 8 (SOF+RBV, n = 248; PEG+RBV, n = 231)
|
99.6 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 12 (SOF+RBV, n = 244; PEG+RBV, n = 224)
|
99.2 percentage of participants
|
92.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Sofosbuvir+RBV
n=253 Participants
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
|
PEG+RBV
n=243 Participants
Participants were randomized to receive PEG+RBV for 24 weeks.
|
|---|---|---|
|
Change From Baseline in HCV RNA
Week 8 (SOF+RBV, n = 248; PEG+RBV, n = 228)
|
-4.63 log10 IU/mL
Standard Deviation 0.850
|
-4.42 log10 IU/mL
Standard Deviation 1.163
|
|
Change From Baseline in HCV RNA
Week 12 (SOF+RBV, n = 243; PEG+RBV, n = 222)
|
-4.65 log10 IU/mL
Standard Deviation 0.820
|
-4.45 log10 IU/mL
Standard Deviation 1.226
|
|
Change From Baseline in HCV RNA
Week 1 (SOF+RBV, n = 239; PEG+RBV, n = 236)
|
-4.26 log10 IU/mL
Standard Deviation 0.689
|
-2.19 log10 IU/mL
Standard Deviation 1.287
|
|
Change From Baseline in HCV RNA
Week 2 (SOF+RBV, n = 246; PEG+RBV, n = 233)
|
-4.60 log10 IU/mL
Standard Deviation 0.820
|
-3.19 log10 IU/mL
Standard Deviation 1.572
|
|
Change From Baseline in HCV RNA
Week 4 (SOF+RBV, n = 250; PEG+RBV, n = 235)
|
-4.64 log10 IU/mL
Standard Deviation 0.816
|
-4.04 log10 IU/mL
Standard Deviation 1.389
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: Full Analysis Set
Virologic failure was defined as either * Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA \< 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement * Viral rebound: \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement * Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)
Outcome measures
| Measure |
Sofosbuvir+RBV
n=253 Participants
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
|
PEG+RBV
n=243 Participants
Participants were randomized to receive PEG+RBV for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Virologic Failure During Treatment
|
0.4 percentage of participants
|
7.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Post-treatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved \< LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.
Outcome measures
| Measure |
Sofosbuvir+RBV
n=249 Participants
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
|
PEG+RBV
n=217 Participants
Participants were randomized to receive PEG+RBV for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Viral Relapse Following Treatment
|
30.5 percentage of participants
|
22.6 percentage of participants
|
Adverse Events
Sofosbuvir+RBV
Serious events: 7 serious events
Other events: 219 other events
Deaths: 0 deaths
PEG+RBV
Serious events: 3 serious events
Other events: 233 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sofosbuvir+RBV
n=256 participants at risk
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
|
PEG+RBV
n=243 participants at risk
Participants were randomized to receive PEG+RBV for 24 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.39%
1/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.00%
0/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Cardiac disorders
Atrioventriclar shock
|
0.00%
0/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.41%
1/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
General disorders
Chest pain
|
0.39%
1/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.00%
0/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Immune system disorders
Allergy to arthropod sting
|
0.39%
1/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.00%
0/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Infections and infestations
Cellulitis
|
0.39%
1/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.00%
0/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Infections and infestations
Infection
|
0.00%
0/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.41%
1/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Infections and infestations
Osteomyelitis chronic
|
0.39%
1/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.00%
0/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
0.39%
1/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.00%
0/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.41%
1/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.41%
1/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.39%
1/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.00%
0/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.41%
1/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.39%
1/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.00%
0/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
0.41%
1/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
Other adverse events
| Measure |
Sofosbuvir+RBV
n=256 participants at risk
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
|
PEG+RBV
n=243 participants at risk
Participants were randomized to receive PEG+RBV for 24 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.8%
20/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
11.5%
28/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
12.3%
30/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
9.5%
23/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
18.0%
46/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
28.8%
70/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
9.0%
23/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
17.3%
42/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
17/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
9.5%
23/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Gastrointestinal disorders
Dry mouth
|
3.9%
10/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
6.2%
15/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
General disorders
Fatigue
|
35.9%
92/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
55.1%
134/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
General disorders
Irritability
|
9.8%
25/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
16.5%
40/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
General disorders
Chills
|
2.7%
7/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
18.1%
44/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
General disorders
Influenza like illness
|
2.7%
7/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
18.1%
44/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
General disorders
Pyrexia
|
2.3%
6/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
13.6%
33/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
General disorders
Pain
|
2.0%
5/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
12.3%
30/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
General disorders
Injection site reaction
|
0.00%
0/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
7.0%
17/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
General disorders
Injection site erythema
|
0.00%
0/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
5.8%
14/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
13/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
2.1%
5/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.6%
17/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
18.1%
44/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
21/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
16.5%
40/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
15/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
14.4%
35/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
9/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
8.2%
20/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Nervous system disorders
Headache
|
25.0%
64/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
44.4%
108/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Nervous system disorders
Dizziness
|
10.5%
27/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
13.6%
33/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Psychiatric disorders
Insomnia
|
12.1%
31/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
29.2%
71/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Psychiatric disorders
Depression
|
5.5%
14/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
14.4%
35/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Psychiatric disorders
Anxiety
|
4.3%
11/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
6.6%
16/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
19/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
8.6%
21/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.0%
18/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
8.2%
20/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
14/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
4.1%
10/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.0%
23/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
17.7%
43/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
19/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
17.3%
42/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.7%
12/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
9.9%
24/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
11/256 • Up to 24 weeks plus 30 days following the last dose of study drug
|
9.5%
23/243 • Up to 24 weeks plus 30 days following the last dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER