Trial Outcomes & Findings for Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection (NCT NCT01965535)
NCT ID: NCT01965535
Last Updated: 2018-11-16
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug. * 1 participant who was randomized to the LDV/SOF + RBV group who received placebo discontinued prior to receiving LDV/SOF + RBV and is excluded from the Full Analysis Set. * 1 participant who was randomized to the LDV/SOF + RBV group received LDV/SOF + placebo, and is counted in the LDV/SOF group for the safety analysis, and in the LDV/SOF+RBV group for the efficacy analysis (ie, in the Full Analysis Set).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled study sites in France. The first participant was screened on 26 September 2013. The last study visit occurred on 12 November 2014.
172 participants were screened.
Participant milestones
| Measure |
LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus placebo to match ribavirin (RBV) in a divided daily dose for 24 weeks
|
LDV/SOF + RBV
Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
77
|
|
Overall Study
COMPLETED
|
76
|
76
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus placebo to match ribavirin (RBV) in a divided daily dose for 24 weeks
|
LDV/SOF + RBV
Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
Baseline Characteristics
Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
Baseline characteristics by cohort
| Measure |
LDV/SOF
n=78 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
|
LDV/SOF + RBV
n=77 Participants
Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
56 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
56 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
151 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
|
75 participants
n=5 Participants
|
76 participants
n=7 Participants
|
151 participants
n=5 Participants
|
|
Hepatitic C Virus (HCV) RNA
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.59 • n=5 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.47 • n=7 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.54 • n=5 Participants
|
|
HCV Genotype
Genotype 1 (no confirmed subtype)
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
HCV Genotype
Genotype 1a
|
50 participants
n=5 Participants
|
48 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
HCV Genotype
Genotype 1b
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participant with genotype 1 HCV infection who were randomized and received at least 1 dose of active study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug. * 1 participant who was randomized to the LDV/SOF + RBV group who received placebo discontinued prior to receiving LDV/SOF + RBV and is excluded from the Full Analysis Set. * 1 participant who was randomized to the LDV/SOF + RBV group received LDV/SOF + placebo, and is counted in the LDV/SOF group for the safety analysis, and in the LDV/SOF+RBV group for the efficacy analysis (ie, in the Full Analysis Set).
Outcome measures
| Measure |
LDV/SOF
n=77 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
|
LDV/SOF + RBV
n=77 Participants
Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
97.4 percentage of participants
|
96.1 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 |
LDV/SOF
n=77 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
|
LDV/SOF + RBV
n=77 Participants
Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
97.4 percentage of participants
|
97.4 percentage of participants
|
|
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
97.4 percentage of participants
|
96.1 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12, and 24Population: Full Analysis Set
Outcome measures
| Measure |
LDV/SOF
n=77 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
|
LDV/SOF + RBV
n=77 Participants
Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24
Week 24
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24
Week 1
|
7.8 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24
Week 2
|
50.6 percentage of participants
|
59.7 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24
Week 4
|
97.4 percentage of participants
|
97.4 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24
Week 8
|
98.7 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24
Week 12
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 8, and 12Population: Participants in Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF
n=77 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
|
LDV/SOF + RBV
n=77 Participants
Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
|
|---|---|---|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 1 (LDV/SOF: n = 75; LDV/SOF + RBV: n = 75)
|
-4.10 log10 IU/mL
Standard Deviation 0.558
|
-4.27 log10 IU/mL
Standard Deviation 0.547
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 2 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)
|
-4.74 log10 IU/mL
Standard Deviation 0.926
|
-4.94 log10 IU/mL
Standard Deviation 0.452
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 4 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)
|
-5.10 log10 IU/mL
Standard Deviation 0.582
|
-5.19 log10 IU/mL
Standard Deviation 0.433
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 8 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)
|
-5.11 log10 IU/mL
Standard Deviation 0.597
|
-5.20 log10 IU/mL
Standard Deviation 0.448
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Week 12 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)
|
-5.11 log10 IU/mL
Standard Deviation 0.595
|
-5.20 log10 IU/mL
Standard Deviation 0.448
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment Week 24Population: Full Analysis Set
Virologic failure is defined as * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
LDV/SOF
n=77 Participants
LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
|
LDV/SOF + RBV
n=77 Participants
Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Virologic Failure
On-Treatment Virologic Failure
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Failure
Virologic Relapse
|
2.6 percentage of participants
|
3.9 percentage of participants
|
Adverse Events
LDV/SOF
Serious events: 8 serious events
Other events: 67 other events
Deaths: 0 deaths
LDV/SOF + RBV
Serious events: 4 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF
n=78 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
|
LDV/SOF + RBV
n=77 participants at risk
Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.3%
1/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.3%
1/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.3%
1/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Ascites
|
1.3%
1/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
General disorders
Oedema peripheral
|
1.3%
1/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
1/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.3%
1/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.3%
1/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Cranial nerve infection
|
1.3%
1/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.3%
1/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
1.3%
1/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.3%
1/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
1/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
0.00%
0/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
Other adverse events
| Measure |
LDV/SOF
n=78 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
|
LDV/SOF + RBV
n=77 participants at risk
Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
3/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.2%
4/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
5/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
2.6%
2/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.0%
7/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
6.5%
5/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
6.4%
5/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
6.5%
5/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
11.5%
9/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
11.7%
9/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
3/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.2%
4/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.8%
3/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.2%
4/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
10.3%
8/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
18.2%
14/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
General disorders
Asthenia
|
44.9%
35/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
58.4%
45/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
General disorders
Fatigue
|
19.2%
15/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
9.1%
7/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
General disorders
Influenza like illness
|
6.4%
5/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
6.5%
5/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Bronchitis
|
16.7%
13/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.2%
4/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
5/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.2%
4/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Infections and infestations
Rhinitis
|
2.6%
2/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.2%
4/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.4%
5/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
7.8%
6/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
3.8%
3/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.2%
4/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
12/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
7.8%
6/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.1%
11/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.2%
4/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.5%
9/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
10.4%
8/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.2%
4/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Nervous system disorders
Dizziness
|
6.4%
5/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.3%
1/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
39.7%
31/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
27.3%
21/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Insomnia
|
16.7%
13/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
22.1%
17/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Irritability
|
11.5%
9/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
9.1%
7/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Psychiatric disorders
Sleep disorder
|
10.3%
8/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
6.5%
5/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.1%
11/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
13.0%
10/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
3/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
11.7%
9/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.6%
2/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
5.2%
4/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.4%
5/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
1.3%
1/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.1%
4/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
15.6%
12/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.0%
7/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
28.6%
22/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
2/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
6.5%
5/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
|
Vascular disorders
Hypertension
|
9.0%
7/78 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
|
9.1%
7/77 • Up to 24 weeks plus 30 days
Safety Analysis Set: participants who were randomized and received at least 1 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