Trial Outcomes & Findings for Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3) (NCT NCT01851330)
NCT ID: NCT01851330
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
647 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at a total of 59 study sites in the United States. The first participant was screened on 06 May 2013. The last participant observation occurred on 07 March 2014.
831 participants were screened.
Participant milestones
| Measure |
LDV/SOF 8 Week
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
215
|
216
|
216
|
|
Overall Study
COMPLETED
|
202
|
200
|
204
|
|
Overall Study
NOT COMPLETED
|
13
|
16
|
12
|
Reasons for withdrawal
| Measure |
LDV/SOF 8 Week
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
10
|
9
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
6
|
9
|
|
Overall Study
Withdrew Consent
|
2
|
1
|
0
|
|
Overall Study
Investigator's Discretion
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
Baseline characteristics by cohort
| Measure |
LDV/SOF 8 Week
n=215 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
Total
n=647 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 10.2 • n=99 Participants
|
51 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
53 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
52 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
272 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
375 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
45 participants
n=99 Participants
|
36 participants
n=107 Participants
|
42 participants
n=206 Participants
|
123 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
164 participants
n=99 Participants
|
176 participants
n=107 Participants
|
167 participants
n=206 Participants
|
507 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
10 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hawaiian or Pacific Islander
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
13 participants
n=99 Participants
|
12 participants
n=107 Participants
|
14 participants
n=206 Participants
|
39 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
200 participants
n=99 Participants
|
204 participants
n=107 Participants
|
202 participants
n=206 Participants
|
606 participants
n=7 Participants
|
|
HCV RNA
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.76 • n=99 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.69 • n=107 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.76 • n=206 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.74 • n=7 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
34 participants
n=99 Participants
|
45 participants
n=107 Participants
|
44 participants
n=206 Participants
|
123 participants
n=7 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
181 participants
n=99 Participants
|
171 participants
n=107 Participants
|
172 participants
n=206 Participants
|
524 participants
n=7 Participants
|
|
HCV Genotype
Genotype 1 (no confirmed subtype)
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
HCV Genotype
Genotype 1a
|
171 participants
n=99 Participants
|
172 participants
n=107 Participants
|
172 participants
n=206 Participants
|
515 participants
n=7 Participants
|
|
HCV Genotype
Genotype 1b
|
43 participants
n=99 Participants
|
44 participants
n=107 Participants
|
44 participants
n=206 Participants
|
131 participants
n=7 Participants
|
|
IL28b Status
CC
|
56 participants
n=99 Participants
|
60 participants
n=107 Participants
|
56 participants
n=206 Participants
|
172 participants
n=7 Participants
|
|
IL28b Status
CT
|
120 participants
n=99 Participants
|
128 participants
n=107 Participants
|
124 participants
n=206 Participants
|
372 participants
n=7 Participants
|
|
IL28b Status
TT
|
39 participants
n=99 Participants
|
28 participants
n=107 Participants
|
36 participants
n=206 Participants
|
103 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants were randomized and received at least one dose of study medication.
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.
Outcome measures
| Measure |
LDV/SOF 8 Week
n=215 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
94.0 percentage of participants
|
93.1 percentage of participants
|
96.3 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
Outcome measures
| Measure |
LDV/SOF 8 Week
n=215 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
|
0 percentage of participants
|
0.9 percentage of participants
|
0.9 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 8 Week
n=215 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
96.3 percentage of participants
|
94.9 percentage of participants
|
96.3 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
94.0 percentage of participants
|
93.1 percentage of participants
|
96.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2Population: Participants in the Full Analysis Set with Available Data were analyzed.
Outcome measures
| Measure |
LDV/SOF 8 Week
n=215 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=214 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 2
|
88.4 percentage of participants
|
91.1 percentage of participants
|
91.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: Participants in the Full Analysis Set with Available Data were analyzed.
Outcome measures
| Measure |
LDV/SOF 8 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=213 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 4
|
100.0 percentage of participants
|
99.1 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: Participants in the Full Analysis Set with Available Data were analyzed.
Outcome measures
| Measure |
LDV/SOF 8 Week
n=215 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=213 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=214 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Week 8
|
100.0 percentage of participants
|
100.0 percentage of participants
|
99.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 2Population: Participants in the Full Analysis Set with Available Data were analyzed.
Outcome measures
| Measure |
LDV/SOF 8 Week
n=215 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=212 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=212 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 2
|
-5.06 log10 IU/mL
Standard Deviation 0.752
|
-5.01 log10 IU/mL
Standard Deviation 0.675
|
-4.99 log10 IU/mL
Standard Deviation 0.750
|
SECONDARY outcome
Timeframe: Baseline; Week 4Population: Participants in the Full Analysis Set with Available Data were analyzed.
Outcome measures
| Measure |
LDV/SOF 8 Week
n=215 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=212 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 4
|
-5.12 log10 IU/mL
Standard Deviation 0.760
|
-5.05 log10 IU/mL
Standard Deviation 0.682
|
-5.05 log10 IU/mL
Standard Deviation 0.758
|
SECONDARY outcome
Timeframe: Baseline; Week 8Population: Participants in the Full Analysis Set with Available Data were analyzed.
Outcome measures
| Measure |
LDV/SOF 8 Week
n=215 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=213 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=213 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Week 8
|
-5.12 log10 IU/mL
Standard Deviation 0.760
|
-5.05 log10 IU/mL
Standard Deviation 0.683
|
-5.04 log10 IU/mL
Standard Deviation 0.761
|
SECONDARY outcome
Timeframe: Baseline to posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as on-treatment virologic failure or virologic relapse. * On-Treatment Virologic Failure was defined as * 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 was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
LDV/SOF 8 Week
n=215 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=216 Participants
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Percentage of Participants Experiencing Virologic Failure
On-treatment virologic failure
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Virologic Failure
Virologic relapse
|
5.1 percentage of participants
|
4.2 percentage of participants
|
1.4 percentage of participants
|
Adverse Events
LDV/SOF 8 Week
Serious events: 4 serious events
Other events: 146 other events
Deaths: 0 deaths
LDV/SOF+RBV 8 Week
Serious events: 1 serious events
Other events: 166 other events
Deaths: 0 deaths
LDV/SOF 12 Week
Serious events: 5 serious events
Other events: 150 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF 8 Week
n=215 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=216 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=216 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax 0
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
0.47%
1/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Colitis
|
0.47%
1/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.47%
1/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Immune system disorders
Anaphylactic reaction
|
0.47%
1/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.47%
1/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
LDV/SOF 8 Week
n=215 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
|
LDV/SOF+RBV 8 Week
n=216 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
LDV/SOF 12 Week
n=216 participants at risk
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.93%
2/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.9%
17/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.93%
2/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
7.0%
15/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
18.1%
39/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
11.1%
24/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
15/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.0%
13/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
4.2%
9/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
4.2%
9/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.6%
12/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.7%
8/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
20.9%
45/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
34.7%
75/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
22.7%
49/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Irritability
|
1.4%
3/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
13.4%
29/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
4.6%
10/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
9/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.6%
12/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.4%
16/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
3/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.6%
12/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.8%
6/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
14.0%
30/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
25.0%
54/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
15.3%
33/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
2.8%
6/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.0%
13/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
4.2%
9/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
5.1%
11/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
12.0%
26/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
6.9%
15/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
3/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.6%
12/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
3.2%
7/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
5.1%
11/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.46%
1/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
3/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
9.3%
20/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.3%
5/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.93%
2/215 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.4%
16/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
2.3%
5/216 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER