Trial Outcomes & Findings for Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis (NCT NCT02226549)
NCT ID: NCT02226549
Last Updated: 2018-11-16
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at 1 study site in the United States. The first participant was screened on 24 July 2014. The last study visit occurred on 06 February 2015.
72 participants were screened.
Participant milestones
| Measure |
LDV/SOF+VDV
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet + vedroprevir (VDV) 80 mg tablet once daily for 8 weeks
|
LDV/SOF+VDV+RBV
LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
LDV/SOF+VDV
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet + vedroprevir (VDV) 80 mg tablet once daily for 8 weeks
|
LDV/SOF+VDV+RBV
LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
|---|---|---|
|
Overall Study
Randomized but Never Treated
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis
Baseline characteristics by cohort
| Measure |
LDV/SOF+VDV
n=22 Participants
LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
|
LDV/SOF+VDV+RBV
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
56 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
57 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
16 participants
n=5 Participants
|
12 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
HCV Genotype
Genotype 1a
|
14 participants
n=5 Participants
|
18 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
HCV Genotype
Genotype 1b
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
HCV Genotype
Genotype 1a,1b
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
IL28b Status
CC
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
IL28b Status
CT
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
IL28b Status
TT
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
IL28b Status
Missing
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
LDV/SOF+VDV
n=22 Participants
LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
|
LDV/SOF+VDV+RBV
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
95.5 percentage of participants
|
87.5 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Safety Analysis Set: participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
LDV/SOF+VDV
n=22 Participants
LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
|
LDV/SOF+VDV+RBV
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Full Analysis Set
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Outcome measures
| Measure |
LDV/SOF+VDV
n=22 Participants
LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
|
LDV/SOF+VDV+RBV
n=24 Participants
LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
|---|---|---|
|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
|
95.5 percentage of participants
|
95.8 percentage of participants
|
Adverse Events
LDV/SOF+VDV
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
LDV/SOF+VDV+RBV
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LDV/SOF+VDV
n=22 participants at risk
LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
|
LDV/SOF+VDV+RBV
n=24 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
|
|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/22 • Up to 8 weeks plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug.
|
8.3%
2/24 • Up to 8 weeks plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
9.1%
2/22 • Up to 8 weeks plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug.
|
12.5%
3/24 • Up to 8 weeks plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • Up to 8 weeks plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug.
|
20.8%
5/24 • Up to 8 weeks plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/22 • Up to 8 weeks plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug.
|
8.3%
2/24 • Up to 8 weeks plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
2/22 • Up to 8 weeks plus 30 days
Safety Analysis Set: participants who received at least 1 dose of study drug.
|
12.5%
3/24 • Up to 8 weeks plus 30 days
Safety Analysis Set: participants who 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