Trial Outcomes & Findings for LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients (NCT NCT02631772)
NCT ID: NCT02631772
Last Updated: 2019-05-07
Results Overview
Treatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
12 Weeks
Results posted on
2019-05-07
Participant Flow
Participant milestones
| Measure |
Late Cohort, Arm 1
LDV/SOF monotherapy x 12 weeks
Sofosbuvir/Ledipasvir x 12 weeks
|
Late Cohort, Arm 2
LDV/SOF+ribavirin x 12 weeks
Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients
Baseline characteristics by cohort
| Measure |
Late Cohort, Arm 1
n=16 Participants
LDV/SOF monotherapy x 12 weeks
Sofosbuvir/Ledipasvir x 12 weeks
|
Late Cohort, Arm 2
n=16 Participants
LDV/SOF+ribavirin x 12 weeks
Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Percent of participants with Previous Interferon use
Previous Interferon use
|
38 %
n=5 Participants
|
50 %
n=7 Participants
|
14 %
n=5 Participants
|
|
Percent of participants with Previous Interferon use
Stopped interferon prematurely
|
67 %
n=5 Participants
|
100 %
n=7 Participants
|
12 %
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 4 • n=5 Participants
|
60 years
STANDARD_DEVIATION 4 • n=7 Participants
|
61 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Days since transplant
|
1862 days
STANDARD_DEVIATION 1309 • n=5 Participants
|
2611 days
STANDARD_DEVIATION 1998 • n=7 Participants
|
2237 days
STANDARD_DEVIATION 1654 • n=5 Participants
|
|
Calculated MELD at Transplant
|
22.3 units on a scale
STANDARD_DEVIATION 6.4 • n=5 Participants
|
24.7 units on a scale
STANDARD_DEVIATION 8.7 • n=7 Participants
|
23.5 units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Number of patients with prior HCV Treatment
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Number of subjects with history of depression
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Number of subjects with history of anemia
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Number of subjects with history of leukopenia
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Number of subjects with history of thrombocytopenia
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Number of subjects with history of chronic kidney disease
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Number of subjects with history of insomnia
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Type of HCV Genotype
Genotype 1a
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Type of HCV Genotype
Genotype 1b
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Number of subjects with resistant mutations
NS5A Resistant Mutation
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Number of subjects with resistant mutations
NS5B Resistant Mutation
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Number of subjects with a previous transplant
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of subjects with CMV positive serostatus
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Number of subjects with Split Liver
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Number of subjects with an HCV positive donor
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Donor age
|
36 years
STANDARD_DEVIATION 13 • n=5 Participants
|
37 years
STANDARD_DEVIATION 14 • n=7 Participants
|
37 years
STANDARD_DEVIATION 14 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksTreatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen
Outcome measures
| Measure |
Late Cohort, Arm 1
n=16 Participants
LDV/SOF monotherapy x 12 weeks
Sofosbuvir/Ledipasvir x 12 weeks
|
Late Cohort, Arm 2
n=16 Participants
LDV/SOF+ribavirin x 12 weeks
Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks
|
|---|---|---|
|
Treatment Efficacy
|
88 % of participants
|
75 % of participants
|
SECONDARY outcome
Timeframe: 12 weeksNumber of participants who had a nonresponse to treatment or a relapse of disease under study.
Outcome measures
| Measure |
Late Cohort, Arm 1
n=16 Participants
LDV/SOF monotherapy x 12 weeks
Sofosbuvir/Ledipasvir x 12 weeks
|
Late Cohort, Arm 2
n=16 Participants
LDV/SOF+ribavirin x 12 weeks
Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks
|
|---|---|---|
|
Number of Participants With Virologic Failure
Nonresponse
|
0 Participants
|
1 Participants
|
|
Number of Participants With Virologic Failure
Relapse
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16Change in hemoglobin levels over the course of the study
Outcome measures
| Measure |
Late Cohort, Arm 1
n=16 Participants
LDV/SOF monotherapy x 12 weeks
Sofosbuvir/Ledipasvir x 12 weeks
|
Late Cohort, Arm 2
n=16 Participants
LDV/SOF+ribavirin x 12 weeks
Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks
|
|---|---|---|
|
Hemoglobin Levels
Hemoglobin levels at Week 4
|
13.1 g/dL
Standard Deviation 2.3
|
12.9 g/dL
Standard Deviation 1.5
|
|
Hemoglobin Levels
Hemoglobin levels at Week 8
|
13.3 g/dL
Standard Deviation 1.7
|
11.2 g/dL
Standard Deviation 1.7
|
|
Hemoglobin Levels
Hemoglobin levels at Week 12
|
13.7 g/dL
Standard Deviation 1.9
|
12.0 g/dL
Standard Deviation 2.3
|
|
Hemoglobin Levels
Hemoglobin levels at Week 16
|
13.6 g/dL
Standard Deviation 1.9
|
13.1 g/dL
Standard Deviation 1.9
|
Adverse Events
Late Cohort, Arm 1
Serious events: 4 serious events
Other events: 11 other events
Deaths: 1 deaths
Late Cohort, Arm 2
Serious events: 12 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Late Cohort, Arm 1
n=16 participants at risk
LDV/SOF monotherapy x 12 weeks
Sofosbuvir/Ledipasvir x 12 weeks
|
Late Cohort, Arm 2
n=16 participants at risk
LDV/SOF+ribavirin x 12 weeks
Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
0.00%
0/16 • 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
0.00%
0/16 • 36 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/16 • 36 weeks
|
12.5%
2/16 • Number of events 2 • 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Fractured hip
|
0.00%
0/16 • 36 weeks
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/16 • 36 weeks
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Syndrom
|
0.00%
0/16 • 36 weeks
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
|
Cardiac disorders
Cardiac Arrest
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
0.00%
0/16 • 36 weeks
|
|
Cardiac disorders
Intermittent Complete heart block
|
0.00%
0/16 • 36 weeks
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
|
Hepatobiliary disorders
Hepatic Encephalopathy
|
0.00%
0/16 • 36 weeks
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
|
General disorders
Recurrent falls when walking
|
0.00%
0/16 • 36 weeks
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/16 • 36 weeks
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
|
Cardiac disorders
COPD
|
0.00%
0/16 • 36 weeks
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
Other adverse events
| Measure |
Late Cohort, Arm 1
n=16 participants at risk
LDV/SOF monotherapy x 12 weeks
Sofosbuvir/Ledipasvir x 12 weeks
|
Late Cohort, Arm 2
n=16 participants at risk
LDV/SOF+ribavirin x 12 weeks
Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/16 • 36 weeks
|
68.8%
11/16 • Number of events 11 • 36 weeks
|
|
General disorders
Fatigue
|
25.0%
4/16 • Number of events 4 • 36 weeks
|
31.2%
5/16 • Number of events 5 • 36 weeks
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
18.8%
3/16 • Number of events 3 • 36 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • 36 weeks
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • Number of events 2 • 36 weeks
|
6.2%
1/16 • Number of events 1 • 36 weeks
|
|
Renal and urinary disorders
Increased creatinine
|
12.5%
2/16 • Number of events 2 • 36 weeks
|
43.8%
7/16 • Number of events 7 • 36 weeks
|
|
General disorders
Insomnia
|
0.00%
0/16 • 36 weeks
|
12.5%
2/16 • Number of events 2 • 36 weeks
|
|
General disorders
headache
|
12.5%
2/16 • Number of events 2 • 36 weeks
|
12.5%
2/16 • Number of events 2 • 36 weeks
|
|
Hepatobiliary disorders
Increased liver function tests
|
0.00%
0/16 • 36 weeks
|
12.5%
2/16 • Number of events 2 • 36 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place