Trial Outcomes & Findings for The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients (NCT NCT03819322)
NCT ID: NCT03819322
Last Updated: 2026-04-30
Results Overview
Adverse events due to sofosbuvir/velpatasvir (Epclusa)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
5 years
Results posted on
2026-04-30
Participant Flow
73 participants signed informed consent. 68 participants were not eligible and not considered enrolled due to: transplanted with a liver from an HCV seronegative donor (37 participants); death on the waitlist (11 participants); transplant candidacy declined (7 participants); removal from the waitlist (6 participants); prior history of HCV (1 participant); still waitlisted (6 participants). 5 participants met eligibility criteria and were considered enrolled.
Participant milestones
| Measure |
HCV Seropositive Non-viremic (HCV Ab+/NAT-) Donor
Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated.
Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
HCV Seropositive Viremic (HCV Ab+/NAT+) Donor
Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
4
|
|
Overall Study
COMPLETED
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
HCV Seropositive Non-viremic (HCV Ab+/NAT-) Donor
n=1 Participants
Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated.
Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
HCV Seropositive Viremic (HCV Ab+/NAT+) Donor
n=4 Participants
Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 Years
STANDARD_DEVIATION 0 • n=1 Participants
|
57 Years
STANDARD_DEVIATION 6 • n=4 Participants
|
59 Years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 Participants
n=1 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: The limited sample sizes (n=1 and n=4) preclude valid statistical inference; accordingly, analyses are restricted to descriptive reporting.
Adverse events due to sofosbuvir/velpatasvir (Epclusa)
Outcome measures
| Measure |
HCV Seropositive Non-viremic (HCV Ab+/NAT-) Donor
n=1 Participants
Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated.
Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
HCV Seropositive Viremic (HCV Ab+/NAT+) Donor
n=4 Participants
Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
|---|---|---|
|
Adverse Events Due to Sofosbuvir/Velpatasvir (Epclusa)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The limited sample sizes (n=1 and n=4) preclude valid statistical inference; accordingly, analyses are restricted to descriptive reporting.
Outcome measures
| Measure |
HCV Seropositive Non-viremic (HCV Ab+/NAT-) Donor
n=1 Participants
Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated.
Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
HCV Seropositive Viremic (HCV Ab+/NAT+) Donor
n=4 Participants
Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
|---|---|---|
|
HCV Free at 1 Year Following Transplantation
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The limited sample sizes (n=1 and n=4) preclude valid statistical inference; accordingly, analyses are restricted to descriptive reporting.
Outcome measures
| Measure |
HCV Seropositive Non-viremic (HCV Ab+/NAT-) Donor
n=1 Participants
Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated.
Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
HCV Seropositive Viremic (HCV Ab+/NAT+) Donor
Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
|---|---|---|
|
Transmission Rate of HCV From HCVAb+/NAT- Donors to HCVAb- Recipients
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The limited sample sizes (n=1 and n=4) preclude valid statistical inference; accordingly, analyses are restricted to descriptive reporting.
Outcome measures
| Measure |
HCV Seropositive Non-viremic (HCV Ab+/NAT-) Donor
n=1 Participants
Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated.
Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
HCV Seropositive Viremic (HCV Ab+/NAT+) Donor
n=4 Participants
Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
|---|---|---|
|
Incidence of Allograft Rejection at 5 Years
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The limited sample sizes (n=1 and n=4) preclude valid statistical inference; accordingly, analyses are restricted to descriptive reporting.
Outcome measures
| Measure |
HCV Seropositive Non-viremic (HCV Ab+/NAT-) Donor
n=1 Participants
Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated.
Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
HCV Seropositive Viremic (HCV Ab+/NAT+) Donor
n=4 Participants
Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
|---|---|---|
|
Incidence of Graft Loss at 5 Years
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The limited sample sizes (n=1 and n=4) preclude valid statistical inference; accordingly, analyses are restricted to descriptive reporting.
Outcome measures
| Measure |
HCV Seropositive Non-viremic (HCV Ab+/NAT-) Donor
n=1 Participants
Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated.
Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
HCV Seropositive Viremic (HCV Ab+/NAT+) Donor
n=4 Participants
Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
|---|---|---|
|
All-cause Mortality at 5 Years
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The limited sample sizes (n=1 and n=4) preclude valid statistical inference; accordingly, analyses are restricted to descriptive reporting.
In days
Outcome measures
| Measure |
HCV Seropositive Non-viremic (HCV Ab+/NAT-) Donor
n=1 Participants
Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated.
Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
HCV Seropositive Viremic (HCV Ab+/NAT+) Donor
n=4 Participants
Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
|
|---|---|---|
|
Waitlist Time After Enrollment
|
94 Days
Standard Deviation 0
|
21 Days
Standard Deviation 18
|
Adverse Events
HCV Seropositive Non-viremic (HCV Ab+/NAT-) Donor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HCV Seropositive Viremic (HCV Ab+/NAT+) Donor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place