End Stage Liver Disease, Hepatitis C
Conditions
Keywords
HCV, Epclusa, ESLD
Brief summary
This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.
Detailed description
Patients will be selected based on diminished likelihood of receiving a liver from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.
Interventions
DRUGTreatment with Direct Acting Antiviral tablet
HCV Treatment for 12 Weeks
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recipient is Age ≥ 18 years * Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant * HCV naïve * Able to sign informed consent
Exclusion criteria
* Pregnant or nursing (lactating) women * Human immunodeficiency virus (HIV) positivity * Need for dual organ transplant * Any contra-indication to liver transplantation per center protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA | 12 weeks post treatment | Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values | 12 weeks | Safety and tolerability of direct acting antiviral therapy in the liver transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant out of range laboratory results as compared to baseline/pretreatment values per patient. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between November 2017 and March 2021. 33 subjects underwent liver transplant from an Hepatitis C Virus (HCV) Antibody (Ab) positive donor. 9 subjects received HCV Ab positive/HCV Ribonucleic acid (RNA) (Nucleic Acid Testing (NAT)-) donors and did not receive Direct Acting Antiviral (DAA) treatment. 24 subjects initiated treatment with DAAs.
Pre-assignment details
Enrolled subjects who did not require treatment with direct acting antivirals were excluded from analysis.
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Direct Acting Antiviral Fixed Dose Combination 12 weeks of HCV treatment with medically appropriate direct acting antiviral
Treatment with Direct Acting Antiviral tablet: HCV Treatment for 12 Weeks | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Treatment With Direct Acting Antiviral Fixed Dose Combination |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Recipient Negative HCV status at time of transplant | 24 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA
Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment.
Time frame: 12 weeks post treatment
Population: 1 subject died and was not included in analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With Direct Acting Antiviral Fixed Dose Combination | Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA | 23 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values
Safety and tolerability of direct acting antiviral therapy in the liver transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant out of range laboratory results as compared to baseline/pretreatment values per patient.
Time frame: 12 weeks
Population: Number of participants receiving at least 1 dose of DAA treatment were included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With Direct Acting Antiviral Fixed Dose Combination | Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values | 0 Participants |