Hepatitis C, Chronic, Lung Transplant
Conditions
Brief summary
The purpose of this study is to evaluate whether treatment with Epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C infection is feasible, safe and effective at curing HCV.
Interventions
DRUGEpclusa
Patients will be treated with this drug for 12 weeks post lung transplant.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HCV RNA \>= 10\^3 IU/ml at screening * Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6 months prior to screening * HCV Genotype 1, 2, 3, 4, 5 or 6 * Otherwise eligible for lung transplant at study site
Exclusion criteria
* Age \<18 * Treatment with any of the following agents: * Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 SOF/VEL * Carbamazepine, phenytoin, phenobarbital, oxcarbazepine * Rifabutin, rifampin or rifapentine * HIV regimens containing tenofovir or tipranavir/ritonavir * St John's wort * PPIs, including: Omeprazole, pantoprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole * Modafinil * Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance * Hepatitis B surface antigen positive * History of hepatic encephalopathy or variceal hemorrhage * Abnormal hematological and biochemical parameters, including: * Hemoglobin \<8g/dL * Platelets \<= 50,000/mm\^3 * ALT (alanine aminotransferase), AST (aspartase aminotransferase) or alkaline phosphatase \>=10 times ULN * Total bilirubin \>3mg/dL * Severe renal impairment, ie creatinine clearance (CrCl) \<30mL/min * Pregnant women or women planning to become pregnant * Women or are breastfeeding * Active or recent history (\<=1 year) of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Eligible for EPCLUSA Treatment | within 12 months of lung transplant | Eligibility for EPCLUSA treatment within 12 months of lung transplant |
| Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA | 1 year | Adverse events resulting in discontinuation of EPCLUSA |
| Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA. | 12 weeks | Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum HCV RNA Levels | 12, 24, and 48 weeks after initiation of EPCLUSA | Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA |
| Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy | 1 year | Adverse events requiring temporary interruption in EPCLUSA therapy |
| Patient Survival | 90 days post-transplant | 90-day post transplant patient survival |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Epclusa Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.
Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Epclusa |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.
Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epclusa | Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA. | 1 Participants |
Primary
Number of Patients Eligible for EPCLUSA Treatment
Eligibility for EPCLUSA treatment within 12 months of lung transplant
Time frame: within 12 months of lung transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epclusa | Number of Patients Eligible for EPCLUSA Treatment | 1 Participants |
Primary
Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA
Adverse events resulting in discontinuation of EPCLUSA
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epclusa | Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA | 0 Participants |
Secondary
Change in Serum HCV RNA Levels
Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA
Time frame: 12, 24, and 48 weeks after initiation of EPCLUSA
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epclusa | Change in Serum HCV RNA Levels | Week 12 | NA IU/mL |
| Epclusa | Change in Serum HCV RNA Levels | Week 24 | NA IU/mL |
| Epclusa | Change in Serum HCV RNA Levels | Week 48 | NA IU/mL |
Secondary
Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy
Adverse events requiring temporary interruption in EPCLUSA therapy
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epclusa | Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy | 0 Participants |
Secondary
Patient Survival
90-day post transplant patient survival
Time frame: 90 days post-transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epclusa | Patient Survival | 1 Participants |
Secondary
Patient Survival
1 year post transplant patient survival
Time frame: 1 year post-tranplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epclusa | Patient Survival | 1 Participants |
Secondary
Patient Survival
90-day post transplant patient survival in recipients of HCV NAT positive donor organ
Time frame: 90 days post-transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epclusa | Patient Survival | 1 Participants |
Secondary
Patient Survival
1 year post transplant patient survival in recipients of HCV NAT positive donor organ
Time frame: 1 year post-transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epclusa | Patient Survival | 1 Participants |