Hepatitis C
Conditions
Brief summary
Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung transplant at NYULH who consent to participate in this study will receive a lung transplant from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week treatment course. Patients will be monitored post-transplant for the development of viremia, and for the time course of clearance of viremia among those who develop viremia.
Interventions
DRUGMavyret
Patients will be on 8 weeks of Mavyret
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Recipient criteria: * Listed for an isolated lung transplant at NYU Langone Health * Between 18-70 years of age * Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation * No active illicit substance abuse * Weight at least 40kg * Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage * Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange * Able and willing to provide informed consent Donor criteria: * Detectable HCV RNA by nucleic acid test (NAT) or positive anti-HCV antibody * Donor lung meets standard NYU Langone Health clinical criteria for procurement
Exclusion criteria
Recipient criteria: * HIV positive * HCV RNA positive or history of previously treated HCV * Evidence of active hepatitis B infection or on active antiviral treatment for HBV * Pregnant or nursing (lactating) women * Use of strong CYP3A inducers * Requires multi-organ transplant Donor criteria: * Confirmed HIV positive * Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable Hepatitis B virus DNA) * Known previously failed treatment for HCV * Donor age \>60 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C | 24 Months | Surveillance for the development of hepatitis C viremia post-transplant |
| Number of Patients With Sustained Virologic Response After Treatment | 24 Months | HCV serologic testing to evaluate the presence of immunity to HCV or the evidence of prior infection with HCV. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Post Lung Transplant Patients The lung transplantation will be performed per standard of care techniques,and all post-transplant management of the transplanted organ, including immunosuppression, will be carried out per standard of care.
Mavyret: Patients will be on 8 weeks of Mavyret | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Post Lung Transplant Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 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 | 4 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 20 |
| other Total, other adverse events | 4 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C
Surveillance for the development of hepatitis C viremia post-transplant
Time frame: 24 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post Lung Transplant Patients | Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C | 16 incidences |
Primary
Number of Patients With Sustained Virologic Response After Treatment
HCV serologic testing to evaluate the presence of immunity to HCV or the evidence of prior infection with HCV.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Post Lung Transplant Patients | Number of Patients With Sustained Virologic Response After Treatment | 20 Participants |