Hepatitis C, Awaiting Organ Transplant
Conditions
Brief summary
This is an open-label, pilot safety and efficacy trial for adults who are active on the heart, lung, or kidney transplantation lists and are eligible to receive an organ from an increased risk donor who has evidence of active or prior hepatitis C infection (HCV).
Detailed description
This is an open label pilot study transplanting organs from Hepatitis C positive donors into HCV uninfected recipients at Brigham and Women's Hospital. Heart, lung and kidney transplant participants will be stratified into two different study arms depending on whether the donor of the organ was HCV nucleic acid amplifications technology (NAT) positive or negative. In the NAT positive arm, the recipients will receive a course of direct acting antivirals (DAA) to begin on the day of transplant. If the donor was HCV antibody (Ab) positive and NAT negative, the recipients will receive close monitoring with serial HCV viral loads (VL) and will only begin treatment with DAA if they develop HCV viremia.
Interventions
2 weeks of treatment beginning on the day of transplant
OTHERMonitoring
Close HCV viral load monitoring Will receive direct acting antiviral treatment with 6 weeks of sofosbuvir/velpatasvir if the recipient develops HCV viremia during the post-transplant HCV viral load testing
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women who are age ≥ 18 years * Active on either the cardiac, lung, or kidney transplant waiting list * Willing and able to provide written informed consent to receive organs from an increased risk donor with a known transmissible infection
Exclusion criteria
* Hepatitis B NAT or viral load positive * Evidence of cirrhosis or clinically significant liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft survival | 6 months post-transplant | Functioning allograft not requiring mechanical support |
| HCV status of the transplant recipient | 6 months post-transplant | Sustained virologic response (SVR) 12 weeks after HCV treatment completion in Arm A or at 6 months in Arm B (SVR defined as HCV RNA \< lower limit of quantification) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment related adverse events | 6 months post-transplant | Number of treatment related adverse events per patient using direct-acting antiviral HCV regimens in post transplant recipients |
Countries
United States
Contacts
Primary ContactAnn Woolley, MD
Outcome results
None listed