Hepatitis C Positive Donor Into Hepatitis C Negative Recipients

• Status: Withdrawn
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys and livers available for transplantation and the number of patients on the transplant waiting list. New donor pools are needed to satisfy the lack of available donor organs, along with expanded criteria for the existing donor pools.

A new standard of care now exists at most local and regional transplant centers. This new standard of care is based on the use of multiple direct-acting antiviral agents (DAAs) for treatment of hepatitis C virus (HCV) that have been approved by the Food and Drug Administration (FDA) for the treatment of hepatitis C and are associated with high HCV cure rates and minimal side effect profiles. The efficacy and tolerability of these medications has allowed the expansion of the available donor pool by making HCV antibody positive non viremic organs and HCV-viremic organs (when HCV is detectable in the blood) available to HCV-naive recipients on the organ transplantation waiting list. Expansion of this donor pool may decrease time on the waiting list and improve quality of life and survival while waiting for organ transplantation.

Study Aim:

We propose a clinical protocol to utilize solid organs from exposed and/or HCV-viremic organ donors for transplantation into HCV negative recipients.

The primary purpose of the clinical protocol is to:

Collect prospective standard of care laboratory data on the results of these interventions

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland; University of Maryland, College Park
• Treatments: Antiviral Agents; Ledipasvir; Ledipasvir, sofosbuvir drug combination; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• RECIPIENT INCLUSION CRITERIA

• Patients undergoing solid organ transplantation, including liver, kidney, and simultaneous liver-kidney who are not chronically infected with HCV

• No evident contraindication for organ transplantation

• HCV RNA negative (can be isolated HCV antibody positive provided the patient will have no history of previously treated HCV)

• Age 18-75 years at the time of transplantation

• Signed Informed Consent Form

• No identified living organ donor

• Able to travel to the University of Maryland for routine post-transplant and HCV follow-up visits

• Men and women must agree to use at least one barrier method to prevent any secretion exchange

• No active illicit drug use

DONOR INCLUSION CRITERIA

• Qualitative HCV nucleic acid test (NAT) positive and/or Hepatitis C antibody positive HCV donors offered to the University of Maryland.

Exclusion Criteria:

RECIPIENT EXCLUSION CRITERIA

• History of prior solid organ transplantation

• HIV infection

• HBV surface antigen or DNA positive. Organs from HCV positive donors who are also Hepatitis B core antibody positive (hepatitis B surface antigen negative) can be used. These patients will however need to undergo prophylaxis for HBV according to their respective organ specific criteria and during treatment for hepatitis C due to the increased risk of reactivation of hepatitis B with DAA therapy

• Waitlisted for a multi-organ transplant (with the exception of simultaneous liver-kidney transplant)

• HCV RNA positive (can be isolated HCV antibody positive provided the patient will have no history of previously treated HCV)

• Prior direct-acting antiviral (DAA) treatment for HCV. Patients previously treated with interferon-based regimens may be included.

DONOR EXCLUSION CRITERIA

• Every donor that is considered unsuitable by the transplant surgeon for any reason.

• Hepatocellular carcinoma

• HIV infection

• Use of HCV positive livers to be determined according to current existing criteria