Kidney Week

Abstract: SA-PO090

Selecting and Educating Hepatitis C Virus (HCV) Un-infected Kidney Transplant (KT) Waiting List Recipients for a Clinical Trial to Receive an HCV-Infected KT

Session Information

• Transplantation: Recipient and Donor Assessment
  October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Transplantation

• 1802 Transplantation: Clinical

Authors

• Sise, Meghan E., Massachusetts General Hospital, Boston, Massachusetts, United States

Meghan E. Sise,

• Chute, Donald F., Massachusetts General Hospital, Boston, Massachusetts, United States

Donald F. Chute,

• Gustafson, Jenna L., Massachusetts General Hospital, Boston, Massachusetts, United States

Jenna L. Gustafson,

• Silva, Sakuni, Massachusetts General Hospital, Boston, Massachusetts, United States

Sakuni Silva,

• Wojciechowski, David, Massachusetts General Hospital, Boston, Massachusetts, United States

David Wojciechowski,

• Elias, Nahel, Massachusetts General Hospital, Boston, Massachusetts, United States

Nahel Elias,

• Chung, Raymond T., MGH, Boston, Massachusetts, United States

Raymond T. Chung,

• Williams, Winfred W., Massachusetts General Hospital, Boston, Massachusetts, United States

Winfred W. Williams,

Background

Using HCV-infected (HCV+) donors for KT into HCV-uninfected (HCV-) recipients is a novel strategy to increase access to KT and decrease high rates of organ discard. Patient (pt) selection and education is key to ensure ability to comply with protocol requirements and fully understand risks/benefits.

Methods

NCT02945150 is an investigator-initiated clinical trial to transplant 11 HCV- KT pts with a HCV+ KT. Pre-emptive use of elbasvir/grazoprevir to cure HCV in the recipient. We describe the criteria used to select pts, education process, characteristics of the consented pts, and study outcomes of HCV+ KT.

Results

We present enrollment criteria and rationale, which focus on ensuring that high quality HCV+ kidneys are accepted for transplantation and recipients have been selected to maximize safety and benefit. The process of enrolling pts is shown in Figure 1. Pt education focuses on 5 themes: 1) HCV in general 2) Effect of HCV on kidney availability 3) Genotypes of HCV and treatment 4) Logistics of study visits 5) Side effects of elbasvir/grazoprevir. The full “education session” is provided. 23 pts have provided consent, mean age 57 (SD 8), 61% Male, 78% White, 13% Black, 9% Hispanic. Two were excluded due to psychosocial or medical comorbidities. Twelve are undergoing medical clearance for KT. Nine were approved and their UNOS status changed to “willing to accept HCV+ organ.” Five underwent KT and four are waiting. All donors had genotype 1A infection. None had resistance-associated variants. (Numbers, transplant, and viral outcomes to be updated at time of presentation).

Conclusion

It is important to have a multidisciplinary team to identify the appropriate pts for HCV+ to HCV- KT and a thorough process of education, consent, and evaluation so that pts understand the risks of the protocol and the KT itself.

Funding

• Commercial Support – Merck