The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients

• Status: Active, not recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, pilot trial to test the safety and efficacy of transplantation of livers from Hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the liver transplant waitlist. Treatment and prophylaxis will be administered, using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Naudia Jonassaint
• Collaborator: University of Pittsburgh Medical Center
• Treatments: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir

Criteria

Inclusion criteria (recipients):

1. Patients with end-stage liver disease listed for liver transplantation at UPMC.

2. Age ≥ 18

3. No available living liver donor

4. Listed for an isolated liver transplant at UPMC

5. Have panel reactive antibody level of <98%

6. Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation

7. Able to provide informed consent

8. Be willing to use a contraceptive method for a year after transplant

Exclusion criteria (recipients):

1. HIV positive

2. HCVAb or HCV RNA positive

3. Presence of behavioral risk factors for contracting HCV. These behavioral risk factors are current injection drug use, current intranasal illicit drug use, current percutaneous/parenteral exposures in an unregulated setting.

4. Hepatitis B surface antigen positive

5. History of atrial fibrillation requiring the use of amiodarone over the past 12m

6. Receipt of prior organ transplant

7. Waitlisted for a multi-organ transplant

8. Pregnant women

9. Known allergy to sofosbuvir/velpatasvir

10. Any condition, psychiatric or physical, that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study

Inclusion criteria (donors):

1. HCV antibody positive

2. HCV NAT negative or positive

Exclusion criteria (donors):

1. Confirmed HIV positive (positive HIV-1 antibody, positive HIV-2 antibody, positive p24 antigen and/or positive HIV NAT)

2. Confirmed HBV positive (positive hepatitis B surface antigen and/or HBV NAT)

3. Known ongoing therapy for HCV