Hepatitis C Positive Liver Transplants for Liver Transplant Recipients

Recruiting in Palo Alto (17 mi)

Overseen byNaudia Jonassaint, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Naudia Jonassaint. MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Research Team

Fernanda Silviera, MD

Principal Investigator

University of Pittsburgh

Naudia Jonassaint, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults over 18 on the UPMC liver transplant waitlist, without HIV or hepatitis B, and no history of multi-organ transplants or certain drug uses. They must be willing to travel for post-transplant care and use contraception for a year.

Inclusion Criteria

Have panel reactive antibody level of <98%

Able to provide informed consent

Listed for an isolated liver transplant at UPMC

See 7 more

Exclusion Criteria

I am currently receiving treatment for hepatitis C.

HCVAb or HCV RNA positive

You are on the waiting list for a transplant involving multiple organs.

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Treatment Details

Interventions

Sofosbuvir/Velpatasvir (Antiviral)

Trial OverviewThe study tests if Hepatitis C positive livers can safely be transplanted into patients without Hepatitis C. It involves two approaches: one where treatment starts only if the virus is detected after transplant, and another with immediate preventive treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: HCV seropositive viremic (HCV Ab+/NAT+) donorExperimental Treatment1 Intervention

Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).

Group II: HCV seropositive non-viremic (HCV Ab+/NAT-) donorExperimental Treatment1 Intervention

Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated. Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).