Sofosbuvir/Velpatasvir for Heart Transplant

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mary E. Keebler, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

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 hearts from HCV seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the heart 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).

Eligibility Criteria

This trial is for adults aged 18-70 on the UPMC heart transplant waitlist with end-stage heart failure and no major issues preventing a liver transplant. They must be able to visit UPMC post-transplant for at least a year, agree to use contraception for that period, and provide informed consent. Both HCV antibody-positive individuals, whether they currently have active hepatitis C or not (HCV NAT negative or positive), can join.

Inclusion Criteria

I have no known reasons preventing me from having a liver transplant.

I can travel to UPMC for follow-up visits for at least a year after my transplant.

My condition is end-stage heart failure.

I am between 18 and 70 years old.

I have been tested for hepatitis C.

Participant Groups

The trial tests if it's safe and effective to transplant hearts from donors with different hepatitis C statuses into recipients without hepatitis C. It uses sofosbuvir/velpatasvir as treatment/prophylaxis after transplantation, depending on the donor's infection status.

2Treatment groups

Experimental Treatment

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

HCV seropositive viremic (HCV Ab+/NAT+) donor hearts to HCV seronegative recipients. Starting post-operative day 1, heart 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). Intervention: Drug: sofosbuvir/velpatasvir

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

HCV seropositive non-viremic (HCV Ab+/NAT-) donor hearts to HCV seronegative recipients. Heart 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). Intervention: Drug: sofosbuvir/velpatasvir