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Sofosbuvir/Velpatasvir for Heart Transplant

Phase 2

Waitlist Available

Research Sponsored by Mary E. Keebler, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No obvious contraindication to liver transplant

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and efficacy of transplanting hearts from HCV seropositive non-viremic and HCV seropositive viremic donors to HCV seronegative recipients. Treatment and prophylaxis will be used to prevent HCV transmission.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of sofosbuvir/velpatasvir include headache, fatigue, nausea, insomnia, and less commonly anemia or skin rash. The risk of organ rejection may also be present due to the nature of transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My condition is end-stage heart failure.

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I am between 18 and 70 years old.

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I have been tested for hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

HCV free at 1 year

Side effects data

From 2019 Phase 4 trial • 11 Patients • NCT03235154

18%

GI distress

Suicidal Ideation

Fatigue

Scabies

Altered Mental Status

Seizure

Visual Hallucination

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm Intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

sofosbuvir/velpatasvir

2017

Completed Phase 4

~20

0 / 5Eligibility criteria met