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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 belowSelect...
I have no known reasons preventing me from having a liver transplant.
Select...
I can travel to UPMC for follow-up visits for at least a year after my transplant.
Select...
My condition is end-stage heart failure.
Select...
I am between 18 and 70 years old.
Select...
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
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 • NCT0323515418%
GI distress
9%
Suicidal Ideation
9%
Fatigue
9%
Scabies
9%
Altered Mental Status
9%
Seizure
9%
Visual Hallucination
100%
80%
60%
40%
20%
0%
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
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Who is running the clinical trial?
Mary E. Keebler, MDLead Sponsor