Expanding the Pool in Orthotopic Heart Transplantation
Hepatitis C, Heart Transplant, Cardiac Transplant
About this trial
This is an interventional other trial for Hepatitis C
Eligibility Criteria
Inclusion criteria (recipients):
- End stage heart failure
- Age ≥ 18 and <71 years
- Listed heart transplant at UPMC
- Have panel reactive antibody level of <98%
- 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
- Able to provide informed consent
- Be willing to use a contraceptive method for a year after transplant
Inclusion criteria (donors):
- HCV antibody positive
- HCV NAT negative or positive
- Acceptable cardiac function for donation
Exclusion criteria (recipients):
- HIV positive
- HCVAb or HCV RNA positive
- 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.
- Hepatitis B surface antigen positive
- History of liver cirrhosis
- Persistently elevated liver transaminases, defined as ALT/AST at least 3 times the upper limit of normal for a minimum of 3 consecutive months
- Waitlisted for a multi-organ transplant
- Pregnant women
- Known allergy to sofosbuvir/velpatasvir
- 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
- Ongoing therapy with amiodarone for atrial or ventricular arrhythmia Prescribed use of Amiodarone
Exclusion criteria (donors):
- Confirmed HIV positive (positive HIV-1 antibody, positive HIV-2 antibody, positive p24 antigen and/or positive HIV NAT)
- Confirmed HBV positive (positive hepatitis B surface antigen and/or HBV NAT) Known ongoing therapy for HCV
Sites / Locations
- UPMC
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
HCV seropositive non-viremic (HCV Ab+/NAT-) donor
HCV seropositive viremic (HCV Ab+/NAT+) donor
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
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