To perform a study (20 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs for hepatitis C negative recipients with post-operative surveillance and treatment only if a recipient infection occurs.
The investigators are proposing a study of efficacy, in which positive donors will be used for HCV negative patients. Following lung transplantation patients will undergo HCV antibody, virus PCR, and liver function testing. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Sofosbuvir/velpatasvir therapy. This initial study would enroll 20 patients and utilize donors that are young, otherwise healthy whom are Hepatitis C antibody positive but Nucleic Acid Amplification Testing (NAT) negative (HCV Ab+/NAT-). The recipients would be limited to those patients who have previously consented to receive a high risk lung transplant, consented to participant in this study, and who are physiologically optimized for transplantation (e.g., low risk for lung transplantation).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.
UPMC
Pittsburgh, Pennsylvania, United States
HCV Viremia
Incidence of HCV Viremia
Time frame: at 2 years
Seroconversion
Rate of HCV seroconversion
Time frame: at 2 years
Liver Function Testing
Assessment of Hepatic function
Time frame: at 2 years
Survival
Survival rates
Time frame: at 2 years
Rejection
The incidence of rejection
Time frame: at 2 years
Waitlist
Time on waitlist will be assessed
Time frame: at 2 years
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