Transplanting Hepatitis C Positive Thoracic Organs
Transplanting Hepatitis C Positive Thoracic Organs
This is an open-label, pilot safety and efficacy trial for adults who are active on the heart
 or lung transplantation lists and are eligible to receive an organ from an increased risk
 donor who has evidence of active or prior hepatitis C infection (HCV).
This is an open label pilot study transplanting thoracic organs from Hepatitis C positive
 donors into HCV uninfected recipients at Brigham and Women's Hospital. Heart and lung
 transplant participants will be stratified into two different study arms depending on whether
 the donor of the thoracic organ was HCV nucleic acid amplifications technology (NAT) positive
 or negative. In the NAT positive arm, the recipients will receive a course of direct acting
 antivirals (DAA) to begin on the day of transplant, or at the earliest time point
 post-transplant. If the donor was HCV antibody (Ab) positive and NAT negative, the recipients
 will receive close monitoring with serial HCV viral loads (VL) and will only begin treatment
 with DAA if they develop HCV viremia.
Inclusion Criteria:

 -  Men and women who are age ≥ 18 years

 -  Active on either the cardiac or lung transplant waiting list

 -  Willing and able to provide written informed consent to receive organs from an
 increased risk donor with a known transmissible infection

 Exclusion Criteria:

 -  HIV antibody or HIV NAT positive

 -  Hepatitis B surface antigen or Hepatitis B NAT or viral load positive

 -  Evidence of cirrhosis or clinically significant liver disease