Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors

The success of transplantation is significantly hindered by the lack of sufficient available donors. Many potential donor organs are not fully utilized in clinical transplantation because donors have chronic viral infections. Currently, donors with chronic hepatitis B virus (HBV) infection are utilized by typically providing nucleoside analogues such as entecavir or lamivudine plus/minus several doses of HBIG. The entecavir or lamivudine are typically given either life-long in liver transplants or for 1 year in non-liver transplants. Donors with chronic HBV infection are Core Antibody positive (HBcAb +ve). These donors carry chronic virus but may be NAT positive or NAT negative. HBcAb+ve donors are routinely used, but NAT positive donors are typically not used. The Toronto lung transplant program commonly applies Ex Vivo Lung Perfusion (EVLP) to organs. This allows for treatment of organs prior to transplantation. The investigators have shown that UV light administered on the EVLP circuit can substantially decrease the amount of infectious virus. Such a strategy was previously employed with hepatitis C virus. The aim of the study is to show that transplantation of organs from HBV NAT+ve donors is safe with the use of UV light treatment on EVLP combined with post-transplant antivirals for the recipient (HBIG and entecavir). The investigators hypothesize that rates of HBV transmission to recipients will be prevented by the use of this approach and any HBV transmission that does occur will be readily treatable. This will be a small pilot study to determine the feasibility of this approach. If successful, the knowledge from this study can have an important impact on patients awaiting lung transplantation by providing a novel strategy for the use of HBV-positive organ donors, simplified through a shorter course of approved antivirals.

• Incidence of any HBV donor to recipient transmission [Срок оценки: From enrollment until 2 years post-transplant]
• Correlation between donor viremia level, and recipient infection [Срок оценки: From enrollment until up to 2 years post-transplant]
• Interval of time from transplantation to viremia development [Срок оценки: From enrollment until 2 years post-transplant]
• HBV suppression rates after treatment for infected patients [Срок оценки: From time of infection until end of treatment or up to 2 years post-transplant]
• Adverse reactions to antiviral therapy [Срок оценки: From enrollment until 2 years post-transplant]
• Incidence of acute liver dysfunction for infected patients [Срок оценки: From enrollment until 2 years post-transplant]
• In-hospital mortality [Срок оценки: From hospital admission until date of discharge or date of death from any cause, whichever comes first, assessed up to 2 years]
• 1-year graft and patient survival [Срок оценки: Measured 1 year post-transplant]
• Organ function at 1 year (FEV1) [Срок оценки: Measured 1 year post-transplant]
• Development of anti-HBV antibodies (anti-HBs, anti-HBc) [Срок оценки: From enrollment until 2 years post-transplant]