Background: This was a single-center pilot study to determine the safety and efficacy of transplanting lungs from hepatitis B virus (HBV) nucleic acid positive (NAT+) donors to HBV vaccinated (sAb+) candidates. We report our study experience, including barriers to utilizing NAT+ donors.
Methods: Primary candidate eligibility criteria included: HBV sAb+, < 70 years old, not on mechanical support, no liver fibrosis, normal esophageal motility, and cPRA < 60. Only brain-dead donors with no marginal characteristics or concurrent hepatitis C virus (HCV) were accepted. Recipients of HBV NAT+ organs would receive intravenous hepatitis B immunoglobulin as well as appropriate HBV antiviral therapy.
Results: A total of 155 patients were screened for eligibility. Most (64.5%) were excluded because they were HBV sAb negative. Of the 25 eligible sAb+ candidates, 13 enrolled, and 6 were listed for HBV NAT+ organs. There were 16 donor offers, all of which were rejected because of quality or concurrent donor HCV infection. No other centers utilized these organs.
Conclusions: Reduced enrollment related to strict eligibility criteria, few HBV immune candidates, and stringent requirements on HBV NAT+ donors were limiting factors. Further studies are needed to assess the safety and efficacy of HBV NAT+ donor lung transplants.
Keywords: clinical trial; hepatitis B immunoglobulin; hepatitis B virus; lung transplant.
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