Lessons From the Utilization of Hepatitis B Virus Nucleic Acid Test Positive Donors for Hepatitis B Vaccinated Lung Transplant Candidates (INHIBITOR) Study.

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.