Use of Corneas from Hepatitis B Positive Donors for Corneal Transplantation

Background: In most of the world, corneas from hepatitis B surface antigen (HBsAg)-positive donors have been considered unsuitable for transplantation because of assumed risk of disease transmission. Methods: In Taiwan, an HBV endemic area, corneas from HBsAg-positive donors can be allocated to recipients who are seropositive for HBsAg or antibody against HBsAg (anti-HBs). Between January, 2015 and December, 2019, we evaluated HBV DNA in serum and corneo-scleral rims retrieved from HBsAg-positive and HBsAg-negative donors. We assessed donor serum HBsAg, anti-HBs, hepatitis B core antibody (anti-HBc) and HBV DNA to predict the presence of their corneo-scleral HBV DNA. We conducted a look-back study of recipients transplanted with corneo-scleral HBV DNA-positive donor grafts. Their HBV serological profiles were examined to identify possible post-transplantation hepatitis B transmission. Findings: Forty-five and 125 corneal grafts from 28 HBsAg-positive and 85 HBsAg-negative donors, respectively, were included. The donor corneo-scleral rim HBV DNA-positive rate was significantly greater in HBsAg-positive donor grafts (80·0%) compared to that of the HBsAg-negative grafts (6·4%, [ P <0·001]). Eight grafts harvested from HBsAg-negative, but anti-HBc-positive donors carried HBV DNA. The donor anti-HBc-positivity provides the highest sensitivity (1·00) and negative predictive value (1·00) in predicting the existence of corneo-scleral HBV DNA. A total 28 out of 40 (70·0%) recipients transplanted with HBV DNA-positive grafts participated in the look-back study, and none developed clinical disease or seroconversion to indicate post-transplantation hepatitis B. InterpretationHBV DNA was detected on corneas from HBsAg-positive and HBsAg-negative, anti-HBc-positive donors. However, the risk of post-transplantation hepatitis B is small in an endemic area. Allocation of corneas from HBsAg-positive or anti-HBc-positive donors to HBsAg-positive or anti-HBs-positive recipients may be a safe and effective way to expand corneal donor pools in hepatitis B endemic areas of the world. Funding: Ministry of Health and Welfare, Taiwan (TORSC-1031006, 1041130, 1051220, 1061030, 1071030) Declaration of Interest: All of the authors have no competing interests. Ethical Approval: The corneo-scleral HBV DNA study was approved by National Taiwan University Hospital Research Ethics Committee (NTUH REC) (No. 201702010RINC).Donor pre-mortem serologies of HBsAg, anti-HBs, and anti-HBc, as well as donor corneal endothelial cell densities were retrieved from the electronic databases of the National Eye Bank of Taiwan.