Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection — U.S. Public Health Service Guideline, 2020

Abstract

Summary The recommendations in this report supersede the U.S Public Health Service (PHS) guideline recommendations for reducing transmission of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) through organ transplantation ( Seem DL, Lee I, Umscheid CA, Kuehnert MJ. PHS guideline for reducing human immunodeficiency virus, hepatitis B virus, and hepatitis C virus transmission through organ transplantation. Public Health Rep 2013;128:247–343 ), hereafter referred to as the 2013 PHS guideline. PHS evaluated and revised the 2013 PHS guideline because of several advances in solid organ transplantation, including universal implementation of nucleic acid testing of solid organ donors for HIV, HBV, and HCV; improved understanding of risk factors for undetected organ donor infection with these viruses; and the availability of highly effective treatments for infection with these viruses. PHS solicited feedback from its relevant agencies, subject-matter experts, additional stakeholders, and the public to develop revised guideline recommendations for identification of risk factors for these infections among solid organ donors, implementation of laboratory screening of solid organ donors, and monitoring of solid organ transplant recipients. Recommendations that have changed since the 2013 PHS guideline include updated criteria for identifying donors at risk for undetected donor HIV, HBV, or HCV infection; the removal of any specific term to characterize donors with HIV, HBV, or HCV infection risk factors; universal organ donor HIV, HBV, and HCV nucleic acid testing; and universal posttransplant monitoring of transplant recipients for HIV, HBV, and HCV infections. The recommendations are to be used by organ procurement organization and transplant programs and are intended to apply only to solid organ donors and recipients and not to donors or recipients of other medical products of human origin (e.g., blood products, tissues, corneas, and breast milk). The recommendations pertain to transplantation of solid organs procured from donors without laboratory evidence of HIV, HBV, or HCV infection. Additional considerations when transplanting solid organs procured from donors with laboratory evidence of HCV infection are included but are not required to be incorporated into Organ Procurement and Transplantation Network policy. Transplant centers that transplant organs from HCV-positive donors should develop protocols for obtaining informed consent, testing and treating recipients for HCV, ensuring reimbursement, and reporting new infections to public health authorities.

Factors associated with hepatitis C antibody seroconversion after transplantation of kidneys from hepatitis C infected donors to hepatitis C naïve recipients

“…Given the increased utilization of PHS IROs, particularly HCV-infected organs for transplantation in HCV naïve recipients, it may be prudent for HCV screening in transplant recipients to consist of testing HCV RNA as opposed to utilizing HCV antibody. The most recent guideline is consistent with our recommendation [21].…”

Infectious Complications in Lung Transplant Recipients

“…Recommended testing includes antibodies to HIV-1/2 (anti-HIV-1/2) and HIV nucleic acid testing (NAT), total antibody to HBV core antigen (anti-HBc), HBV surface antigen (HBsAg), and HBV NAT, as well as antibodies to HCV (anti-HCV) and HCV NAT [7]. The recommendations further state that all deceased donor should be tested within 96 hours of organ procurement, and transplant candidates should be tested immediately prior to transplantation, as well as 4-6 weeks post-transplant, regardless of donor risk profile [7]. Transplant recipients are also at an increased risk for cervical cancer due to human papilloma virus (HPV), and should be screened with an increased frequency, concurrent with guidelines for HIV-infected individuals [8].…”

“…In 2020, new guidelines by the Centers for Disease Control and Prevention (CDC) regarding screening for human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV) were released. Recommended testing includes antibodies to HIV- 1/2 (anti-HIV-1/2) and HIV nucleic acid testing (NAT), total antibody to HBV core antigen (anti-HBc), HBV surface antigen (HBsAg), and HBV NAT, as well as antibodies to HCV (anti-HCV) and HCV NAT [ 7 ]. The recommendations further state that all deceased donor should be tested within 96 hours of organ procurement, and transplant candidates should be tested immediately prior to transplantation, as well as 4–6 weeks post-transplant, regardless of donor risk profile [ 7 ].…”

Donor derived hepatitis B virus infection: Analysis of the Organ Procurement & Transplantation Network/United Network for Organ Sharing Ad Hoc Disease Transmission Advisory Committee

“…In conclusion, although donor‐derived HBV transmission was a rare finding in the cases reported to DTAC, special care should be taken to understand the results of donor testing so that recipients can be placed on the proper prophylaxis if needed. Universal testing of donors by HBV NAT and of all recipients after transplant as recommended by new PHS guidance will better assist with understanding the risks for donor derived HBV infection 10 …”