PHS GUIDELINE FOR REDUCING
TRANSMISSION OF HUMAN
IMMUNODEFICIENCY VIRUS,
HEPATITIS B VIRUS AND HEPATITIS C
VIRUS THROUGH SOLID ORGAN
TRANSPLANTATION
ACOT Conference Call
February 28, 2012
Mandate
• The National Organ Transplantation Act (1984
Pub.L. 98-507), which governs most aspects of
organ transplantation in the United States,
specifically requires the Secretary of the
Department of Health and Human Services to
contract with an Organ Procurement and
Transplantation Network (OPTN) which, among
other things, is required to:
“adopt and use standards of quality for the acquisition and
transportation of donated organs, including standards for
preventing the acquisition of organs that are infected with the
etiologic agent for acquired immune deficiency syndrome.”
Current Reporting
• In 2005, OPTN policy was revised to require OPOs and
transplant centers to report potential donor-derived
infections to the OPTN
• Current standards by the Association of Organ
Procurement Organization require deceased donor
serum be maintained for 10 years following
procurement of organs.
• When an organ recipient is suspected of having a
donor-derived infection, investigation ensues with
testing of stored donor serum and recipient specimens
in order to determine the infection source.
Current Testing
• OPTN policy requires deceased donor
screening for anti-HIV, HBsAg, anti-HBc, and
anti-HCV.
• An FDA-licensed screening test is required for
HIV, HBV and HCV
• FDA approved tests include enzyme
immunoassays that detect antibodies to the
virus, antigen assays, and NAT.
Magnitude of Problem
• The estimated incidence of undetected viremia for normal-risk
potential donors is 1 in 50,000 for HIV and 1 in 5,000 for HCV.
For high-risk potential donors, the incidence of undetected
viremia is 1 in 11,000 for HIV and 1 in 1,000 for HCV
• A recent OPO survey found that the percentage of recovered
organ donors who were reported as having “increased risk”
behaviors varied among these organizations from a range of
2.3% to 26.1% of annual donor volume.
• Of the 80 potential donor-derived disease transmissions
reported to UNOS from 2005-2007, 30 cases were confirmed
with HIV, HBV and HCV were among the top five most reported
suspected donor-derived transmissions. Of note, further
testing of stored donor specimens were negative using NAT in
most cases.
• Update to 1994 Public Health Service (PHS) Guidelines for
Preventing Transmission of HIV through Transplantation of
Human Tissue and Organs
• The most significant changes involve:
– expanding the guideline to include hepatitis B virus (HBV) and
hepatitis C virus (HCV), in addition to human immunodeficiency
virus (HIV);
– utilizing factors known to be associated with increased
likelihood of HIV, HBV or HCV to identify potential donors at
increased risk for transmitting infection;
– distinguishing between expected and unexpected transmission
of HBV and HCV in goals for prevention; and
– limiting the focus to solid organ transplants and vessel conduits
recovered for organ transplant purposes.
“This guideline was based on a
targeted systematic review of the best
available evidence on preventing
transmission of HIV, HBV, and HCV
through solid organ transplantation.”
Proposed ACOT Recommendation
• Although ACOT appreciates the efforts made by the
CDC and PHS to minimize the risk of transmission of
HIV, HBV and HCV through organ donation, the initial
intent of the current document was to provide both
evidence based and expert input into how best to
implement viral screening into both living and
deceased donor solid organ transplantation. Given the
limitations of the current draft version, the ACOT
recommends to the Secretary of HHS to direct the CDC
and PHS to work together with the varied
representatives of the transplant and organ donor
communities to revise the draft to better address the
concerns outlined in their responses.