Checking Organ Donors and Recipients for HIV and Hepatitis B and C: 2020 Guideline

What changed, and why

In 2020 the U.S. Public Health Service (PHS) replaced its 2013 guideline on reducing transmission of HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) through solid organ transplantation. Three things had moved on:

• every organ donor is now screened for all three viruses by nucleic acid testing (NAT);
• the risk factors for an infection a donor's tests would miss are better understood;
• highly effective treatments exist for all three.

The main changes:

• new criteria for spotting donors at risk of an undetected infection, and a shorter window — risk behavior in the 30 days before organ procurement, not 12 months;
• no special term for donors with risk factors — "increased risk donor" is gone;
• NAT for every donor, for all three viruses;
• testing every recipient after transplant.

The guideline is for organ procurement organizations (OPOs), transplant centers and other clinicians caring for recipients. It covers solid organs from donors with no laboratory evidence of HIV, HBV or HCV — not blood products, tissues, corneas or breast milk. Separate considerations, not required in national policy, cover organs from donors with HCV infection.

How the rules evolved

• Early years: after HIV was found to pass through blood transfusion, PHS in 1985 recommended screening organ donors for anti-HIV antibody. 53 HIV transmissions through organs and tissues had been reported before donor antibody testing began; from 1987 to 1992, seven recipients got HIV from donors who had tested negative.
• 1994: PHS issued comprehensive recommendations — universal antibody screening, standard questions about risk, and better tracking. Donors with certain high-risk behaviors in the previous 12 months or 5 years were to be excluded unless the benefit outweighed the risk.
• 2013: after more rare transmissions, PHS added HCV NAT and 12 medical or social criteria within 12 months that labeled a donor an "increased risk donor" (IRD) — a softer term than "high risk" — bringing extra testing, specific informed consent and recipient testing.

The case for revising again

Organs from IRDs appeared to be underused, though candidates who turn them down have higher rates of death and graft failure than those who accept, and IRDs are often younger and healthier. The label may have caused apprehension, and the opioid epidemic was making IRDs a growing share of donors.

In 2018–2019, the transplant community told CDC and the Health Resources and Services Administration that:

• some criteria weren't actually linked to significant risk;
• with universal NAT since 2017, the 12-month window should be shorter;
• every recipient should be tested after transplant, because donors with risk factors were increasing, effective treatment (and a cure for HCV) existed, and next-of-kin answers about a donor's risks can be wrong.

CDC's own studies found:

• adult donors classed as IRDs rose from 9.3% in 2010 to 26.2% in 2017;
• 16% of IRDs had HCV RNA in their blood, against 1% of other donors;
• HBV and HCV still passed from IRDs to recipients despite NAT — but early recipient testing led to early treatment, possibly averting graft failure or death;
• the IRD label was linked to underuse of adult kidneys, mostly at a subset of centers, and minimal underuse of adult lungs and pediatric hearts;
• for donors screened by NAT 30 days after their latest risk behavior, the chance of a missed infection was fewer than one per 1 million for HIV and hepatitis C, and close to one per 1 million for hepatitis B.

How it was revised

PHS drew on CDC's studies; Organ Procurement and Transplantation Network (OPTN) data on transmissions reviewed in 2008–2018; a literature review; the Advisory Committee for Blood and Tissue Safety and Availability, which met in April 2019; and 38 public comments on a draft in the Federal Register.

The recommendations

Donor risk assessment

OPOs should confidentially find out whether any of these applied to a donor in the 30 days before procurement:

• sex (any kind) with a person known or suspected to have HIV, HBV or HCV;
• a man who has had sex with another man;
• sex in exchange for money or drugs, or sex with a person who did so;
• drug injection for nonmedical reasons, or sex with a person who did so;
• incarceration — jail, prison or juvenile detention — for 72 hours or more in a row;
• a child breastfed by a mother with HIV, or born to a mother with HIV, HBV or HCV;
• an unknown medical or social history.

Dropped as criteria: a woman who has had sex with a man who has had sex with another man; a recently diagnosed or treated sexually transmitted disease; hemodialysis; a hemodiluted test sample; and a mother merely at increased risk. None had been linked to a transmission, or only once — the hemodilution case dates to 1986, before today's tests. The eight criteria kept had been repeatedly reported in transmissions.

Living donors with ongoing risk should get individual counseling to avoid exposure before surgery.

Why 30 days? The window period, when a donor is infected but NAT can't yet see the virus, averages 11–13 days for HIV, 20–22 days for HBV and 3–5 days for HCV. The risk of a missed infection falls below one per 1 million donors 14 days after the last exposure for HIV, 35 days for HBV and 7 days for HCV. No donor-derived HIV transmission has been reported in the United States from a deceased donor since 2007, or a living donor since 2009.

Donor testing

Test every potential donor, whatever the risk criteria, with serology — anti-HIV antibody, total anti-HBc, HBsAg and anti-HCV — and NAT for all three viruses, using FDA-approved donor screening assays.

• Living donors: as close to surgery as possible, and within 28 days before procurement.
• Deceased donors: sample collected within 96 hours before procurement, results in hand at procurement.

A donor already known to have one virus needn't be retested for it.

Informed consent

• Start the conversation before a patient is put on the waiting list, with room to discuss transmission risks.
• When a donor meets a risk criterion, the OPO tells the transplant center, and the center includes it in the discussion — no separate consent form. The discussion should explain that:
• • the risk of an undetected infection is very low but not zero;
  • recipients will be tested after transplant, and effective treatment exists if an infection passes;
  • accepting such an organ may give a better chance of survival than waiting for one without risk factors.

Recipient testing and vaccination

• Before transplant, during the admission: HIV by CDC's recommended laboratory algorithm; HBV by total anti-HBc, HBsAg and anti-HBs; HCV by anti-HCV and NAT. Results needn't be back before the operation.
• 4–6 weeks after: NAT for all three viruses, in every recipient — earlier might miss an infection still in its window.
• Liver recipients: watch for late hepatitis B, and consider HBV NAT at 1 year.
• Any recipient with signs of liver injury, such as jaundice, should be tested for viral hepatitis even after negative tests.
• Every candidate should be vaccinated against hepatitis B, though an emergency transplant may not allow a full series.

Specimens

• Keep donor blood samples for at least 10 years, collected within 24 hours before procurement: one for serology and a separate EDTA plasma sample for NAT.
• Quarantine any stored vessel conduits from an infected donor at once, unless needed for the first transplant, then dispose of what's left.

Tracking and reporting

When a donor meets a risk criterion or is infected, or a recipient's infection may come from the donor, the OPO or center should alert OPTN, the other centers and any tissue and eye recovery organizations, and notify public health authorities of any infection. Living donors who test positive should be told.

Organs from donors with HCV

Direct-acting antiviral (DAA) drugs can now cure hepatitis C, and early evidence suggests that giving them to HCV-negative recipients of organs from HCV-viremic donors is safe and effective — a way to enlarge the supply of organs. Reported problems include graft rejection, delayed graft function, other viral infections, and delays in insurance approval for DAAs. Centers doing these transplants should:

• plan education and specific informed consent;
• have a testing and treatment protocol;
• make sure payment doesn't delay diagnosis or treatment;
• watch for the other infections linked to drug injection — hepatitis A, HBV, HCV, HIV, bacteria and fungi;
• report new HCV infections to public health authorities.

For organs from donors with HIV, the HIV Organ Policy Equity (HOPE) Act sets the rules.

Sources

Based on "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," by Jefferson M. Jones and colleagues of CDC, the Health Resources and Services Administration and the U.S. Department of Health and Human Services, MMWR Recommendations and Reports, CDC; a work of the United States government in the public domain. Full lists of the 2013 and 2020 recommendations: CDC Stacks.