March 17, 2011— -- Organ donors should be screened for HIV within a week of the operation, the federal Centers for Disease Control and Prevention recommended Thursday. The call came after the first documented U.S. case of HIV spread by a living donor -- a man who tested negative 10 weeks before a sick patient got his kidney.
The recipient, a kidney failure patient on hemodialysis, contracted HIV months after receiving a kidney from a man who tested negative at his initial screening, but subsequently engaged in unprotected sex, said Claudia Hutton, director of public affairs for the New York State Department of Health in Albany. Her department, along with New York City's Department of Health, conducted a public health investigation because the 2009 transplant took place at a New York City hospital, which she declined to identify. However, she said the hospital had followed the necessary protocols. All agencies involved in the investigation have declined to provide the recipient's gender because of privacy concerns.
On Monday, New York health officials issued interim recommendations calling for hospital administrators, organ transplant directors, and transplant coordinators to follow up initial blood tests for HIV, hepatitis B and hepatitis C with repeat testing. They recommended using more sensitive testing, called nucleic acid testing, which can detect these viruses within 8 to 10 days. That is well before the immune system responds to the virus by developing antibodies, typically 3 weeks to 8 weeks after exposure.
The state health agency said the additional tests should be performed "no longer than 14 days preceding organ donation" and recommended that potential living donors receive counseling to avoid unprotected sex and injection drug use, which could place them -- and the recipient -- at risk for HIV and hepatitis between the initial screening and the time the organs are transplanted.
"That's our advice, it's not a mandate," Hutton said. Asked about the CDC's recommendation for testing "close to the time of organ recovery as logistically feasible, but no longer than 7 days before organ donation," she said, "We think that there will need to be broad national discussion in the medical community on this before a consensus is reached on what the outside limit of days should be."
Case Expected to Generate Discussion About Making Sure It Doesn't Happen Again
"The shorter the time period, the better, but you have to be realistic," said Dr. Elizabeth Donegan, a professor of clinical anesthesia at the University of California, San Francisco, who directed a landmark, federally funded study examining transmission of HIV and other infections through blood transfusions.
Donegan said that UCSF flies blood samples overnight to a laboratory in Phoenix for nucleic acid testing. "It takes a while to do the test, and if there's a false positive, you have to do it again. That being said, a week is realistic, 10 days, two weeks -- as long as it's reasonably close."
Donegan predicted that the New York case would generate considerable discussion about "ways to make sure it doesn't happen again." Given that the New York donor became infected through unsafe sex, she said, "They're going to need to heavily counsel these donors. We're going to have to document that there's a trained counselor counseling these donors, and that they not only counsel them when they agree to donate, but they counsel them again before the actual transplant, giving them a private way to back out of the donation if need be."
The CDC's new recommendation appeared in an account of the New York case published in this week's Morbidity and Mortality Weekly Report. That report said that the donor was screened "10 weeks before organ procurement, but was not rescreened close to the date of transplant surgery."
Dr. Matthew Kuehnert, director of the CDC's Office of Blood, Organ and Other Tissue Safety, said the New York case represented a "sentinel event" that "brought to light that we don't have a national policy" on how to effectively prevent HIV transmission from living organ donors.
Routine antibody screening since 1985 has made HIV infection a rare complication of organ transplantation -- so much so that the New York case represents the first documented incident of HIV being transmitted by a living organ donor in this country since 1985 -- and the first such case documented worldwide since 1989, when a transplant-related HIV case occurred in Italy, Kuehnert said.
However, he said he suspected "there are cases out there that are unrecognized," because they never come to the attention of public health officials. "The nation would benefit from a system to track transplant-related adverse events similar to the surveillance system we have for transfusion-related problems," he said.
CDC Recommends HIV Screening Near Time of Organ Donation
"There is no national policy on the type of testing or the timing of testing for living donors in the United States," Kuehnert said. "It's a blind spot for organ donation because the donor pool is increasingly being made up of living donors." The number of living donors has risen steadily in recent years, from 1,829 in 1988, to 6,609 in 2009, according to CDC figures.
To fill in that blind spot, he said the CDC recommended that blood tests at the initial evaluation of potential donors be followed by additional blood tests and nucleic acid testing within 7 days of a transplant operation. That's one day less than the minimum of 8 days scientists believe it takes for a new HIV infection to become detectable with nucleic acid tests.
Speaking by telephone from Varese, Italy, where he was attending a conference on transplant infection, Kuehnert said that right now, transplant centers don't do nucleic acid testing on living donors.
Dr. Michael Shapiro, chief of organ transplantation at Hackensack University Medical Center in New Jersey, explained that part of the reason is that the centers can obtain health histories by interviewing living donors. But, he said, the quality of those histories depends upon full disclosure. "I think what Ronald Reagan said is applicable: 'trust but verify'...No one is doing an adequate job of taking a psychosocial history of a potential donor if they haven't asked about high-risk behavior."
Shapiro, a member of the ethics panel for the United Network for Organ Sharing, a private, nonprofit organization under contract with the federal government to manage the nation's organ transplant system, acknowledged that because of organ shortages, transplant centers have increasingly turned to living donors from groups considered high-risk for HIV, which generally has been gay men. "We have told those people -- or at least asked -- that they not engage in any potential high-risk behavior between the time of their last negative test and the time of their donation. That seems only prudent."
Shapiro said that with living donors, "it's not a bad recommendation that we tighten up screening," even if the overall risk of spreading HIV through a living organ donation is small.
Kuehnert said that if the CDC recommendations are widely adopted, some cases of HIV still will be spread via living donors. "There always will be risks because organs can't be sterilized," he said. "That's why it's so important for living donors to understand that if they have high-risk behavior, no matter what test they do, it's possible the test will not pick it up." Similarly, he said, all potential transplant recipients should be counseled that despite the more sensitive donor screening, "a very small risk remains that they could acquire HIV or other infections as a result of transplantation."
Tracing Cause of Kidney Recipient's HIV Infection Took Time
In an interview Thursday, Hutton said the New York case only came to light recently. "It took us a while to trace the cause."
She said that after the transplant, the recipient was hospitalized several times for what doctors suspected was rejection of the transplanted kidney. During the year after the transplant, the recipient developed yeast infections of the mouth and esophagus that didn't respond to treatment. Such yeast infections are often associated with HIV infection. HIV tests came back positive, and the patient had a low CD4 cell count, an indication of a weakened immune system that likely resulted from immune-suppressing drugs prescribed to prevent rejection of the transplanted kidney.
When doctors inquired about the patient's risk for HIV, they found no history of sexually transmitted infections, injection drug use, sex with injection drug users or other high-risk sexual activity. The patient had received blood transfusions in 2006, but none before that, and had tested negative for HIV 12 days before the transplant operation.
Investigators then began looking more closely at the donor, who met eligibility criteria of being a generally healthy, willing donor whose blood and tissues were compatible with those of the intended recipient.
A routine evaluation six months after the transplant found him to be HIV-negative, although when he asked his own doctor to re-test him for sexually transmitted infections a year after his donation, he tested HIV-positive, the CDC report said. The transplant team learned of his HIV infection during a follow-up visit a year after the transplant.
The HIV diagnoses of both donor and recipient "raised the possibility of transplant-transmitted HIV infection," the CDC said, and led New York City health authorities to launch a public health investigation that revealed the donor had unprotected sex with a male partner during the year before the transplant, "including the time between his initial evaluation and organ recovery. He did not know his partner's HIV status."
The origin of the kidney recipient's infection became clearer when tests showed both donor and recipient had the same strain of HIV, for which both are receiving treatment, Hutton said.
Case Already Affecting Transplant Programs
Shapiro called the New York case scary, even though "this isn't a surprise that it would happen at some point." It already has affected the Hackensack transplant program.
After Shapiro shared an account of the case with his transplant coordinator, he received a response telling him: "'I'm going to start doing NAT testing now," he said.
"Because we've had a better social history and had the opportunity to counsel living donors, we've thought that was enough. Today proves it wasn't."