CLEVELAND, Ohio -- As of Aug. 29, nearly 112,000 people in the United States are on the waiting list for an organ transplant. As many as a few hundred of those patients are HIV-positive.
To address the extreme shortage of organs available for patients on the national transplant waiting list, four major organizations have joined forces to call for the end of the universal ban on transplants from HIV-infected deceased donors.
Lifting the ban, they hope, will allow HIV-positive patients quicker access to suitable organs. That, in turn, could ease the wait, however slightly, for everyone else on the list.
In July, the four groups -- the American Society of Transplant Surgeons, American Society of Transplantation, Association of Organ Procurement Organizations and the United Network for Organ Sharing -- released a joint statement urging for a change in the law that prohibits the procurement of organs from HIV-positive people.
Getting rid of the ban, in place since the National Organ Transplant Act was amended in 1988 over fears of the transmission of AIDS, would allow for carefully designed and monitored research, including identification and transport safeguards to prevent accidental transplantation into uninfected recipients.
"We believe that, in the modern era of HIV care, a universal ban on transplants from HIV-infected donors may no longer be justified," the joint statement reads.
Additional research also is necessary to ascertain whether or not HIV-positive patients on the transplant waiting list could benefit from such organs, in turn shortening the overall waiting list.
An article published in the June 2011 issue of the American Journal of Transplantation estimated approximately 500 HIV-infected potential donors exist each year in the United States "with well-controlled HIV and causes of death compatible with organ donation" for kidney and liver transplants.
That number might be a bit optimistic, said Dr. John Fung, director of the Cleveland Clinic's Transplantation Center and chairman of the Clinic's Digestive Disease Institute. "But even if there are 10 donors, that would save 10 lives," he said.
Someone may ask, why even transplant organs into HIV-infected patients, given their complicated health history, when the waiting list is so long?
That question is moot, Fung said. "There aren't a lot of [HIV] patients, only 200 to 300 people in the country [on the list] at any one time. Every patient counts."
Even though antiretroviral and other medications have made it possible for HIV-positive people to have a longer, better quality of life, those waiting for a kidney, lung or other organ are more likely to die on the waiting list than someone not infected, simply because of the danger of having more compromised immune systems.
Those who do undergo a transplant are at risk of the virus becoming more unmanageable, said Dr. Dan Lebovitz, a pediatric critical care physician with Akron Children's Hospital and medical director for Lifebanc, the organ procurement organization for Northeast Ohio.
The Clinic performed the first heart transplant on an HIV-positive recipient in 2001. Since 2005, the Clinic has performed eight more transplants on HIV-positive patients. Seven have been liver transplants, and one was a combined liver/kidney transplant.
Other Ohio transplant centers have since performed surgery on HIV-positive patients as well.
In 2009, University Hospital in Cincinnati transplanted a kidney into an HIV-positive patient. Three other HIV-positive patients there are on the waiting list for a kidney. Since 2003, the hospital has performed liver transplants for two HIV-positive patients.
But when it comes to an HIV-positive person becoming an organ donor, the federal law has not budged in more than 20 years, even with the state of Illinois in 2004 becoming the first (and, so far, only) state to make it legal for HIV-positive people to donate organs to other HIV-positive people.
All potential donors are tested for HIV shortly after their death. If the person is found to have been infected with the virus, he or she is eliminated from consideration.
The organs of people who at the time of their death have active cancer, an active infection such as sepsis, or are known intravenous drug users also are rejected.
Because neither the Centers for Disease Control and Prevention, UNOS nor AOPO keep track, no one can say how many potential organ donors are discovered to be HIV-positive each year in the United States.
"Within Northeast Ohio, it's a very infrequent phenomenon, but we have had positive tests to come back," Lebovitz said.
The New York City Department of Health and Mental Hygiene disclosed this year that a patient contracted HIV in 2009 after undergoing a kidney transplant at an unnamed hospital. The donor had tested negative for HIV less than two weeks before the surgery. It was the first time since 1989 that a living donor infected a transplant recipient with the virus.
In 2007, four transplant recipients at three Chicago hospitals contracted HIV and hepatitis C from the same deceased organ donor whose HIV test had erroneously registered negative. It was the first known case of HIV transmission since 1985.
Publicity puts the pressure on
Those highly publicized cases underscore the need for strong public education surrounding any discussion about allowing HIV-positive people to be organ donors, said Tim Brown, president of the Association of Organ Procurement Organizations and the executive director of Donor Network of Arizona.
"To me, they're separate issues, but this is going to push us into making sure that people are reassured [of their safety]," he said. Organs from HIV-positive donors, he stressed, would be separated from the general pool.
"[Any change in the law] is really dependent on the transplant surgeons themselves," Brown said. "You have an inherent risk when you're trying to recover organs or do surgery on an HIV-positive patient. The surgeon is always going to take into account the safety of their team. Some will be very comfortable. Some will give it a second thought."
Roughly 20 percent of the country's 250 transplant centers perform surgery on HIV-positive patients, said Dr. Bijan Eghtesad, a transplant surgeon who, like Fung, came to Cleveland from the University of Pittsburgh Medical Center, a leader in treating HIV-positive organ recipients.
Those who are comfortable said they're ready to move forward.
"Our transplant program would support allowing HIV-positive donors to provide organs for HIV-positive recipients," said Dr. Paul Volek, director of Transplant, Dialysis & Metabolic Diseases at University Hospital in Cincinnati. "With advances in HIV therapy, the life expectancy of potential transplant recipients is commensurate with the expected kidney graft survival -- hence, we do not discriminate against this group of recipients for transplantation as our mission is to save lives; all lives."
Such a change won't be an easy one to accomplish, Fung said. But it is something he said he would support.
"This highlights the big issue: We need more organs," he said. "We need to get people to understand that a donor organ isn't something that we can manufacture. As long as there has been transplantation going on, there has been a donor shortage."
Another aspect awaits study
One aspect of research that can be studied only if the federal ban on HIV-positive organ donors is lifted is the effect on HIV-positive recipients, who could be at risk if given an organ from a donor with a more virulent serotype, or strain, of HIV that is very drug-resistant.
"By accepting that organ, I have no idea what kind of HIV I'm dealing with," Eghtesad of the Clinic said hypothetically. "I have no idea what kind of strength of HIV or what kind of genotype."
The challenge of collecting that information quickly from a deceased donor, when time is of the essence, could be insurmountable, he said.
But, Eghtesad said, if a patient is willing to be a living donor to give someone a kidney, "There's time, several months to evaluate a patient."
Until those challenges are removed, "I haven't been able to convince myself that I would offer [an organ from an HIV-positive donor] to a patient with HIV," he said.
One approach to lessen the risk of a recipient's status changing from HIV to AIDS, wrote Johns Hopkins University researchers in an article published this year in the American Journal of Transplantation, may be to use organs from "donors who were on HAART [a drug cocktail that stands for highly active antiretroviral therapy] and who were virologically suppressed for at least six months prior to donation," or from people who had not yet been treated for HIV -- people, perhaps, unaware of their HIV status.
In South Africa, researchers performed four kidney transplants in 2008 involving HIV-infected donors who had not undergone any antiretroviral therapy and who were otherwise healthy, and HIV-positive recipients. One year out, all four patients were doing well. The selection process and treatment were outlined in a letter that appeared in the June 17, 2010, New England Journal of Medicine.
"They showed that you can successfully transplant in a small number of patients," said Lebovitz of Lifebanc. A change in the law here could have a similar impact, he said.
"With the increasing disparity of the number of available organs versus the number of people on the [transplant] waiting list, it's important for those of us involved to look at potential opportunities to help these people," he said.
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