Should certain patients be denied access to organs?
Studies challenge views of HIV-positive status
HIV-positive patients with end-stage liver disease (ESLD) long have been excluded from consideration for an organ transplant because their HIV status was considered an absolute contraindication for treatment. Although recent advances in antiretroviral therapy have made transplanting some of these patients more feasible, many centers are still holding fast to the commonly held belief that all HIV-positive patients are ineligible.
This attitude not only may keep some of these patients from receiving effective treatment, it also may hinder medical science in gathering data that can lead to advances in transplant surgery and treatment of patients with life-threatening viruses such as HIV and hepatitis virus types B and C (HBV and HCV).
"I look at things like we have wiped the slate clean and are starting all over again," says John J. Fung, MD, PhD, chief of the division of transplantation surgery at the University of Pittsburgh, one of the few centers in the United States that performs transplants in HIV-positive patients. "People ought not to have a preconceived notion that HIV is an absolute contraindication. But, rather, hopefully they would base [the transplant decision] on some real outcome data."
Fung and Nigel D. Heaton, MD, a transplant surgeon at King’s College Hospital in London, presented the results of their experience with performing transplants in HIV-positive patients at the August 26 meeting of the Fifth Congress of the International Liver Transplanta tion Society in Pittsburgh. (For additional information on the reaction of the studies, see story, p. 117.)
Although the data may not seem encouraging, when considered in the overall context of long-term survival of all patients with ESLD, they do provide justification for referring some HIV-positive patients for transplant, Fung says. "There is enough preliminary data to find that because the HIV is under better control with drugs, we ought to go ahead and do them."
Ethics committees shouldn’t immediately change their organ allocation policies to accommodate those changes, Fung advises. "They should assess how well their center is prepared to handle performing these transplants and to assess this capability before changing a policy."
Perhaps surgeons at each hospital should examine the data from the studies and recommend policy changes suitable for each hospital, Fung suggests. Establish inclusion criteria, for example, for certain HIV-positive patients and then establish a method for ranking those patients on the allocation list in order of the gravity of their liver disease, he suggests.
For some time, conventional medical wisdom has held that HIV-positive patients are not candidates for transplant surgery because the immune system-suppressing drugs given to facilitate transplant could complicate their HIV status.
"The main reason is that it seems irrational to immunosuppress someone whose immune system is already suppressed," says Fung. "And, in fact, if you were just suppressing an immunosuppressed or immunocompromised patient, it does not make sense. But, we are not looking at the same kind of suppression."
The medical science involving organ transplantation has made significant strides in managing immune suppression effectively, even in some patient groups who already have compromised immune systems. In addition, medical knowledge about the virus and its clinical manifestations has advanced considerably.
"The techniques and historic results of [successful] transplantation rates of HIV in organ transplant haven’t been all that great, either. There were a lot of things that we know now, that we did not know then," Fung explains. "An example is how we treat the opportunistic infections."
Perhaps most promising, Fung and Heaton found that HIV levels themselves do not increase due to immune suppression for transplant.
"The fact is that there is a peculiar effect on HIV immunosuppression," Fung notes. "The immunosuppression itself tends to stabilize the disease. In fact, some new treatments are being developed that may help the treatment of HIV."
Complications with immune suppression primarily arise when the patient has both HIV and a coexisting viral infection, such as HBV or HCV.
"We have effective retroviral therapy for HIV and hepatitis B, and we do seem to be able to produce long-term survival," Heaton explains. "We don’t have an effective treatment regime yet for hepatitis C."
Heaton adds that many other populations of immunodeficient or immunocompromised patients already are considered candidates for transplant. "We have developed transplant strategies for a wide variety of immune-suppressed patients. We are doing combined liver and bone marrow transplants for children with combined immunodeficiency, and we have successful survival after both," he says.
Heaton attributes the reluctance to transplant HIV-positive patients to the perception of their HIV status as a "death sentence."
"When HIV was first isolated, the prognosis of people was very poor," he explains. "And in some parts of the public, medical minds included, it is still very poor. However, in reality, the advent of effective antiretroviral therapy has transformed the prognosis. Patients can now look forward to 10 to 15 years’ and possibly 20 years’ survival with these agents. That has dramatically altered the circumstances under which we would consider HIV-positive patients for liver transplantation."
Little change predicted
Although their data are just beginning to define which HIV-positive patients would be good candidates for transplant surgery and which would be poor, Heaton and Fung predict little change in overall policy at most centers.
"People are fairly conservative in the transplant community," says Fung. "Even if the results show pretty good outcomes, there are going to be people who will not do them. So I think that what is going to have to happen is that the large centers who see a need for it — San Francisco or New York that really have a pressing community need to do it — will start. I don’t think places that don’t see a lot of HIV patients are going to ask to do it."
Fung also says that not all HIV-positive patients are, or should be, candidates for transplant. His focus is getting the community to consider which patients could be transplanted instead of excluding all positive patients.
"There are degrees of HIV, too. If you have a patient with end-stage AIDS, also with the ravages of liver disease, and you have a mix of end-stage disease with another end-stage disease, they should not be transplanted," he says. "There is nothing really that you could do for those patients. I am talking about patients who have good control of their HIV, but they also have this disease. We could reverse the clinical stigmata of the additional liver disease with a transplant."
Even if centers were willing to transplant HIV-positive patients, Heaton says there is often an obstacle — at least in the United Kingdom — to those patients being referred for transplant in the first place. In the United States, there is the added complication of a shortage of available organs.
"The public perception about how patients acquire HIV infection also is important," he says. "For the hemophiliacs or other people who get it through transfusion, I think the public feels nothing but sympathy.
"There may be other segments of the population that do not view it so simply, who may cast the liver transplantation of these patients in a less satisfactory light. The message needs to be gotten across that all of the patients are requiring professional medical care. Our duty is just to make sure that the treatment is appropriate in the context of that particular disease."
Many of the studies of immune suppression for the purposes of organ transplant have helped point the way toward the new antiretroviral therapies for patients with HIV in addition to yielding better transplant strategies, says Fung. Continued study could continue that trend, he adds.
"I would encourage whoever participates to collect the data, and we should pool the data so we can all look, because there is no center that is going to do more than three or four of these a year," he says. "If we can pool the data, we can come up with more uniform protocols to get into the studies, for collecting research samples with the study. The more centralized the data collection, the more likely we will come up with data that within a couple of years, rather than five or seven years, will change the whole field."
Suggested reading
• Ragni MV, Dodson SF, Hunt SC, Fung JJ. Liver transplantation in hemophilia with acquired immunodeficiency syndrome. Blood 1999; 93:1,113-1,114.
• McCarthy M, Gane E, Pereira S, et al. Liver transplantation for haemophiliacs with hepatitis C cirrhosis. Gut 1996; 39:870-875.
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