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1st appeared 29 November 1999

New Frontiers -- Organ Transplantation for HIV-Positive Patients

UCSF is one of only a handful of medical centers around the world poised to transplant organs into HIV-positive patients, a procedure that remains controversial both in terms of its medical success and social acceptance.

The prospect of offering transplants to HIV-positive individuals is one of the spillovers of the success of treatments with "cocktail" combinations of the anti-HIV drugs known as HAART -- highly active antiretroviral therapy. Suddenly, HIV-positive individuals are living long enough to make it reasonable to consider transplantation as a treatment for hepatitis and other co-morbidities that imperil liver or kidney function.

The decision to transplant organs into HIV-positive recipients remains controversial, in part because the demand for organs continually outstrips the supply. According to the United Network for Organ Sharing, a national group responsible for allocating organs for transplantation, 13,600 people are on the waiting list for livers; last year 1,319 people died while on the list. The list for kidneys is even longer, but kidney patients can often be sustained by dialysis while awaiting an organ.

Some observers have expressed doubts about the wisdom of opening up the transplant waiting list to HIV-positive individuals. "It seems almost crazy to be exploring new possibilities for transplant when the shortage is so severe," said Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics, in an interview with the Pittsburgh Post-Gazette. "You don’t want to discriminate against anybody, but you want to take into account the chances of success and the likelihood that people will live with the transplant."

Caplan's skepticism has been shared by insurers, a fact that is not surprising to UCSF's Michelle Roland, an internist who treats patients with HIV disease. "There are reasonable reasons for third-party payers to say 'Why do we want to fork out hundreds of thousands of dollars to do this intervention when you have no data?'"

So far, conjecture about how HIV-positive patients will fare as transplant recipients is based on very circumscribed experience. There are limited historical data from patients whose HIV status was unbeknown to the transplant team; only a handful of transplants have taken place when recipients were known to be HIV-positive. Roland speculates that insurers will change their tune, "if we can do a reasonable pilot study that shows…patients' grafts are functioning and surviving for a reasonable period of time."

UCSF is about to undertake such a pilot study of liver and kidney transplantation in HIV-positive patients. The study is the result of intensive lobbying by AIDS activists, research by a host of UCSF physicians and surgeons, and support from the state government. Late this summer, the California legislature appropriated $1 million to UCSF to conduct up to ten transplants. The funding earmark came at the behest of Assemblywoman Carole Migden (D-San Francisco), with a nudge from the irrepressible Jeff Getty, an Oakland AIDS activist who came to national attention in 1996 when he received a baboon's bone marrow in a transplant procedure directed by UCSF's Steven Deeks.

Although a million dollars is a relatively modest sum when it comes to transplantation (liver transplant costs typically exceed $300,000), the prospect of some public funding helped galvanize researchers and focus their energies. A team led by Peter Stock of the department of surgery, Michelle Roland of the department of medicine, and Leslie Floren of the School of Pharmacy's department of biopharmaceutical sciences met with other UCSF researchers and community advisors to hammer out two protocols, one for kidney transplantation and the other for liver transplantation.

The protocol development required an almost unprecedented level of interdisciplinary cooperation. "You have all the transplant people and their multidisciplinary approach and all the HIV people and our multidisciplinary approach...so the collaborative process has been challenging," Roland said in a recent interview, with a politic tone of understatement in her voice.

The fundamental obstacle the protocol team faced was clear: People with HIV have been excluded from transplantation largely because of concerns that immunosuppressive drugs administered to ward off the body's efforts to reject any foreign organ might worsen a patient's HIV infection or interfere with the workings of antiretroviral drugs.

This led to protracted discussions of just how sick eligible patients should be, echoing a debate already well known to transplant surgeons, bioethicists, and desperate patients and families. Patients would need to be both healthy enough to benefit from an organ transplant and in a position to take care of their new organs. (This latter consideration would bar active alcoholics or injection drug users from receiving organs.)

Jeff Getty, a member of the Community Advisory Board (CAB) advising UCSF on the transplant protocols, described the decision in an ACT UP/Golden Gate Writers Pool article. "CAB members agreed that since there were plenty of [HIV-positive] patients waiting for organs that met this criteria [a nadir of 200 CD4 cells and no previous AIDS-defining opportunistic infections], it would be best to start with healthier patients first.…CAB members agreed that the higher the HIV-positive survival rate, the more likely it will be for medical insurance payment and HIV inclusion in future transplants. Unfortunately, patients with low CD4 numbers or progressed AIDS will be turned away for now. This decision was not taken lightly by the group."

Last month, UCSF researchers reprised these discussions in a meeting convened by the National Institutes of Health (NIH). NIH brought together representatives from Mt. Sinai, Georgetown, Loyola, and the University of Pittsburgh to develop, if not a common multi-site research protocol, at least the beginnings of a national registry of HIV-positive transplant recipients.

Source: Jeff Stryker

Jeff Stryker is Senior Editor of the UCSF AIDS information website, HIV InSite. He is also a Specialist at the UCSF Center of AIDS Prevention Studies and has been active in AIDS policy for more than a decade.

This article appeared originally in the UCSF AIDS Research Institute's Fall newsletter.

Links:

AIDS Research Institute

ARI Newsletter

Center for AIDS Prevention Studies

HIV InSite


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