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Activist's liver transplant a key for HIV patients

Saturday, August 18, 2001

By Christopher Snowbeck, Post-Gazette Staff Writer

If doctors at the University of Pittsburgh Medical Center succeed in transplanting a liver to novelist, playwright and AIDS activist Larry Kramer, more could be at stake than the life of one man.

The transplant also could have importance for the scores of HIV-positive patients today -- and countless patients in the future -- who are just beginning to get access to liver transplants.

"This transplant could have a tremendous influence," said Kramer's friend and fellow activist, Jeff Getty of Oakland, Calif. "For people who have HIV, need a transplant and want their insurance companies to pay for it, the Kramer transplant is a high risk proposition because all eyes will be on Kramer and his survival."

Many transplant centers are unwilling to consider patients with HIV for transplants of scarce livers. But even one of the centers that accepts HIV-positive patients wouldn't treat Kramer because of the levels of HIV in his blood.

Although Kramer, 66, would be the oldest HIV-positive patient to receive a liver transplant so far, Dr. John Fung, chief of transplantation at UPMC, maintains that Kramer is a good candidate for the operation.

What's more, the activist, whose plight was recently profiled by Newsweek magazine, is in much better shape for surgery today than he was even a few months ago, friends say. That's because of an experimental drug that is fighting his hepatitis B, the disease that damaged his liver and continues to make a transplant necessary.

In the past, HIV patients were ruled out for transplants because their life expectancy was so short. That started to change when new drug regimens began transforming HIV from an infection that preceded a fatal bout of AIDS into a chronic condition.

UPMC has been among the few hospitals willing to transplant HIV-positive patients, providing livers to eight patients since 1997. Now, UPMC is being joined by other centers in enrolling patients in a study at the University of California, San Francisco, that will examine how well HIV-positive patients do with transplants. With a grant from the National Institutes of Health, the study currently includes 11 transplant centers and, depending on the outcome of a current grant application, could include another seven hospitals.

Raising ethical concerns

Demonstrating the viability of transplants for these patients is particularly important given the chronic shortage of organs and because of concern that the immunosuppression drugs taken by transplant recipients might accelerate the progression of AIDS.

"It's a very complicated issue because there are so few livers out there," Kramer said. "If someone says to me, 'Well, how do you feel about taking this away from someone who is in other ways completely healthy?' I'd have to say, 'I feel badly for everyone that can't get one, and that would include myself.'

"If the government has seen fit to try and learn something from me on this protocol, then I feel that is kind of a major contribution. I'm putting my life on the line, but it is not an unmixed blessing."

Larry Kramer first made a name for himself in the film industry, earning an Academy Award nomination in 1969 for his adaptation of D.H. Lawrence's "Women in Love." After writing the satirical novel "Faggots" in the 1970s, Kramer came to the fore in the 1980s as a leading proponent of social change within the gay community and government funding for AIDS research.

Kramer was diagnosed with HIV in 1988, but that disease isn't the one that's killing him. Doctors told him this winter that his liver was so damaged by hepatitis that he might only have a year to 18 months of life without a transplant. Kramer sought help from the transplant center at Mount Sinai Medical Center in New York City, where he lives, but he did not qualify for their program.

Hospital officials did not comment on the case, but Kramer says Mount Sinai doctors wanted him to have undetectable levels of HIV in his blood. Kramer has a relatively small amount of the virus in his blood -- a small "viral load" -- but to reduce that to undetectable levels would require him to start taking the protease inhibitors and other AIDS medicines that have dramatically changed the life expectancy of HIV-positive patients.

Kramer said he has friends who had low levels of HIV but decided to take the drugs, and "they've all had side effects and they have fewer options now. My decision was a gamble. I don't know that anybody knows who was right yet."

The viral load issue is not a problem at UPMC, where doctors previously transplanted two HIV-positive patients with detectable virus levels. Fung said he feels comfortable transplanting these patients as long as their viral loads will be controllable after the surgery.

"By definition, we are more aggressive than other [transplant] programs, simply because we have done the most and done them first," Fung said.

A living donor dilemma

The UCSF study will take into account the variations in viral load among patients transplanted at different centers, said Dr. Michelle Roland of UCSF. But the study will favor enrolling HIV-positive patients who are relatively healthy.

"We're selecting the patient population that is most likely to do well with this intervention, trying to prove the concept that immunosuppression in HIV patients does not accelerate HIV," she said.

In this phase of the study, researchers want to enroll 75 liver transplant patients over three years. There is also a study of kidney transplants in HIV-positive patients. In the next phase of the study, researchers hope to enroll 300 patients needing liver, kidney and heart transplants.

In the process of planning for and carrying out the study, researchers are dealing with a number of sticky ethical issues that were highlighted during a conference last month in Washington, D.C.

Living donors, for example, can now provide partial livers for transplant by undergoing a risky surgery. But does the donor have a right to know if the recipient is HIV-positive?

"In many states, it's illegal to disclose HIV status," Roland said. "But donors have the right to as much information as possible to make a well-informed decision, and that decision is going to be influenced by their understanding of their own risks and the potential benefits of the interventions. ... We will probably have a donor informed consent that will have language saying there are unknowns about this particular set of circumstances."

Thus far, there have been three cases at the San Francisco hospital where recipients hadn't told their living donors about their HIV status.

"We asked them to disclose it to them and they did," said Dr. Peter Stock, a transplant surgeon there. "We suspect that when they're in the hospital, the donor will find out somehow. ... We didn't want the donor to be mad at us."

Another tricky issue is the risk to doctors and nurses performing the transplant. In an emergency case several years ago, Stock stuck himself with a scalpel while operating on an HIV-positive patient. He took AIDS medicines for several days after this exposure to the virus -- a process that gave him great empathy for patients who must take them regularly.

"I think it's ethically imperative for me to do the surgery, but [for others] it gets into this gray zone in a patient who's a marginal candidate," he said.

Since 1988, 37 people with HIV have received transplants, most since 1997, according to the United Network for Organ Sharing. But the Richmond, Va.-based group acknowledges that their numbers might not be accurate because of state laws that limit disclosure of AIDS information.

At UPMC, doctors provided liver transplants to 15 HIV-positive patients between 1981 and 1988; six of the patients were infected before transplant and nine acquired their disease from either blood transfusions or the donated organ. Two of these patients survived for more than 12 years after the transplantation, but the overall experience led UPMC to place a moratorium on transplanting HIV-positive patients.

After the introduction of highly effective AIDS drugs in 1997, UPMC started transplanting HIV-positive patients again. Two of the patients have died, but the longest-living survivor has made it more than three years. Kramer is one of four HIV-positive patients on UPMC's waiting list; another four patients could be added soon.

Fung recognizes that Kramer's transplant could be influential in determining the future likelihood of HIV-positive patients getting liver transplants.

"But I hope people would look at statistics rather than any one person," he said. "I'd like to think that one case doesn't make or break the whole thing."

For his part, Kramer has been working for months to put on weight, gain muscle mass and prepare himself for the transplant.

"It's a lot of responsibility, but I'm ready," Kramer said. "I'm champing at the bit, really, to get on that plane, be put on the table and be put to sleep. ... It doesn't sound so awful that I can't get through it somehow and I do feel I'm doing it for the movement, so to speak, as well as for myself."

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