A $1 million grant has been awarded by the Universitywide AIDS Research Program of the University of California to conduct the first pilot study on liver and kidney transplantation in persons with HIV infection.
The funds have been awarded to the University of California, San Francisco, to study the safety, efficacy and long-term benefits of the transplant procedures in up to seven HIV- infected patients receiving treatment at UC San Francisco. Assemblywoman Carole Migden of San Francisco played a key role in authoring and carrying the legislation for $1 million for research on liver and kidney transplants for people with HIV. "People with HIV and AIDS are too often deemed ineligible for organ transplants on the basis that more research needs to be done," Migden said. "This important research is needed to show whether organ transplantation should be included in the list of procedures that are covered by insurance payers for persons with HIV."
AIDS Activist Jeff Getty, one of the most vocal proponents of organ transplants for HIV-patients, said, "AIDs activists have been involved in the process of developing this study every step of the way because we believe it is vitally important. There are many people with HIV who are living longer and healthier lives, yet we can see that organ failure is the next wave that is claiming their lives. Until now, no one has done anything."
Like all patients considered for transplant, the patients likely to be included in this study are evaluated and placed on a waiting list. The UC San Francisco study team is led by Peter Stock, MD, and Michelle Roland, MD, physicians from the Departments of Surgery and Medicine, respectively, at UCSF.
"We view this initial study as a proof of principle study," Stock said. While we recognize that many people are in need of solid organ transplantation, such procedures cannot be performed until and unless this 'proof of principle' is established. Once that happens, many more centers and payers will be willing to perform these procedures and provide reimbursement for them."
Tom Coates, Ph.D., director of the UCSF AIDS Research Institute, said, "A number of crucial scientific and clinical questions will be addressed in this pilot study that can provide information to guide the safest management of other HIV-positive people with end-stage kidney or liver disease. We are also working with the National Institutes of Health and a group of collaborators from transplant centers across the United States to discuss the feasibility of a future national multi-center trial."
"The results of this innovative and cutting-edge study are likely to help persons with HIV in California as well as throughout the United States," said George Lemp, Dr. P.H., director of the Universitywide AIDS Research Program, which allocated the funds.
Lemp explained, "Although the new combination therapies are extending the lives of many persons with HIV, a substantial number now die from other causes, such as end-stage liver and kidney disease. A careful study to demonstrate safety and efficacy of organ transplantation in HIV-infected patients is essential given the increasing numbers of HIV-infected persons confronted with end-stage liver and kidney diseases."
Indeed, a recent report from the Tufts University School of Medicine in Massachusetts revealed that 50 percent of the 22 deaths among HIV-infected patients treated at that institution in 1998-99 were attributable to end-stage liver disease. Co-infection with hepatitis C virus, which can cause chronic liver damage and failure, is often the reason for end-stage liver disease in HIV-infected patients, although some deaths may result from the potential toxicity of the combination drugs used in highly active antiretroviral therapy. Current policy and practice have generally excluded HIV-infected individuals with end-stage liver and kidney diseases from receiving transplants. The concern has been that patients with HIV would have a poor prognosis because of their shorter life expectancy and because their immune system already may have been compromised due to their disease and the therapies used to treat HIV. It was felt that organ transplants, which require lifelong suppression of the immune system, would only worsen their condition.
However, recent advances in therapy have extended the life expectancy of many with HIV, and recent but limited studies have indicated that some HIV infected individuals could tolerate immunosuppressive treatments and benefit from transplantation of organs.
The University of California established the Universitywide AIDS Research Program in 1983 at the request of the state Legislature. The program, which is part of the UC Office of the President in Oakland, has awarded a total of 1,600 research grants totaling more than $135 million.
Jeff Getty can be reached for comment at 510-653-6278
George Lemp is available for comment at 510-987-9004
Peter Stock can be reached at 415-353-1117 or via UCSF News Services 415-476-2557