UC Among First to Test Solid Organ Transplant in HIV Patients
Researchers and clinicians at the UC Medical Center were among the first in the U.S. to begin enrolling patients in a National Institutes of Health (NIH) trial evaluating the protocol for liver and kidney transplantation for HIV-positive patients. The trial is part of a multi-center study aimed at determining the best way to manage HIV patients and guarantee long-term survival. The first liver transplant in UC's study was performed in November at University Hospital. The recipient has since been released and is doing well.
Since the availability of multi-drug "cocktails" in the late 1990s, life expectancy for HIV-positive patients has increased significantly. As a result, incidences of chronic diseases have increased for these patients. Death from complications of HIV has been replaced by increased death rates due to liver disease. It is reported that liver disease has emerged as the leading cause of death among HIV-positive patients in Western countries.
"The use of medications active against HIV has dramatically altered the landscape of this deadly disease. We now rarely see development of AIDS. Instead, we see patients with end-stage liver disease whose HIV is not even detectable in their blood samples," said Kenneth Sherman, MD, PhD, director of Hepatology at UC and site principal investigator for the study.
While HIV-positive patients meeting criteria for organ transplantation are already allowed to receive transplants, there has never been an established multi-center protocol for dealing with the preparation, procedure and follow-up that is specific to this virus and its medications. Last month, the NIH informed UC that they would be among the first of 14 centers to begin enrollment in this study. UC is an international leader in the study of HIV treatment and associated liver disease. It is expected that 18 patients will be enrolled locally in the study. This complex process has been performed in less than 100 patients worldwide with varying success. The transplant work-up, procedure, and subsequent care requires management by a highly trained, multi-disciplinary team. This team includes the following faculty members:
Judith Feinberg, MD, professor in the Department of Internal Medicine/Division of Infectious Diseases. Dr. Feinberg leads the HIV/AIDS clinical research at UC and is the principal investigator for the AIDS Clinical Trials Unit, which has been continuously funded by National Institutes of Health since 1987.
Frederick L. Weber Jr., MD and Stephen D. Zucker, MD, associate professors in the Department of Internal Medicine/Division of Digestive Diseases. As Co-investigators for the study, Drs. Weber and Zucker will participate in evaluation and management decisions for the study.
Rita Alloway, PharmD, research professor, Department of Internal Medicine/Divison of Nephrology and Hypertension. Alloway is a pharmacologist with expertise in the interactions between the immunosuppressive medications needed in the transplant setting and the HIV treatment medications.
Transplant surgeons from the UC Department of Surgery include: Steven Rudich, MD, PhD, Joseph Buell, MD and Steve Woodle, MD. The Liver Transplant program is among the most active (8th) in the United States and continues to push the envelope of research and patient care in Liver Disease. It is anticipated that kidney transplants in HIV-infected patients will be performed shortly.
Liver disease is the leading cause of death in HIV-infected patients in Western countries since the introduction of highly active anti-retroviral therapy (cocktails). Causes include viral hepatitis, including hepatitis C (the primary cause of liver transplantation in non-HIV infected patients) and hepatitis B, and medication toxicities.
Patients receiving livers (and eventually kidneys) through this trial are on the same waiting list managed by The United Network for Organ Sharing (UNOS).
As with any hospital procedure, Universal Precautions are in place during all phases of this trial. Due to the "cocktail" therapies, patients have HIV that is so well-controlled that tests "can't detect" HIV in serum. The risk of disease transmission is thought to be greatest for healthcare workers when the HIV status is unknown.