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University of Cincinnati Academic Health Center
Publish Date: 07/17/01
Media Contact: AHC Public Relations, (513) 558-4553
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College of Medicine Studies Hemophiliacs Infected with Hepatitis C and HIV

Cincinnati--The University of Cincinnati (UC) College of Medicine has received a $2.5 million grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health to study the genomic variability of hepatitis C (HCV) in infected hemophiliac patients also infected with HIV, the virus that causes AIDS. Hemophilia is a bleeding disorder in which certain factors in the blood needed to form a clot are missing or reduced, resulting in difficulty controlling hemorrhage.

"Hemophiliacs infected with both hepatitis C and HIV have more rapidly progressive liver failure than patients with hepatitis C alone," said Kenneth Sherman, MD, PhD, associate professor of internal medicine and principal investigator of the study. "We really don't understand the reason for this accelerated liver disease process. Treating physicians who care for patients with hemophilia need additional guidance in how to best manage this complicated group of patients. AIDS and liver diseases, such as hepatitis C, have now emerged as major causes of death in people with hemophilia. This grant represents the importance of studying this group of patients who through no fault of their own got terrible diseases."

Human blood contains proteins known as clotting factors which are crucial in preventing excessive bleeding. Hemophiliacs frequently receive transfusions of clotting factors, called factor concentrates, to increase levels of the missing factor. The factor concentrates are pulled and isolated from large pools of human blood donations. Prior to 1987, almost all factor concentrates were contaminated with hepatitis C and HIV. Beginning in 1987, the heat treatments that were used to pull factor concentrates from the blood killed hepatitis C. Screening donated blood for HIV began in 1985. Universal screening of blood donations for hepatitis C was implemented in 1992.

The first phase of the four-year grant will involve the study of banked specimens from the National Cancer Institute (NCI) Hemophilia Cohort Study. The NCI study is a longitudinal study following patients who have had hemophilia and AIDS for 20 years or more. Over the course of the NCI study, patients have had frequent evaluations of their health status and blood samples taken. All of the data from the study has been recorded and stored in a large information bank. Sherman and his colleagues will perform a very detailed study of the specimens from the bank for factors associated with the progression of liver disease.

Phase two of the study will be a clinical trial with approximately 25 patients enrolled at seven national sites who have hemophilia, hepatitis C and/or HIV. Patients enrolled in the treatment phase will include selected hemophiliacs who have never been treated for hepatitis C and do not yet have end-stage liver disease. These patients will be treated with a new generation of hepatitis drugs called PEG-Interferon and Ribavirin and closely followed after their treatment for up to three years to study long-term treatment effects and immune responses.

"We are hoping to understand the mechanisms of rapid liver disease progression and identify features associated with response or lack of response to treatment in patients with hemophilia," Sherman said.

UC will serve as the primary study site. The study will be performed in collaboration with researchers from the National Hemophilia Foundation; Pennsylvania State University; Harvard Medical College; Tulane University; Medical College of Wisconsin at Milwaukee; University of Texas at Houston; Emory University and Georgetown University.



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