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University of Pittsburgh Receives $7.7 Million to Lead a Study on Racially Based Differences in Response to Hepatitis C Therapy

PITTSBURGH, October 8, 2001 — A national multi-site study coordinated by the University of Pittsburgh Graduate School of Public Health (GSPH) will, for the first time, examine differences in how blacks and whites respond to the latest optimal treatment for hepatitis C, an infectious disease affecting some four million Americans. GSPH has received $7.7 million from the National Institute of Diabetes and Digestive and Kidney Diseases to coordinate the trial, known as the Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis-C (VIRAHEP-C).

"We are experiencing an epidemic of hepatitis C-induced liver disease in the United States, and the treatments used to treat hepatitis C have not worked well, particularly among African-Americans," said principal investigator Steven Belle, Ph.D., associate professor of epidemiology and biostatistics, referring to smaller studies showing that blacks respond poorly to treatment for hepatitis C. "Through this study, we will determine whether African-Americans indeed have a poorer response rate to treatment, and if so, why. The results will lead to more effective and appropriate treatments for different groups of people."

There are several forms of hepatitis, an inflammation of the liver, with types B and C being the most serious -- often leading to permanent liver damage. Hepatitis C infection occurs most often as a result of recreational IV drug use, hemodialysis, tattoos, body piercing or blood transfusions that took place before screening for the virus began in 1990. Prevalence of hepatitis C is disproportionately high in the black population.

But symptoms of hepatitis C can take up to 20 years to develop, and many people carry it unknowingly and can transmit it to others. The virus can lead to cirrhosis, liver cancer or liver failure, and it is the main reason why patients require liver transplants in the United States. The rise in incidence of liver disease seen in recent years is a result of the equally dramatic rise in incidence of hepatitis C infection in the 1960s, '70s and '80s, according to Dr. Belle.

Several treatments have been used for hepatitis C over the past decade, including interferon, interferon combined with anti-viral therapies, and a newer interferon administered as a weekly shot.

"None of the medications used to date for hepatitis C have worked well, and they often cause serious flu-like side effects," Dr. Belle said.

In this study, investigators will recruit 400 hepatitis C patients (200 African-American and 200 white) at each of eight clinical sites around the United States. Each participant will receive pegylated interferon, a newer type of interferon with larger molecules that remain in the body for a longer period of time, combined with the anti-viral medication ribavirin, which enhances the effects of interferon. This combination has been approved recently by the U.S. Food and Drug Administration for treatment of hepatitis C.

After patients have been treated for one year, researchers will determine whether there are real outcome differences between blacks and whites, and the clinical, biochemical, virological, cellular, immunological and genetic factors that could be responsible for any differences.

For instance, studies have shown that interferon therapy is impaired by iron overload, which could affect some 30 percent of the black population in the United States, and by the presence of fat in the liver, which is influenced by age, gender, body mass index, body composition, alcohol use, diabetes, insulin resistance syndromes and cholesterol level.

Also, investigators will look at the viral kinetics, or the rising and falling of viral load. "Currently, we notice a quick drop in viral load after therapy is initiated, and then the drop slows down," said Dr. Belle. "Different people have different patterns of viral kinetics, and we want to know if these patterns can tell us who will ultimately respond to a treatment."

Sites for the trial are as follows: University of Maryland, University of North Carolina, University of Illinois, University of California-San Francisco, University of Michigan, Beth Israel Deaconess Medical Center, Columbia University and University of Miami.

Established in 1948, the Graduate School of Public Health at the University of Pittsburgh is world-renowned for contributions that have influenced public health practices and medical care for millions of people. It is the only fully accredited school of public health in the Commonwealth of Pennsylvania and is one of the top-ranked schools of public health in the United States. It is one of eight schools across the country to be designated a Public Health Training Center by the U.S. Department of Health and Human Services.

For more information about the GSPH, access the school’s website at http://www.publichealth.pitt.edu.

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