UNC Recives $1.5 Million to Conduct Hepatitis C Study

UNC will receive $1.5 million during the next five years to conduct the study, said Michael Fried, principal investigator in the study.

UNC was chosen to participate in a study on a hepatitis C vaccine coordinated by the University of Pittsburgh Graduate School of Public Health. UNC will act as a clinical site along with seven other universities.

"UNC is one of the major treatment centers for hepatitis C in the country," Fried said.

The purpose of the study is to determine if blacks are more resistant to hepatitis C treatment and, if so, what causes them to be more resistant.

Past studies indicated that blacks might be less responsive to treatment than whites, but these studies included a small number of blacks, Fried said.

"This trial should determine if the preliminary results are true," Fried said.

Patients who participate in the study will receive a new type of interferon, which naturally occurs in the body and fights infections, and an anti-viral medication, approved by the U.S. Food and Drug Administration.

UNC will collaborate with the University of Maryland, University of Illinois, University of California-San Francisco, University of Michigan, Beth Israel Deaconess Medical Center, Columbia University and the University of Miami.

UNC researchers are now determining how to conduct the study.

"It should all be up and running by the first quarter of next year," Fried said.

Hepatitis C is a liver disease spread by contact with infected blood. It might also be contracted by intravenous drug use and through transfusions or sex, though these instances are rare.

"Hepatitis C is the most common form of hepatitis in the U.S.," Fried said. "It stays (in the body) as a chronic illness."

About four million Americans are infected with hepatitis C, and 8,000 die per year.

Hepatitis C can cause jaundice, fatigue, pain and vomiting. It affects the liver, leading to cirrhosis and even cancer.

Currently, UNC is conducting a study using three FDA approved vaccines for hepatitis A and B.

Hepatitis B, which is different from hepatitis C, is caused by a virus that attacks the liver (HBV). It is sexually transmitted and is entirely preventable by the vaccine, Fried said.

David Halajko, clinical research coordinator with the liver program, said the study is a safety trial that will measure and compare the amount of redness and pain at the injection site.

The vaccine Twinrix is being compared to the Havrix and Engerix vaccines. Twinrix is a combination drug used to treat hepatitis A and B. Havrix is meant for treating hepatitis A and Engerix is used to treat hepatitis B. Havrix and Engerix are both administered to patients, Halajko said.

"Participants in the study will complete `diary cards' about their symptoms," Halajko said.

Participants will monitor their temperature as well as the redness and swelling of the injection site. They also will be asked to rate pain on a scale of zero to three.

Twinrix, a new vaccine, was approved by the FDA in May. It allows for patients to receive two injections less than with the Havrix and Engerix vaccines and is just as effective, Halajko said.

"The vaccines have a low percentage of side effects, including a low grade fever, fatigue and gastro-intestinal problems," Halajko said.

Twenty-five other institutions also are participating in the study and include both universities and private medical practices.

Participants in the study must be more than 18 years of age and must not have been previously vaccinated for hepatitis A or B. Participants will receive compensation in the amount of $50.

"Hepatitis B doesn't get the same amount of publicity as HIV or AIDS," Fried said. "But it's important to be vaccinated."

The University Editor can be reached at udesk@unc.edu.