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Do The Right Thing
Eliminating Racial Disparities in Viral Hepatitis Drug Development

By Lei Chou and Tracy Swan, presented at HEP DART 2009

Winter 2010

"Questions of justice have long been associated with social practices such as punishment, taxation and political representation. Until recently these questions have not generally been associated with scientific research ... conceptions of justice are relevant to research involving human subjects."

-- The Belmont Report, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979

As with HIV, African Americans bear a disproportionate burden of viral hepatitis. Hepatitis C virus (HCV) is twice as prevalent, and hepatitis B virus (HBV) is nearly five times more prevalent among African Americans than Caucasians. The death toll from viral hepatitis complications, such as liver cancer, is almost twice as high among African Americans versus Caucasians.

These grim statistics prompted TAG's Lei Chou and Tracy Swan to investigate racial disparities in viral hepatitis drug development. They found that African Americans comprised less than 4% of all participants in eight phase III viral hepatitis treatment trials.

Adequate enrollment of African Americans matters, for scientific, practical and ethical reasons. For instance, researchers have been trying to figure out why HCV treatment is less effective for African Americans than Caucasians. Recent research identified a genetic polymorphism associated with favorable response to HCV treatment that is more common in Caucasians than African Americans. This important discovery would not have been possible without an adequate number of African American study participants.

Chou and Swan also analyzed factors contributing to racial disparities, and offered ways to address them. In December 2009, they presented their findings as a poster, called Do The Right Thing: Addressing Racial Disparities in Viral Hepatitis Drug Development at the HEP DART meeting. HEP DART is focused on viral hepatitis drug development; it is attended by a mixture of researchers, clinicians, basic scientists, epidemiologists, activists and investors.

According to published data from phase 3 trials involving U.S. participants, an average of 2.5% of enrollees in eleven HBV studies and 3.8% of enrollees in two HCV studies were African American.
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Do the Right Thing

HEP DART information

Underrepresentation of Underrepresented Minorities in Academic Medicine: The Need to Enhance the Pipeline and the Pipe. Merchant JL, Omary MB. Gastroenterology November 2009.

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