Did you know that millions of Americans (mostly baby boomers) are living with chronic Hepatitis and up to 2/3 may not even know they are infected? Annually, in May, the public health community commemorates “Hepatitis Awareness Month” to bring attention to this disease, its symptoms, testing, and treatment options. This year, we are working with the Centers for Disease Control and Prevention (CDC) to conduct outreach for minority groups most affected by Hepatitis: Asian/Pacific Islanders (API) and African-Americans (AA).
What’s the issue?
Hepatitis, which means “inflammation of the liver”, can cause nausea, abdominal pain, jaundice, joint pain, and malaise. Chronic hepatitis can lead to serious complications like cirrhosis, end-stage liver disease, or cancer. Hepatitis A (HAV), hepatitis B (HBV), and hepatitis C (HCV) are the most common strains found in the United States. Knowing your status and getting treatment early can potentially prevent these life threatening complications.
The statistics below show alarming disparities in the number of APIs and AAs being diagnosed with and dying from hepatitis.
- 50% or more of Americans living with chronic HBV are APIs
- APIs experience mortality rates from HBV 7 times greater than Whites
- 25% of all patients living with HCV are AAs
- Among 45-65 year old AA’s, HCV-related chronic liver disease is the leading cause of death
- HCV accounts for 8% of all AA deaths compared to 4% of White deaths
- Patients with sickle cell disease (which primarily affects AAs) are at increased risk for contracting hepatitis if they received a blood transfusion prior to 1992, when blood banks began screening blood.
What is FDA’s Role?
FDA is committed to advancing the health, safety, and well-being of all Americans through the regulation of diagnostic tests, medicines, and vaccines, as well as monitoring post market safety of healthcare products and ensuring diversity in clinical trials. The most recent safety warning about possible side effects of hepatitis drugs can be found on FDA’s safety bulletin.
One area that my office specifically focuses on is increasing diversity in clinical trials. Data has shown that African Americans and other races respond differently to hepatitis treatments. For example, in the VIRAHEP-C clinical trial, 28% of African-Americans were cured by the tested treatment, compared to 52% of whites. These results highlight why it is important to increase diversity of participants in clinical trials so we can learn how all groups respond to FDA regulated products, thus helping to ensure the safety of medical products for all.
We are actively spearheading FDA’s efforts on the FDASIA 907: Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data. Under our leadership, we help the agency improve the quality and quantity of data collected; increase clinical trial participation; and increase the transparency of clinical trial data. In addition to the information on our website, we created a clinical trials brochure which discusses the importance of volunteering in clinical trials.
Call to Action
May 19th is National Hepatitis Testing Day!
Spread the word to increase testing and early treatment. These resources are available to help your community:
- CDC’s hepatitis risk assessment tool;
- Testing site locator; and
- Campaign materials (translated in Asian languages).
Patients and health professionals can receive updates about drug approvals, drug safety updates and other issues related to hepatitis by subscribing to the Hepatitis Email Updates.
More information about FDA’s OMH can be found here: www.fda.gov/minorityhealth
Follow FDA’s OMH on Twitter @FDAOMH
Cross-posted from FDA Voice, FDA’s official blog http://blogs.fda.gov/fdavoice/
Editor’s note: This post originally appeared on May 18, 2015 on the FDA Voice, the official blog of the Food and Drug Administration.