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Ed. note: This was originally published on the AIDS.gov Blog.
The epidemic of chronic hepatitis C virus (HCV) infection impacts over 3 million individuals in the United States, and over 50% of infected people are undiagnosed. In an effort to increase the number of people who are aware of their HCV infection and link them to care, in 2012 the U.S. Centers for Disease Control and Prevention (CDC) recommended that all persons born from 1945 through 1965 be tested for HCV, given that this group currently accounts for more than 75% of adults infected with hepatitis C in the U.S. and are five times more likely to be infected than other adults. Subsequently, in 2013, the U.S. Preventive Services Task Force also recommended a one-time HCV screening for adults born between 1945 and 1965.
Hepatitis C among African Americans
These screening guidelines are especially important for African Americans, a group that is disproportionately affected by HCV infection. An estimated 1 in 12 African-American men born from 1945 through 1965 have been exposed to HCV (Armstrong, et al. 2006) Exit Disclaimer. African Americans experience high rates of death due to cirrhosis and liver cancer, often related to chronic HCV infection (Ly, et al. 2014) Exit Disclaimer. However, some people may be reluctant to be tested or seek treatment because of serious and often debilitating side effects associated with the previous standard of care for treating HCV, which included injections of interferon-alfa. Furthermore, interferon-based treatment resulted in cure rates among African Americans that were significantly lower than among Caucasian populations, highlighting the need for new treatment options to increase the possibility of cure for all patients. This blog will summarize the recent rapid advances in HCV treatment that now allow most patients, including African Americans, to be treated and cured without interferon.
HCV Treatment History
Pegylated interferon-alfa (Peg-IFN) and ribavirin (RBV) were used to treat genotype 1 HCV from 2002 until 2011. This combination cured about 40% to 50% of Caucasians, but only 19% to 21% of African Americans, so there was reluctance among many African American patients to take injections of Peg-IFN, with many difficult side effects, for 48 weeks, with only a 1 out of 5 chance of being cured. For years, it was unclear why African Americans did not respond well to interferon. Finally, in 2009, it was discovered that African Americans are much less likely to inherit genes (IL28B polymorphisms) that allow Peg-IFN to work by helping liver cells eliminate the HCV (Ge, et al. 2009). It was clear that in order to improve HCV cure rates for African Americans, alternative treatments would be needed.
New HCV Treatments: Faster, Better Tolerated, Higher Cure Rates for All
The past four years have seen significant advances in HCV treatment, with several new drugs coming to market that can now cure HCV in a shorter period of time and with fewer side effects. The first oral, direct-acting antiviral drugs, telaprevir and boceprevir, were approved by the Food and Drug Administration (FDA) in 2011 and increased cure rates but still required co-administration with Peg-IFN. Clinical trials using boceprevir or telaprevir showed that African Americans had increased cure rates of 53% to 62%, but these rates were still lower than the 68% to 78% cure rate seen for Caucasians.
In October 2014, the combination of sofosbuvir plus ledipasvir (Harvoni™) received FDA approval. This treatment represented a dramatic shift in the approach to HCV therapy as it is a single pill taken once a day that effectively blocks HCV replication. The treatment course lasts from 8 to 24 weeks, depending on if a patient was previously treated unsuccessfully for HCV or if cirrhosis of the liver is present. Furthermore, it can be used for people who have HIV-HCV coinfection, cirrhosis, liver failure, and liver transplant, and it is very well tolerated. Researchers studied 308 people who identified as Black in clinical trials of Harvoni™. The cure rate was 95% in Black/African American patients compared with 97% in non-Black patients. This is the first time we have seen a study in which nearly all African Americans were cured of their HCV infection (Jeffers, et al. AASLD 2014 Abstract #237).
In December 2014 another new HCV therapeutic regimen, this one containing paritaprevir, ritonavir, ombitasvir and dasabuvir (Viekira Pak™), taken with or without RBV, was approved by the FDA. While clinical trials for Viekira Pak™ included a relatively small number of African Americans, cure rates for African Americans are also similar compared with Caucasians (Vierling, et al. AASLD 2014 Abstract #1968). With more new therapies still in development, it is important that African Americans are included in ongoing trials of both newly approved drugs and drugs in development so that we can improve our understanding about which are most effective in this disproportionately affected population.
While the substantial increase in cure rates have delivered great promise for addressing the HCV epidemic, the cost of these new treatments presents access and affordability challenges for many people. Now that patients, providers, and insurers have two highly effective regimens from which to choose, the price of these regimens has decreased substantially since their initial launch. We are now paying the lowest price per cure of genotype 1 hepatitis C infections in history. However, since there are several million people in the U.S. who need to be diagnosed and treated for HCV, the overall costs are still large. Because of this, some insurance companies and state Medicaid programs are prioritizing paying for treatment of people who already have severe liver disease or other complications that require urgent treatment. Hopefully, as treatment prices pose less of a barrier, everybody who seeks treatment for HCV will be able to achieve a cure.
Curing HCV is the most effective way to decrease the likelihood that a person will die from liver cancer or liver failure. African Americans have nearly twice the death rate from HCV as Caucasians, so our nation has an urgent need to find people who are infected, link them into care, and evaluate their need for antiviral treatment. As the baby boomer population continues to age, and many remain unaware of their HCV infections, we have a narrow window of time to prevent unnecessary deaths from this curable infection. By raising greater awareness in African-American communities and making best use of these new curative treatments we can decrease or eliminate the health disparities faced by African Americans living with HCV.
Editor’s Note: April is Minority Health Month, bringing a national focus on advancing health equity and ending health disparities. During April we will be sharing several blog posts about responding to viral hepatitis disparities among minority communities.
Camilla Graham, M.D., M.P.H., Co-Director, Viral Hepatitis Center, Division of Infectious Disease, Beth Israel Deaconess Medical Center, Boston, Massachusetts
During April, the Office of Minority Health marks National Minority Health Month.
Despite our nation’s progress toward ending health disparities, racial and ethnic minorities still lag behind the U.S. population as a whole on many health fronts:
The effect of health disparities is far too costly to ignore. Studies have shown health inequities cost the economy an estimated $300 billion per year. This, coupled with the number lives lost too soon to preventable causes, makes health disparities an issue relevant to all Americans.
This year marks the 30th anniversary of the Report of the Secretary’s Task Force on Black and Minority Health (also known as the Heckler Report).This landmark report marked the first convening of a group of health experts by the U.S. government to conduct a comprehensive study of racial and ethnic minority health and elevated minority health to a national stage.
This milestone anniversary serves as a paramount opportunity to highlight national and local efforts towards eliminating health disparities and advancing health equity, including legislative policy and actions such as the Affordable Care Act, the HHS Action Plan to Reduce Racial and Ethnic Health Disparities, and the National Partnership for Action to End Health Disparities.
Everyone has a role to play in reducing health disparities. Together, we can accelerate the momentum towards achieving a nation free of disparities in health and health care.
We invite you to join us during National Minority Health Month in taking action for health equity. Please sign up for the Take Action for Health Equity Thunderclap.
Richard Washington is the Digital Media Specialist at the Office of Minority Health Resource Center
At the Food and Drug Administration (FDA), essential to our mission in public health protection is to determine if medical products, such as medications and devices, are safe and effective for the patients likely to need them. Sometimes demographic subgroups – women, racial and ethnic minorities, the elderly – may respond differently to some medical products, so we must advance our understanding of health disparities and the development of treatments that work better for them.
That’s why it was important that in 2010, FDA’s Office of Minority Health (FDA OMH) was established by the Affordable Care Act to advise FDA on ways to reduce health disparities among racial and ethnic subgroups. The creation of this office was one of the many milestones that have served as a driving force to advance health equity since the Report of the Secretary’s Task Force on Black and Minority Health (also known as the Heckler Report), which was the first time the U.S. government convened a group of experts to conduct a comprehensive study of the health status of minorities.
We believe it is critical to advancing health equity to have more demographic subgroups participate in clinical trials. More diverse study participants will increase the knowledge base FDA reviewers draw on to determine if medical products are “safe and effective” (the legal standard for approving a product) for these groups. This information will also allow consumers and their medical providers to make the best, most informed decisions on which medical products will garner the best health outcome.
Historically, racial and ethnic minorities and women have been underrepresented in clinical trials. To remedy this situation, FDA is working with patient advocates and industry to raise awareness among minority patients of opportunities to participate in clinical trials and to include more providers who care for diverse patients in the design of clinical trials.
Last year, FDA took steps to protect and promote minority health by releasing the Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data. It has 27 action items addressing three priorities:
These action items aim to improve the quality of data collected, and the transparency and availability of easily understood data from clinical trials. We have implemented several activities and initiatives since the action plan’s release. Some of these include:
At FDA, we are proud of our progress to date – but we can always do more to advance public health and reduce health disparities. We plan to hold a public meeting in 2016, 18 months after the Action Plan’s release. Your insight and feedback on the Action Plan’s progress are vital to its success.
Sign up for our newsletter to stay informed about upcoming meetings and other topics of interest. For more information about FDA OMH, visit our website at www.fda.gov/minorityhealth and follow us on Twitter at @FDAOMH.
Jonca Bull, MD is the Director of the Food and Drug Administration Office of Minority Health.
On the 30th anniversary of the Report of the Secretary’s Task Force on Black and Minority Health (also known as the Heckler Report), the Health Resources and Services Administration (HRSA) recognizes the far-reaching impact of this landmark publication. Put forth by the Secretary’s Task Force on Black and Minority Health, the Heckler Report, illustrated the “…state of knowledge that contributes to the health status of Blacks, Hispanics, Asian/Pacific Islanders, and Native Americans” – a first of its kind report by the U.S. government on the study of racial and ethnic minority health. In essence, the Heckler Report set the precedent for greater attention to the persistent health disparities experienced by minority Americans.
Increasing the nation’s knowledge of the health status of minorities is a matter inherent to HRSA’s mission as the agency continues to improve health and achieve health equity through access to quality services, a skilled health workforce, and other innovative programs that reach vulnerable populations. Whether directly or indirectly, the priorities of the Heckler Report are reflected across all HRSA programs which aim to reduce health disparities and promote diversity in the health care workforce; provide high quality, culturally appropriate health care services; deliver comprehensive public health services; and support a wide variety of technical assistance, outreach and other support services focused on underserved populations.
The Office of Health Equity (OHE) within HRSA is one of eight Offices of Minority Health across HHS and the National Institutes of Health, all of which grew out of recommendations from the Heckler Report. OHE serves as the principle advisor and coordinator for special needs of minority and disadvantaged populations and spearheads collaboration to enhance the attention on the current health status of minority Americans, as well as identify innovative approaches to address their health care needs. Through collaborations with other program offices, HRSA continues to focus on driving the needle in the right direction to achieve health equity.
To support HRSA’s strategic goal to Improve Health Equity, the Office of Planning, Analysis and Evaluation (OPAE), Office of Health Equity (OHE), and HRSA Learning Institute (HLI) convened a small group of HRSA employees to strengthen their public health competency in health equity. The group piloted a web-based course called Roots of Health Inequity designed to help the public health workforce explore the root causes of inequity in the distribution of disease, illness and death.
The Roots pilot groups are part of an approved activity under the agency-level National Organizations for State and Local Officials (NOSLO) cooperative agreement awarded to the National Association of County and City Health Officials (NACCHO). HRSA is introducing the Roots of Health Inequity course to employees to strengthen their public health competency in health equity and take greater action to address health disparities across the country.
Opportunities to fund these types of health and human services would not have been possible without a concerted effort to tackle health equity head on – made possible in part by the Heckler Report and the monumental changes in research, policy, programs and legislation it helped spur to ensure a healthier tomorrow for future generations.
Michelle Allender-Smith, RN, BSN, MS, is the Director of the HRSA Office of Health Equity.
Ed. note: This was originally published on the USDA Blog.
At the 2014 Kids’ State dinner at the White House, Braeden Mannering, the 2013 Kid’s State Dinner winner from Delaware, introduces First Lady Michelle Obama at last year’s Kid’s State Dinner in East Room of the White House.
Calling all budding chefs! Do you like to cook and make healthy food for your friends and family? If so, you might be able to show off your skills and creativity to the First Lady of the United States and your peers from across the country. Learn more about how you can represent your state at the Kids’ “State Dinner” at the White House this summer.
First Lady Michelle Obama, the U.S. Department of Agriculture, U.S. Department of Education, and WGBH Boston invite you to enter the fourth annual Healthy Lunch Time Challenge & Kids’ “State Dinner.” Check out the past events here on the Let’s Move! website and get inspired to participate in this year’s challenge.
In order to be eligible for this challenge, lunch submissions need to be an original recipe, created by a kid between the ages of 8-12 years old, and need to follow the MyPlate nutritional guidelines. Fruits and vegetables should make up about half of the recipe or dish, and it should also include whole grains, lean protein and low-fat dairy.
Submissions also need to tell the story behind the food, including why the food is:
The top recipe from each of the 50 states and territories will be chosen. The top chef and their parent or guardian will be flown to Washington, DC where they will attend the Kids’ State Dinner hosted by Michelle Obama. Submission for the Healthy Lunchtime Challenge must be received by April 30, 2015.
To learn more about this exciting opportunity, including how to enter, visit: http://www.pbs.org/parents/lunchtimechallenge/home/