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) . African Americans experience high rates of death due to cirrhosis and liver cancer, often related to chronic HCV infection (Ly, et al. 2014) . 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.