Roughly 3.2 million Americans, more than 1% of the population, are living with hepatitis C, and only half are aware of their infection. Black Americans, representing 12% of the population, account for 22% of those with hepatitis C. According to the CDC, Black Americans are twice as likely to be infected with HCV compared to the general U.S. population. Overall, infections are rising across all age groups, especially among younger adults, leading to a significant increase in hepatitis C cases. A recent systematic research review published in JAMA, titled “Hepatitis C in Black Individuals in the US: A Review” by Falade-Nwulia et al. delineated how discrimination and structural racism have resulted in higher hepatitis C infection and hepatitis C related mortality rates among Black Americans.

Left untreated, hepatitis C can lead to severe liver disease, liver cancer, and death. Black Americans are dying of hepatitis C at nearly twice the rate as white Americans. Treatment not only prevents these dire consequences but also halts the transmission of the virus.

The current two-step diagnostic testing process for hepatitis C is cumbersome, impeding access and under-detection of current infections. This process disproportionately affects those in rural settings, lower economic groups, and minoritized racial and ethnic groups. In a retrospective patient care study, 90% of Black American patients were lost to follow-up when awaiting results.  This lack of awareness about HCV infection status poses a significant barrier to connecting patients to care, a vital step for access to curative treatment.

A rapid diagnostic test can streamline this, offering diagnostic testing within minutes instead of days and administered without the specialty skills of a phlebotomist.

Despite the availability of a cure, the United States faces low treatment initiation rates, with the number of people initiating treatment declining from 2015 to 2020. Black Americans are less likely as white Americans to be offered or receive HCV treatment. Moreover, a rapid diagnostic test would allow a test-and-treat approach, dispensing treatment medication at the time of diagnosis, further streamlining the current 3-6 visit referral to care process into a single visit, saving time and resources for patients and the healthcare system.

Bringing care to the community through community clinics and co-location at trusted community centers—churches, resource centers, libraries – addresses the second barrier to addressing racial/ethnic disparities in hepatitis C: discrimination. In a recent single-arm clinical trial of hepatitis C treatment at the time of testing delivered in a neighborhood setting for socially marginalized people, 97% of those offered HCV treatment at the time of diagnosis chose to start treatment immediately. Of the 87 who started treatment, 79% completed 12 weeks of DAA treatment, and 58 (84%) were cured of their HCV infection. This success rate is approximately three times higher than the treatment uptake and cure rates observed in the real world.

But without a rapid hepatitis C diagnostic test, this all remains a dream for Americans. Comparable rapid tests already exist for COVID-19, HIV, and pregnancy detection, emphasizing the need for a similar approach to hepatitis C diagnosis. Shockingly, a rapid HCV test using blood from a stick of your finger has been developed and approved for use abroad since 2018. While considerable investment in cultivating the US industry’s development of HCV rapid diagnosis testing and a part of Biden’s HCV initiative, led by Dr. Francis Collins, aims to streamline the approval process, companies, including Cepheid, have not pursued authorization in the US.

To be sure, additional contextual considerations including removing all prior treatment authorization restrictions, and alternative treatment payment models are also needed for improved access to DAA therapy. These are secondary to having a rapid diagnostic test available in the US.

The call to action is clear: Cepheid and other device companies must bring rapid diagnostic testing to the US market for health equity and business success. It’s time for a comprehensive approach to eliminate hepatitis C, addressing racial disparities and ensuring timely diagnosis and treatment initiation. Rapid diagnostic testing is not radical; it’s common sense. Let’s bring curative therapy to every American living with hepatitis C.