Selected and summarized by Ronald O. Valdiserri, MD, MPH, Professor, Department of Epidemiology, Rollins School of Public Health, Emory University, and Co-Chair of HepVu.
Dr. Valdiserri reviews significant articles on prevention, public health, and policy advances in viral hepatitis. This month, he highlights “HCV Testing and Treatment of Adults in the United States: 2014 Through 2021—Data From Two National Commercial Testing Laboratories.”
What question(s) does this study address?
In 2014, the breakthrough availability of direct acting agents (DAA) to cure Hepatitis C virus (HCV) infection made the elimination of this deadly virus a very real possibility. Subsequent strategic plans developed by both the Department of Health and Human Services (DHHS) as well as the U.S. Centers for Disease Control and Prevention (CDC) called for increasing the proportion of people tested for HCV, identifying those who are infected, referring them to care and providing curative treatment, thereby preventing the development of life-threatening liver disease and interrupting further spread of the virus.
Both the DHHS and CDC plans aim to increase the proportion of people infected with HCV who have cleared the virus to at least 80% by 2030. However, if the nation is to reach this goal, a number of challenges and barriers at the patient, provider, and health system levels must be overcome. Consider that a 2023 CDC analysis, using data from a national commercial laboratory (Quest Diagnostics), found that between 2013 through 2022, among the 1.0 million persons with evidence of initial HCV infection, only 34%, overall, were cured—and rates of cure were even lower for those who were younger than age 40 years and lacked health insurance. Using data from two commercial laboratories (LabCorp and Quest Diagnostics), Ghany and his colleagues identified the number of U.S. persons who were diagnosed with HCV infection, initiated treatment, and achieved viral cure in the time period 1/1/2014 to 12/31/2021.
What are the major findings of this report/article?
- During the study period, a total of 46,646,661 individuals were tested for Hepatitis C antibody at the two nationwide commercial laboratories; 4.8% (2,253,500) were found to be positive for HCV antibody.
- The number of persons tested for HCV antibody increased yearly from 2014 through 2019 but decreased in 2020, likely due to the COVID 19 pandemic; this was followed by a testing increase in 2021.
- During the study period, 3,117,372 persons were tested for HCV RNA and 62.6% (1,951,742) were positive, that is, viremic.
- The proportion of individuals receiving reflex HCV RNA testing on specimens found to be HCV antibody positive increased from 21% in 2014 to 36% in 2021.
- Receipt of HCV treatment and subsequent cure was imputed using previously validated algorithms based on declining viral load and continued negative HCV RNA test results. In total, 672,745 individuals received HCV treatment and 96% (an estimated 643,043) were cured.
- The rate of treatment for HCV RNA (+) persons did not vary by gender or viral genotype. However, treatment rates were higher among older persons, those with higher liver fibrosis scores (a calculated value based on other lab tests), those with HIV infection, those living in urban areas, and those living in the Northeast U.S. Data on the race and ethnicity of persons tested and treated were not available.
What are the implications for the prevention and control of viral hepatitis?
- Consistent with the earlier CDC analysis, only 35% of HCV RNA (+) individuals received treatment—although almost all (96%) of those who were treated were cured of their HCV infection.
- Despite the observed increases in testing for HCV antibody over time, persistent patient, provider, and system-level barriers continue to result in low HCV treatment uptake in the U.S. Of note, persons who were diagnosed by reflex testing (i.e., if HCV antibody is detected, HCV RNA is tested on the same blood sample, precluding the need for an additional lab visit) were more likely to receive HCV treatment compared to individuals for whom HCV antibody and HCV RNA testing were ordered separately (30% vs. 8%).
- Removing barriers to HCV diagnosis and treatment and developing innovative models of care can result in tremendous advances in treatment uptake, as demonstrated by the Veterans Health Administration (VHA). In a national cohort of over 133,000 veterans with Hepatitis C in VHA care (2021-2022), HCV treatment was initiated in 80% and 92% of those persons were cured.
- In 2023, the White House proposed a plan to eliminate Hepatitis C in the US. Its major components included: improving timely HCV diagnosis by accelerating the availability of point-of-care (POC) diagnostic tests; providing broad access to curative HCV medications, especially among underserved populations; and working with community partners and other stakeholders to improve HCV screening and to develop innovative models of care.
- At the time of this writing, a bipartisan bill (the Cure Hepatitis C Act) has been introduced into the U.S. Senate to expand HCV treatment access for low-income and “hard-to-reach” persons.
- The tools to eliminate Hepatitis C in the US are available, but this analysis provides further evidence that additional resources will be necessary in order to create the infrastructure and systems necessary to achieve this goal.
