Until 2012, HCV screening was based on risks or medical indications and was targeted to persons with a history of injection-drug use, those with persistently elevated liver function tests, and those who received a blood transfusion before 1992 (before the blood supply was tested for hepatitis C). These screening strategies left 50 to 75 percent of infected persons unaware of their infection.
In August 2012, CDC published testing recommendations stating all Americans born from 1945 to 1965 should get a one-time test for hepatitis C. Because about 50 percent of chronically infected people will develop cirrhosis in their lifetimes, researchers hope to prevent a potential wave of liver disease and death through expanded testing, care and treatment.
Getting infected with hepatitis C is much less likely today than it used to be, primarily because of improved screening of the blood supply and better infection control in health-care settings. But people born during 1945–1965, or “baby boomers,” are more likely than others to have the virus due to possible exposure to the virus decades ago. Not all people who are infected get sick, but those who do may not have symptoms for decades. When they do start experiencing weight loss, fatigue, or depression, a doctor may attribute those issues to age or other illnesses, missing the underlying cause. This lack of diagnosis and effective care and treatment allows the illness to progress to liver disease and, in some cases, liver failure; hepatitis C is one of the nation's leading causes of liver transplants.
With a combination of federal funding and grants from private-sector partners to the CDC Foundation, CDC researchers are collaborating with medical centers in New York, Detroit, Birmingham, and Houston to better understand the benefits and impact of the birth-year-based screening strategy as compared to the previous risk-based approach. Called the Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C), the study consists of three phases: a retrospective, prospective and extension.
In the retrospective study (12 months), four sites collected data on anti-HCV screening practices and prevalence. These data were stratified by demographics, socio-economic status, and reason to test, including HIV status, elevated alanine aminotransferase (ALT) levels and injection drug use. In 2014, a paper examining physician knowledge and attitudes toward HCV testing and treatment was published in Health Promotion Practices and an additional paper reporting the HCV prevalence was published in Clinical Infectious Diseases for publication.
In the prospective study, CDC conducted HCV birth cohort testing trials at three of the retrospective study healthcare centers using variations of the randomized controlled trial design. These interventions evaluated the feasibility and effectiveness of three distinct interventions designed to increase HCV testing and linkage to care. Preliminary findings, including the announcement that these strategies increased the likelihood of identifying HCV five-fold, were presented at AASLD in November 2014. Findings for the electronic health record prompt were presented at the Annual Meeting of the Society for General Internal Medicine in San Diego.
The extension study recently began data collection, which will continue for the next two years. Clients identified through the prospective study will be tracked to observe their medical care, such as receiving an HCV-oriented appointment, treatment decisions and treatment outcomes. The study will also monitor the care received by control populations at the three sites to evaluate any differences.
The retrospective study was funded with public funds, and the prospective study was funded through support by Genentech, a member of the Roche Group, Janssen Therapeutics, Merck Sharp & Dohme Corp. and Vertex Pharmaceuticals. The extension study is funded by AbbVie.