FDA Approves Rapid Test for Antibodies to Hepatitis C Virus

The U.S. Food and Drug Administration today (June 25) announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer.

OraQuick is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain results from the test.

“Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Getting faster treatment is an important public health step to control this dangerous disease.”

OraQuick is not approved for HCV screening of the general population.

According to the U.S. Centers for Disease Control and Prevention, there are approximately 3.2 million people in the United States chronically infected with HCV and each year, about 17,000 people are newly infected. Chronic HCV infection is a leading reason for a liver transplants in the United States and HCV is associated with an estimated 12,000 deaths annually. Approximately 75 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection.

OraQuick is manufactured by Bethlehem, Penn.-based OraSure Technologies Inc.

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New Report Forecasts Hepatitis C Virus Epidemic Among Baby Boomers; Untreated HCV Progressing to Severe Liver Disease

New Report Forecasts Hepatitis C Virus Epidemic Among Baby Boomers; Untreated HCV Progressing to Severe Liver Disease Seen Driving U.S. Costs to $85 Billion

(BUSINESS WIRE)--Over three million Americans, mostly baby boomers, are living with hepatitis C virus (HCV) and nearly 80% don’t know they’re living with a disease that, absent intervention, may give rise to advanced liver disease, including liver cancer. A new study prepared by the actuarial firm Milliman, Inc. reports that, without changes in how these patients are identified and managed, the annual cost of advanced liver disease in HCV patients will jump to $85 billion in the next two decades. Medicare costs will soar 500%, from $5 billion to $30 billion. Most individuals living with HCV were born between 1946 and 1964 and a disproportionate disease burden is borne by African Americans, who are almost twice as likely to have HCV as the general population. The $85 billion estimated cost includes overall direct medical costs for patients with HCV infection.

Consequences of Hepatitis C Virus (HCV): Costs of a Baby Boomer Epidemic of Liver Disease, a new study commissioned by Vertex Pharmaceuticals, projects the direct medical cost impact of HCV on commercial and government payers over the next 20 years assuming no changes to current HCV management. Milliman employed payer datasets, population survey results and disease progression information to project chronic HCV disease states and associated direct medical costs. Societal burdens other than costs of HCV disease were not considered in the study.

"Hepatitis C presents a looming and underappreciated public health epidemic, with vital consequences for our nation's health and health care costs. As with other chronic diseases, much more can and should be done to prevent it and its complications. By addressing viral hepatitis with urgency, we have a real opportunity to spare millions of people from the consequences of advanced liver disease and liver cancer and avoid billions of dollars in potential costs," said Dr. Mark B. McClellan, Director, Engelberg Center for Health Care Reform, Brookings Institution.

The authors point out that “receiving treatment for HCV prior to the onset of severe complications can reduce long-term, life-threatening consequences, though only an estimated 22% of those infected with HCV are diagnosed.” The report concludes that, “as the population ages and the disease progresses, government payers will bear the majority of the financial impact of chronic HCV infection.”

"Millions of patients are affected by hepatitis C and hundreds of thousands will experience serious consequences of advanced liver disease, many, if not most, within their retirement years. This report is the clarion call for increased focus and resources to address preventable consequences of this mostly unrecognized infection," according to Gary L. Davis, M.D., Baylor University Medical Center in Dallas, Texas.

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