ADVANCE: According to a Nov. 11 article in MedPage Today and a CDC analysis of death statistics from 1999 through 2007, HCV now causes more deaths in the U.S. than HIV.1 Why do you think we are seeing this growth in the mortality rate?
Michels: According to the CDC, there is an estimated 4 million people in the U.S who are infected with hepatitis C-four times the rate of people believed to be infected with HIV in the U.S. And, while there is no cure for HIV, treatments have extended lives dramatically in the past 30 years since the disease was first diagnosed. As a result, we are now seeing the death rate for HIV decline.
Today, one in 30 baby boomers-people born between 1945 and 1964-are infected with hepatitis C, but most do not know it. As a result of this high prevalence, we are now seeing an epidemic of HCV-related diseases because this population is entering into the period of risk for developing complications of HCV such as liver cancer and other liver diseases. Many are dying from these complications.
ADVANCE: Hepatitis C is a major health crisis because most people who are infected do not know they have the disease and may miss the chance to receive life-saving medical treatment and prevent liver disease. Can you discuss this issue?
Michels: Similar to the HIV virus, a person with the HCV virus can be asymptomatic for years, or even decades and not know that they have the disease. And, once symptoms present, the virus has already severely damaged the liver. However, unlike HIV, HCV can be cured. That is why it is so critical that people understand the risk factors for HCV and get tested, particularly if you were born between the years of 1945 and 1964, where the majority of chronic HCV cases currently reside. New therapies are now available that can effectively treat a high percentage of people with HCV infection, making expanded and accessible testing for HCV a critical step in fighting this epidemic.
ADVANCE: A new study published in the Annals of Internal Medicine2 discusses how a broader and more proactive HCV screening strategy in the U.S. could identify more than 800,000 unidentified cases and save many thousands of lives each year. Can you respond to this call for more aggressive screening and discuss how the OraQuick® HCV Rapid AntibodyTest as well as some other companies' technologies are helping to more rapidly identify more individuals who have HCV?
Michels: We would be very supportive of a broader and more proactive HCV screening strategy such as discussed in the recent study published in the Annals of Internal Medicine. Our OraQuick HCV test can be a critical part of this strategy, as it will enable healthcare providers, those on the front lines of fighting this devastating disease, to use this quick and accurate test in physician offices and outreach settings so more individuals infected with hepatitis C can be diagnosed, treated and hopefully be cured. Used in conjunction with new treatments available from Merck and Vertex, an expanded HCV screening program would help us identify and cure thousands of HCV infected individuals every year.
ADVANCE: In November, the FDA granted OraSure Technologies Inc. a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its OraQuick® HCV Rapid Antibody Test for use with fingerstick whole blood and venous whole blood specimens. How will the FDA waiver for the test help a variety of labs gain access to new HCV testing technologies?
Michels: The FDA waiver for the OraQuick® HCV Test, making it available for use by more than 180,000 laboratories registered under CLIA in the United States, including hospitals, physician offices, health clinics, outreach clinics, HIV counseling centers and community-based organizations.
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