HCV Data Sharing

Hep Talk by Larry Buhl

Three Steps
New hep C data sharing may lead to more testing


Last year the U.S. Centers for Disease Control and Prevention (CDC) made a big stir in the medical community when it issued its recommendation that everyone in the Baby Boomer cohort be tested for hepatitis C, whether or not they have any symptoms or risk factors for the virus. The thinking was just being born between 1945 and 1965 was risk enough, what with blood transfusions or organ transplants that had no effective hepatitis screening before 1992, and recreational injection of drugs that could have led to a liver infection that has gone undetected all these years. More than seventy-five percent of American adults with hepatitis C are baby boomers, and infection rates were highest in the seventies and eighties, the CDC said.

In June, an influential health advisory group that initially dismissed the CDC’s recommendation reversed itself and agreed that all baby boomers could benefit from an initial test for hepatitis C. The United States Preventive Services Task Force said that after reviewing some new studies and the public comments that there was a clear and growing effectiveness of treatment which boosted the case for screening people who don’t have any symptoms or risk factors, such as an entire generation of baby boomers.

The task force’s preliminary recommendation in November, 2012, was grade C, meaning testing could be offered to select patients and would probably have a small benefit. The final recommendation has a grade B, suggesting that one-time hepatitis C screening for all adults born between 1945 and 1965 would have a moderate benefit. That B grade is enough, under the Affordable Care Act, for preventative services to be provided without co-payments from patients.

Now one diagnostic testing service has announced a new collaboration with the CDC to help implement the Center’s recommendations by enhancing screening, diagnosis and medical intervention for the estimated 3.2 million Americans infected with hepatitis C.

Under an agreement, medical experts, scientists and health informatics experts from Quest Diagnostics and the CDC’s Division of Viral Hepatitis will share de-identified (patient identifiers removed) hepatitis C test results—in a HIPAA compliant manner, they emphasize—from the Quest Diagnostics Health Trends national clinical laboratory database. The de-identified data will include results of screening and confirmatory diagnostic tests as well as genotyping and viral load tests used by clinicians to manage treatment.

Data will be evaluated to identify and track epidemiological trends in hepatitis C virus infection, testing and treatment, and evaluate how those trends differ based on gender, age, geography and clinical management. The organizations may jointly publish results of their research, such as in peer-reviewed publications and scientific conferences.

There are three steps in the continuum of testing, before a patient gets into care:

• An initial test for hepatitis C antibodies
• A confirmation test of whether the patient is currently infected
• A genotype test, to suggest the proper course of therapy for those who are infected

By gathering data at each of these testing steps, Quest and the CDC will be able to see, among other demographic information, patterns in testing behavior. Not everyone who tests positive for the hepatitis C antibodies actually returns for a confirmation test, and many who test positive in the confirmation don’t return for the genotype test.

Quest’s data collection and data sharing with the CDC can help the medical community better understand who is less or more likely to show up, or not show up, at each of these stages, as well as data on viral loads and genotyping for those who make it through all three stages of testing, according to Rick Pesano, MD, PhD, Medical Director for Infectious Diseases and Immunology at Quest.

“Quest is the first company to engage in this type of data sharing with the CDC, and I hope other companies will also consider collaborating like this,” Pesano told A&U.

By analyzing demographic data of those who get tested—and those who don’t follow up at any stage of the testing and treatment continuum—Quest will help the CDC better target their hepatitis outreach and communication efforts, Pesano added.

Much of this data will be published in medical journals, but there may be additional avenues for reaching doctors with the data and helping them understand what it means, Pesano said. “At this point, awareness of the necessity of testing this cohort, both for physicians and patients, is key to saving lives.”

For more information about the data sharing, visit: QuestDiagnostics.com/HealthTrends.

Larry Buhl wrote about how the Affordable Care Act will affect HCV care in the August Hep Talk.