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Eliminating Screening Barriers for HCV

Eliminating Screening Barriers for HCV
Author Information (click to view)

Carol Brosgart, MD

Clinical Professor of Medicine, Biostatistics & Epidemiology
University of California, San Francisco

Carol L. Brosgart, MD, has indicated to Physician’s Weekly that she has worked as a consultant for Dynavax Technologies, Chimerix, Contravir, Eiger, and FIPRA International. None of her current consulting includes HCV. In the past, she has worked as a consultant for Quest Diagnostics, Astex, Theravance, Janssen, Theraclone, the CDC Foundation, and the Viral Hepatitis Action Committee of the CDC Foundation and the CDC Division of Viral Hepatitis. She was employed by Gilead Sciences from 1998-2009; the Children’s Hospital and Research Center Oakland from 2009-2011; and Alios Biopharma in 2011. Dr. Brosgart is also a member of the Board of Directors of Tobira Therapeutics (area of research is HIV and NASH and was on the board of an influenza vaccine company, Juvaris. The company is no longer active, but she does own shares in the company. She notes that she is on the Executive Committee of the Forum for Collaborative HIV Research; the steering committee of the National Viral Hepatitis Roundtable; and, the Board of Pangaea Global AIDS Foundation. She also serves on the HCV Task Force of the Infectious Diseases Society of America and on the Public and Clinical Policy Committee of the American Association for the Study of Liver Disease.

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Carol Brosgart, MD (click to view)

Carol Brosgart, MD

Clinical Professor of Medicine, Biostatistics & Epidemiology
University of California, San Francisco

Carol L. Brosgart, MD, has indicated to Physician’s Weekly that she has worked as a consultant for Dynavax Technologies, Chimerix, Contravir, Eiger, and FIPRA International. None of her current consulting includes HCV. In the past, she has worked as a consultant for Quest Diagnostics, Astex, Theravance, Janssen, Theraclone, the CDC Foundation, and the Viral Hepatitis Action Committee of the CDC Foundation and the CDC Division of Viral Hepatitis. She was employed by Gilead Sciences from 1998-2009; the Children’s Hospital and Research Center Oakland from 2009-2011; and Alios Biopharma in 2011. Dr. Brosgart is also a member of the Board of Directors of Tobira Therapeutics (area of research is HIV and NASH and was on the board of an influenza vaccine company, Juvaris. The company is no longer active, but she does own shares in the company. She notes that she is on the Executive Committee of the Forum for Collaborative HIV Research; the steering committee of the National Viral Hepatitis Roundtable; and, the Board of Pangaea Global AIDS Foundation. She also serves on the HCV Task Force of the Infectious Diseases Society of America and on the Public and Clinical Policy Committee of the American Association for the Study of Liver Disease.

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Approximately 3.9 million Americans are chronically infected with the hepatitis C virus (HCV), making it the most common chronic bloodborne infection in the United States, according to the CDC. If left untreated, HCV can result in serious organ damage to the liver and kidneys as well as premature death. On average, HCV patients die 20 years earlier than those without the infection. Research shows that HCV symptoms often do not manifest for decades and patient awareness of their infection status is low. Despite recent advances in therapeutics, diagnostic assessments, technology and public health policy for HCV, research suggests that a substantial number of people remain undiagnosed and untreated.

Facilitating access to new therapies is paramount to making progress in the fight against HCV. Many stakeholders are working to develop solutions to address the cost of direct-acting antiviral agents, but access to therapy is just one of the barriers to reducing disease incidence. One of the most important barriers in care involves the quality of screening and diagnosis. Published guidelines from the CDC and United States Task Force for Preventive Services have helped guide clinicians on who should be screened, including baby boomers born between 1945 and 1965, and how to screen them.

Unfortunately, screening often involves a two-step approach to testing. When patients receive a positive antibody screen, they may need to return for a subsequent doctor’s visit and blood draw to produce a specimen on which to perform a molecular test to confirm active infection. Studies indicate that as many as 60% of patients who receive a positive antibody screening test for hepatitis C in the U.S. do not undergo subsequent molecular testing. The net result is some of these people may not receive prompt—or any—treatment to slow disease progression before a potentially life-threatening but preventable event occurs.

 

Addressing the Issue

There are two simple actions that the medical community can take immediately to address this gap in testing approach. First, the medical community must better communicate with patients about HCV-related issues, including the value of screening baby boomers and other at-risk populations. Clinicians, nurses, and other medical personnel must strive to avoid negative dialogue that might stigmatize patients from seeking screening or treatment.

Second, it is important to eliminate any remaining barriers that might potentially impede the identification of HCV. This includes streamlining diagnostic screening processes. Quest Diagnostics, for example, recently discontinued offering stand-alone antibody screenings for positive screen results. Instead, any positive HCV antibody test result automatically triggers additional reflex molecular testing of the specimen. This change simplifies test ordering and reduces the need for more than one blood draw and office visit for patients. Using this approach is medically responsible and appropriate because it will improve the likelihood that patients and their clinicians receive clear insights into confirmed HCV infection cases.

 

Coordinating Efforts

Modern medicine has conquered many infectious disease epidemics, including yellow fever, typhus, cholera, and smallpox, among others. Although an HCV vaccine is not currently available, clinicians do have curative oral therapies in their armamentarium. HCV could be eliminated with a sound public health campaign to identify individuals who are chronically infected and linking them to care and treatment. With a coordinated, aggressive campaign that facilitates appropriate screening, diagnosis, and access to effective medical therapies, we may be able to prevail in the HCV epidemic.

Readings & Resources (click to view)

AIDS.gov. Action Plan for the Prevention, Care, & Treatment of Viral Hepatitis. Available at: https://www.aids.gov/pdf/viral-hepatitis-action-plan.pdf.

Moyer VA, on behalf of the U.S. Preventive Services Task Force. Screening for hepatitis C virus infection in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013;159:349-357.

Chou R, Wasson N. Blood tests to diagnosis fibrosis or cirrhosis in patients with chronic hepatitis C virus infection: a systematic review. Ann Intern Med. 2013;158:807-820.

Abdelwahab KS, Ahmed Said ZN. Status of hepatitis C virus vaccination: recent update. World J Gastroenterol. 2016;22:862-873.

Smith BD, Morgan RL, Beckett GA, et al; Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep. 2012;61:1-32.

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