AbbVie Characterizes Evolving Hepatitis C (HCV) Patient Landscape in the United States Using Comprehensive Dataset

NORTH CHICAGO, Ill., Nov. 9, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present data from two studies that assessed HCV screening and diagnosis practices and linkage to care in the United States (US) at The Liver Meeting® 2018, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), in San Francisco. The two studies, which highlight gaps in the care cascade, are part of a comprehensive dataset that can now be accessed through MappingHepC.com, a new interactive online resource that features national and state-level data on HCV screening, diagnosis and treatment.

"Until now, the HCV patient landscape has been poorly understood, with out-of-date data sources and under-reporting of HCV infections," said Sammy Saab, M.D., David Geffen School of Medicine, UCLA.  "The availability of this epidemiology data provides a clearer picture of where the most concentrated populations of people with HCV are located, which is a crucial step towards eliminating the virus in the US."

To address the need for more accurate HCV patient landscape data, AbbVie analyzed two large national laboratory datasets including over 17 million HCV antibody tests and 1.5 million HCV RNA tests in US patients between 2013 and 2016.¹ Unlike other sources for national HCV estimates, MappingHepC.com relies on actual patient HCV antibody and confirmatory RNA test results.

The findings of AbbVie's analysis include:

• Washington D.C. and West Virginia had the highest number of HCV RNA positive patients per 100,000 population in 2016.
• West Virginia and Kentucky had the highest percentage of HCV RNA positive patients between the ages of 30-52 in 2016.

"As a leader in the fight against chronic liver disease, we strive to provide healthcare professionals with the most current education and information on chronic liver disease," said Marcelo Kugelmas MD, Board of Trustees Member of the Chronic Liver Disease Foundation.  "MappingHepC.com will help physicians navigate the HCV landscape, understand the epidemiology of their specific geographic area and hopefully, be a resource for action towards the elimination of HCV."

HCV is the most common chronic infectious disease in the US with an estimated 3.4 million people infected.² While highly-effective treatments are available for the majority of patients today, addressing the societal and behavioral barriers that prevent people with HCV from accessing treatment is the biggest challenge to eliminating the disease.

"We are excited to provide the HCV community with up-to-date information on the evolving HCV landscape," said Vipan Sood, vice president, Health Economics and Outcomes Research, AbbVie. "The accessibility of this data will allow stakeholders to focus resources and expertise to their specific communities and to come together to maximize our efforts."

Complementing the launch of the website, two AASLD abstracts from the same dataset highlight gaps in the care cascade.^3,4 Data show that while overall rates of HCV screening are improving, there is an increase in the number of young adults from 2013-2016, specifically between the ages of 18 – 39 years old, who were antibody positive (2.8-3.9 percent). In addition, there was a decline in the rate of antibody positive baby boomers between the ages of 48-71 years (9.1-8.1 percent). When patients were examined longitudinally in a second study, differences persisted with young adults less likely to see an HCV specialist (9.2 percent vs 23.4 percent) and receive treatment (22.6 percent vs 32 percent) than baby boomers. The website will be updated in 2019 to include information from the two AASLD abstracts.

Study Methods
"National Estimates for HCV Screening and Diagnosis Rates in the United States (2013-2016) Based on Large Real-World Dataset"
The study on screening and diagnosis rates included 17,149,480 unique patients who were screened based on an antibody test between the years of 2013 and 2016. Active HCV infection was defined as having a positive HCV RNA after a positive antibody test. Antibody screening rates, antibody positive rates, RNA follow-up testing rates and RNA positive rates were assessed descriptively by year and stratified by baby boomers 48-71 years old and young adults 18-39 years old, to reflect the evolving disease epidemiology.³

"National Examination of HCV Linkage to Care in the United States (2013-2016) Based on Large Real-World Dataset"
The study on linkage to care included a care cascade defined as: screening (HCV antibody test), diagnosis (HCV RNA findings), seeing an HCV specialist (i.e., gastroenterologist/hepatologist/infectious disease) and receiving HCV treatment (based on an algorithm). This analysis was limited to patients that had undergone HCV antibody screening. Patients who tested positive for HCV antibodies were longitudinally assessed to determine the steps of the care cascade they completed. Given the evolving disease epidemiology with the influx of young, newly infected people, the analysis was stratified by two age cohorts: baby boomers 48-71 years old and young adults 18-39 years old. The care cascade was additionally delineated within each year between 2013 and 2016 as well as by individual states and payer types (commercial insurance, Medicare, Medicaid, out-of-pocket).⁴

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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¹ Chirikov, V.V., Marx, S.E., Manthena, S.R. et al. Adv Ther (2018) 35: 1087.
² Center for Disease Control and Prevention. Hepatitis C Questions and Answer for Health Professionals.  https://www.cdc.gov/hepatitis/hcv/hcvfaq.htm Last accessed November 6, 2018. 
³ Sulkowski et al. National Estimates for HCV Screening and Diagnosis Rates in the United States (2013-2016) Based on Large Real-World Dataset. AASLD The Liver Meeting 2018.
⁴ Reau et al. National Examination of HCV Linkage to Care in the United States (2013-2016) Based on Large Real-World Dataset. AASLD The Liver Meeting 2018.

SOURCE AbbVie

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