Viktor V Chirikov1, Steven E Marx2, Shivaji R Manthena3, John P Strezewski3, Sammy Saab4. 1. Pharmerit International, LP 4350 East-West Highway Suite 1110, Bethesda, MD, 20814, USA. 2. AbbVie, 26525 Riverwoods Blvd, Mettawa, IL, 60048, USA. steve.marx@abbvie.com. 3. AbbVie, 26525 Riverwoods Blvd, Mettawa, IL, 60048, USA. 4. UCLA Medical Center, 200 UCLA Medical Plaza, Suite 214, Los Angeles, CA, 90095, USA.
Abstract
INTRODUCTION: Chronic infection with hepatitis C virus (HCV) is a leading cause of liver disease and infectious disease deaths. While recent and emerging treatment options for HCV patients have enabled higher rates of sustained virologic response (SVR), the demographic, clinical, geographic, and payer characteristics of the estimated 3.4 million chronic HCV patients in the USA are poorly understood. The goal of this study was to create a dataset describing the current HCV patient landscape in the USA. METHODS: Data from two large national laboratory companies representing the majority of US patients screened for HCV antibody and/or tested for HCV RNA from 2013 through 2016 were organized into the present study dataset. Age, gender, payer channel, 3-digit ZIP code and ordering physician specialty, and 3-digit ZIP code information were available for all patients. Among RNA-positive patients, additional clinical characteristics included HCV genotype, fibrosis stage, renal function, and HIV status. Initiating treatment and attaining cure were imputed using data-driven algorithms based on successive RNA viral load measurements. RESULTS: The number of RNA-positive HCV patients increased from 200,066 patients in 2013 to 469,550 in 2016. The availability of clinical data measurements and rates of treatment initiation increased over the study period, indicating improved care engagement for HCV patients. Treatment and cure rates varied by age, disease severity, geographic location, and payer channel. Sensitivity and specificity of the cure prediction algorithms were consistently above 0.90, validating the robustness of the data imputation approach. CONCLUSION: This is the largest, most comprehensive dataset available to describe the current US HCV patient landscape. Our results highlight that the epidemiology of HCV is evolving with an increasing number of patients who are younger and have milder disease than described in previous years. Results of this study should help guide efforts toward the elimination of HCV in this country. Future work will focus on factors associated with varying treatment and cure patterns and describing recent changes in the HCV patient landscape. FUNDING: AbbVie. Plain language summary available for this article.
INTRODUCTION:Chronic infection with hepatitis C virus (HCV) is a leading cause of liver disease and infectious disease deaths. While recent and emerging treatment options for HCVpatients have enabled higher rates of sustained virologic response (SVR), the demographic, clinical, geographic, and payer characteristics of the estimated 3.4 million chronic HCVpatients in the USA are poorly understood. The goal of this study was to create a dataset describing the current HCVpatient landscape in the USA. METHODS: Data from two large national laboratory companies representing the majority of US patients screened for HCV antibody and/or tested for HCV RNA from 2013 through 2016 were organized into the present study dataset. Age, gender, payer channel, 3-digit ZIP code and ordering physician specialty, and 3-digit ZIP code information were available for all patients. Among RNA-positive patients, additional clinical characteristics included HCV genotype, fibrosis stage, renal function, and HIV status. Initiating treatment and attaining cure were imputed using data-driven algorithms based on successive RNA viral load measurements. RESULTS: The number of RNA-positive HCVpatients increased from 200,066 patients in 2013 to 469,550 in 2016. The availability of clinical data measurements and rates of treatment initiation increased over the study period, indicating improved care engagement for HCVpatients. Treatment and cure rates varied by age, disease severity, geographic location, and payer channel. Sensitivity and specificity of the cure prediction algorithms were consistently above 0.90, validating the robustness of the data imputation approach. CONCLUSION: This is the largest, most comprehensive dataset available to describe the current US HCVpatient landscape. Our results highlight that the epidemiology of HCV is evolving with an increasing number of patients who are younger and have milder disease than described in previous years. Results of this study should help guide efforts toward the elimination of HCV in this country. Future work will focus on factors associated with varying treatment and cure patterns and describing recent changes in the HCVpatient landscape. FUNDING: AbbVie. Plain language summary available for this article.
Authors: Jodie Dionne-Odom; Andrew O Westfall; Julia C Dombrowski; Mari M Kitahata; Heidi M Crane; Michael J Mugavero; Richard D Moore; Maile Karris; Katerina Christopoulos; Elvin Geng; Kenneth H Mayer; Jeanne Marrazzo Journal: Clin Infect Dis Date: 2020-12-03 Impact factor: 9.079
Authors: Nancy Reau; Mark S Sulkowski; Emmanuel Thomas; Vinay Sundaram; Qingqing Xu; Wei-Han Cheng; Steven E Marx; Oscar A Hayes; Shivaji R Manthena; Viktor Chirikov; Douglas E Dylla; Hannah Brooks; Jana M Carabino; Sammy Saab Journal: Adv Ther Date: 2021-10-27 Impact factor: 3.845
Authors: Eli S Rosenberg; Elizabeth M Rosenthal; Eric W Hall; Laurie Barker; Megan G Hofmeister; Patrick S Sullivan; Patricia Dietz; Jonathan Mermin; A Blythe Ryerson Journal: JAMA Netw Open Date: 2018-12-07