Racial differences in hepatitis C treatment eligibility

Authors

  • Michael T. Melia,

    Corresponding author
    1. Johns Hopkins University School of Medicine, Baltimore, MD
    • Johns Hopkins University School of Medicine, 1830 E. Monument St., #448, Baltimore, MD 21287
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    • fax: (410) 502-7029

  • Andrew J. Muir,

    1. Duke Clinical Research Institute and Division of Gastroenterology, Duke University, Durham, NC
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    • M.T. Melia serves as advisor for Tibotec. A.J. Muir consults for Zymogenetics, receives grant/research support from Schering-Plough, Valeant, Vertex, Zymogenetics, and speaks for Schering-Plough. J. McCone speaks for Schering-Plough and Roche. M.L. Shiffman serves as advisor for Gilead, Schering-Plough, Anadys, Vertex, Biolex, Human Genome Sciences, Novartis, and Zymogenetics, consults for Roche and Pfizer, receives grant/research support from Roche, Schering-Plough, Vertex, Biolex, GlaxoSmithKline, Globeimmune, Human Genome Sciences, Idenix, Tibotec, Zymogenetics, and Gilead, and speaks for Roche and Schering-Plough. J. King and F.A. Nunes receive grant/research support from Schering-Plough. S.K. Herrine receives grant/research support from Human Genome Sciences, Roche, and Schering-Plough. G.W. Galler serves as advisor for Schering-Plough and Gilead and speaks for Takeda. J. Bloomer and W. Cassidy receive grant/research support from Schering-Plough and Roche. K.A. Brown serves as advisor for Schering-Plough, consults for Blue Cross, receives grant/research support from Schering-Plough, Bristol-Myers Squibb, and Bayer-Onyx, and speaks for Schering-Plough, Roche, Gilead, and Bayer-Onyx. K.D. Mullen serves as advisor for Salix, Ocera, and Hyperion, receives grant/research support from Salix, and speaks for Hoffman La Roche and CLDG. N. Ravendhran receives grant/research support from Schering-Plough, Roche, Gilead, and Bristol-Myers Squibb. R. Ghalib receives grant/research support from Roche, Schering-Plough, Gilead, Vertex, Pharmasett, Debio, Biolex, Abbott, Merck, Medarex, Bristol-Myers Squibb, Idenix, Idera, Cleveland Clinic, and Duke Clinical Research and speaks for Roche and Three Rivers. N. Boparai is an employee of Schering-Plough Research Institute. S. Noviello consults for Schering-Plough. C.A. Brass is an employee of and holds stock in Schering-Plough. J.K. Albrecht is an employee of Schering-Plough. J.G. McHutchison consults for Abbott, Anadys, Biolex, Gilead, National Genetics Institute, Pharmasset, Pfizer, and United Therapeutics and receives grant/research support from GlaxoSmithKline, Globe Immune, Human Genome Sciences, Idera, Intarcia, Medtronics, Novartis, Roche, Schering-Plough, Vertex Pharmaceuticals, Virochem, and Osiris Therapeutics. M.S. Sulkowski serves as advisor for Roche, Schering-Plough, Merck, Human Genome Sciences, BIPI, Gilead, Vertex, Tibotec, Bristol-Myers Squibb, and Pfizer and receives grant/research support from Mederax, Peregrine, Debiopharm, and Abbott. R. Jiang has nothing to disclose.

  • Jonathan McCone,

    1. Mt. Vernon Endoscopy Center, Duke University, Durham, NC
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  • Mitchell L. Shiffman,

    1. Liver Institute of Virginia, Bon Secours Health System, Newport News, VA
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  • John W. King,

    1. Louisiana State University Health Sciences Center, Shreveport, LA
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  • Steven K. Herrine,

    1. Thomas Jefferson University, Philadelphia, PA
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  • Greg W. Galler,

    1. Kelsey-Seybold Research Foundation, Houston, TX
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  • Joseph R. Bloomer,

    1. University of Alabama at Birmingham Liver Center, Birmingham, AL
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  • Frederick A. Nunes,

    1. Pennsylvania Hospital, Philadelphia, PA
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  • Kimberly A. Brown,

    1. Henry Ford Hospital, Detroit, MI
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  • Kevin D. Mullen,

    1. Metro Health Medical Center, Cleveland, OH
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  • Natarajan Ravendhran,

    1. Digestive Disease Associates, Baton Rouge, LA
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  • Reem H. Ghalib,

    1. Liver Institute at Methodist Dallas, Dallas, TX
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  • Navdeep Boparai,

    1. Schering-Plough Research Institute, now Merck Research Laboratories, Kenilworth, NJ
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  • Ruiyun Jiang,

    1. Schering-Plough Research Institute, now Merck Research Laboratories, Kenilworth, NJ
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  • Stephanie Noviello,

    1. Schering-Plough Research Institute, now Merck Research Laboratories, Kenilworth, NJ
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  • Clifford A. Brass,

    1. Schering-Plough Research Institute, now Merck Research Laboratories, Kenilworth, NJ
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  • Janice K. Albrecht,

    1. Schering-Plough Research Institute, now Merck Research Laboratories, Kenilworth, NJ
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  • John G. McHutchison,

    1. Duke Clinical Research Institute and Division of Gastroenterology, Duke University, Durham, NC
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  • Mark S. Sulkowski,

    1. Johns Hopkins University School of Medicine, Baltimore, MD
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  • on behalf of the IDEAL Study Team

    1. Duke Clinical Research Institute and Division of Gastroenterology, Duke University, Durham, NC
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  • Supported by grants from Schering-Plough Research Institute, now Merck Research Laboratories. Trial Registration: ClinicalTrials.gov; NCT00081770; www.clinicalTrials.gov.

  • Presented in part at the 60th Annual Meeting of the American Association for the Study of Liver Diseases; October 30-November 3, 2009; Boston, MA. Poster #848.

Abstract

Black Americans are disproportionally infected with hepatitis C virus (HCV) and are less likely than whites to respond to treatment with peginterferon (PEG-IFN) plus ribavirin (RBV). The impact of race on HCV treatment eligibility is unknown. We therefore performed a retrospective analysis of a phase 3B multicenter clinical trial conducted at 118 United States community and academic medical centers to evaluate the rates of and reasons for HCV treatment ineligibility according to self-reported race. In all, 4,469 patients were screened, of whom 1,038 (23.2%) were treatment ineligible. Although blacks represented 19% of treated patients, they were more likely not to be treated due to ineligibility and/or failure to complete required evaluations (40.2%) than were nonblack patients (28.5%; P < 0.001). After the exclusion of persons not treated due to undetectable HCV RNA or nongenotype 1 infection, blacks were 65% less likely than nonblacks to be eligible for treatment (28.1% > 17.0%; relative risk, 1.65; 95% confidence interval, 1.46-1.87; P < 0.001). Blacks were more likely to be ineligible due to neutropenia (14% versus 3%, P < 0.001), anemia (7% versus 4%, P = 0.02), elevated glucose (8% versus 3%, P < 0.001), and elevated creatinine (5% versus 1%, P < 0.001). Conclusion: Largely due to a higher prevalence of neutropenia and uncontrolled medical conditions, blacks were significantly less likely to be eligible for HCV treatment. Increased access to treatment may be facilitated by less conservative neutrophil requirements and more effective care for chronic diseases, namely, diabetes and renal insufficiency. (HEPATOLOGY 2011;)

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