title: Non-cirrhotic thrombocytopenic patients with hepatitis C virus: Characteristics and outcome of antiviral therapy.
abstract: OBJECTIVE
  Thrombocytopenia is frequently observed in patients with chronic hepatitis C virus (HCV) infection and cirrhosis, although it can also be observed in patients without cirrhosis by a virus-mediated phenomenon. This study assessed the prevalence, characteristics, and outcomes of antiviral therapy in patients with chronic HCV infection and thrombocytopenia not associated with cirrhosis.
  
  
  METHODS
  The study included 1268 patients with HCV infection and thrombocytopenia enrolled in the phase 3 ENABLE studies that assessed the impact of eltrombopag on achieving a sustained virologic response to pegylated interferon and ribavirin. The study population was subdivided according to baseline FibroSURE test results into patients with non-cirrhosis (FibroSURE < 0.4) and cirrhosis-related (FibroSURE ≥ 0.75) thrombocytopenia.
  
  
  RESULTS
  Compared with patients with cirrhosis-related thrombocytopenia (n = 995; 78.5%), non-cirrhotic patients with thrombocytopenia (n = 59; 4.6%) were younger (mean age [95% confidence interval (CI)]: 43.9 [40.7-47.2] vs 52.7 [52.2-53.3] years; P < 0.0001), predominantly female (64% [51-76] vs 30% [27-33]; P < 0.0001), and less frequently had a Model for End-Stage Liver Disease score ≥ 10 (24% [14-37] vs 45% [42-49]; P = 0.0012), low albumin levels (≤ 35 g/L; 2% [0-9] vs 32% [29-35]; P < 0.0001), and prevalence of diabetes mellitus (3% [0-12] vs 21% [19-24]; P = 0.0005). The sustained virologic response rate was higher in non-cirrhotic patients with thrombocytopenia (46% [95% CI, 33-59] vs 16% [14-18]; P < 0.0001).
  
  
  CONCLUSIONS
  Patients with thrombocytopenia associated with HCV who have lower FibroSURE test results may have better preserved liver function and higher sustained virologic response rates than patients with cirrhosis.
authors.affiliation: Department of Internal Medicine, University of Genoa, Genoa, Italy.
authors.forename: Edoardo G
authors.initials: EG
authors.lastname: Giannini
authors.affiliation: Division of Gastroenterology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Nezam H
authors.initials: NH
authors.lastname: Afdhal
authors.affiliation: Department of Medicine, New York University School of Medicine, New York, New York, USA.
authors.forename: Samuel H
authors.initials: SH
authors.lastname: Sigal
authors.affiliation: Duke Clinical Research Institute, Division of Gastroenterology, Duke University Medical Center, Durham, North Carolina, USA.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Muir
authors.affiliation: University of Pennsylvania School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: K Rajender
authors.initials: KR
authors.lastname: Reddy
authors.affiliation: Department of Medical Gastroenterology, Sri Ramachandra University, Chennai, India.
authors.forename: Shanthi
authors.initials: S
authors.lastname: Vijayaraghavan
authors.affiliation: Department of Hepatology, Toronto Liver Center, Toronto, Canada.
authors.forename: Magdy
authors.initials: M
authors.lastname: Elkashab
authors.affiliation: Unit for Medical and Surgical Management of Digestive Diseases and CIBERehd, Valme University Hospital, University of Seville, Sevilla, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Romero-Gómez
authors.affiliation: Centre for Hepatology, University College London Medical School, London, UK.
authors.forename: Geoffrey M
authors.initials: GM
authors.lastname: Dusheiko
authors.affiliation: GlaxoSmithKline, Collegeville, Pennsylvania, USA.
authors.forename: Malini
authors.initials: M
authors.lastname: Iyengar
authors.affiliation: GlaxoSmithKline, Collegeville, Pennsylvania, USA.
authors.forename: Sandra Y
authors.initials: SY
authors.lastname: Vasey
authors.affiliation: GlaxoSmithKline, Stockley Park, Uxbridge, UK.
authors.forename: Fiona M
authors.initials: FM
authors.lastname: Campbell
authors.affiliation: GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
authors.forename: Dickens
authors.initials: D
authors.lastname: Theodore
mesh_terms: D000328:Adult; D000367:Age Factors; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000188:drug therapy* / Q000453:epidemiology / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008103:Liver Cirrhosis; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D015995:Prevalence; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use*; D012737:Sex Factors; D013921:Thrombocytopenia / Q000453:epidemiology / Q000209:etiology*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a
keywords: cirrhosis; eltrombopag; hepatitis C virus; interferon; platelets