Iron depletion before HCV antiviral therapy: A pilot, randomized, controlled trial

Authors

  • Ivan Gentile,

    Corresponding author
    1. Department of Public Medicine and Social Security, Section of Infectious Diseases, University “Federico II,” Naples, Italy
    • Dipartimento di Malattie Infettive e Medicina Legale (ED. 18), Università di Napoli “Federico II”, via S. Pansini, 5, Naples I-80131, Italy
    Search for more papers by this author
  • Chiara Viola,

    1. Department of Public Medicine and Social Security, Section of Infectious Diseases, University “Federico II,” Naples, Italy
    Search for more papers by this author
  • Luigi Paesano,

    1. Transfusion Medicine Unit, “S. Giovanni Bosco” Hospital, Naples, Italy
    Search for more papers by this author
  • Marcello D'Onofrio,

    1. Transfusion Medicine Unit, “S. Giovanni Bosco” Hospital, Naples, Italy
    Search for more papers by this author
  • Elio D'Agostino,

    1. Immunohematology and Transfusion Medicine Service, University “Federico II,” Naples, Italy
    Search for more papers by this author
  • Raimondo Cerini,

    1. Department of Public Medicine and Social Security, Section of Infectious Diseases, University “Federico II,” Naples, Italy
    Search for more papers by this author
  • Francesco Borrelli,

    1. Department of Public Medicine and Social Security, Section of Infectious Diseases, University “Federico II,” Naples, Italy
    Search for more papers by this author
  • Marcello Piazza,

    1. Department of Public Medicine and Social Security, Section of Infectious Diseases, University “Federico II,” Naples, Italy
    2. Center for Basic and Clinical Immunology Research (CISI), University “Federico II,” Naples, Italy
    Search for more papers by this author
  • Guglielmo Borgia

    1. Department of Public Medicine and Social Security, Section of Infectious Diseases, University “Federico II,” Naples, Italy
    2. Center for Basic and Clinical Immunology Research (CISI), University “Federico II,” Naples, Italy
    Search for more papers by this author

Abstract

It is not known whether iron depletion before pegylated IFN or combination treatment improves sustained virological response (SVR) rate in patients with chronic hepatitis C, despite its use in clinical practice in this setting. We aimed to investigate whether blood letting improves the efficacy (SVR) and tolerability of PEG-IFNα2b + Ribavirin in chronic hepatitis C patients. Patients with chronic hepatitis C and ferritin >100 ng/mL were randomized to: (1) repeated phlebotomies to obtain a ferritin level <50 ng/mL followed by pegylated-Interferon α2b + ribavirin (active arm); or (2) pegylated-Interferon α2b + ribavirin (control arm). Primary endpoint was SVR rate, secondary endpoint was frequency of clinical and laboratory grade 3–4 adverse events. Thirty-three patients were enrolled in the study (19 in active arm, 14 in control arm). The 19 patients in the active arm underwent a median of 5 phlebotomies (range: 1–9) to achieve the targeted ferritin (<50 ng/mL). Phlebotomies significantly reduced ferritin, iron, transferrin saturation, aspartate aminotransferase, alanine aminotransferase, and hemoglobin levels. Platelet count significantly increased, whereas HCV-RNA levels remained unchanged. After antiviral therapy overall SVR was 31.6% in active arm and 21.4% in control arm (P = 0.698). Considering only the 18 patients who were naive to antiviral therapy, SVR was 60% in active arm versus 25% in control arm (P = 0.188). Tolerability, drug dose reduction or withdrawal were similar in the two arms. In conclusion phlebotomies do not increase the overall efficacy of antiviral therapy. However, the strong trend to higher SVR in naive patients undergoing phlebotomies warrants further investigation. J. Clin. Apheresis 2009. © 2009 Wiley-Liss, Inc.

Ancillary