title: Natural leukocyte interferon alfa for the treatment of chronic viral hepatitis in heart transplant recipients.
abstract: BACKGROUND
  A more rapid and aggressive course of hepatitis B virus (HBV)-related and hepatitis C virus (HCV)-related infection in organ transplant recipients has been described. Interferon alfa is the most accepted drug for treating HBV and HCV chronic infections. However, the use of interferon alfa-N3 has been contraindicated in heart transplant (HTx) recipients because of the hypothesized greater risk of triggering acute cellular rejection. The aim of this clinical pilot study was to evaluate tolerability, safety, and efficacy of natural leukocyte interferon alfa in the treatment of chronic HBV and HCV in HTx recipients.
  
  
  METHODS
  Seven HTx recipients were enrolled in the study: two with HBV, four with HCV, and one with combined HBV-HCV chronic infection. The patients had a mean follow-up after heart transplantation of 8.5+/-3 years, before starting interferon alfa-N3 treatment at a dose of 6 MU three times per week, intramuscularly for 12 months.
  
  
  RESULTS
  All patients completed the treatment with no major side effects. No unexpected episodes of acute cellular rejection were observed during the treatment. Mean aminotransferase serum levels were significantly lower than before transplantation at 3 (P<0.03), 6 (P<0.02), and 12 (P<0.02) months of treatment and at the 12-month follow-up (P<0.02). A complete and sustained response was achieved in all subjects with HBV-related chronic hepatitis, whereas sustained virologic response was observed in one of four HCV patients.
  
  
  CONCLUSIONS
  The preliminary data emerging from our study indicate that natural leukocyte interferon alfa-N3 can be safely administered in HTx recipients with chronic HBV or HCV viral hepatitis. Further studies with larger numbers of patients are needed to assess the efficacy of interferon alfa-N3 on HCV virologic response.
authors.affiliation: Gastroenterology, Department of Surgical and Gastroenterological Sciences, University of Padua, Via Giustiniani 2, 35128 Padua, Italy. fagiuoli@unipd.it
authors.forename: Stefano
authors.initials: S
authors.lastname: Fagiuoli
authors.forename: Sara
authors.initials: S
authors.lastname: Pevere
authors.forename: Francesco
authors.initials: F
authors.lastname: Minniti
authors.forename: Ugolino
authors.initials: U
authors.lastname: Livi
authors.forename: Alida L P
authors.initials: AL
authors.lastname: Caforio
authors.forename: Remo
authors.initials: R
authors.lastname: Naccarato
authors.forename: Maria
authors.initials: M
authors.lastname: Chiaramonte
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D016027:Heart Transplantation / Q000009:adverse effects*; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy* / Q000209:etiology*; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000209:etiology*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012449:Safety; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha