title: Efficacy and safety of peginterferon alfa-2b plus ribavirin for HCV-positive mixed cryoglobulinemia: a multicentre open-label study.
abstract: OBJECTIVE
  The aim of the present study is to provide information on clinical outcome of the patients affected by HCV-positive mixed cryoglobulinemia (MC) treated with PEG-IFN and Ribavirin for 6 or 12 months according to the HCV genotype.
  
  
  METHODS
  Eighty-six patients (42 women and 44 men) were enrolled in 8 Italian centres. All the patients had MC in the active phase of the disease. The patients received Peginterferon alfa-2b 1.5 mcg/kg/once a week (QW) and daily oral Ribavirin (800/1,000/1,200) according to their body weight for 48 weeks for genotype 1 and 4 and for 24 weeks for genotypes 2 and 3.
  
  
  RESULTS
  In the 44 patients who underwent 12 months of therapy, 17 cases (39%) could be considered as 'non-responders' and 11 relapsed, therefore only 16 patients (36%) obtained a sustained virological response. In the 42 patients who underwent six months of therapy only 7 cases (17%) could be considered as 'non-responders' and 8 relapsed, therefore 27 patients (64%) obtained a sustained virological response. Purpura score dropped in both group (p<5.79 x 10-17) and only 5 cases of the group A (11%) and 5 of the group B (12%) did not show any improvement. Arthralgias showed a similar behaviour. Many patients relapsed after the end of the treatment.
  
  
  CONCLUSIONS
  This study documents a lower response rate than that observed in the clinical trials with HCV chronic hepatitis, but the presence of comorbidities and older age should be taken into consideration. Most patients (88.5%) showed a complete and persistent recovery from clinical symptoms.
authors.affiliation: Department of Internal Medicine, Pordenone General Hospital, Pordenone, Italy. mazzaro@iol.it
authors.forename: Cesare
authors.initials: C
authors.lastname: Mazzaro
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Monti
authors.forename: Francesco
authors.initials: F
authors.lastname: Saccardo
authors.forename: Anna Linda
authors.initials: AL
authors.lastname: Zignego
authors.forename: Clodoveo
authors.initials: C
authors.lastname: Ferri
authors.forename: Salvatore
authors.initials: S
authors.lastname: De Vita
authors.forename: Armando
authors.initials: A
authors.lastname: Gabrielli
authors.forename: Marco
authors.initials: M
authors.lastname: Lenzi
authors.forename: Carlo
authors.initials: C
authors.lastname: Donada
authors.forename: Massimo
authors.initials: M
authors.lastname: Galli
authors.forename: Maurizio
authors.initials: M
authors.lastname: Pietrogrande
authors.forename: Gabriele
authors.initials: G
authors.lastname: Pozzato
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D003449:Cryoglobulinemia / Q000188:drug therapy* / Q000821:virology; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects / Q000276:immunology / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use*; 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