title: Effects of two different alpha-interferon regimens on clinical and virological findings in mixed cryoglobulinemia.
abstract: OBJECTIVE
  As previous studies have shown a good response of mixed cryoglobulinemia (MC) to alpha-interferon (IFN) therapy, we investigated the efficacy and tolerability of two IFN regimens in a group of 36 patients affected by MC.
  
  
  METHODS
  The patients, diagnosed on the basis of standard clinical and laboratory criteria, were randomly divided into 2 groups: group A (18 cases) received alpha 2b-IFN 3 M.U. thrice a week for six months, while group B (18 cases) received alpha 2b-IFN thrice a week for 1 year. The patients were followed for six months after the end of therapy. Liver function tests, cryoglobulin determinations and a clinical examination were performed each month. HCV serology and HCV-RNA detection by PCR were performed before therapy and at the end of the follow-up period.
  
  
  RESULTS
  The two study groups were comparable in age, male/female ratio, purpura score, cryoglobulin level, mean ALT serum activity and liver histology. 32 patients (89%) were positive for anti-HCV antibodies and 29 (81%) for HCV-RNA. During therapy all patients showed a significant (p < 0.001) decrease in their cryoglobulin level as well as improvement (p < 0.05) in their purpura score. In group A, five patients (28%) showed normalized ALT, but three later relapsed. In group B seven patients (39%) responded to treatment but three relapsed after suspension of the drug. Two patients from group B developed severe side effects (hypothyroidism and depression) and therapy was discontinued after 9 and 11 months, respectively. In all the non-responders and relapsed patients, purpura, ALT, and cryoglobulins rose to pre-treatment levels within a few months. At the end of follow-up, two patients from group A (11%) and four in group B (22%) had achieved complete remission.
  
  
  CONCLUSIONS
  This study indicates that IFN is useful in MC and that viral replication can be considered the target of the therapy. Despite the absence of a statistical difference in the response rate between the two regimens (due to the low number of subjects), the one-year therapy course seemed to show a better efficacy, although associated with higher toxicity.
authors.affiliation: First Division of Medicine, Pordenone General Hospital, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Mazzaro
authors.forename: T
authors.initials: T
authors.lastname: Lacchin
authors.forename: M
authors.initials: M
authors.lastname: Moretti
authors.forename: P
authors.initials: P
authors.lastname: Tulissi
authors.forename: O
authors.initials: O
authors.lastname: Manazzone
authors.forename: R
authors.initials: R
authors.lastname: Colle
authors.forename: G
authors.initials: G
authors.lastname: Pozzato
mesh_terms: D000328:Adult; D000368:Aged; D001483:Base Sequence; D001706:Biopsy; D003449:Cryoglobulinemia / Q000473:pathology / Q000628:therapy* / Q000821:virology; D003450:Cryoglobulins / Q000032:analysis; D017931:DNA Primers; D005260:Female; D005500:Follow-Up Studies; D016174:Hepacivirus / Q000235:genetics; D018937:Hepatitis C Antibodies / Q000032:analysis; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D010976:Platelet Count / Q000187:drug effects; D012367:RNA, Viral / Q000032:analysis; D012008:Recurrence
chemical_list: D003450:Cryoglobulins; D017931:DNA Primers; D018937:Hepatitis C Antibodies; D016898:Interferon-alpha; D012367:RNA, Viral