title: Peg-IFNα/ribavirin/protease inhibitor combination in hepatitis C virus associated mixed cryoglobulinemia vasculitis: results at week 24.
abstract: BACKGROUND
  The standard-of-care treatment of patients with hepatitis C virus (HCV)-mixed cryoglobulinemia (MC) vasculitis includes pegylated interferon α (PegIFN)-α plus ribavirin and/or rituximab. About 30-40% of patients are non-responders or relapsers to such combination.
  
  
  OBJECTIVE
  To analyse the safety and efficacy of Peg-IFNα/ribavirin/protease inhibitor combination in HCV-MC vasculitis.
  
  
  METHODS
  Open-label, prospective, cohort study including 23 patients with HCV-MC vasculitis. Peg-IFNα/ribavirin was associated to telaprevir (375 mg three times daily, for 12 weeks, (n=15)) or boceprevir (800 mg three times daily, for 44 weeks, (n=8)) for 48 weeks.
  
  
  RESULTS
  The median age was 59 (52.5-66) years, with 48.8% women. Thirteen patients (56.5%) were complete clinical responders, and 10 (43.5%) were partial responders at week 24. The virological response (ie, HCV RNA negativation) was of 69.6% at week 24 (p=0.005). The cryoglobulin level decreased from 0.44 to 0.06 g/l (p=0.0006) and the C4 level increased from 0.09 to 0.15 g/l (p=0.045). Grades 3 and 4 adverse events (mainly anaemia, neutropenia and thrombocytopenia) were observed in 10 cases (43.5%). Twenty patients (87%) received erythropoietin, 9 (39.1%) had red cell transfusion, and 2 (8.7%) had granulocyte stimulating agents. Antiviral therapy discontinuation was required in 8 (34.7%) patients for virological non-response (n=5), virological relapse (n=2) and depression (n=1).
  
  
  CONCLUSIONS
  Peg-IFNα/ribavirin/protease inhibitor combination seems highly effective in HCV-MC. Such therapeutic regimen should be administered cautiously considering the high rate of side effects.
authors.affiliation: Department of Internal Medicine, Service de Médecine Interne, AP-HP, Groupe Hospitalier Pitié-Salpétrière, , Paris, France.
authors.forename: David
authors.initials: D
authors.lastname: Saadoun
authors.forename: M
authors.initials: M
authors.lastname: Resche Rigon
authors.forename: V
authors.initials: V
authors.lastname: Thibault
authors.forename: M
authors.initials: M
authors.lastname: Longuet
authors.forename: S
authors.initials: S
authors.lastname: Pol
authors.forename: F
authors.initials: F
authors.lastname: Blanc
authors.forename: G
authors.initials: G
authors.lastname: Pialoux
authors.forename: A
authors.initials: A
authors.lastname: Karras
authors.forename: D
authors.initials: D
authors.lastname: Bazin-Karra
authors.forename: C
authors.initials: C
authors.lastname: Cazorla
authors.forename: D
authors.initials: D
authors.lastname: Vittecoq
authors.forename: L
authors.initials: L
authors.lastname: Musset
authors.forename: O
authors.initials: O
authors.lastname: Decaux
authors.forename: J M
authors.initials: JM
authors.lastname: Ziza
authors.forename: O
authors.initials: O
authors.lastname: Lambotte
authors.forename: Patrice
authors.initials: P
authors.lastname: Cacoub
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D003449:Cryoglobulinemia / Q000188:drug therapy* / Q000821:virology; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage / Q000009:adverse effects; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011392:Proline / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D011480:Protease Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014657:Vasculitis / Q000188:drug therapy / Q000821:virology
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D009842:Oligopeptides; D011480:Protease Inhibitors; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D011392:Proline; C100416:peginterferon alfa-2a