title: Sofosbuvir plus ribavirin for hepatitis C virus-associated cryoglobulinaemia vasculitis: VASCUVALDIC study.
abstract: BACKGROUND
  Hepatitis C virus (HCV) is the aetiological agent for most cases of cryoglobulinaemia vasculitis. Interferon-containing regimens are associated with important side effects and may exacerbate the vasculitis.
  
  
  OBJECTIVE
  To evaluate safety and efficacy of an oral interferon-free regimen, sofosbuvir plus ribavirin, in HCV-cryoglobulinaemia vasculitis.
  
  
  METHODS
  We enrolled 24 consecutive patients (median age of 56.5 years and 46% of women) with HCV-cryoglobulinaemia vasculitis. Sofosbuvir (400 mg/day) was associated with ribavirin (200-1400 mg/day), for 24 weeks. The primary efficacy end point was a complete clinical response of the vasculitis at the end of treatment (week 24).
  
  
  RESULTS
  Main features of HCV-cryoglobulinaemia vasculitis included purpura and peripheral neuropathy (67%), arthralgia (58%), glomerulonephritis (21%) and skin ulcers (12%). Twenty-one patients (87.5%) were complete clinical response at week 24. Complete clinical response was achieved in six (25%) patients at week 4, four (16.6%) at week 8, seven (29.2%) at week 12, three (12.5%) at week 16 and one (4.2%) at week 20. The cryoglobulin level decreased from 0.35 (0.16-0.83) at baseline to 0.15 (0.05-0.45) g/L at week 24. The C4 serum level increased from 0.10 (0.07-0.19) to 0.17 (0.09-0.23) g/L at week 24. Seventy-four per cent of patients had a sustained virological response at week 12 post treatment. The most common side effects were fatigue, insomnia and anaemia. Two serious adverse events were observed.
  
  
  CONCLUSIONS
  Sofosbuvir plus ribavirin combination was associated with a high rate of complete clinical response and a low rate of serious adverse events in HCV-cryoglobulinaemia vasculitis.
authors.affiliation: Inflammation-Immunopathology-Biotherapy Department (DHU i2B), Sorbonne Universités, UPMC Univ Paris 06, Paris, France INSERM, UMR_S 959, Paris, France CNRS, FRE3632, Paris, France Groupe Hospitalier Pitié-Salpêtrière, Department of Internal Medicine and Clinical Immunology, AP-HP, Paris, France.
authors.forename: David
authors.initials: D
authors.lastname: Saadoun
authors.affiliation: Groupe Hospitalier Pitié-Salpétrière, Department of Virology, APHP, Paris, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Thibault
authors.affiliation: Department of Hepatology, Hôpital Orléans, Orléans, France.
authors.forename: Si Nafa
authors.initials: SN
authors.lastname: Si Ahmed
authors.affiliation: Department of Internal Medicine-Digestive, Centre hospitalier universitaire Purpan, UMR 152 Toulouse 3 University, Toulouse, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Alric
authors.affiliation: Groupe Hospitalier Pitié-Salpétrière, Department of Hepatology, AP-HP, Paris, France.
authors.forename: Maxime
authors.initials: M
authors.lastname: Mallet
authors.affiliation: Department of Internal Medicine, Hôpital Henri Mondor, Créteil, France.
authors.forename: Constance
authors.initials: C
authors.lastname: Guillaud
authors.affiliation: Groupe Hospitalier Pitié-Salpétrière, Department of Nephrology, APHP, Paris, France.
authors.forename: Hassane
authors.initials: H
authors.lastname: Izzedine
authors.affiliation: Department of Hepatology, APHP, Hôpital Beaujon, Clichy, France.
authors.forename: Aurélie
authors.initials: A
authors.lastname: Plaisier
authors.affiliation: Department of Hepatology, APHP, Hôpital Cochin, Paris, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Fontaine
authors.affiliation: Groupe Hospitalier Pitié-Salpétrière, Biological Hematology, APHP, Paris, France.
authors.forename: Myrto
authors.initials: M
authors.lastname: Costopoulos
authors.affiliation: Groupe Hospitalier Pitié-Salpétrière, Biological Hematology, APHP, Paris, France.
authors.forename: Magali
authors.initials: M
authors.lastname: Le Garff-Tavernier
authors.affiliation: Department of Hepatology, APHP, Hôpital Henri Mondor, Créteil, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Hezode
authors.affiliation: Department of Hepatology, APHP, Hôpital Cochin, Paris, France.
authors.forename: Stanislas
authors.initials: S
authors.lastname: Pol
authors.affiliation: Groupe Hospitalier Pitié-Salpétrière, Department of Immunology, UF d'Immunochimie et d'autoimmunité, APHP, Paris, France.
authors.forename: Lucile
authors.initials: L
authors.lastname: Musset
authors.affiliation: Groupe Hospitalier Pitié-Salpétrière, Department of Hepatology, AP-HP, Paris, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Poynard
authors.affiliation: Inflammation-Immunopathology-Biotherapy Department (DHU i2B), Sorbonne Universités, UPMC Univ Paris 06, Paris, France INSERM, UMR_S 959, Paris, France CNRS, FRE3632, Paris, France Groupe Hospitalier Pitié-Salpêtrière, Department of Internal Medicine and Clinical Immunology, AP-HP, Paris, France.
authors.forename: Patrice
authors.initials: P
authors.lastname: Cacoub
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage*; D003449:Cryoglobulinemia / Q000188:drug therapy* / Q000821:virology; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus; D006526:Hepatitis C / Q000150:complications / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012254:Ribavirin / Q000008:administration & dosage*; D000069474:Sofosbuvir / Q000008:administration & dosage*; D016896:Treatment Outcome; D014657:Vasculitis / Q000188:drug therapy* / Q000821:virology
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin; D000069474:Sofosbuvir
keywords: Autoimmune Diseases; Infections; Systemic vasculitis