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Extended report
Peg-IFNα/ribavirin/protease inhibitor combination in hepatitis C virus associated mixed cryoglobulinemia vasculitis: results at week 24
  1. David Saadoun1,2,
  2. M Resche Rigon3,
  3. V Thibault4,
  4. M Longuet1,
  5. S Pol5,
  6. F Blanc6,
  7. G Pialoux7,
  8. A Karras8,
  9. D Bazin-Karra9,
  10. C Cazorla10,
  11. D Vittecoq11,
  12. L Musset12,
  13. O Decaux13,
  14. J M Ziza14,
  15. O Lambotte15,
  16. Patrice Cacoub1,2
  1. 1Department of Internal Medicine, Service de Médecine Interne, AP-HP, Groupe Hospitalier Pitié-Salpétrière, Paris, France
  2. 2Université Pierre et Marie Curie, Paris VI, UMR CNRS 7211, INSERM U959, Groupe Hospitalier Pitié-Salpétrière, Paris, France
  3. 3Department of Biostatistics, Hôpital Saint-Louis, Paris, France
  4. 4Department of Virology, Groupe Hospitalier Pitié-Salpétrière, Paris, France
  5. 5Department of Hepatology, Hôpital Necker, Paris, France
  6. 6Department of Internal Medicine, Hôpital Lapeyronie, Montpellier, France
  7. 7Department of Infectious diseases, Hôpital Tenon, Paris, France
  8. 8Department of Nephrology, Hôpital Européen George Pompidou, Paris, France
  9. 9Department of Nephrology, Hôpital de la Robertsau, Strasbourg, France
  10. 10Department of Internal Medicine, Centre hospitalier de Nouvelle calédonie, Nouméa, France
  11. 11Department of Infectious diseases, Hôpital Paul Brousse, Villejuif, France
  12. 12Laboratory of Immunochemistry, Groupe Hospitalier Pitié-Salpétrière, Paris, France
  13. 13Department of Internal Medicine, Hôpital Sud, Rennes, France
  14. 14Department of Internal Medicine, Hôpital Croix Saint Simon, Paris, France
  15. 15Department of Internal Medicine, Hôpital Bicêtre, Kremlin Bicêtre, France
  1. Correspondence to Dr David Saadoun and Patrice Cacoub, Department of Internal Medicine, Service de Médecine Interne, AP-HP, Hôpital Pitié-Salpêtrière, Paris F-75013 France; david.saadoun{at}psl.aphp.fr or patrice.cacoub{at}psl.aphp.fr

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.

Patients and 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.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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