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Clinical Trial
. 2014 May;73(5):831-7.
doi: 10.1136/annrheumdis-2012-202770. Epub 2013 Apr 20.

Peg-IFNα/ribavirin/protease inhibitor combination in hepatitis C virus associated mixed cryoglobulinemia vasculitis: results at week 24

David Saadoun  1 , M Resche Rigon, V Thibault, M Longuet, S Pol, F Blanc, G Pialoux, A Karras, D Bazin-Karra, C Cazorla, D Vittecoq, L Musset, O Decaux, J M Ziza, O Lambotte, Patrice Cacoub
Affiliations
Free PMC article
Clinical Trial

Peg-IFNα/ribavirin/protease inhibitor combination in hepatitis C virus associated mixed cryoglobulinemia vasculitis: results at week 24

David Saadoun et al. Ann Rheum Dis. 2014 May.
Free PMC article

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.

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Figures

Figure 1
Figure 1
Study design. All patients received antiviral therapy with Peg-IFNα ((2a, 180 µg/week, n=15) or (2b, 1.5 µg/kg/week, n=8), subcutaneously) plus ribavirin (600–1200 mg/day orally) for 48 weeks. Treatment with telaprevir consisted of oral administration at a dose of 750 mg three times daily for 12 weeks and boceprevir consisted of oral administration at a dose of 800 mg three times daily for 44 weeks. All patients received Peg-IFNα plus ribavirin during the 4-week lead-in period.
Figure 2
Figure 2
Kinetics of hepatitis C virus RNA (A), cryoglobulinemia (B) and C4 serum level (C). **p<0.01, *p<0.05.
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Comment in

References

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