PegIFNα/ribavirin/protease inhibitor combination in severe hepatitis C virus-associated mixed cryoglobulinemia vasculitis.

Abstract

BACKGROUND & AIMS:

The aim of this study was to analyse the safety and efficacy of the PegIFNα/ribavirin/protease inhibitor combination in severe and/or refractory hepatitis C virus (HCV)-mixed cryoglobulinemia (MC) vasculitis.

METHODS:

This prospective cohort study included 30 patients (median age 59 years [53-66] and 57% of women) with HCV-MC vasculitis. PegIFNα/ribavirin (for 48 weeks) was associated with telaprevir (375 mg three times daily, for 12 weeks, [n = 17]) or boceprevir (800 mg three times daily, for 44 weeks, (n = 13]).

RESULTS:

Twenty three patients (76.7%) were non-responders to previous antiviral therapy. At week 72, twenty patients (66.7%) were complete clinical and sustained virological responders. The cryoglobulin level decreased from 0.45 to 0 g/L (p<0.0001) and the C4 level increased from 0.09 to 0.14 g/L (p = 0.017). Complete clinical responders had a higher frequency of purpura (16/20 [80%] vs. 4/10 [40%], p = 0.045), and a trend towards lower frequency of neuropathy (9/20 (45%) vs. 8/10 [80%], p = 0.12) compared with partial responders. Serious adverse events occurred in 14 patients (46.6%) during the 72 weeks of follow-up. Twenty eight patients (93.3%) received erythropoietin, 14 (46.6%) had red blood cell transfusion and 2 (6.6%) received granulocyte stimulating agent. The baseline factors associated with serious adverse events included liver fibrosis (p = 0.045) and a low platelet count (p = 0.021).

CONCLUSIONS:

The PegIFNα/ribavirin/protease inhibitor combination is highly effective in severe and/or refractory HCV-MC at the cost of frequent side effects. Baseline platelet count and liver fibrosis are useful in guiding treatment decisions.

• Authors: David Saadoun, Matthieu Resche Rigon, Stanislas Pol, Vincent Thibault, François Blanc, Gilles Pialoux, Alexandre Karras, Dorothée Bazin-Kara, Cécile Cazorla, Daniel Vittecoq, Lucile Musset, Julie Peltier, Olivier Decaux, Jean-Marc Ziza, Olivier Lambotte, Patrice Cacoub
• Journal: Journal of hepatology (J Hepatol) Vol. 62 Issue 1 Pg. 24-30 (Jan 2015) ISSN: 1600-0641 [Electronic] Netherlands
• PMID: 25135864 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Chemical References

• Antiviral Agents
• Drug Carriers
• Interferon-alpha
• RNA, Viral
• Recombinant Proteins
• Polyethylene Glycols
• Ribavirin
• peginterferon alfa-2a

Topics

• Aged
• Antiviral Agents (therapeutic use)
• Cryoglobulinemia (diagnosis, drug therapy, etiology)
• Drug Carriers
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Hepacivirus (genetics)
• Hepatitis C, Chronic (complications, drug therapy, virology)
• Humans
• Interferon-alpha (therapeutic use)
• Male
• Middle Aged
• Polyethylene Glycols (therapeutic use)
• Prospective Studies
• RNA, Viral (analysis)
• Recombinant Proteins (therapeutic use)
• Reverse Transcriptase Polymerase Chain Reaction
• Ribavirin (therapeutic use)
• Severity of Illness Index
• Treatment Outcome
• Vasculitis (diagnosis, drug therapy, etiology)