Format

Send to

Choose Destination
J Hepatol. 2015 Jan;62(1):24-30. doi: 10.1016/j.jhep.2014.08.015. Epub 2014 Aug 15.

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

Author information

1
Department of Internal Medicine and Clinical Immunology, AP-HP, Hôpital Pitié-Salpétrière, DHU I2B, Immunopathology, Inflammation, Biotherapy, Paris, France; Université Pierre et Marie Curie, Paris VI, UMR CNRS 7211, INSERM U959, Hôpital Pitié-Salpétrière, Paris, France. Electronic address: david.saadoun@psl.aphp.fr.
2
Department of Biostatistics, Hôpital Saint-Louis, Paris, France.
3
Department of Hepatology, Hôpital Necker, Paris, France.
4
Department of Virology, Hôpital Pitié-Salpétrière, Paris, France.
5
Department of Internal Medicine, Hôpital Lapeyronie, Montpellier, France.
6
Department of Infectious Diseases, Hôpital Tenon, Paris, France.
7
Department of Nephrology, Hôpital Européen George Pompidou, Paris, France.
8
Department of Nephrology, Hôpital de la Robertsau, Strasbourg, France.
9
Department of Internal Medicine, Centre Hospitalier de Nouvelle Calédonie, Nouméa, France.
10
Department of Infectious Diseases, Hôpital Paul Brousse, Villejuif, France.
11
Laboratory of Immunochemistry, Hôpital Pitié-Salpétrière, Paris, France.
12
Department of Nephrology, Hôpital Tenon, Paris, France.
13
Department of Internal Medicine, Hôpital Sud, Rennes, France.
14
Department of Internal Medicine, Hôpital Croix Saint Simon, Paris, France.
15
Department of Internal Medicine, Hôpital Bicêtre, Kremlin Bicêtre, France.
16
Department of Internal Medicine and Clinical Immunology, AP-HP, Hôpital Pitié-Salpétrière, DHU I2B, Immunopathology, Inflammation, Biotherapy, Paris, France; Université Pierre et Marie Curie, Paris VI, UMR CNRS 7211, INSERM U959, Hôpital Pitié-Salpétrière, Paris, France. Electronic address: patrice.cacoub@psl.aphp.fr.

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.

KEYWORDS:

Antiviral treatment; Hepatitis C virus; Mixed cryoglobulinemia; Treatment; Vasculitis

PMID:
25135864
DOI:
10.1016/j.jhep.2014.08.015
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center