Safety and Efficacy Of Peg-IFNa/Ribavirin/Protease Inhibitor Combination In 34 Patients With HCV-Mixed Cryoglobulinemia Vasculitis

David Saadoun¹, Stanislas Pol², Vincent Thibault³, Gilles Pialoux⁴, François Blanc⁵, Lucile Musset⁶, Alexandre Karras⁷, Olivier Decaux⁸, Jean-Marc Ziza⁹, Olivier Lambotte¹⁰ and Patrice Cacoub Sr.¹¹, ¹Groupe Hospitalier Pitié Salpétrière, Service de Médecine Interne, DHU i2B, Paris, France, ²Hepatology, Cochin Hospital, Paris, France, ³Virology, Pitié-Salpétrière, Paris, France, ⁴hôpital Tenon, Paris, France, ⁵hôpital Montpellier, Montpellier, France, ⁶Laboratoire d'immunochimie, Pitié- Salpêtrière, Paris, France, ⁷Nephrology, Hôpital Européen Georges Pompidou, APHP, Paris, France, ⁸Department of Internal Medicine, Rennes University Hospital, Rennes, France, ⁹Refferal center for bone and joint infections, Croix Saint Simon Hospital, Paris, France, ¹⁰Internal Medicine, Hopital Kremlin Bicêtre, Kremlin Bicêtre, France, ¹¹Department of Internal Medicine 2., CHU Pitié-Salpêtrière, Paris, France

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: Cryoglobulinemia, interferons, treatment and vasculitis

Session Information

Title: Vasculitis II

Session Type: Abstract Submissions (ACR)

Background/Purpose: The standard of care treatment of patients presenting a HCV-mixed cryoglobulinemia (MC) vasculitis includes Peg-IFNaplus Ribavirin, w/wo Rituximab. Thirty to 40% of patients are non-responders or relapsers to such combination.

Objective: To analyze the safety and efficacy of a Peg-IFNa/Ribavirin/Protease inhibitor combination in HCV-MC vasculitis.

Methods: Open label, prospective, cohort study including 34 patients with HCV-MC vasculitis. Peg-IFNa/Ribavirin was associated to Telaprevir [375 mg three times daily for 12 weeks, 19 patients (56%) or Boceprevir (800 mg three times daily, 15 patients (44%) for 44 weeks] for 48 weeks.

Results: Mean age 58.9 years, 50% women, and 30/34 (88%) had HCV genotype 1. Twenty eight (83%) patients received previous antiviral therapy with Peg-IFNa/Ribavirin and the remaining 6 were naïve of antiviral therapy. Of the 28 patients with HCV-MC vasculitis previously treated with Peg-IFNaRibavirin, 16 (57.1%) were non-responders, 5 (17.8%) were partial responders and 7 (25.1%) were relapsers. Mean HCV RNA level was 5.7 Log copies/mL, mean ALT level was of 49.85 IU/mL and severe liver fibrosis (i.e. Metavir score 3 and 4) was noted in 14 (41.1%) cases. Twenty six patients had a type II MC and 7 had a type III. Main HCV-MC manifestations included purpura (n=21), polyneuropathy (n=19), arthralgia (n=14), and kidney involvement (n=9). The mean serum cryoglobulin and C4 rheumatoid factor levels were of 0.8 g/l and 0.10 g/l, respectively. Nineteen (55.9%) patients showed a complete clinical response of MC vasculitis and 15 (44.1%) were partial responders at the end of follow up. Sustained virological response (i.e. at week 60) could be assessed in 27/34 HCV MC patients and was achieved in 15 (55.5%) cases. All 34 patients experienced at least one treatment side effect including grade 3 anemia in 32%, grade 3 neutropenia in 6%, infection in 30%, pruritus in 35% and skin eruption under Telaprevir (6%). Antiviral therapy discontinuation was required in 12 (35.3%) patients for virological non-response (n=8), virological relapse (n=3) and depression (n=1).

Conclusion: Peg-IFNa/Ribavirin/protease inhibitor combination represents an effective new therapeutic option in HCV-MC vasculitis. Such therapeutic regimen should be administered cautiously considering the high rates of side effects.

Disclosure:

D. Saadoun,
None;

S. Pol,
None;

V. Thibault,
None;

G. Pialoux,
None;

F. Blanc,
None;

L. Musset,

Inova Diagnostics, Inc.,

A. Karras,
None;

O. Decaux,
None;

J. M. Ziza,
None;

O. Lambotte,
None;

P. Cacoub Sr.,
None.

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