Sofosbuvir Plus Daclatasvir for Hepatitis C Virus Associated Cryoglobulinemia Vasculitis

David Saadoun¹, yasmina ferfar¹, AS Bouyer², laurent alric³, christophe hezode⁴, SN Si Ahmed⁵, L Musset⁶, Luc De Saint Martin Pernot⁷, SN Pol⁸, Dominique Larrey⁹, T Poynard¹⁰ and Patrice Cacoub², ¹Sorbonne Universités, UPMC Univ Paris 06, UMR 7211, and Inflammation-Immunopathology-Biotherapy Department (DHU i2B), F-75005, Paris, France; Department of Internal Medicine and Clinical Immunology, F-75013, Paris, France, Paris, France, ²Sorbonne Universités, UPMC Univ Paris 06, UMR 7211, and Inflammation-Immunopathology-Biotherapy Department (DHU i2B), F-75005, Paris, France; Department of Internal Medicine and Clinical Immunology, F-75013, Paris, France, paris, France, ³Department of Internal Medicine-Digestive, Centre hospitalier universitaire Purpan, UMR 152 Toulouse 3 University, Toulouse, toulouse, France, ⁴Department of Hepatology, APHP, Hôpital Henri Mondor, Créteil, creteil, France, ⁵Department of Hepatology, Hôpital Orléans, Orléans, Orleans, France, ⁶Department of Immunology, UF d’Immunochimie et d’autoimmunité, APHP, Groupe Hospitalier Pitié-Salpétrière, Paris, France, paris, France, ⁷Department of internal medicine, CHRU Brest, Brest, France, ⁸Department of Hepatology, APHP, Hôpital Cochin, Paris, paris, France, ⁹Department of hepatology, CHRU Montpellier, France, montpellier, France, ¹⁰Department of Hepatology, APHP, Groupe Hospitalier Pitié-Salpétrière, Paris, paris, France

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: October 19, 2016

Keywords: Cryoglobulinemia, Hepatitis C, Late-Breaking 2016, treatment and vasculitis

Session Information

Date: Tuesday, November 15, 2016

Title: ACR Late-Breaking Poster Session

Session Type: ACR Late-breaking Abstract Session

Session Time: 9:00AM-11:00AM

Background/Purpose: Hepatitis C virus (HCV) is the aetiological agent for most cases of cryoglobulinemia vasculitis. Interferon containing regimens are associated with important side effects and may exacerbate the vasculitis. Objective: To evaluate safety and efficacy of an oral interferon free regimen, sofosbuvir plus daclatasvir in HCV cryoglobulinemia vasculitis.

Methods: We enrolled 35 patients (median age of 57 years and 45% of women) with HCV cryoglobulinemia vasculitis. Sofosbuvir (400mg/day) was associated with Daclatasvir (60mg/day) for 12 or 24 weeks. The primary efficacy end point was a complete response of the vasculitis at the end of treatment. Secondary endpoints included (i) immunological response (i.e. clearance of cryoglobulin), (ii) sustained virological response (viral eradication, i.e. prolonged negative viremia), and safety.

Results: HCV genotype was 1 (n=21), 2 (n=2), 3 (n=7), 4 (n=3) and 5 (n=2). Seventeen (48.6%) had cirrhosis. Main features of HCV cryoglobulinemia vasculitis included arthralgia (66%), purpura (54%) peripheral neuropathy (54%), skin ulcers (11%) and glomerulonephritis (11%).Thirty two (91%) were complete clinical response at end of treatment. The mean cryoglobulin and alanine aminotransferase levels decreased from [0.36 ± 0.12 to 0.10 ± 0.08 g/L, (p=0.019) and 57.6 ± 7.1 to 20.4 ± 2.0 IU/ml, (p<0.0001)], respectively at week 12 post treatment. Fifty percent of patients achieved complete immunological response (i.e. clearance of cryoglobulin). All patients had a sustained virological response at week 12 post treatment and the HCV viral load dropped from 5.6 to 1.18 IU/ml at week 4, (p<0.0001). The most common side effects were asthenia (14.3%), nausea (8.6%), and insomnia (3%). No serious adverse event was reported.

Conclusion: S Sofosbuvir plus daclatasvir antiviral combination is highly and quickly active in HCV-cryoglobulinemia vasculitis, with a good tolerance profile.

Disclosure: D. Saadoun, Gilead, 2,Abbvie, Medimmune, Gilead, Glaxo Smith Kline, Roche, Servier., 5; Y. ferfar, None; A. Bouyer, None; L. alric, None; C. hezode, None; S. Si Ahmed, None; L. Musset, None; L. De Saint Martin Pernot, None; S. Pol, None; D. Larrey, None; T. Poynard, None; P. Cacoub, Gilead,, 2,Abbvie, Astra Zeneca, Bayer, Boehringer Ingelheim, Gilead, Glaxo Smith Kline, Janssen, Merck Sharp Dohme, Pfizer, Roche, Servier, Vifor., 5.

To cite this abstract in AMA style:

Saadoun D, ferfar Y, Bouyer A, alric L, hezode C, Si Ahmed S, Musset L, De Saint Martin Pernot L, Pol S, Larrey D, Poynard T, Cacoub P. Sofosbuvir Plus Daclatasvir for Hepatitis C Virus Associated Cryoglobulinemia Vasculitis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/sofosbuvir-plus-daclatasvir-for-hepatitis-c-virus-associated-cryoglobulinemia-vasculitis/. Accessed .

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