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 July 15, 2018.
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