Title: Vasculitis: Clinical Trials
Session Type: Abstract Submissions (ACR)
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.
To analyze the safety and efficacy of a Peg-IFNa/Ribavirin/Protease inhibitor combination on HCV-MC vasculitis.
Open label prospective single-center cohort study, 27 patients with HCV-MC vasculitis entered the study, of whom 13 with sufficient follow-up were analysed. Peg-IFNa/Ribavirin was associated to Telaprevir (375 mg three times daily, 8 patients) or Boceprevir (800 mg three times daily, 5 patients).
Mean age 61 years, 54% women, all 13 HCV genotype 1 patients received previous antiviral therapy with Peg-IFNa/Ribavirin, including 5 (38%) relapsers and 8 (62%) non-responders; 10 (77%) had been also treated by Rituximab. Mean HCV RNA level was 5.85Log copies/mL; Metavir fibrosis score was of stage 4 in 6 cases, stage 3 in 4 cases and stage 2 in 3 cases. Twelve patients (92%) had a type II IgMk MC and 1 had a type III. Main HCV-MC manifestations included purpura (n=10), polyneuropathy (n=10), arthralgia (n=6), and kidney involvement (n=3). The mean serum MC, C4 and rheumatoid factor levels were of 1.3 g/l, 0.09 g/l and 157 IU/ml, respectively. After 1 month of Peg-IFNa/Ribavirin/protease inhibitor, 11 (85%) patients showed an early virological response (HCV RNA level <1.1 Log copies/mL). Nine (69%) patients showed a complete clinical response of MC vasculitis and 4 (31%) were partial responders. After 3 months of Peg-IFNa/Ribavirin/protease inhibitor, MC serum level dropped from 1.3 to 0,3g/l while C4 level increased from 0.09 to 0.13g/l. All 13 patients experienced at least one treatment side effect including asthenia in 92%, anaemia in 84%, neutropenia and bacterial infection in 53%, nausea and low grade (<3) skin eruption under Telaprevir in 30% and thrombocytopenia in 15%.
Peg-IFNa/Ribavirin/protease inhibitor combination seems highly effective in HCV-MC vasculitis. Such therapeutic regimen should be administered cautiously considering the high rates of side effects.
P. Lebray Sr.,
P. Cacoub Sr.,
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