Abstract

Type II mixed cryoglobulinemia (MC) is a systemic vasculitis usually associated with hepatitis C virus (HCV). The present trial was performed to investigate the efficacy of therapy with pegylated interferon alfa-2a (PEG-IFN alfa-2a) plus ribavirin in patients with HCV-related MC vasculitis and evaluate the factors associated with clinical remission of MC. A total of 46 consecutive patients with HCV-related Type II MC received PEG-IFN alfa-2a (standard dose 180mg/week) subcutaneously plus oral ribavirin (800-1,200mg/day) for 48weeks. The response to treatment was analyzed by comparing clinical, immunologic, and virologic parameters at the initial evaluation with those observed at the end of follow-up. Logistic regression was used to assess the factors associated with clinical remission. A total of 22 patients (48%) had a sustained virologic response and were complete clinical responders. Serum cryoglobulin disappeared in 26 of 46 patients (56%), and complement levels normalized in 70% of the patients. In univariate analysis, factors associated with complete clinical response were early virologic response at 4weeks [OR 1.4 (95% CI 0.1-17.1)], proteinuria [OR 1.4 (95% CI 0.2-8.2)] and the fibrosis score [OR 1.09 (95% CI 0.6-1.9)], peripheral neuropathy [OR 0.9 (95% CI 0.1-6.5)], arthralgia [OR 0.7 (95% CI 0.1-3.9)], sicca syndrome [OR 0.6 (95% CI 0.1-3.2)], cryoglobulin [OR 0.2 (95% CI 0.07-1.09)], and purpura [OR 0.1 (95% CI 0.01-1.3)]. In multivariate analysis, only cryoglobulinemia was independently associated with complete clinical response. No patient had side effects for which discontinuation of therapy was required. The results indicated that treatment with PEG-IFN alfa-2a plus ribavirin can achieve a complete clinical response in patients with HCV-related MC. Complete clinical response correlates with the eradication of HCV.

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