Hisham R El Khayat1, Yasser M Fouad2, Ezzat Ali Ahmad3, Hussein El Amin4, Faten Ismael5, Amal Rizk6. 1. Department of Gastroenterology, Theodore Bilharz Institute, Cairo, Egypt. 2. Department of Tropical Medicine, Minia University, Minia, Egypt. yasserfouad10@yahoo.com. 3. Department of Internal Medicine, Alexandria University, Alexandria, Egypt. 4. Department of Internal Medicine, Assiut University, Assiut, Egypt. 5. Department Rheumatology, Minia University, Minia, Egypt. 6. Department Rheumatology, Cairo University, Cairo, Egypt.
Abstract
OBJECTIVE: 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. METHODS: A total of 46 consecutive patients with HCV-related Type II MC received PEG-IFN alfa-2a (standard dose 180 mg/week) subcutaneously plus oral ribavirin (800-1,200 mg/day) for 48 weeks. 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. RESULTS: 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 4 weeks [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. CONCLUSION: 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.
OBJECTIVE: 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. METHODS: A total of 46 consecutive patients with HCV-related Type II MC received PEG-IFN alfa-2a (standard dose 180 mg/week) subcutaneously plus oral ribavirin (800-1,200 mg/day) for 48 weeks. 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. RESULTS: 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 4 weeks [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. CONCLUSION: 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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