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ABSTRACT: Aim: Efficacy and safety of double filtration plasmapheresis (DFPP) for chronic hepatitis C were prospectively analyzed in Japanese clinical settings.Methods: All patients who received DFPP in combination with interferon (IFN) therapy for chronic hepatitis C were serially recruited at 36 institutions between April 2008 and July 2009 in Japan.Results: A total of 239 patients were analyzed for the safety of DFPP and 206 patients for the efficacy. Of the 206 patients, 181 patients were treated with DFPP in combination with pegylated interferon plus ribavirin (PEG-IFN/RBV + DFPP). Among the 181 patients, 60 patients (33.1%) were treatment-naïves, 35 (19.3%) relapsers and 62 (34.3%) non-responders. Complete early virological response (cEVR) in patients treated with PEG-IFN/RBV + DFPP was achieved in 57.5% overall, 70.0% in treatment-naïves, 57.1% in relapsers and 41.9% in non-responders. In patients with previous PEG-IFN/RBV therapy, cEVR were found in 63.0% of relapsers and 18.9 % of non-responders, and cEVR in patients with other than PEG-IFN/RBV therapy as previous IFN therapy, relapsers and non-responders was 37.5% and 76.0%, respectively. Adverse events were found in 55 patients (23.0%). Serious adverse events were found in four patients (1.7%) who showed puncture-site injury. Adverse events were related to female sex, but not related to age, and DFPP could be performed safely.Conclusion: The cEVR results in this study suggest that high rates of sustained virological response can be achieved in retreated and treatment-naïve patients using DFPP in combination with PEG-IFN/RBV therapy. Results indicate that this therapy could be safely conducted, even in elderly patients.
Hepatology Research 09/2010; 40(11):1072 - 1081. DOI:10.1111/j.1872-034X.2010.00708.x · 2.22 Impact Factor