Irsogladine maleate for the treatment of recurrent aphthous stomatitis in hepatitis C virus patients on pegylated-interferon and ribavirin: A pilot study

Background and Aim Aphthous stomatitis is one of the adverse effects associated with interferon (IFN) that forces dose reduction of IFN and there is no established therapy. This study was aimed to investigate whether irsogladine maleate, which enhances the functions of intercellular communication through the gap junctions, is effective for the treatment of aphthous stomatitis developed in hepatitis C virus (HCV) patients on pegylated-interferon (PEG-IFN) and ribavirin. Methods Nineteen patients with HCV were treated with PEG-IFN and ribavirin for 48 weeks. Ten out of 19 patients developed aphthous stomatitis during treatment with PEG-IFN and ribavirin. Within 12 weeks after development of aphthous stomatitis, 4mg irsogladine maleate was orally administered daily to all patients and the therapeutic and adverse effects of irsogladine maleate were examined on every week. The degree of aphthous stomatitis was evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Results Out of 10 patients, aphthous stomatitis was evaluated as grade 3 in three patients (30%) and grade 2 in seven patients (70%) by CTCAE. CTCAE grade was improved to 0 after 1 week in six patients, after 2 weeks in two patients, and after 3 weeks in two patients after the start of administration of irsogladine maleate. Aphthous stomatitis has not recurred in patients who had been on irsogladine maleate continuously during treatment of PEG-IFN and ribavirin. Conclusions Irsogladine maleate is effective for the treatment of aphthous stomatitis developing during PEG-IFN and ribavirin administration in HCV patients.