Alanine aminotransferase elevations during triple therapy with simeprevir, pegylated interferon plus ribavirin

Abstract

In the clinical trials of triple therapy with simeprevir, pegylated interferon plus ribavirin, alanine aminotransferase (ALT) elevations have not been reported in detail during treatment. In the present study, we examined the frequencies and characteristics of ALT elevations in 321 chronic hepatitis C patients who were treated with triple therapy and became HCV-RNA negative during treatment. ALT elevations more than 100 U/L were observed in 5.0％ (16/321) during treatment (100-200 U/L: 13 patients, 200-400 U/L: 2 patients, 400＜ U/L: 1 patient). Out of these patients, 8 patients showed that serum ALT levels rapidly increased between 8 and 12 weeks. All patients except one patient whose treatment was discontinued due to the marked elevation of ALT level (663 U/L), serum ALT levels decreased soon after simeprevir administration was finished. Periodic liver function tests were needed since ALT elevations can occur during simeprevir, pegylated interferon plus ribavirin therapy.