Lo, Ching-ChuChing-ChuLoChuang, Wan-LongWan-LongChuangKuo, Hsing-TaoHsing-TaoKuoChen, Wei-MingWei-MingChenQin, AlbertAlbertQinTsai, Chan-YenChan-YenTsaiYI-WEN HUANGChen, Chi-YiChi-YiChen2025-01-212025-01-212024-01https://scholars.lib.ntu.edu.tw/handle/123456789/725035Ropeginterferon alfa-2b is a novel mono-pegylated proline-interferon. Its biweekly dosing schema has demonstrated tolerability and clinical efficacy for treating chronic hepatitis in previous clinical studies. This trial evaluates the pharmacokinetics of 400 μg ropeginterferon alfa-2b in patients with chronic hepatitis C virus (HCV) and provides the data to support the clinical utility of ropeginterferon alfa-2b at 400 μg. Seventeen patients with chronic HCV genotype 2 were enrolled to receive a single injection of 400 μg ropeginterferon alfa-2b plus 14-day treatment of ribavirin. Pharmacokinetics, safety, and HCV RNA reduction/clearance were assessed. T was 154.003 h and T was 114.273 h. The C was 29.823 ng mL. AUC was 9364.292 h∗ng mL and AUC was 11084.317 h∗ng mL. All adverse events were mild or moderate, and there were no serious adverse events. A 1000-fold reduction in the geometric mean of HCV RNA was observed 14 d after the single injection of ropeginterferon alfa-2b. Two patients achieved clearance of HCV RNA, and the other five patients had HCV RNA levels lower than 200 IU mL. Ropeginterferon alfa-2b at 400 μg led to PK exposures associated with safety and notable clinical activity in patients with chronic HCV. This study suggests that ropeginterferon alfa-2b at 400 μg is an acceptable dosing regimen for treating chronic HCV and also provides supporting data for the clinical use of ropeginterferon alfa-2b at a higher starting dose for other indications.enClinical trialHepatitis C virus genotype 2Pegylated interferon[SDGs]SDG3journal article10.1016/j.jfma.2023.08.02337666718