Glecaprevir and pibrentasvir combination therapy for hepatitis C virus-infected Japanese patients on hemodialysis

Background: It remains unclear whether hepatitis C virus (HCV)-infected Japanese patients on hemodialysis (HD) have an altered viral response to glecaprevir (GLE) and pibrentasvir (PIB) combination therapy and whether this treatment is safe for this patient group. Therefore, we investigated the characteristics associated with virological response to GLE and PIB combination therapy for HCV in Japanese patients undergoing HD. This study aimed to evaluate the safety and efficacy of GLE and PIB combination therapy in HCV-infected Japanese patients on HD. Methods: This multicenter, single-Arm, open-label, and prospective study was conducted at four centers in Japan and enrolled Japanese patients with chronic HCV genotype 1b, 2a, and 2b infections. Enrolled patients received 300 mg GLE in combination with 120 mg PIB once daily for either 8 or 12 weeks. The primary endpoint of this trial was the rate of sustained virological response at 12 weeks after treatment (SVR12). Furthermore, pharmacological effects and adverse events associated with combination therapy were evaluated. Results: A total of 18 HD patients with HCV infection were enrolled in this study. Of these patients, 17 (94.4%) achieved SVR12. Among patients receiving combination therapy for 8 weeks, only one experienced a virological relapse at week 12 after the end of treatment. Despite the absence of treatment-related deaths, adverse events were observed in 9 patients (50.0%) during treatment. The most frequent adverse event was pruritus, which occurred in 7 patients (38.9%). Conclusions: GLE and PIB combination therapy was effective and tolerable in Japanese HD patients with chronic HCV genotype 1b, 2a, and 2b infections. Trial registration: This study was registered at the UMIN Clinical Trials Registry as UMIN000029781 (registered 21 November 2017, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034026). © 2018 The Author(s).