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

Abstract

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.

Glecaprevir and Pibrentasvir Combination Antiviral Therapy for Hemodialysis Patients Infected with the Hepatitis C Virus

“…We observed that HD patients demonstrated good GLE/PIB therapy tolerance. Adverse effects in our group were only skinrelated (itching) in a small proportion of patients, which is fully consistent with the data provided by Hotta N & Tanaka Y et al [19,20]. There were no cases of the early termination of the antiviral therapy.…”

“…In three other Japanese studies, HD patients with genotypes 1 and 2 were treated with this combination for 8 or 12 weeks, with the duration of the treatment determined by the cirrhosis status. According to Kumada H et al [18] and Hotta N [19], SVR12 was 100% as was in our HD patients' group, while Tanaka Y [20] reported a SVR12 rate of 94.4%. There is a lack of data related to HCV treatment in 2k/1b-infected patients, especially with modern DAA therapy.…”

Road to elimination of HCV: Clinical challenges in HCV management

“…However, patients with end-stage renal disease or who are undergoing haemodialysis can be successfully treated with glecaprevir/pibrentasvir, although some patients may experience pruritus. [32][33][34][35]…”

“…Furthermore, patients who underwent prior hepatitis C treatment, received a liver transplant, had known or suspected hepatocellular carcinoma (HCC), are positive for HIV or HBsAg, or who have experience decompensated cirrhosis may not be eligible for this simplified treatment. However, patients with end‐stage renal disease or who are undergoing haemodialysis can be successfully treated with glecaprevir/pibrentasvir, although some patients may experience pruritus 32‐35 …”