Safety and efficacy of glecaprevir and pibrentasvir in north Tohoku Japanese patients with genotype 1/2 hepatitis C virus infection.

Abstract

Background and aimsTo assess the efficacy and safety of treatment with glecaprevir/pibrentasvir in Japanese patients with genotype (GT) 1/2 hepatitis C virus (HCV) infection in a real‐world clinical setting.MethodsA total of 230 patients from 12 centers in northern Tohoku Japan with chronic hepatitis (CH) or compensated liver cirrhosis (LC) and GT1/2 HCV infection were treated with glecaprevir/pibrentasvir and followed up for 12 weeks after treatment completion. Those patients were evaluated by dividing them into the following three groups: CH GT1/2 HCV‐infected, direct‐acting antiviral agents (DAA)‐naive patients received 8 weeks of treatment (8‐week initial treatment group), compensated LC GT1/2 HCV‐infected, DAA‐naive patients received 12 weeks of treatment (12‐week initial treatment group), and GT1/2 HCV‐infected patients with previous failed DAA treatment were assigned to 12‐week treatment (12‐week re‐treatment group).ResultsThe overall sustained virologic response (SVR) rate in the modified intention‐to‐treat population was 99% (222/225). The SVR rate in 8‐week initial treatment group, 12‐week initial treatment group, and 12‐week re‐treatment group were 99% (118/119), 98% (104/106), and 97% (56/58), respectively. SVR rates based on chronic kidney disease (CKD) stage were 99% in stage 1/2, 96% in stage 3, and 100% in stage 4/5 patients. SVR rate among the three treatment groups was not influenced by CKD stage. Furthermore, all 18 patients (six in the 8‐week initial treatment group, 12 in 12‐week initial treatment group) who underwent hemodialysis attained SVR. Serious treatment‐associated adverse events (grade ≥ 3) occurred in 12 patients (5.2%). Five patients (2.2%) discontinued treatment because of adverse events; however, three of these patients achieved SVR.ConclusionPrimary treatment and re‐treatment with glecaprevir/pibrentasvir are effective and safe for patients without decompensated LC and GT1/2 HCV infection in a real‐world clinical setting. Furthermore, the SVR rate was not influenced by CKD stage.