Virological response to daclatasvir and asunaprevir combination therapy for chronic hepatitis C virus genotype 1b infection in dialysis patients: a prospective, multicenter study

BackgroundThe introduction of direct-acting antiviral agents (DAAs) for the treatment of chronic hepatitis C virus (HCV) infection in patients undergoing hemodialysis (HD) has improved sustained virological response (SVR) rates. Our aim was to assess the characteristics of the virological response to daclatasvir (DCV) and asunaprevir (ASV) combination therapy for HCV in HD patients.MethodsA multicenter prospective study was conducted at eight centers in Japan. Patients on HD with chronic genotype 1b HCV infections were orally administered DCV and ASV for 24 weeks at doses of a 60-mg capsule once daily and a 100-mg tablet twice daily, respectively. The primary endpoint of this trial was the proportion of patients with a sustained virological response at 24 weeks after the treatment ended (SVR24). We also investigated the characteristics associated with the virological response to combination therapy.ResultsThirty patients were enrolled in this study, and the proportion that achieved an SVR24 after treatment was 83.3% (25/30). Virological failure was observed in 4 patients (13.3%). Two exhibited virological breakthrough at weeks 16 and 20 of drug administration, and viral relapse occurred in 2 patients at weeks 4 and 8 after the end of treatment. Virological failure was defined as HCV-RNA levels exceeding 5.5 log10 IU/mL, and resistance-associated variants (RAVs) NS5A-L31M/V and Y93H were not exhibited at baseline.ConclusionsDCV and ASV therapy for chronic HCV on HD was significantly effective. Most importantly, patients with the low viral loads undergoing HD demonstrated a higher response to combination therapy regardless of RAV.Trial registrationUMIN Clinical Trials Registry UMIN000016181