Effectiveness of a fixed combination formula of ombitasvir/paritaprevir/ritonavir for hepatitis C virus infection in patients on maintenance haemodialysis

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Globally, more than 185 million people had hepatitis C virus (HCV) antibodies (the prevalence rate 2.8% worldwide),1 including 1.5 to 2.0 million infected patients in Japan. The proportion of patients positive for HCV antibodies at the commencement of HD has been reported to be as high as 7.3%2 and 14.4%.3 Until 2011, standard initial therapy for HCV infection was pegylated interferon (Peg‐IFN)‐α plus ribavirin. Generally, IFN‐based therapy is effective for patients with HCV, and IFN‐based therapy alone is often recommended for HD patients.4 However, approximately 70% of patients with HCV infection in Japan have genotype 1b, which often does not respond well to IFN‐based treatment. In addition, IFN‐based therapy may often become problematic because of the number of adverse reactions.
According to a meta‐analysis, the prognosis of HD patients infected with HCV was significantly worse.5 Moreover, HCV infection in HD patients is strongly associated with the number of deaths due to hepatic disorders. The cumulative 10‐years mortality of patients who achieved sustained virological response at 24 weeks (SVR24) after IFN‐based therapy has been reported 8.9%; in contrast, the mortality is apparently worse in patients who did not achieve SVR24(26.0%). These data suggest that the therapy aiming at achieving a higher SVR24 rate was associated with a significant reduction in the hazard of overall death.6
Recently, owing to the appearance of direct‐acting antivirals (DAAs), anti‐HCV therapy has been expanded in a new therapeutic dimension. The DAAs suppress intracellular viral replication by inhibiting HCV proteins directly. Treatment with DAAs is expected to have multiple advantages such as good response to pan‐genotypic HCV, low risk of tolerance, short duration of treatment, and a high rate of SVR.7 Furthermore, a newer combination of DAAs with IFN, approved in 2011, has shown that the therapeutic effect for patients without chronic kidney disease (CKD) having HCV genotype 1b was about 90%.8 Unfortunately, these combination therapies are contraindicated to patients with advanced CKD.
In September 2014, when combined therapy with daclatasvir plus asunaprevir was approved for patients infected with HCV genotype 1b in Japan, we started to evaluate the usefulness of such a combination therapy in CKD patients including those requiring HD.9 Subsequently, in September 2015, therapy with a fixed‐dose triple combination of OBV, PTV and RTV was newly approved in Japan, and it can be applicable to patients with CKD on advanced stage.
This report describes for the first time on the clinical use of a fixed‐dose formula in a small patient population who underwent HD to confirm its safety and efficacy.

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