Abstract
PurposeThe tolerability and efficacy of simeprevir in combination with peginterferon and ribavirin in patients infected with hepatitis C virus (HCV) genotype 1 under actual clinical conditions were investigated.MethodsA total of 176 patients with chronic HCV genotype 1 infection were treated with simeprevir for 12 weeks plus Peg-IFN/RBV for 24 weeks. Overall, 107 (60.7 %) patients were aged 60 years or more, and 16 (9 %) patients were aged 70 years or more. Treatment discontinuation, sustained virological response 12 (SVR12), and viral relapse were evaluated and compared between younger patients and elderly patients.ResultsThe rates of undetectable HCV RNA at the end of treatment were 95.8, 100 and 93.1 % in treatment-naïve, prior relapse, and prior non-responders, respectively. However, the rates of SVR12 were 82.4, 88.2 and 69.2 %, respectively. Especially in prior non-responders, viral relapse was relatively frequent. Treatment discontinuation and SVR12 were not different between patients aged <70 and ≥70 years, but viral relapse after completing treatment was significantly more frequent in patients aged ≥70 years (p = 0.012).ConclusionsIn simeprevir with peginterferon and ribavirin therapy, viral relapse was relatively frequent. Especially in elderly patients, the relapse rate was high after completing treatment, instead of low frequency of discontinuation by the adverse events.
Highlights
Hepatitis C virus (HCV) infection is a major public health concern
IL28B rs8099917 polymorphisms were determined in 91 patients; 69 patients were major allele TT, and 22 patients were minor allele TG/GG
In patients treated with just Peg-IFN and ribavirin, IL28B genotype and advanced fibrosis are associated with a low rate of sustained virologic response (SVR) (Tanaka et al 2009; Manns et al 2001; Fried et al 2002)
Summary
Hepatitis C virus (HCV) infection is a major public health concern. Japan has one of the highest rates of HCV infection worldwide, and around 2 million people are. Combination therapy with peginterferon (Peg-IFN) and ribavirin (RBV) for 48–72 weeks has been standard care for HCV genotype 1 infection for many years The development of direct-acting antiviral agents (DAAs), including protease inhibitors (PIs), represents a major breakthrough in the treatment of chronic HCV infection. First-generation HCV PIs, such as telaprevir and boceprevir, are associated with multiple daily dosing and the potential for adverse events, including anemia, rash, and renal dysfunction (Poordad et al 2011; Zeuzem et al 2011), leading to high rates of treatment discontinuation (Hayashi et al 2012; McHutchison et al 2009)
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