Abstract
The aim of this study was to characterize the treatment response and serious adverse events of ledipasvir plus sofosbuvir therapies in Japanese patients infected with hepatitis C virus (HCV) genotype 1 (GT1). This retrospective study analyzed 240 Japanese HCV GT1 patients treated for 12 weeks with 90 mg of ledipasvir plus 400 mg of sofosbuvir daily. Sustained virological response at 12 weeks post-treatment (SVR12) was achieved in 236 of 240 (98.3%) patients. Among treatment-naïve patients, SVR12 was achieved in 136 of 138 (98.6%) patients, and among treatment-experienced patients, SVR12 was achieved in 100 of 102 (98.0%) patients. In patients previously treated with peginterferon plus ribavirin with various HCV NS3/4A inhibitors, 100% SVR rates (25/25) were achieved. Two relapsers had HCV NS5A resistance-associated variants (RAVs), but no HCV NS5B-S282 was observed after they relapsed. We experienced two patients with cardiac events during treatment. In conclusion, combination of ledipasvir plus sofosbuvir for 12 weeks is a potential therapy for HCV GT1 patients. Caution is needed for HCV NS5A RAVs, which were selected by HCV NS5A inhibitors and cardiac adverse events.
Highlights
Hepatitis C virus (HCV) infection constitutes great threats to public health globally, and leads to a large number of deaths every year
We retrospectively examined the effect of the combination treatment of ledipasvir and sofosbuvir for 12 weeks in real-world patients infected with HCV genotype 1 (GT1) in Japan and showed that the combination of ledipasvir and sofosbuvir is highly effective for HCV GT1 patients
We demonstrated that the combination of ledipasvir and sofosbuvir is effective for HCV GT1 Japanese patients with treatment failure of peginterferon plus ribavirin with HCV NS3/4A protease
Summary
Hepatitis C virus (HCV) infection constitutes great threats to public health globally, and leads to a large number of deaths every year. Hepatocellular carcinoma (HCC) has a poor prognosis, and the 5- and 10-year survival rates of HCC in Japan are 34% and 16%, respectively [1]. HCV causes ~70% of HCC in Japan [2]. It is important to eradicate HCV at the early stage of infection as well as to diagnose HCC early [3,4]. Eradication of HCV by interferon prevents the occurrence of HCC and development of liver fibrosis, providing survival benefits for patients infected with HCV [5,6]. It is important for patients with HCV infection to eradicate this virus
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