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Int. J. Mol. Sci. 2017, 18(5), 906; doi:10.3390/ijms18050906

Real-World Experiences with the Combination Treatment of Ledipasvir plus Sofosbuvir for 12 Weeks in HCV Genotype 1-Infected Japanese Patients: Achievement of a Sustained Virological Response in Previous Users of Peginterferon plus Ribavirin with HCV NS3/4A Inhibitors

1
Department of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
2
Department of Molecular Virology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
3
Safety and Health Organization, Chiba University, 1-33 Yayoicho, Inage-ku, Chiba 263-8522, Japan
Present address: Japan Community Health Care Organization Funabashi Central Hospital, 6-13-10 Kaijin, Funabashi 273-8556, Japan.
*
Author to whom correspondence should be addressed.
Academic Editor: William Chi-shing Cho
Received: 4 April 2017 / Revised: 19 April 2017 / Accepted: 21 April 2017 / Published: 25 April 2017
(This article belongs to the Special Issue Hepatitis Virus Infection and Research)
View Full-Text   |   Download PDF [525 KB, uploaded 25 April 2017]   |  

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. View Full-Text
Keywords: genotype 1; hepatitis C virus; ledipasvir; NS3/4A inhibitors; sofosbuvir genotype 1; hepatitis C virus; ledipasvir; NS3/4A inhibitors; sofosbuvir
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Kanda, T.; Yasui, S.; Nakamura, M.; Suzuki, E.; Arai, M.; Ooka, Y.; Ogasawara, S.; Chiba, T.; Saito, T.; Haga, Y.; Takahashi, K.; Sasaki, R.; Wu, S.; Nakamoto, S.; Tawada, A.; Maruyama, H.; Imazeki, F.; Kato, N.; Yokosuka, O. Real-World Experiences with the Combination Treatment of Ledipasvir plus Sofosbuvir for 12 Weeks in HCV Genotype 1-Infected Japanese Patients: Achievement of a Sustained Virological Response in Previous Users of Peginterferon plus Ribavirin with HCV NS3/4A Inhibitors. Int. J. Mol. Sci. 2017, 18, 906.

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