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Simeprevir ( TMC435 ) once daily with peginterferon‐α‐2b and ribavirin in patients with genotype 1 hepatitis C virus infection: The CONCERTO ‐4 study
Author(s) -
Kumada Hiromitsu,
Hayashi Norio,
Izumi Namiki,
Okanoue Takeshi,
Tsubouchi Hirohito,
Yatsuhashi Hiroshi,
Kato Mai,
Rito Ki,
Komada Yuji,
Seto Chiharu,
Goto Shoichiro
Publication year - 2015
Publication title -
hepatology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.123
H-Index - 75
eISSN - 1872-034X
pISSN - 1386-6346
DOI - 10.1111/hepr.12375
Subject(s) - ribavirin , simeprevir , medicine , neutropenia , gastroenterology , hepatitis c virus , pegylated interferon , adverse effect , combination therapy , hepatitis c , virology , immunology , virus , chemotherapy
Aim The efficacy and safety of simeprevir in combination with peginterferon‐α‐2b and ribavirin ( PEG IFN‐α ‐2b/ RBV ) were investigated in patients infected with hepatitis C virus ( HCV ) genotype 1 who were treatment‐naïve or had previously received interferon ( IFN )‐based therapy. Methods CONCERTO ‐4 ( NCT01366638 ) was an open‐label, non‐comparative, multicenter study of once‐daily simeprevir ( TMC435 ) 100 mg in combination with PEG IFN‐α ‐2b/ RBV in treatment‐naïve and ‐experienced patients (prior relapsers or non‐responders to IFN ‐based therapy) with chronic HCV genotype 1 infection. Twelve‐week combination treatment was followed by 24/48‐week response‐guided PEG IFN‐ α‐2b/ RBV therapy for treatment‐naïve patients and prior relapsers, and 48‐week PEG IFN‐ α‐2b/ RBV therapy for prior non‐responders. Patients were followed for 72 weeks after treatment initiation. The proportions of patients with sustained viral response ( SVR ; undetectable HCV RNA ) at treatment end and 12 weeks after the last treatment ( SVR12 ) were among the major efficacy end‐points. Safety, including adverse events ( AE ), was monitored. Results Of the 79 patients treated, the proportion achieving SVR12 was highest among treatment‐naïve patients (91.7%) and prior relapsers (100%) versus 38.5% of prior non‐responders. All treatment‐naïve patients and prior non‐responders who achieved SVR12 also achieved SVR at treatment end and 24 weeks after last dose; 96.6% of prior relapsers achieved both end‐points. Most AE were of grade 1 or 2 severity. Grade 3 AE occurred in 17 patients, most frequently neutropenia (6.3%). Conclusion Simeprevir combined with PEG IFN‐α ‐2b/ RBV was effective in patients infected with HCV genotype 1, both for initial treatment of naïve patients and for retreatment of patients in whom previous IFN ‐based therapy had failed.