• Yoshio Katamura, Fumitaka Suzuki, Norio Akuta, Hitomi Sezaki, Hiromi Yatsuji, Norihiro Nomura, Yusuke Kawamura, Tetsuya Hosaka, Masahiro Kobayashi, Yoshiyuki Suzuki, Satoshi Saito, Yasuji Arase, Kenji Ikeda, Mariko Kobayashi, and Hiromitsu Kumada.
• Department of Hepatology, Toranomon Hospital, Tokyo.
• Intern. Med. 2008 Jan 1; 47 (21): 182718341827-34.

ObjectiveThe aim of this pilot study was to determine the safety and efficacy of natural human interferon beta (nIFNbeta) plus ribavirin (RBV) in patients with chronic hepatitis C who did not respond to pegylated interferon alpha (PEG-IFN), with special emphasis on the incidence of mental disorders or refusal for fear of adverse effects.MethodsWe studied 19 patients with HCV genotype 1b, 2a or 2b and a high viral load, including 8 patients with mental disorders. They were treated with nIFNbeta-RBV. Eleven patients with HCV genotype 1b of these patients were treated with nIFNbeta-RBV for 48 weeks (group A), and compared with 22 matched controls treated with PEG-IFN plus RBV for 48 weeks (group B). The other 8 patients with HCV genotype 2 were treated with nIFNbeta-RBV for 24 weeks.ResultsSix of 8 patients with mental disorders and 9 of 11 patients without mental disorders completed nIFNbeta-RBV therapy; 1 patient with mental disorder dropped out due to exacerbation of depression, and 3 patients suspended the therapy due to insufficient response. The sustained virological response (SVR) was 27% (3/11) in group A and 41% (9/22) in group B (p = 0.70). During treatment, platelet count increased in group A but not in group B. SVR was 88% (7/8) in patients of genotype 2 and high viral load treated with nIFNbeta plus RBV.ConclusionnIFNbeta-RBV therapy offers sufficient safety and efficacy for patients with mental disorders, and thus could represent an excellent second-line therapy for subpopulations that are not suitable for PEG-IFN-RBV.

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