Natural human interferon beta plus ribavirin combination therapy in Japanese patients infected with hepatitis C virus and a high viral load.

Abstract

OBJECTIVE:

The 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.

METHODS:

We 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.

RESULTS:

Six 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.

CONCLUSION:

nIFNbeta-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.

• Authors: 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, Hiromitsu Kumada
• Journal: Internal medicine (Tokyo, Japan) (Intern Med) Vol. 47 Issue 21 Pg. 1827-34 ( 2008) ISSN: 1349-7235 [Electronic] Japan
• PMID: 18981624 (Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Ribavirin
• Interferon-beta

Topics

• Adult
• Aged
• Asian People (genetics)
• Drug Therapy, Combination
• Female
• Hepacivirus (drug effects, genetics)
• Hepatitis C, Chronic (drug therapy, genetics, virology)
• Humans
• Interferon-beta (administration & dosage)
• Male
• Mental Disorders (drug therapy, genetics, virology)
• Middle Aged
• Pilot Projects
• Retrospective Studies
• Ribavirin (administration & dosage)
• Viral Load