Natural Human Interferon β Plus Ribavirin Combination Therapy in Japanese Patients Infected with Hepatitis C Virus and a High Viral Load
Internal medicine (Tokyo. 1992)
Objective The aim of this pilot study was to determine the safety and efficacy of natural human interferon β (nIFNβ) 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 nIFNβ-RBV.
... d with nIFNβ-RBV. Eleven patients with HCV genotype 1b of these patients were treated with nIFNβ-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 nIFNβ-RBV for 24 weeks. Results Six of 8 patients with mental disorders and 9 of 11 patients without mental disorders completed nIFNβ-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 nIFNβ plus RBV. Conclusion nIFNβ-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.