Abstract
Objective: Limited data has been reported comparing natural human interferon β (nIFNβ) and pegylated IFN-α (PEG-IFNα) when Ribavirin (RBV) is combined. This case-control study was done to compare the efficacy and adverse effects of a combination treatment of nIFNβ or PEG-IFNα plus RBV for chronic hepatitis C patients. Methods: Sixty patients with chronic hepatitis C, 42 infected with hepatitis C virus (HCV) genotype 1 and 18 infected with genotype 2, were treated with nIFNβ plus RBV. Of them, 23 (38.3%) suffered pre-treatment severe depression. Their data was compared with 60 undepressed patients treated with a combination of PEG-IFNα plus RBV. nIFNβ was given intravenously and PEG-IFNα was injected subcutaneously. Results: Sustained virological response (undetectable HCV RNA at 24 weeks after the end of treatment) did not significantly differ between the nIFNβ and PEG-IFNα treated patients (genotype 1, 21.4% vs. 33.3%, P=0.328; genotype 2, 72.2% vs. 88.9%, respectively, P=0.402). None of the nIFNβ treated patients showed exacerbation of depression, while 7 (11.7%) of 60 PEG-IFNα treated patients developed severe depression or malaise. The platelet count of nIFNβ treated patients increased to higher than baseline after week 8, but the platelet count of PEG-IFNα treated patients decreased throughout the treatment. There were significant differences of the changes of platelet counts between the both groups throughout the treatment (all P<0.001). Conclusion: nIFNβ plus RBV treatment was well tolerated by chronic hepatitis C patients with depression or thrombpcytopenia.
Highlights
Hepatitis C virus (HCV) infection is a major cause of chronic hepatitis, cirrhosis, and hepatocellular carcinoma (HCC) and represents a significant public health problem [1,2]
We previously reported that the eradication of HCV infection decreases the occurrence of hepatocellular carcinoma [4]
No significant differences in baseline serum HCV RNA levels, histology of fibrosis, or distribution of interleukin 28B (IL28B) or inosine triphosphate pyrophosphatase (ITPA) genotype were found between the B1 and A1 or B2 and A2 groups
Summary
Hepatitis C virus (HCV) infection is a major cause of chronic hepatitis, cirrhosis, and hepatocellular carcinoma (HCC) and represents a significant public health problem [1,2]. Pegylated interferon α (PEG-IFNα) plus Ribavirin (RBV) combination treatment has improved the SVR rate for patients with chronic hepatitis C [5]. Previous studies reported that 25-40% of such patients discontinued the combination treatment due to adverse effects, such as psychological problems or cytopenia [5,6,7,8]. In Japan, natural human interferon β (nIFNβ) and RBV combination treatment has been approved and recommended for depressed patients with chronic hepatitis C, and some studies have shown that nIFNβ plus RBV treatment has equivalent efficacy and mild adverse effects [9,10,11]
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