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The early phase respone to Interferon in patients with Chronic Hepatitis C

S Hige, A Nagasaka, M Maruya, Y Sasaki, M Asaka and T Matsushima^{*} 3rd Dept. of Int. Medicine, Hokkaido Univ. School of Medicine and ^{*}Dept. of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan

We have reported the relationship between the decrease of HCV-RNA as the early phase response of interferon (IFN) treatment and the final effects in patients with chronic hepatitis C. Recently, Enomoto et al. reported correlation between responses to IFN and mutations in the nonstructural protein 5A (NS5A) of HCV genotype 1b (N Engl J Med 1996; 334: 77-81). In this study, we investigated the early phase response including the mutation of NS5A region.

Methods: Thirty-four patients with chronic hepatitis C (type 1b) were treated with 6MU of IFN-[alpha] everyday for 4 weeks and thrice a week for 20 weeks afterward. The amounts of HCV-RNA were measured by branched DNA probe (b-DNA) assay and with Amplicor^{TM} HCV-monitor kits (Nippon Roche). Nucleotide sequencing of the NS5A gene was performed according to the method reported by Enomoto et al. and the number of amino acid substitutions of NS5A (aa 2209-2248) was measured by comparing the sequence of HCV-J.

Results: Sustained responders were 8 (23.5%) out of 34 cases. In four weeks, HCV-RNA became undetectable by Amplicor^{TM} kits in 21 cases, and 8 cases had 10^{2}-10^{3}, 5 cases had more than 10^{4} (copies/ml) of HCV-RNA. Then, HCV-RNA levels of all sustained responders were under the detectable limit. In NS5A (aa 2209-2248) region, 17 cases had no substitutions (wild type), 13 cases had 1 to 3 (intermediate type), and 4 cases had more than 4 substitutions (mutant type). Sustained responses were obtained in 1 (5.9%), 3 (23.1%) and 4 (100%) of these types, respectively. Of 21 cases whose viral levels were undetectable in 4 weeks, 12 cases (57.1%) had at least one amino acid substitutions in NS5A (aa 2209-2248). Sustained response rate of those cases was 7/12 (58.3%). On the other hand, the response rate of those without substitutions was 1/9 (11.1%)

Conclusions: The early phase response was useful factor for predicting the effects of IFN therapy. Especially, the negative result of HCV-RNA in 4 weeks was necessary factor for the sustained response. Moreover, mutations of NS5A region indicated susceptibility to IFN, and correlated to the early phase response.

Source: American Association for the Study of Liver Diseases - 1996 Annual Meeting

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