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E Keeffe, LM Blatt, G Dusheiko, MJ Tong, FB Hollinger, S James, K Mullen, G Everson, N Pimstone, EJL Heathcote, J Donovan, A Conrad, P Schmid, D Albert, T Gerrard and the Consensus Interferon Study Group Standford University, Palo Alto, CA, Amgen Inc., Boulder, CO and the CIFN study sites

Chronic HCV patients infected with genotype 1 have been shown to be more difficult to treat with IFN [alpha]-2b than those infected with other genotypes. Although the genotype assay yields important information, it is difficult to perform and expensive to use. In order to assess the utility of using the less expensive and easier to use serotype assay, we determined the HCV serotype and genotype of 704 patients who were enrolled in the Phase 3 CIFN pivotal study. In this study, patients with chronic HCV infection were randomized to receive CIFN at doses of 3 or 9 µg or IFN [alpha]-2b at a dose of 15 µg (3 MU) three times weekly (TIW) for 24 weeks followed by 24 weeks of observation. HCV serotype was determined using the Murex synthetic peptide assay and genotype was determined using the Inno-Lippa assay. There was a high level of correspondence between genotype and serotype for genotypes and serotypes 1, 2, and 3 (rho=0.93, P < 0.001). There was a significant difference in the HCV RNA response rates (by RT-PCR) among serotypes. Patients infected with serotypes 2 and 3 had higher HCV RNA response rates than patients infected with serotype 1 (P < 0.001 at end of treatment and at end of posttreatment observation). This difference was independent of treatment group and follows the same pattern observed for the analysis of HCV RNA response by HCV genotype. Comparison of HCV RNA response by serotype for the three treatment groups at the end of the treatment period revealed a statistically significant greater number of HCV RNA responders for serotype 1 patients treated with 9 µg CIFN (29%) as compared with serotype 1 patients treated with 15 µg IFN [alpha]-2b (14%) (P=0.003). By the end of the posttreatment observation period, 9% of serotype 1 patients who were treated with 9 µg CIFN had a durable HCV RNA response as compared with 4% of serotype 1 patients who were treated with 15 µg IFN [alpha]-2b. These data demonstrate the utility of HCV serotyping and suggest that CIFN may be a more effective therapy than IFN [alpha]-2b for treatment of chronic HCV patients infected with serotype 1.
This research was funded by Amgen Inc., Boulder, CO.

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

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