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TREATMENT OF HIGH VIRAL TITER CHRONIC HCV PATIENTS WITH CONSENSUS INTERFERON (CIFN) RESULTS IN A SIGNIFICANTLY GREATER NUMBER OF SUSTAINED HCV RNA RESPONDERS AS COMPARED TO TREATMENT WITH INTERFERON [alpha]-2b

DM Jensen, LM Blatt, MJ Tong, WM Lee, K Mullen, JC Hoefs, E Keeffe, FB Hollinger, EJL Heathcote, H White, RT Foust, EL Krawitt, H Fromm, M Black, D Albert, T Gerrard and the Consensus Interferon Study Group, Rush-Presbyterian Hospital, Chicago, IL, Amgen Inc., Boulder, CO and the CIFN study sites.

Chronic HCV patients with high baseline viral levels have been shown to be less responsive to treatment with IFN [alpha]-2b. In order to assess response in chronic HCV patients with high pre-treatment viral levels, data evaluating biochemical and virological response to CIFN and IFN [alpha]-2b from the Phase 3 CIFN clinical trial was analyzed. In this study, 704 patients with chronic HCV infection were randomized, in equal proportions, 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. The median concentration of HCV RNA as measured by the RT-PCR assay was 3.0x10^{6} copies/mL. High titer was defined as a baseline HCV RNA concentration of >=4.8 x 10^{6} copies/mL which represented the upper 25% quartile for the baseline HCV RNA concentration distribution of the 704 patients enrolled in this study. There were no significant differences with respect to pre-treatment HCV RNA concentrations among the treatment groups. Responses were assessed by measurement of changes in serum HCV RNA values and by quantitative RT-PCR analysis which had a lower limit of detection of 100 copies/mL (Table 1). Table 1. Response Rates in High Titer Chronic HCV Patients

                                   Percent HCV RNA            Percent
                                      Negative              ALT Normal
     Treatment                   End of     End of       End of    End of
     Group                 N   Treatment  Observation  Treatment  Observation
     9 µg CIFN             69      28%         7%^{*}      29%       13%
     15 µg IFN [alpha]2b   61      16%         0%^{*}      31%       15%
     
     ^{*} (p<0.01)

There was a statistically significant greater number of sustained HCV RNA responders among the high titer patients treated with 9 µg CIFN as compared to high titer patients treated with IFN [alpha]-2b (p<0.01) at the end of observation. No significant differences among the treatment groups were observed for the ALT responses. Based on this study, CIFN lowered HCV RNA to undetectable limits (measured by RT-PCR) in patients with pre-treatment high HCV RNA levels. The sustained HCV RNA response rate in this subset of patients was significantly greater in patients treated with CIFN than IFN [alpha]-2b. 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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