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BIOCHEMICAL AND VIROLOGICAL RESPONSE TO CONSENSUS INTERFERON
(CIFN) IN LOW VIRAL TITER CHRONIC HCV PATIENTS
EL Krawitt, LM Blatt, MJ Tong, WM Lee, K Mullen, JC Hoefs, E
Keeffe, FB Hollinger, EJL Heathcote, H White, RT Foust, DM Jensen,
H Fromm, M Black, D Albert, T Gerrard and the Consensus Interferon
Study Group University of Vermont, Burlington, VT, Amgen Inc.,
Boulder, CO and the CIFN study sites
Chronic HCV patients with low baseline viral concentrations have
been shown to be highly sensitive to treatment with interferon
alpha 2. In order to assess the response to CIFN, a novel
non-naturally occurring type 1 interferon, to chronic HCV patients
with low baseline viral concentrations, we analyzed data from the
phase 3 CIFN clinical trial. In this study, 232 patients with
chronic HCV infection were treated with CIFN at a dose of 9 µg
three times weekly (TIW) for 24 weeks followed by 24 weeks of
observation. HCV RNA concentrations were determined using a
quantitative RT-PCR assay that had a lower limit of detection of
100 copies/mL. Low HCV RNA titer was defined as a baseline HCV RNA
concentration of <=1.15 x10{6} copies/mL which represented the
lower 25% quartile for the baseline HCV RNA concentration
distribution of all the patients enrolled in this study. Responses
for HCV RNA <=1.15x10{6} copies/mL (low titer) and HCV RNA
>=1.15 x 10{6} copies/mL were assessed by measurement of changes
in serum ALT and HCV RNA values (quantitative RT-PCR
analysis)(Table 1). Table 1. Response Rates in Low Titer Chronic
HCV Patients.
Percent HCV RNA Percent
Negative ALT Normal
Group End of End of End of End of
N Treatment Observation Treatment Observation
HCV RNA 55 51% 24%* 60% 35%*
<=1.15 x10{6}
copies/mL
HCV RNA 177 30% 8%* 37% 16%*
>=1.15 x 10{6}
copies/mL
p<0.01 for both comparisons
A statistically significant difference in the
number of sustained HCV RNA and ALT responders was observed at the
end of observation for patients with low baseline HCV RNA titers as
compared to the responses seen in the patients with baseline HCV
RNA above the 1.15 x 10{6} copies/mL cutoff (p<0.01 for both
comparisons). These data confirm previous observations that chronic
HCV patients with low baseline viral titers respond to IFN
treatment better than patients with higher baseline viral loads.
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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