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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