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Extended Treatment of 72 versus 48 Weeks for Chronic Hepatitis C Patients with
Genotype 1 and High Viral Load using Daily Consensus Interferon and Ribavirin
P. Kaiser1; H. Holger1; L. Bissinger1; L. Bettina1; B. Sauter1; M. Gregor1
1. Medicine I, University of Tuebingen, Tuebingen, Germany.

 
Objective: Treatment of naive, genotype 1, high viral load chronic Hepatitis C
patients with pegylated interferon and ribavirin (RBV) results in sustained
viral response rates of about 30 –35 %. Recently improved response rates have
been suggested in treatment trials using an extended treatment duration of 72
weeks. Furthermore, treatment with an bio-optimized interferon, Consensus
interferon (CIFN), has shown higher response rates in difficult-to-treat
patients such as nonresponders and relapsers.

Methods: The efficacy of CIFN daily dosing + RBV for 48 versus 72 weeks in
genotype 1, high viral load patients was evaluated. 108 patients have been
included, average weight of patients was 79 kg. Patients were either treated
with CIFN at 9 ug QD for 48 or 72 weeks both in combination with weight-based
RBV.

Results: Data show that after the initial 12 weeks a primary response with a
2-log drop of HCV-RNA (EVR) was observed in 89% and 92% of patients in the
CIFN QD 48 week and 72 week treatment group. At the end of treatment at week
48 and 72, respectively, a negative PCR was observed in 79 % and in 81%
(p=n.s.). The sustained viral response rates (SVR) were 51 and 68 %,
respectively (p<0.05), indicating a significantly higher relapse rate in
patients treated with CIFN for 48 weeks compared to 72 weeks. No growth
factors were used in this study. Three patients experienced grade III
thrombocytopenias, while no grade IV neutropenias or thrombocytopenias were
observed. The overall tolerability of the CIFN QD regimen was comparable to
PEG IFN standard combination therapy, while the 72 week regimen lead to a
higher rate of injection site reactions and a slightly higher drop out rate of
7% versus 4% (p=n.s.). >

Conclusions: Extended CIFN daily dosing combination therapy for 72 weeks shows
promising response rates in difficult-to-treat patients with genotype 1 and
high viral load when compared to a standard treatment period of 48 weeks.
Although a significant proportion of patients also experienced a relapse after
cessation of a 72 week treatment period, the overall sustained response rates
are nevertheless promising showing a SVR in up to 70% of patients. It is
concluded that extended treatment with CIFN in combination with RBV may be an
effective treatment modality for this difficult-to-treat patient group.